
==== Front
Global Spine J
Global Spine J
spgsj
GSJ
Global Spine Journal
2192-5682
2192-5690
SAGE Publications Sage CA: Los Angeles, CA

38321700
10.1177_21925682241230922
10.1177/21925682241230922
Review Articles
Radiofrequency Denervation of the Spine and the Sacroiliac Joint: A Systematic Review based on the Grades of Recommendations, Assesment, Development, and Evaluation Approach Resulting in a German National Guideline
https://orcid.org/0000-0003-1180-9908
Klessinger Stephan MD, PhD 12
Casser Hans-Raimund MD, PhD 3
Gillner Sebastian MD 4
Koepp Holger MD 5
Kopf Andreas MD 6
Legat Martin MD 7
Meiler Katharina 8
Norda Heike 9
Schneider Markus MD 10
Scholz Matti MD, PhD 11
Slotty Phillipp J. MD, PhD 12
Tronnier Volker MD, PhD 13
https://orcid.org/0000-0003-3245-1941
Vazan Martin MD 14
Wiechert Karsten MD 15
1 Neurochirurgie Biberach , Biberach, Germany
2 Universitätsklinikum Ulm , Ulm, Germany
3 DRK Schmerz-Zentrum , Mainz, Germany
4 39564 Sana Krankenhaus Benrath , Düsseldorf, Germany
5 Wirbelsäulenzentrum, 72204 St Josefs-Hospital , Wiesbaden, Germany
6 Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin, 14903 Charité-Universitätsmedizin Berlin , Berlin, Germany
7 Schmerzzentrum Zofingen , Zofingen, Switzerland
8 Städtisches Klinikum Magdeburg , Magdeburg, Germany
9 UVSD SchmerzLOS eV , Neumünster, Germany
10 alphamed Bamberg , Bamberg, Germany
11 61391 ATOS Orthopädische Klinik Braunfels GmbH & Co KG , Braunfels, Germany
12 39064 Universitätsklinikum Düsseldorf , Düsseldorf, Germany
13 54360 Universitätsklinikum Schleswig-Holstein , Lübeck, Germany
14 Wirbelsäulen- und Rückenzentrum Dresden, Praxis für Neurochirurgie , Dresden, Germany
15 Rückenzentrum am Michel , Hamburg, Germany
Stephan Klessinger, Neurochirurgie Biberach, Eichendorffweg 5, Biberach 88400, Germany. Email: klessinger@neurochirurgie-bc.de
6 2 2024
9 2024
14 7 21242154
© The Author(s) 2024
2024
AO Spine, unless otherwise noted. Manuscript content on this site is licensed under Creative Commons Licenses
https://creativecommons.org/licenses/by-nc-nd/4.0/ This article is distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs 4.0 License (https://creativecommons.org/licenses/by-nc-nd/4.0/) which permits non-commercial use, reproduction and distribution of the work as published without adaptation or alteration, without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).

Study Design

Systematic review of the literature and subsequent meta-analysis for the development of a new guideline.

Objectives

This manuscript summarizes the recommendations from a new clinical guideline published by the German Spine Society. It covers the current evidence on recommendations regarding the indication, test blocks and use of radiofrequency denervation. The guidelines aim is to improve patient care and efficiency of the procedure.

Methods

A multidisciplinary working group formulated recommendations based on the Grades of Recommendations, Assessment, Development, and Evaluation (GRADE) approach and the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.

Results

20 clinical questions were defined for guideline development, with 87.5% consensus achieved by committee members for one recommendation and 100% consensus for all other topics. Specific questions that were addressed included clinical history, examination and imaging, conservative treatment before injections, diagnostic blocks, the injected medications, the cut-off value in pain-reduction for a diagnostic block as well as the number of blocks, image guidance, the cannula trajectories, the lesion size, stimulation, repeat radiofrequency denervation, sedation, cessation or continuation of anticoagulants, the influence of metal hardware, and ways to mitigate complications.

Conclusion

Radiofrequency (RF) denervation of the spine and the SI joint may provide benefit to well-selected individuals. The recommendations of this guideline are based on very low to moderate quality of evidence as well as professional consensus. The guideline working groups recommend that research efforts in relation to all aspects of management of facet joint pain and SI joint pain should be intensified.

radiofrequency denervation
back pain
neck pain
sacroiliac joint
facet joint
medial branch block
chronic spinal pain
spine intervention
typesetterts10
==== Body
pmcIntroduction

Pain originating from the joints of the spine is a frequent cause of pain and is classified as specific back pain. The structure of the facet joints in the spine is similar to other synovial joints which are richly supplied with nociceptors. 1 They can therefore be a source of pain in the cervical, thoracic, and lumbar spine. The sacroiliac joint is an amphiarthrosis, in combination with the posterior ligaments it is also a possible specific cause of pain.

The prevalence of facet joint pain in the lumbar spine varies in the literature, acknowledging the age dependency of specific anatomical structures causing pain. 2 Over the age of 55, the facet joints are the most common source of back pain, followed by the SI joint, since degenerative changes and arthrosis tend to increase with rising age.

These different prevalences can be explained, among other things, by the fact that it is difficult to identify facet joint pain with great diagnostic certainty. 3 History and clinical examination are important and useful in making the suspected diagnosis, but there is no single clinical test protocol that is pathognomonic for facet joint pain. 4 For the SI joint, the combination of several clinical tests can provide some diagnostic certainty. 5 Additionally, the correlation between degenerative findings in spinal imaging and pain is also poor.6,7

Nevertheless, it is important to prove a specific cause of pain with sufficient diagnostic certainty since RF denervation classifies as a therapeutic method for specific back pain. RF denervation is only indicated if specific facet joint pain or SI joint pain is confirmed. Test blocks are therefore performed with a local anesthetic to confirm the diagnosis. However, there are differences in the literature both in the technique of the test block and in the interpretation of the results. Intra-articular injections into the joint space or injections into the joint capsule are possible.8,9 Alternatively, the 2 nerves supplying the joint are blocked with local an anesthetic (medial branch block). 10 How much pain reduction is necessary for the test block to be considered positive is handled differently in the studies. As with any other test, there are false-positive and false-negative results. 11 To increase the diagnostic validity, a number of authors recommend to verify the result of the first test block by repeating it with local anesthetics of different durations (comparative block) or at least to perform a repeated block. 12

These diagnostic questions are relevant for the therapeutic options. The indication for RF denervation and the different approaches to test blocks have a significant impact on the subsequent denervation result. For this reason, questions on clinical history, physical examination, imaging, and diagnostic interventions were included in the guideline so that recommendations and statements are also made on these issues.

The idea of RF denervation is the interruption of the conduction of nociceptive information by coagulation of the afferent nerves (medial branch) of the facet joints. 13 The goal is to coagulate a reasonable length of the nerve because evidence exists that the length of the segment of nerve that was obliterated correlates with the duration of pain reduction after RF denervation. 14 The size of the lesion depends on the diameter of the electrode, the specific protocol of increasing reaching the target temperature and the target temperature itself, the duration of the application, the number of lesions and the cannula position. 15 It seems obvious that a parallel position of the electrode to the targeted nerve coagulates a longer distance than a perpendicular position. 16 Regarding all these parameters mentioned and also with regard to the electrode position to the nerve, there is no uniform procedure in the studies carried out to date.

Methods

Study Design

The guideline of the German Spine Society is based on a critical systematic review of the literature followed by a meta-analysis of evidence. The Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach 17 was used for assessing the overall quality (strength) of evidence for a specific outcome. The quality of evidence is described as high, moderate, low, or very low, based on the confidence that the observed effect sizes reflect the true effect. 18

The final guideline was appraised using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) criteria 19 to assess the validity of the guideline and the development process and to determine major areas of deficiency. Informed consent or Institutional Review Board approval is not necessary for a systematic literature review.

Work Process

The guideline was developed under the auspices of the “Deutsche Wirbelsäulengesellschaft” (DWG, German Spine Society). DWG is the largest specialist spine society in Europe with an interdisciplinary forum for basic researchers and those working in conservative and surgical treatment.

A representative multidisciplinary work group was assembled by invitation from relevant professional organizations and scientific associations. The working group was composed of orthopedic and trauma surgeons, neurosurgeons, an anesthesiologist, and a patient representative. They were involved in all parts of the process including formulating 20 clinical PICO questions (patient/intervention/comparator/outcome), 20 selecting literature, data extraction, rating the quality of evidence, and formulating recommendations. One in-person meeting and several webinars were used throughout the process. Three levels of recommendations were used: A: strong recommendation, B: weak recommendation and 0: open recommendation. If there was no evidence in the literature, an expert consensus (EC) was noted.

Finally, a modified Delphi pre-match was conducted by letter. All elected representatives were able to vote anonymously on the statements and recommendations. The final consensus conference took place under the neutral moderation of the Association of the Scientific Medical Societies of Germany (AWMF). The guideline was internally and externally appraised; results of these reviews, a summary of the final voting, as well as any substantial changes to the guideline were documented. Finally, the work was approved by the AWMF using Appraisal of Guidelines for Research and Evaluation II (AGREE II) criteria. 19

Systematic Review of Evidence

For each of the clinical questions, a systematic search strategy consisting of 3 consecutive steps was followed: Firstly, national and international guideline databases were searched for clinical guidelines regardless of the age of the guideline. Seven International, European and North American guidelines were evaluated.4,21-27 Secondly, the Cochrane Library was searched for systematic reviews. A review of RF denervation from 2015 28 was covered. The literature mentioned in this review was evaluated. Thirdly, Medline and the Cochrane Library were searched for randomized clinical trials (RCTs) and clinical observational studies. The date of the Cochrane review (2015) was used as the lower limit for the new search in step 3. The lead reviewer screened and retrieved titles and abstracts. Potentially eligible papers were then collected in full text and screened for inclusion or exclusion.

The overall quality of evidence was determined using methods outlined by the GRADE Working Group. 17 In general, the risk of bias, consistency, directness, precision, and publication bias were assessed across included studies for each critical or important outcome. The final overall quality of evidence expresses the confidence that the effect estimate lies close to the true effect: high confidence that the estimate reflects the true effect, moderate confidence, low confidence, or very low confidence; the true effect is likely to be substantially different from the estimated effect.

Results

The clinical guideline addressed 20 clinical questions (Table 1), which were structured according to History and Examination, Imaging and Diagnostic test blocks and RF denervation.Table 1. Clnical Questions.

Question 1: Can a SI joint pain or a facet joint pain be diagnosed by history and physical examination?	
Question 2: Is there a correlation between imaging findings and RF denervation outcome?	
Question 3: Is conservative therapy necessary before a diagnostic block, for how long?	
Question 4: Are medial branch blocks suitable for diagnosing facet joint pain?	
Question 5: Are medial blocks better than intra-articular/pericapsular blocks for diagnosing facet joint pain?	
Question 6: Which diagnostic blocks should be performed on the SI joint prior to denervation?	
Question 7: Which drugs are useful for a diagnostic test block?	
Question 8: Which pain threshold after a therapeutic block is considered positive?	
Question 9: How many diagnostic blocks are necessary before denervation?	
Question 10: What image guidance is recommended for RF denervation?	
Question 11: Does the size of the lesion determine the outcome of the denervation? How can the lesion be enlarged?	
Question 12: What type of electrode is recommended?	
Question 13: Is the position of the electrode to the nerve (parallel, perpendicular) important?	
Question 14: Is sensory or motor test stimulation necessary?	
Question 15: Can an RF denervation be repeated, after what time?	
Question 16: Do anticoagulants and antiplatelet drugs have to be stopped before RF denervation?	
Question 17: Is sedation useful for RF denervation?	
Question 18: Is RF denervation possible in patients with metal implants?	
Question 19: Is RF denervation possible in patients with cardiac pacemakers or SCS?	
Question 20: What are typical complications of RF denervation?	

Question 1: Can a SI Joint Pain or a Facet Joint Pain be Diagnosed by History and Physical Examination?

Pain Maps Cervical Spine

Two studies29,30 created pain maps for the individual levels of the cervical spine in volunteers after facet joint provocation. These results were confirmed by medial branch blocks in patients. 31 In 2 studies, the pain maps helped to identify the symptomatic joints.32,33

Examination Cervical Spine

There are studies that show a positive correlation between a manual medical examination 34 or a muscle tension 35 and the symptomatic level in the cervical spine. However, other studies showed poor specificity for the clinical examination.36-38 1 study evaluated the success of RF denervation of the cervical spine depending on the clinical examination. 39 A positive correlation was found for muscular stiffness and a negative correlation for pain radiating to the head, opiate use, and an increase in pain during extension and/or rotation (Table 2).Table 2. Literature Review of Studies on Clinical Examination of the Cervical Spine.

Study	Design	Population/Control	Results	
Diagnostic test block	
 Jull et al 34 1988	Prospective observational study	20	Positive correlation between manual medical examination and symptomatic level	
 Aprill et al 32 1990	Prospective observational study	10	Pain maps helpful for identification of symptomatic level	
 Barnsley & Bogduk 1993 33	Prospective observational study	16	
 Lord et al 1994 35	Prospective observational study	100	Positive correlation between muscle tension and symptomatic level	
 King et al 36 2007	Observational study, consecutive patients	173	Poor specificity for the clinical examination	
 Smith et al 2013 37	Cross-sectional study	90/30	
 Schneider et al 38 2014	Prospective cohort study	125	
RF-denervation	
 Cohen et al 2007 39	Retrospective observational study	92	Success of RF denervation of the cervical spine depending on the clinical examination. Positive correlation for muscular stiffness and a negative correlation for pain radiating to the head, opiate use, and an increase in pain during extension and/or rotation	

Examination Lumbar Spine

A better response to an intra-articular block at the lumbar spine was found with less leg pain,40,41 a negative straight leg test, 40 increased pain with flexion, 40 and with muscle tenderness.41,42 In contrast, Lewinnek and Warfield 43 found no correlation between response to an intra-articular block and the clinical examination.

Revel et al 44 found in responders to a facet joint block often an age greater than 65 years, pain that was not exacerbated by coughing, not worsened by hyperextension, not worsened by forward flexion, not worsened when rising from flexion, not worsened by extension rotation, and well relieved by recumbency. In a placebo-controlled, randomized follow-up study, 45 the sensitivity was 92% and the specificity 80% for the presence of facet joint pain if at least 5 of these criteria were present. Other studies could not find any correlation of the results of test blocks with a clinical examination46,47 and could not confirm the criteria of Revel either.48-52 Young et al 53 again found a positive correlation when there was no pain when standing up from a sitting position and a negative correlation for centralizing pain. In the study of DePalma et al 54 paraspinal pain was positively correlated, lack of muscle hardening was negatively correlated.

A study by Cohen et al 39 examined the success of RF denervation depending on the clinical examination. A paraspinal hardening was positively correlated, an increase in pain during extension-rotation (facet-load) was negatively associated. Cohen et al 55 examined the influence of Waddell signs on the result. Fewer Waddell signs resulted in a better result, but with a loss to follow up of 41.5% (Table 3).Table 3. Literature Review of Studies on Clinical Examination of the Lumbar Spine.

Study	Design	Population	Results	
Diagnostic test block	
 Fairbank et al 40 1981	Prospective observational study	25	Better response to an intra-articular block with a negative straight leg test	
 Lewinnek & Warfield 1986 43	Retrospective observational study	21	No correlation between response to an intra-articular block and the clinical examination	
 Helbig & Lee 42 1988	Retrospective observational study	22	Better response to an intra-articular block with muscle tenderness	
 Jackson et al 1988 41	Prospective observational study	454	
 Revel et al 44 1992	Prospective observational study	40	Responders to a facet joint block often had an age greater than 65 years, pain that was not exacerbated by coughing, not worsened by hyperextension, not worsened by forward flexion, not worsened when rising from flexion, not worsened by extension rotation, and well relieved by recumbency	
 Schwarzer et al 1994b 71	Prospective observational study	176	No correlation of the results of test blocks with a clinical examination	
 Schwarzer et al 1995b 47	Prospective study with placebo injections	63	
 Revel et al 1998 45	Placebo-controlled, randomized study	43	Sensitivity 92%, specificity 80% for the presence of facet joint pain if at least 5 of criteria were present (pain that was not exacerbated by coughing, not worsened by hyperextension, not worsened by forward flexion, not worsened when rising from flexion, not worsened by extension rotation, and well relieved by recumbency)	
 Manchikanti et al 48 1999	Prospective observational study	120	The criteria of Revel were not confirmed	
 Manchikanti et al 2000a 49	Prospective observational study	200	
 Manchikanti et al 2000b 50	Prospective observational study	180	
 Young et al 2003 53	Prospective observational study	23	Positive correlation between faect joint pain and examination when there was no pain when standing up from a sitting position and a negative correlation for centralizing pain	
 Laslett et al 2004 51	Prospective observational study	116	The criteria of Revel were not confirmed	
 Laslett et al 52 2006	Prospective observational study	120	
 DePalma et al 2011b 54	Retrospektive Chart review	52	Positive correlation between faect joint pain and examination with paraspinal pain, negative correlation with lack of muscle hardening	
RF-denervation	
 Cohen et al 2007a 39	Retrospective observational study	192	Success of RF denervation depending on the clinical examination. A paraspinal hardening was positively correlated, an increase in pain during extension-rotation was negatively associated	
 Cohen et al 2020b 55	Prospective observational study	53	Fewer Waddell signs resulted in a better result of RF-denervation (loss to F/U 41.5%)	

Examination Sacroiliac Joint

The first studies that compared the results of clinical examination tests and provocation tests of the SI joint with the results of intra-articular injections for the SI joint did not find any positive association.56-59 Later studies showed a positive correlation of more than 3 provocation tests with a positive result after an intra-articular injection. 53 Laslett et al 60 calculated a sensitivity of .91, a specificity of .78 and a positive likelihood ratio of 4.16 for at least 3 positive provocation tests and in a follow-up study 61 a sensitivity of .94, a specificity of 0.78 and a positive likelihood ratio of 4.29. In addition, pain of the SI joint can be ruled out if no test is positive. Similar results can also be found in the study of van der Wurff et al 62 (sensitivity .85, specificity .79, LR + 4.02).

However, the 2 most recent studies found no positive correlation between clinical tests and the outcome of the intra-articular injection. Schneider et al 5 found a positive LR of only 1.26 for at least 5 positive tests. Without a positive test, the diagnosis of facet joint pain is very unlikely. Mekhail et al 63 found no predictability of the outcome of the injection from clinical testing. However, the sensitivity is good, so that injections could be avoided in the case of negative clinical provocation tests. A systematic review with meta-analysis 64 using GRADE criteria showed that a combination of several clinical tests does not result in sufficient test accuracy for the diagnosis of SI joint pain (meta-analysis: sensitivity .83 (.62-.93), specificity .59 (.36-.79), false positive rate .41 (.21-.64), positive LR 2.13 (1.2-3.9). Negative tests can rule out SI joint pain with a high degree of probability (Table 4).Table 4. Literature Review of Studies on Clinical Examination of the Sacroiliac Joint.

Study	Design	Population	Results	
Schwarzer et al 56 1995a	Prospective observational study	43	No positive association between clinical examination and provocation tests with the results of intra-articular injections	
Maigne et al 1996 57	Prospective observational study	54	
Dreyfuss et al 58 1996	Prospective observational study	85	
Slipman et al 1998 59	Prospective cohort study	50	
Young et al 2003 53	Prospective observational study	57	Positive correlation of more than 3 provocation tests with a positive result after an intra-articular injection	
Laslett et al 60 2003	Observational study	34	Sensitivity of .91, specificity .78, LR + 4.16 for at least 3 positive provocation tests	
Laslett et al 2005 61	Observational study	48	
van der Wurff et al 62 2006	Prospective observational study	60	Sensitivity .85, specificity .79, LR + 4.02	
Schneider et al 2020b 5	Prospective observational study	35	LR + 1.26 for at least 5 positive tests. Without a positive test, the diagnosis of facet joint pain is very unlikely	
Mekhail et al 2021 63	Prospective observational study	200	No predictability of the outcome of the injection from clinical testing	

Existing Guidelines

Two guidelines4,22,23 recommend selecting the level at the cervical and lumbar spine based on the muscle tension at examination and on pain maps. One guideline 27 recommends 6 provocation tests for the SI joint. If none of these tests are positive, the SI joint can be ruled out as the cause of the pain.Recommendations and statements:1.1 There are no symptoms or clinical investigations pathognomonic for the presence of cervical facet joint pain. (Quality of evidence: low)

1.2 Pain maps and the results of the segmental clinical examination should be used to identify the levels at the cervical spine for testing. (Recommendation: B, quality of evidence low)

1.3 There are no symptoms or clinical investigations pathognomonic for the presence of lumbar facet joint pain. There is a weak correlation to a positive result of a test block for paravertebral pain and tenderness. (Quality of evidence: low)

1.4 The results of the segmental clinical examination should be used to identify the levels at the lumbar spine for testing. (Recommendation: B, quality of evidence low)

1.5 Evidence is conflicting as to whether the combination of multiple clinical provocation tests (≥3 tests) can predict outcome of intra-articular SI joint injection. (Quality of evidence: very low)

1.6 In the absence of positive provocation tests, no test block should be carried out on the SI joint. (Recommendation: B, quality of evidence: low)

Question 2: Is there a Correlation Between Imaging Findings and RF Denervation Outcome?

X-Ray and CT

Since the 1980s, in many studies no correlation was seen between degenerative changes in the X-ray image and pain in the cervical or lumbar spine.65-67 Computed tomography (CT) is well suited for displaying the facet joints. Nevertheless, it is not possible to detect a painful facet joint or to predict the outcome of an infiltration68-72 with CT.

MRI

Stojanovic et al 73 found a positive correlation between magnetic resonance imaging (MRI) and the result of medial branch blocks, but not with the result of RF denervation. Also, Cohen et al39,74 found no correlation of MRI findings with the results of RF denervation of the cervical or lumbar spine. There is no study for the SIJ that compares MRI findings with results of injections. 75 It is assumed that MRI has a very low specificity regarding SI joint pain, since changes (eg, bone edema) are also often found in healthy subjects. 76 However, MRI is of great importance for diagnosing ankylosing spondylitis. 77

SPECT/CT

Two studies have compared the results of radionuclide bone scanning with intra-articular injections in the sacroiliac joint.78,79 Both studies found very low sensitivity (13% and 46%) with high specificity (100% and 90%). Several studies found better outcomes of injections in SPECT/CT positive patients compared to SPECT/CT negative patients.80-83 In contrast, Matar et al 84 showed activity in SPECT/CT in 52% of the patients in the cervical spine, but a correlation with the clinical findings in only 12.5% (38% correlation in the lumbar spine). Lehmann et al 85 found no correlation of facet joint injections or medial branch blocks with SPECT/CT findings.

Two randomized controlled trials show conflicting results. Jain et al 86 found significantly more responders after a medial branch block or an intra-articular SI joint injection in the SPECT/CT positive group. In contrast, Freiermuth et al 87 found only moderate sensitivity and specificity regarding the agreement between SPECT/CT and the result of placebo-controlled medial branch blocks, so that a SPECT/CT examination is not recommended for primary diagnostics.

PET/MRI

A very small study of 10 patients 88 found significantly better results of CT-guided injection into the cervical joint capsule when the joint was selected using positive 18F-FDG PET/MRI compared to joint selection using clinical examination for negative ones 18F-FDG PET/MRI (Table 5).Table 5. Literature Review of Studies on Imaging.

Study	Design	Population/Control	Results	
X-Ray	
 Heller et al 1983 65	Retrospektive case control studie	653/365	No correlation between degenerative changes and X-ray	
 Gore et al 66 1987	Retrospective observational study	205	
 Rudy et al 2015 67	Retrospective cross-sectional study	322	
CT	
 Schwarzer et al 68 1995	Prospektive cross-sectional study	63	No possibility to detect a painful facet joint or to predict the outcome of an infiltration	
 Elgafy et al 2001 69	Retrospective observational study	62/50	
 Hechelhammer et al 2007 70	Retrospective observational study	37	
 Morishita et al 72 2008	Retrospective observational study	32/183	
 Le Clec’h et al 2016 71	Prospective cohort study	91/30	
MRI		
 Stojanovic et al 2010 73	Retrospective observational study	127	Positive correlation between MRI and the result of medial branch blocks, but not with the result of RF denervation	
SPECT/CT		
 Dolan et al 80 1996	Prospective comparative study	22/36	Better outcomes of injections in SPECT/CT positive patients compared to SPECT/CT negative patients	
 Slipman et al 78 1996	Prospective observational study	31/19	Sensitivity 13%, specificity 100% comparing the results of radionuclide bone scanning with intra-articular injections in the sacroiliac joint	
 Maigne et al 1998 79	Prospective observational study	32/34	Sensitivity 46%, specificity 90% comparing the results of radionuclide bone scanning with intra-articular injections in the sacroiliac joint	
 Pneumaticos et al 2006 81	Prospective observational study	31/16	Better outcomes of injections in SPECT/CT positive patients compared to SPECT/CT negative patients	
 Koh et al 82 2011	Prospective observational study	28/5	
 Matar et al 84 2013	Retrospective observational study	25 HWS
49 LWS	Activity in SPECT/CT in 52% of the patients in the cervical spine, but a correlation with the clinical findings in only 12.5% (38% correlation in the lumbar spine)	
 Lehmann et al 2014 85	Retrospective observational study	74	No correlation of facet joint injections or medial branch blocks with SPECT/CT findings	
 Jain et al 86 2015	RCT	40/40	Significantly more responders after a medial branch block or an intra-articular SI joint injection in the SPECT/CT positive group	
 Freiermuth et al 2015 87	RCT	9/20	Moderate sensitivity and specificity regarding the agreement between SPECT/CT and the result of placebo-controlled medial branch blocks	
 Nolan 3rd et al 2022 83	Retrospective cohort study	89/23	Better outcomes of injections in SPECT/CT positive patients compared to SPECT/CT negative patients	
PET/MRI		
 Sawicki et al 88 2017	Retrospective observational study	6/4	Significantly better results of CT-guided injection into the cervical joint capsule when the joint was selected using positive 18F-FDG PET/MRI	

Existing Guidelines

One guideline 4 sees moderate evidence to use SPECT/CT to identify painful lumbar facet joints prior to medial branch block. However, another guideline 25 does not see sufficient evidence for or against the use of SPECT/CT to diagnose lumbar facet joint pain. There is weak evidence for a CT or an MRI to identify a painful facet joint in the lumbar spine. 4 For the cervical spine, the current evidence would not be sufficient to weigh the harms and benefits of imaging regarding the success of a cervical facet block; existing imaging should be considered for planning.22,23 Imaging is important in relation to the detection of other essential diseases, 24 but it is not required as a prerequisite for RF denervation. 21 Recommendations and statements2.1 There is insufficient evidence to diagnose symptomatic facet joints or a symptomatic SI joint using imaging methods (X-ray, CT, MRI, SPECT, PET) alone. (Quality of evidence: low)

2.2 Imaging diagnostic procedures have no predictive value regarding the results of diagnostic blocks (intra-articular, medial branch block) or the result of RF denervation. (Quality of evidence: low)

2.3 Image diagnostic methods provide relevant information on differential diagnostic diseases (eg herniated disc, ankylosing spondylitis, infections, tumors). (Quality of evidence: low)

2.4 Existing imaging should be considered along with history and clinical examination findings when deciding which levels to treat. (Recommendation: B, quality of evidence: low)

Question 3: Is Conservative Therapy Necessary before a Diagnostic Block, for How Long?

There are currently no studies comparing RF denervation after conservative therapies of different duration. Likewise, there is no evidence for RF denervation in acute neck pain or acute low back pain. In all randomized studies that compared RF denervation with sham, chronic pain, and usually also explicitly previous conservative therapy for 2 months, 89 3 months,15,90-95 6 months,96-100 1 year 101 or even 2 years 89 are an inclusion criterion.

Existing Guidelines

The existing guidelines also recommend conservative therapy for at least 3 months.4,16,22–24Recommendations3.1 Chronic pain is a prerequisite facet joint testing and RF denervation. (Recommendation: A, quality of evidence: moderate)

3.2 Patients suspected of having a chronic pain disorder with somatic and psychological factors require interdisciplinary evaluation before an intervention. (Recommendation: EC)

Question 4: Are Medial Branch Blocks Suitable for Diagnosing Facet Joint Pain?

In this guideline, the terms medial branch and medial branch block are used for the medial rami C4 to C8 and the medial rami L1 to L4, but also for the third occipital nerve (TON) and the dorsal ramus L5, without these differences being explicitly pointed out in each case. The dorsal innervation of the SI joint is called lateral branch.

The validity of clinical tests is often validated by a reference examination (eg, laboratory values, histology, or imaging). Since pain is a subjective perception, there is no such reference value for medial branch blocks. Engel et al 102 tried to answer the question of diagnostic validity of medial branch blocks philosophically and were able to conclude that the 8 criteria they selected provide an axiomatic basis for diagnostic blocks in general and serve to show what empirical evidence needs to be gathered in order to validate a particular block.

It can be considered whether medial branch blocks are prognostic, predictive or diagnostic. Since studies on healthy volunteers have shown that facet joints can be pain generators 29 and that a medial branch block is specific33,103 and can protect against facet joint pain 104 the guideline uses the term diagnostic medial branch blocks.

A systematic review105,106 dealt with the diagnostic use of medial branch blocks. „Strong evidence“ was certified.Statement4.1 Medial Branch Blocks are useful as a test block prior to RF denervation. (Quality of evidence: moderate)

Question 5: Are Medial Blocks Better than Intra-Articular/Pericapsular Blocks for Diagnosing Facet Joint Pain?

There are 3 studies comparing the predictive value of facet blocks to medial branch blocks. A case control study 107 found a higher success rate after medial branch blocks, a RCT (indirect evidence since cryotherapy was used) 8 found a higher success rate after medial branch blocks only after 3 months. In another RCT 9 there were 3 groups: intra-articular injection of a local anesthetic and steroid, medial branch block with local anesthetic only, and injection with saline. The results are only significantly different when compared to the saline group, not when comparing the intra-articular and the medial branch block group. A review of randomized studies 108 concludes that intra-articular injections cannot be recommended to predict a positive outcome of RF denervation (Table 6).Table 6. Literature Review of Studies Comparing Intra-articular Injektions and Medial Branch Blocks.

Study	Design	Population/Control	Results	
Birkenmaier et al 8 2007	RCT	13/13	Higher success rate after medial branch blocks compared to intra-articular injections only after 3 months	
Cohen et al 2015 107	Case control study	212/212	Higher success rate after medial branch blocks compared to intra-articular injections	
Cohen et al 2018 9	RCT	45/48	Comparing intra-articular local anesthetic, intra-articular saline and medial branch block. Significant differences compared to saline group, no differences between intra-articular local anesthetic and medial branch block	

Existing Guidelines

All guidelines considered4,16,21 and the Greater Manchester EUR Policy Statement on Facet Injections 109 recommend performing medial branch blocks.Recommendation5.1 Medial branch blocks should be performed as a test block prior to RF denervation. (Recommendation: B, quality of evidence: low)

Question 6: Which Diagnostic Blocks should be Performed on the SI Joint Prior to Denervation?

In the case of intra-articular test blocks, the target structure of an RF denervation (the lateral branches) is not tested. The dorsal pain generators (ligaments) are not included in the test. Another weakness of intra-articular injections as a diagnostic test is the lack of specificity. Fortin et al 110 were able to demonstrate that during arthrography of the SI joint in 61% of the joint injections, contrast medium was detectable outside the joint (dorsal foramina, superior recess closed to the L5 spinal nerve, ventral towards the lumbosacral plexus). In a cadaver study by Stelzer et al 111 a localization exclusively within the joint was found in only 50% of the joints after the injection of red latex under fluoroscopic guidance. In the other patients, injectate was found in the dorsal ligaments or intravenously. In a systematic review with evaluation according to the GRADE methods, 112 a false-positive rate of diagnostic intra-articular blocks of 19-22% was found. In 4-20% of the patients it was anatomically not possible to perform an intra-articular injection.

When using lateral branch blocks as a test block, the lateral branch is the target of the test injection and the RF denervation. However, the parts of the joint with a ventral innervation are not included in the test. Only 2 primary studies have examined lateral branch blocks. 113 A double-blind, randomized study on volunteers 114 was able to show that only 40% of the subjects were protected from provocative pain by intra-articular volume administration by a “single-site, single-depth” injection to the lateral branches. Target nerves were reached in only 36% of the injections. Thus, single-site, single-depth injections are not suitable for diagnostic or prognostic purposes. A “multi-site, multi-depth” technique was also developed in a double-blind, randomized, placebo-controlled follow-up study. 115 Either a local anesthetic or saline was injected to the medial branch L5 and the lateral branches at various sites around the foramen, followed by stimulation of the dorsal ligaments and the joint capsule. 70% of the patients with the local anesthetic but only 10% of the patients in the control group felt no pain. An anatomical study showed that 91% of the lateral branches were reached with this technique. Stout et al 116 studied the anatomy of the lateral branches in cadavers in relation to an ideal electrode position and determined positions for an RF electrode in which only 3% of the lateral branches are at the foramen S1, 1% at the foramen S2 and zero% at the foramen S3 are not reached. A denervation of the lateral branch L5 is also necessary. Vorobeychik et al 117 found that all patients after positive lateral branch blocks and successful RF denervation of the SI joint showed hypoesthesia in the area supplied by the cluneal nerves. It was concluded that the absence of hypoesthesia indicates an inadequate technique. It is thus possible to clinically check the quality of lateral branch blocks and RF denervation on the SI joint.

RCTs

Three RCTs95,98,100 investigated a RF denervation at the sacroiliac joint compared to sham after intra-articular test blocks. Different electrodes (conventional, cooled RF, bipolar) for denervation were used. Only 1 RCT 99 used 2 test blocks to the lateral branch before RF denervation (cooled-RF L5–S3). Comparing the RCTs with an intra-articular test block to the RCT with a lateral branch block, there are only 2 common endpoints, namely NRS and ODI changes after 3 months. Significant changes are found for ODI changes after a lateral branch block, but not after intra-articular test blocks (Table 7).Table 7. Literature Review of the RCTs RF Denervation vs Sham.

Study	Design	Population/Control	Results	
Intraarticular block	RF denervation vs sham. Different electrodes (conventional, cooled RF, bipolar). Comparing intraarticular blocks vs lateral branch blocks after 3 months significant changes in ODI wer found after lateral branch blocks	
 Cohen et al 98 2008a	RCT	14/14	
 van Tilburg et al 2016 95	RCT	30/30	
 Mehta et al 100 2018	RCT	11/6	
Lateral branch block	
 Patel et al 2012 99	RCT	34/17	

Existing Guidelines

The guidelines of the American Society of Pain and Neuroscience (ASPN) 27 recommend performing diagnostic lateral branch blocks using the “multi-side, multi-depth” technique. The North American Spine Society (NASS) 25 recommends RF denervation of the sacroiliac joint after 2 intra-articular test blocks. Studies regarding lateral branch blocks are necessary.

The review by Schneider et al 75 suggests initially performing a therapeutic intra-articular SI joint injection and, if unsuccessful, a lateral branch block for RF denervation. Also, in the RCT by Cohen et al 9 intra-articular, therapeutic injections were possible before the diagnostic test infiltration.

According to current knowledge, it seems useful to differentiate joint pain from pain in the dorsal (ligamentous) structures.Recommendations6.1 Intra-articular injections can be used as the primary (therapeutic) intervention for SI joint pain. (Recommendation 0, Quality of evidence: very low)

6.2 An intra-articular injection with local anesthetic can be used as test prior to RF denervation of the sacroiliac joint. (Recommendation 0, Quality of evidence: very low)

6.3 Multi-site, multi-depth lateral branch blocks should be performed as test prior to RF denervation at the SI joint. (Recommendation B, Quality of evidence: very low)

Question 7: Which Drugs are Useful for a Diagnostic Test Block?

To reduce the number of false positive results, medial branch blocks are often performed as controlled medial branch blocks (the same local anesthetic is used), or with 2 local anesthetics of different durations of action (comparative medial branch blocks). Under strict test conditions, the medial branch block can only be considered positive if the patient reports a duration of pain reduction that corresponds to the duration of action of the local anesthetic. However, the pharmacological duration of action of the local anesthetics could not be confirmed in a clinical study. 118

Looking at the existing RCTs comparing RF denervation vs sham, different volumes were used for the medial branch blocks: .3 mL, 97 .5 mL,15,119 .75 mL 101 or 1.0 mL. 89 Cohen et al 120 compared .5 mL vs .25 mL volume for medial branch blocks and found (non-significantly) less aberrant contrast agent distribution at lower volume. There were no differences in pain reduction between the 2 groups. On cadavers, Wahezi et al 121 compared the distribution of .25 mL and .5 mL injectate on the lumbar spine. In both groups, the medial branch was adequately irrigated, but with .5 mL of injectate there was distribution in the muscles and distal branches of the dorsal ramus. Therefore, a volume of .25 mL was recommended for a specific medial branch block. Similar results in the comparison of .25 mL and .5 mL could also be shown for the cervical spine. 122

In a cadaver study with subsequent injections to the medial branches of volunteers, 103 the distribution of contrast medium at different puncture sites was examined in the CT. It was concluded that the administration of contrast medium prior to the injection of local anesthetic is necessary for the test block to be specific for the medial branch. Kennedy et al 123 investigated the frequency of intravascular injections in medial branch blocks. Intravascular contrast medium was detected in 19% of medial branch blocks. Without contrast medium, it is not possible to detect intravascular drug distribution and to avoid drug distribution to structures other than the medial branch. The possible side effects (allergic reaction to contrast media) must be considered.

Existing Guidelines

The SIS Practice Guidelines 16 recommend the use of long-acting and short-acting local anesthetics with comparative medial branch blocks. No more than .5 mL should be used, .3 mL is sufficient. Contrast agent is recommended under live fluoroscopy. The consensus guidelines4,92,101 recommend using less than .5 mL total volume for a medial branch block at the lumbar spine and even less than .3 mL total volume for the cervical spine. Both guidelines recommend the use of contrast media under live fluoroscopy. The British Pain Society technical guideline 26 recommends the use of levobupivacaine. The guidelines of the American Society of Interventional Pain Physicians (ASIPP) 24 recommend using less than .5 mL for medial branch blocks.Recommendations7.1 Both a short-acting and a long-acting local anesthetic can be used for a diagnostic test block. (Recommendation: 0, quality of evidence: very low)

7.2 The volume used for a medial branch block should be less than .5 mL. (Recommendation: B, quality of evidence: low)

7.3 Contrast media should be used for diagnostic medial branch blocks. (Recommendation: B, quality of evidence: low)

Question 8: Which Pain Threshold after a Therapeutic Block is Considered Positive?

It can be assumed that strict test criteria (100% pain reduction) lead to better results of a subsequent RF denervation. However, there will be patients with false-negative test blocks who, given these strict criteria, would be deprived of a potentially effective therapy.

Cohen et al 124 chose 50% as the threshold in a prospective study, but patients who reported less than 50% pain reduction after medial branch block but were satisfied with the pain reduction were also treated with RF denervation. The success rate was 58.2% at the threshold ≥50% and 17% at < 50%, however, due to the small number of cases (6 patients), the difference is not significant.

Two studies compared a threshold of ≥80% with a threshold between 50 and 80%. Cohen et al 125 found no significant difference in the success of RF denervation. Manchikanti et al 126 reported 51% vs 89.5% reported success in both groups; this difference is significant, although different forms of therapy (RF denervation and therapeutic facet blocks) were used in both groups.

A threshold of 100% was compared with a threshold of 70-100% and 80-100% in 3 studies (cervical and lumbar spine).127-129 In all studies, the difference in pain reduction after RF denervation was not significant.

Derby et al 130 examined 10% steps of thresholds and found a significant difference at 80% threshold for 1 medial branch block and at 70% for 2 medial branch blocks (Table 8).Table 8. Literature Review of Studies Comparing Medial Branch Block Cutoff Values.

Study	Design	Population	Rsults	
Cohen et al 124 2013b	Prospective correlational study	55/6	50% threshold. Success rate 58.2% at the threshold ≥50%, 17% at < 50%, only 6 patients, not significant	
Cohen et al 2008b 125	Retrospective clinical data analysis	145/117	Threshold ≥80% vs 50-80%. No significant difference in the success of RF denervation	
Manchikanti et al 126 2010	Retrospective observational study	110/152	Threshold ≥80% vs 50-80%. 51% vs 89.5% success (significant). Different forms of therapy (RF denervation and therapeutic facet blocks)	
Holz & Sehgal 2016 127	Retrospective observational study	18/26	100% threshold vs 70-100% or 80-100%. No significant difference in pain reduction after RF denervation	
Burnham et al 128 2020	Cross-sectional cohort study	26/24	
Burnham et al 2022b 129	Cross-sectional study	58/42	
Derby et al 2012 130	Retrospective observational study	51	Cutoff values in 10% increments. Significant difference at 80% threshold for 1 medial branch block and at 70% for 2 medial branch blocks	

Existing Guidelines

The SIS Practice Guidelines 16 recommend ideally using 100% pain reduction of index pain as a positive result of a medial branch block, but at least 80%. The consensus guidelines4,22,23 recommend that ≥50% pain reduction be rated as positive. The Comprehensive Guidelines of the American Society of Interventional Pain Physicians (ASIPP) 24 recommend a threshold of ≥80% for the lumbar spine and ≥80% or 100% for the cervical spine. The North American Spine Society (NASS) 25 sees no evidence for or against the 50% threshold in its guideline.Recommendation8.1 A threshold of 50% pain reduction after a medial branch block should be used for the test block to be considered positive. (Recommendation: B, quality of evidence: low)

Question 9: How Many Diagnostic Blocks are Necessary Before Denervation?

Comparing the RCTs RF comparing denervation to sham, which used either 1 or more than 1 medial branch block as an inclusion criterion, only individual studies per endpoint with small patient numbers can be found. More significantly better results are found when using more than 1 medial branch block.

Only 1 randomized study 131 examined the outcome of RF denervation after 0, 1, or 2 medial branch blocks. After 3 months, the best results are seen after 2 medial branch blocks (33% success vs 39% vs 64%), but the results are not significantly different. Three other studies73,130,132 examined patients with 1 or more medial branch blocks without randomization. The results after 2 medial branch blocks were not significantly better than after 1 medial branch block (Table 9).Table 9. Literature Review of Studies Comparing the Number of Medial Branch Blocks.

Study	Design	Population /Control	Results	
Cohen et al 2010b 131	Randomized study	18/14	Outcome of RF denervation after 0, 1, or 2 medial branch blocks. After 3 months: 33% success vs 39% vs 64%	
Stojanovic et al 2010 73	Retrospective data analysis	43/17	No randomization. Results after 2 medial branch blocks not significantly better than after 1 medial branch block	
Derby et al 2012 130	Retrospective data analysis	38/13	
Cohen et al 132 2015	Case-control study	181/31	

Existing Guidelines

The SIS Practice Guidelines 16 recommend conducting controlled medial branch blocks, ideally as comparative medial branch blocks. The Comprehensive Guidelines of the American Society of Interventional Pain Physicians (ASIPP) 24 also recommend performing 2 diagnostic medial branch blocks. However, the NICE Guidelines 21 recommend a single medial branch block prior to RF denervation. Likewise, with the justification “maximize access to care”, only 1 medial branch block is recommended in the consensus guidelines.4,22,23Recommendation9.1 Prior to RF denervation, two diagnostic medial branch blocks with a positive response should usually be performed. (Recommendation: B, quality of evidence: low)

Question 10: What Image Guidance is Recommended for RF Denervation?

One study 133 dealt with RF denervations in the cervical spine using computed tomography. There is no information on the inclusion criteria and the number of patients, but 70% success is reported, although success was not defined in more detail.

A cadaver study 134 examined the needle position in CT vs fluoroscopy on 10 specimens. Under CT guidance, the tip of the electrode often failed to reach the nerve and the needle had less contact area to the medial branch compared to fluoroscopy. The authors concluded that computed tomography should not be used for RF denervation. In a follow-up study, 135 the technical feasibility of a parallel needle position with a corresponding puncture angle in computed tomography was demonstrated on 10 cadavers. 54.6% of the needles met the requirement of maximum parallelism and proximity to the medial branch.

Lee et al 136 investigated the possibility of RF denervation at the cervical spine using ultrasound on 5 cadavers. RF denervation was performed on the cadaver and then the medial branch was examined histologically. 30 of the 34 denervations were histologically successful. In a clinical study on RF denervation with ultrasound of the cervical spine, 137 15 patients were prospectively examined. With strict inclusion criteria, 80% pain reduction was seen in 87% of patients at 6 months and 40% of patients at 12 months. The median duration of pain relief was 44 weeks. A cadaver study 138 evaluated the accuracy of the needle position at the lumbar spine under ultrasound using a cooled-RF electrode with right-angle access. In 6 cadavers, the electrode was placed under fluoroscopy on 1 side and ultrasound on the other side, using a trocar with an electromagnetic sensor. An accuracy of 97% was achieved with ultrasound. Loh et al 139 report on a clinical study with 31 patients in whom significant pain reduction was achieved for up to 9 months using RF denervation and ultrasound (Table 10).Table 10. Literature Review of Clinical Studies About Imaging Guidance.

Study	Design	Population	Results	
Nguyen et al 2017 133	Technical report	>90	Cervical spine with CT. 70% success. No information on inclusion criteria, number of patients unknown, success not defined	
Siegenthaler et al 2011 137	Prospective study, consecutive patients	15	Cervical spine, ultrasound. 80% pain reduction in 87% of patients at 6 months and 40% of patients at 12 months	
Loh et al 2022 139	Prospective observational study	31	Sacoiliac joint, ultrasound. Significant pain reduction for up to 9 months	

Existing Guidelines

The consensus guidelines4,22,23 recommend the use of fluoroscopy for RF denervation of the lumbar or cervical spine. All RCTs were performed with fluoroscopy.Recommendation10.1 RF denervation should be performed with fluoroscopy. (Recommendation: B, quality of evidence: very low)

10.2 The diagnostic test block (medial branch block and lateral branch block) should be performed with the same imaging as the later RF denervation. (Recommendation: B, quality of evidence: very low)

Question 11: Does the Size of the Lesion Determine the Outcome of the Denervation? How can the Lesion be Enlarged?

Only a few clinical studies have compared different parameters during RF denervation. A clinical study 140 retrospectively compared results of RF denervations at 80°C and 90°C. Patients with RF denervation at 90°C had a 3.1 times greater chance of at least 50% improvement (P = .0004). The chance of a patient-reported improvement of at least 75% was 2.8 times better in the 90°C group (P = .002). A randomized study 141 double-blindly assigned patients with RF denervations to one of 3 groups with 90°C, 50 s or 85°C, 60 s or 70°, 90 s. No significant difference in pain reduction was found after 6 months in all 3 groups, which was attributed to using a similar amount of energy in all 3 groups (higher temperature but shorter time or lower temperature with longer time) (Table 11).Table 11. Literature Review of Studies Comparing Different Radiofrequency Parameter.

Study	Design	Population Parameter 1/2/3	Results	
Costandi et al 140 2015	Retrospective observational study	100/99	At 90°C 3.1 times greater chance of at least 50% improvement (P = .0004). Chance of a patient-reported improvement of at least 75% was 2.8 times better in the 90°C group (P = .002)	
Ertilav et al 2020 141	RCT	31/32/33	Three groups: 90°C, 50 s or 85°C, 60 s or 70°, 90 s. No significant difference in pain reduction was found after 6 months. Similar amount of energy in all 3 groups	

Existing Guidelines

The consensus guidelines for the cervical and lumbar spine4,22,23 suggest that a larger lesion increases the probability of medial branch neurotomy and that a larger lesion increases the duration of pain reduction. The SIS Practice Guidelines 16 recommend a temperature of 80 °C-85°C and a duration of denervation of 60-90 s. Multiple lesions (2-3) are also recommended depending on the diameter of the cannula and the length of the active tip. The British Pain Society technical guideline 26 recommends an 18 G cannula with a 10 mm curved active tip and a temperature of 80°C for 120 s with 2 lesions per nerve. The guidelines of the American Society of Pain and Neuroscience (ASPN) 27 recommend 60 °C-80°C for 60-90 s at the cervical spine and 60-90 s at the lumbar spine.Recommendations and statements11.1 It can be assumed that a larger lesion leads to a longer-lasting reduction in pain. (Quality of evidence: low)

11.2 A temperature of 75-90°C should be used for denervation with conventional electrodes. (Recommendation: B, quality of evidence: very low)

11.3 A lesion duration of between 60 s and 120 s is recommended when using conventional electrodes. (Recommendation: EC)

11.4 A large diameter of the cannula of at least 18G is recommended when using conventional electrodes. (Recommendation: EC)

11.5 An active tip length of 10 mm is recommended for conventional electrodes in the lumbar spine and SIJ, on the cervical spine a length of 5 mm is also possible. (Recommendation: EC)

11.6 When using conventional electrodes, multiple lesions per medial branch or lateral branch are recommended. (Recommendation: EC)

Question 12: What Type of Electrode is Recommended?

A conventional monopolar electrode was used in all RCTs at the lumbar or cervical spine comparing RF denervation vs sham. Two observational studies142,143 examined the results of different electrode types for the lumbar spine. A conventional electrode was compared to a cooled-RF or to an electrode with 3 active parts of the tip. There were no significant differences regarding pain and ODI. In a systematic review with meta-analysis, 144 no significant differences were found between conventional RF denervation and cooled RF denervation regarding pain reduction.

The RCTs of the SI joint comparing RF denervation vs sham used conventional RF electrodes, cooled-RF, or a combination of conventional RF with cooled-RF, or a combination of conventional RF with an electrode with 3 active areas combining bipolar and monopolar. An observational study 145 compared conventional electrodes to cooled-RF with no significant difference in duration of pain reduction. A systematic review including 9 studies comparing these electrodes 146 also found no significant difference in pain reduction and improvement in quality of life. Two studies147,148 compared conventional RF denervation with the use of an electrode that has 3 active areas combining bipolar and monopolar. Taken together, there are significantly better results for the combined electrode for the outcome “success”. Both retrospective observational studies have high rates of loss to follow up. One clinical study 149 found significantly better outcomes in terms of pain reduction at up to 12 months, duration of pain reduction, procedure duration, and radiation exposure for patients with bipolar palisade technique compared to cooled-RF denervation. Finally, 1 study compared cooled-RF denervation to denervation using an electrode that has 3 active areas combining bipolar and monopolar. 150 Pain reduction and the success rate were significantly better for the patients with cooled-RF denervation but with a longer procedure duration (Table 12).Table 12. Literature Review of Comparative Studies Comparing Different Types of Electrodes.

Study	Design	Population Type 1/2		
McCormick et al 2019a 142	Prospective, randomized, blinded study	22/21	Lumbar, conventional vs cooled-RF. No significant differences regarding pain and ODI.	
Deng et al 2022 143	Pre-post crossover observational study	10/41	Lumbar, conventionell vs TridentⓇ. No significant differences regarding pain and ODI.	
Cheng et al 2013 145	Retrospective observational study	30/58	SIJ, conventionell vs cooled-RF. No significant difference in duration of pain reduction	
Bayerl et al 2020 147	Retrospective analysis of prospectively collected data	57/64	SIJ, conventionell vs Simplicity IIIⓇ. Significantly better results for the combined electrode for the outcome success. High loss to F/U	
Speldewinde 148 2020	Retrospective observational study	41/32	
Cheng et al 2016 149	Retroospective observational study	62/31	SIJ, cooled-RF vs bipolar. Significantly better outcomes in terms of pain reduction at up to 12 months, duration of pain reduction, procedure duration, and radiation exposure for patients with bipolar palisade technique compared to cooled-RF denervation	
Tinnirello et al 2017 150	Retroospective observational study	21/22	SIJ cooled-RF vs Simplicity IIIⓇ. Pain reduction and success rate significantly better with cooled-RF denervation but longer procedure duration	

Existing Guidelines

Without considering different types of electrodes, the North American Spine Society (NASS) 25 recommends in its guideline cooled RF in patients with proven SI joint pain. The guidelines of the American Society of Pain and Neuroscience (ASPN) 27 recommend a bipolar technique or cooled-RF electrodes for SI joint denervation.Statement12.1 Based on the available evidence in the literature, a recommendation for or against the use of a certain type of electrode cannot be given for denervations of the cervical, lumbar, or sacroiliac joints. (Quality of evidence: very low)

Question 13: Is the Position of the Electrode to the Nerve (Parallel, Perpendicular) Important?

Currently, there are 2 dominant techniques in the literature regarding needle guidance in RF denervation, which differ primarily in the angle at which the electrode is inserted. In 1 technique, (curved) electrodes are placed tangentially to the medial branch so that contact to the nerve occurs along the long side of the non-insulated electrode tip. Compared to the medial branch block, a much flatter puncture angle is required for RF denervation. 151 This is called a parallel needle position. 152 The other technique uses a needle direction like that of the medial branch block, so that the needle tip contacts the nerve perpendicular.

The results of studies using the parallel technique should therefore be distinguished from the results of studies using the perpendicular technique. When comparing both techniques, only the conventional electrode is taken into account, since the distribution of the heat field in relation to the extent distal to the tip is different with other electrode types (eg, cooled-RF). 153

Cervical Spine

In a randomized study with parallel needle placement, 15 a clear advantage after cervical RF denervation in terms of pain reduction could be worked out. This result is supported by a large systematic review about RF denervation at the cervical spine, 154 in which a success rate of 59.5% is given for the endpoint pain after comparative medial branch blocks with a 50% reduction in pain. A randomized study 91 with an alternative access (rather perpendicular) vs sham found no effect in terms of 30% pain reduction, global impression, neck disability index or medication consumption (Table 13).Table 13. Literature Review of Studies Comparing a Perpendicular or a Parallel Electrode Position for the Cervical Spine.

Study	Design	Population /Control	Results	
Lord et al 1996b 15	RCT	12/12	Parallel needle placement. Clear advantage after cervical RF denervation in terms of pain reduction (success rate of 59.5%)	
Engel et al 154 2020	Systematic review	21 studies	
van Eerd et al 2021 91	Randomized study	37/39	“Alternative approach” (perpendicular). No effect in terms of 30% pain reduction, global impression, neck disability index or medication consumption	

Lumbar Spine

Only 1 comparative study compared an “advanced Australian technique” (rather parallel needle position) with an “early Australian technique” (rather perpendicular needle position) on the lumbar spine. 155 However, the exact position of the needle is not described. There was no significant difference between the 2 groups regarding pain reduction. For the critical endpoint duration of action, however, the results were significantly better when the needle was in parallel position. Randomized trials comparing parallel electrode placement with sham in the lumbar spine showed significant differences in pain reduction and ODI reduction at 6 and 12 months.89,97 On the other hand, only 1 randomized study comparing a perpendicular electrode position with sham showed an improvement in pain and ODI after 2 months, and successful therapy after 3, 6, or 12 months. 101 All other studies regarding perpendicularity vs sham94,96,156 found no significant difference for the endpoints pain after 3, 6 or 12 months and global impression after 6 months. A systematic review 157 concludes that RF denervation with perpendicular electrode placement is no better than placebo treatment. With a parallel needle position, better results than placebo can be expected, depending on the inclusion criteria (medial branch block) (Table 14).Table 14. Literature Review of Studies Comparing a Perpendicular or a Parallel Electrode Position for the Lumbar Spine.

Study	Design	Population /Control	Results	
Loh et al 2015 155	Retrospective observational study	82/241	“Early Australian” (parallel) vs “advanced Australian” (perpendicular) technique. Exact needle position not described. No significant difference regarding pain reduction. Significant better results for pain duration with parallel placement	
Tekin et al 2007 97	RCT	20/20	Parallel needle placement. Significant differences in pain reduction and ODI reduction at 6 and 12 months	
Nath et al 2008 89	RCT	20/20	
van Kleef et al 1999 101	RCT	15/16	Perpendicular needle placement. Improvement in pain and ODI after 2 months, successful therapy after 3, 6, or 12 months	
van Wijk et al 96 2005	RCT	40/41	Perpendicular needle placement. No significant difference for the endpoints pain after 3, 6 or 12 months and global impression after 6 months	
van Tilburg et al 94 2016	RCT	30/30	
Juch et al 2017 157	RCT	125/126	

Existing Guidelines

The consensus guidelines for the cervical spine22,23 recommend a parallel needle position via a posterior or oblique posterior approach for conventional electrodes. The Consensus Guidelines for LWS 4 also recommend a parallel electrode position. The guidelines of the American Society of Pain and Neuroscience (ASPN) 27 recommend choosing a sagittal and oblique approach to the cervical spine to denervate a long part of the nerve. A parallel needle position is required for the lumbar spine.Recommendations13.1 When using a conventional electrode in the cervical spine, a parallel needle position should be selected via a posterior or oblique posterior approach, if necessary, with a curved needle. (Recommendation: A, quality of evidence: moderate)

13.2 On the lumbar spine, a parallel needle position should be selected when using a conventional electrode. (Recommendation: B, quality of evidence: low)

Question 14: Is Sensory or Motor Test Stimulation Necessary?

In a prospective study by Dreyfuss et al. 14 RF denervation with prior motor stimulation and impedance measurement was performed in 15 patients. There was no correlation between success and impedance or the observation of muscle twitches. Cohen et al 158 specifically investigated the influence of sensory testing on the result of RF denervation. There was no significant relationship between the mean sensory stimulation threshold and the result after RF denervation. A retrospective study 82 examined the duration of success after RF denervation as a function of muscle twitching after motor stimulation. Although there was a longer effect in patients with muscle twitch, the difference was not significant. Only when the paravertebral muscle twitching was observed within 1.6 times the voltage level at which sensory provocation was achieved, a significant difference (P = .03) was found (Table 15).Table 15. Literature Review of Studies About Test Stimnulation.

Study	Design	Population	Results	
Dreyfuss et al 14 2000	Prospective observational study	15	RF denervation with motor stimulation and impedance measurement. No correlation between success and impedance or muscle twitches	
Cohen et al 158 2011	Prospective observational study	61	Influence of sensory testing on the result of RF denervation. No significant relationship between the mean sensory stimulation threshold and the result	
Koh et al 82 2017	Retrospective case-control study	68	Duration of success after RF denervation as a function of muscle twitching after motor stimulation. Significant difference (P = .03) only when paravertebral muscle twitching was observed within 1.6 times the voltage level of sensory provocation	

Existing Guidelines

The SIS Practice Guidelines16,159 do not recommend sensory or motor testing, but instead localize the electrode according to anatomical landmarks in multiplanar fluoroscopy. A warning is given against motor stimulation without adequate imaging. The Consensus Guidelines4,22,23 recommend sensory and motor testing for the cervical and lumbar spine. In the British Pain Society technical guideline, 26 sensory testing is recommended, but not motor testing. The guidelines of the American Society of Pain and Neuroscience (ASPN) 27 recommend both sensory and motor testing of the lumbar spine.Recommendation14.1 Sensory and motor stimulation can be performed to provide information on the safety and proximity of the electrode to the nerve in addition to orientation to the anatomical landmarks in the fluoroscopic image. (Recommendation: 0, quality of evidence: moderate)

Question 15: Can an RF Denervation be Repeated, After What Time?

In a systematic review, 160 repeated RF denervation in the cervical spine was successful in 88% of patients and in 59% of patients in the lumbar spine. Success was defined as minimum 50% pain reduction for at least 3 months. The duration of success was comparable to the first RF denervation. Further studies confirmed these results.161-163 No significant differences in pain reduction were found with first, second, or third RF denervation. The duration of the effect was also not significantly different between the first, second and third RF denervation.161,162,164,165 Similar results were also described for repeating a cooled-RF on the SI joint. 166

A review 160 examined the results of a second RF denervation after an unsuccessful first denervation and found a success rate of only 38%. Lord et al 167 found a success rate of only 33% for repeated application after a short-term success <90 days after the first application. If the first RF denervation was unsuccessful, the repeat success rate was zero%.

In none of the evaluated studies retesting was performed using a medial branch block prior to repeated RF denervation (Table 16).Table 16. Literature Review of Studies About Repeat RF-Denervation.

Study	Design	Population	Results	
Schoffermann et al 2004 161	Retospective observational study	20 lumbar	The duration of success was comparable to the first RF denervation. Duration of effect was not significantly different between the first, second and third RF denervation	
Husted et al 162 2008	Retospective observational study	22 cervical	
Smuck et al 160 2012	Systematic review	115 cervical
29 lumbar	Success of repeat RF denervation: 88% cervical, 59% lumbar	
Rambaransingh et al 2010 163	Prospective observational study	15 cervical
58 lumbar	The duration of success was comparable to the first RF denervation	
Son et al 164 2010	Retospective observational study	60 lumbar	Duration of effect was not significantly different between the first, second and third RF denervation	
Kim et al 2014 165	Retospective observational study	56 lumbar	Duration of effect was not significantly different between the first, second and third RF denervation	
Kurklinsky et al 166 2020	Retospective observational study	41 SIJ	Cooled RF. Duration of effect was not significantly different between the first, second and third RF denervation	

Existing Guidelines

The NICE Guidelines 21 advise caution in recommending repeat RF denervation until more long-term data are available. The consensus guidelines 4 recommend repeat RF denervation for the lumbar spine for patients who have experienced at least 3 (or preferably 6) months of success after the first RF denervation. The Consensus-Guidelines for the cervical spine22,23 also recommend repetition after a response for at least 3 months, but no more frequently than twice a year. The guidelines of the American Society of Pain and Neuroscience (ASPN) 27 recommend repeating the cervical spine after 6 months at the earliest.Recommendations15.1 After successful RF denervation with at least 50% pain reduction for at least 3 months, another RF denervation should be offered, if the same pain recurs. (Recommendation: B, quality of evidence: low)

15.2 If a technically correct RF denervation was unsuccessful (less than 50% pain reduction or shorter than 3 months of effect), no repeat RF denervation of the same medial branches should be performed. (Recommendation: B, quality of evidence: low)

15.3 If the same pain recurs after the first successful RF denervation, no further test blocks should be carried out before another RF denervation. (Recommendation: B, quality of evidence: low)

Question 16: Do Anticoagulants and Antiplatelet Drugs have to be Stopped Before RF Denervation?

No relevant bleeding complications after RF denervation have been described in the literature.168–171 In contrast, thromboembolic complications after discontinuation of anticoagulants or platelet aggregation inhibitors are found in the literature. Although the risk is rather low, complications can be serious and even fatal. 169

Several observational studies have evaluated the risk of bleeding events in patients on anticoagulants/antiplatelets. Goodman et al 172 performed 197 interventions in 74 patients under medication without a relevant bleeding complication. Van Helmond et al 173 observed a hematoma at the puncture site of an RF denervation in one of 467 patients with medication. Ehsanian et al 174 saw no bleeding event in cervical and lumbar medial branch blocks and RF denervations with continued medication.

Endres et al169,175 conducted a comparative study in which 1 user performed interventions when continuing the medication and 1 user performed interventions when discontinuing anticoagulants or platelet aggregation inhibitors. There were no bleeding complications in either group. Only in the group of patients who had discontinued their medication thromboembolic complications occurred, some of which were catastrophic. The risk of a thromboembolic event is .48% (.2-.9%). A myocardial infarction after discontinuation of antiplatelets for lumbar RF denervation was reported by Galbraith et al. 176

A systematic review 170 evaluating 120 studies according to the GRADE system was only able to demonstrate bleeding complications for epidural injections with interlaminar access. No bleeding events have been reported in the literature for medial branch blocks or RF denervations. For lumbar medial branch block, the risk of bleeding was calculated as less than .3% on anticoagulants and less than .4% on antiplatelets (Table 17).Table 17. Literature Review of the Comparative Studies Continuing vs Discontinuing Anticoagulants or Platelet Aggregation Inhibitors.

Referenz	Design	Population /Control	Results	
Endres et al 2017 169	Retospective observational study	4766/2074
MBB: 2074/636
RF: 57/504	No bleeding complications in either group. In the group discontinuing their medication thromboembolic complications occurred, some of which were catastrophic. The risk of a thromboembolic event was .48% (.2-.9%)	
Update: Endres et al 2020 175	Retospective observational study	7004/2672
Facet joint: 3670/492
RF: 145/1180	

Existing Guidelines

The guidelines of the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anesthesia and Pain, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain 177 have lumbar RF denervation classified as a low-risk procedure (when performed with image guidance), cervical spine denervation as a medium-risk for a bleeding complication. For medium-risk interventions, it is recommended to decide on preparations with acetylsalicylic acid based on risk assessment, discontinue Coumarin and new oral anticoagulants. Discontinuation of preparations containing acetylsalicylic acid is not recommended for low-risk interventions, but a case-by-case decision is made for oral anticoagulants. The SIS Practice Guidelines 16 generally recommend not stopping the medication. However, the risk of bleeding should be individually weighed against the risk of a thromboembolic complication, with the latter risk being classified as higher. 178 For the cervical spine, it is recommended to examine the imaging regarding anatomical variants in the course of the blood vessels before an intervention.159,171 Whether anticoagulants or platelet aggregation inhibitors should be discontinued should be determined in an individual case together with the patient, considering that complications were only seen in the group of patients after discontinuation of the medication. It should always be considered not to perform an intervention on the cervical spine if the risk seems too high.Recommendations16.1 There is no evidence that continuing medication with anticoagulants or platelet aggregation inhibitors leads to a clinically relevant increased risk of bleeding. (Quality of evidence: low)

16.2 Anticoagulants or antiplatelet agents should not be discontinued prior to RF denervation of the lumbar spine or sacroiliac joint, the risk and benefit always being a case-by-case basis. (Recommendation: B, quality of evidence: low)

16.3 In the case of RF denervation of the cervical spine, an individual risk/benefit assessment should be made for each individual patient regarding continuation or discontinuation of anticoagulants or platelet aggregation inhibitors. (Recommendation: B, quality of evidence: low)

Question 17: Is Sedation Useful for RF Denervation?

In a survey of 500 patients who received an epidural or facet joint injection, 17% requested sedation prior to the injection. For a second injection, 28% would have wanted sedation. 179 Kim et al 180 offered sedation before injections to 301 patients. 58% chose sedation because of anxiety. 90% of these patients were satisfied with the anxiolytic effect. Of the patients without sedation, 93% were satisfied, only 1.5% would have liked sedation. Diehn et al 181 used sedation for transforaminal, epidural injections (indirect evidence) in only .1% of patients. The satisfaction of the non-sedated patients was still over 96%. Kennedy et al 182 studied the incidence of a vasovagal syncope with and without sedation. Out of 6364 injections (214 with sedation), 205 vasovagal reactions occurred exclusively in patients without sedation. A history of a vasovagal reaction was known in 134 patients, in 21 of 90 patients without sedation a reaction occurred again, but in none of the 44 patients with sedation (Table 18).Table 18. Literature Review of Studies Investigating Sedation.

Study	Design	Population /Control	Results	
Cucuzzella et al 2006 179	Survey	500	17% patients requested sedation prior to the injection. 28% for a second injection	
Kim et al 180 2007	Survey	176/125	58% patients chose sedation. 90% of these patients were satisfied. Of the patients without sedation, 93% were satisfied	
Diehn et al 2013 181	Retospective observational study	6871/7	Transforaminal injections (indirect evidence). Sedation in .1% of patients. The satisfaction of the non-sedated patients was >96%	
Kennedy et al 182 2015b	Prospective observational study	6150/214	Patients with/without sedation. 205 vasovagal reactions only in patients without sedation	

Existing Guidelines

The SIS Practice Guidelines 16 do not recommend sedation as routine and require that the patient be always responsive when RF denervation occurs. The NICE guidelines 21 state that RF denervation can be performed under light sedation. The American Society of Interventional Pain Physicians (ASIPP) Comprehensive Guidelines 24 state that moderate sedation can be used. The American Society of Anesthesiologists 183 issued a statement on anesthesiologic care during pain therapy interventions. In general, local anesthetic is sufficient. However, if sedation is given, the patient should be responsive to report changes in pain or sensory disturbances. Light sedation is recommended for most interventions; moderate sedation (“conscious sedation”) would be an option for RF denervation, which requires the patient to lie still for an extended period of time.Recommendation17.1 Responsive sedation can be used for RF denervation. (Recommendation: 0, quality of evidence: low)

Question 18: Is RF Denervation Possible in Patients with Metal Implants?

Several observational studies were able to demonstrate significant warming of the metal implants, but no complications were observed (Table 19).184-186Table 19. Literature Review of Studies With an RF Denervation in Patients With Metal Implant.

Study	Design	Population	Results	
Elwood et al 2018 184	Retospective observational study	36	No complications	
Abd-Elsayed et al 2019 185	Case Series	5	
Klessinger 186 2016b	Retospective observational study	40	

In a FactFinder, 158 the SIS recommends avoiding direct contact of the electrode with the metal. Existing axial imaging should be evaluated. The consensus guidelines 4 recommend using multiplanar fluoroscopic images for the LWS and avoiding direct contact of the electrode with the metal. The consensus guidelines for the cervical spine22,23 also recommend multiplanar imaging under fluoroscopy and a more posterior approach to avoid direct contact with the metal.Recommendation18.1 A multiplanar fluoroscopic view should be used to view the implant and electrode, avoiding direct contact of the electrode with the metal. (Recommendation: B, quality of evidence: low)

Question 19: Is RF Denervation Possible in Patients with Cardiac Pacemakers or SCS?

Electromagnetic fields can lead to malfunctions in implanted devices such as cardiac pacemakers, defibrillators or brain or spinal cord stimulators.187-189 There are several observational studies that have examined cardiac RF ablations (indirect evidence) in patients with pacemakers or defibrillators.189-192 In all studies, pacemaker malfunctions were observed during RF application. In some cases, the pacemaker had to be reprogrammed after the ablation. However, there was never a defect in the generator. A current retrospective cohort study 193 could not observe any significant differences in the parameters of the generators before and after cardiac ablation. Case reports on RF ablations in malignancies also show similar results.194,195

Only 2 studies refer to RF denervation of the spine. Barbieri and Bellini 196 retrospectively observed patients with RF denervations in the thoracic, lumbar, and sacroiliac spine and found no malfunctions or changes in parameters. Bautista et al 197 reported 1 case each of bipolar RF denervation of the cervical and lumbar spine without observing any malfunction of the pacemaker (Table 20).Table 20. Literature Review of Studies Investigating RF Denervation in Patients With Implanted Medical Devices.

Study	Design	Population	Results	
Pfeiffer et al 1995 189	Observational study	25	Cardiac RF ablations (indirect evidence). Pacemaker malfunctions were observed during RF application. No defect in the generator	
Ellenbogen et al 1996 190	Observational study	35	
Sadoul et al 1997 191	Observational study	38	
Burke et al 192 2001	Retospective observational study	107	
Jabri et al 2022 193	Retrospective cohort study	119	No significant differences in the parameters of the generators before and after cardiac ablation (indirect evidence)	
Tong et al 194 2004	Case report	1	RF ablations in malignancies indirect evidence). No significant differences in the parameters of the generators before and after ablation	
Donohoo et al 2007 195	Case report	1	
Barbieri & Bellini 196 2014	Retospective observational study	26	RF denervations in the thoracic, lumbar, and sacroiliac spine without malfunctions or changes in parameters	
Bautista et al 2016 197	Case report	2	Bipolar RF denervation of the cervical and lumbar spine without malfunction of the pacemaker	

Existing Guiedlines

The American Society of Anesthesiologists guideline 198 recommends keeping the high-frequency electric field as far away from the pacemaker electrodes as possible. The consensus guidelines4,22,23 also recommend a distance of at least 15 cm between the neutral electrode and pacemaker electrodes. The SIS recommends close cooperation with an experienced cardiologist even before the RF denervation. 199 Recommendations19.1 RF denervation in patients with an implanted pacemaker or defibrillator should be done in close collaboration with a cardiologist. (Recommendation: A, quality of evidence: very low)

19.2 The neutral electrode should be placed in such a way that the electrical field between the lesion electrode and the neutral electrode does not affect the pacemaker/defibrillator. (Recommendation: B, quality of evidence: very low)

19.3 An implanted neurostimulator should be turned off for the duration of RF denervation. (Recommendation: EC)

Question 20: What are Typical Complications of RF Denervation?

No RCT reported deaths after a RF denervation. Likewise, no serious or life-threatening complications were mentioned. Several studies only generally reported that no complications had occurred.89,92,93,97,99,101 In 1 study, 96 the incidence of pain, sensory disturbances, and motor deficit in the RF group was compared with that in the sham group; there were no significant differences. In an RCT on RF denervation of the cervical spine, Lord et al 15 reported the occurrence of sensory disturbances, which were found in five of 12 patients after RF denervation, in addition a Koebner's phenomenon was found in 1 patient. At the SI joint, Cohen et al 98 reported sensory disturbances in one of 14 patients in the RF group in their RCT (Table 21)Table 21. Literature Review of Randomized Studies Investigating Complications in the Lumbar Spine.

Study	Design	Population /Control	Results	
Gallagher et al 92 1994	RCT	22/17	Lumbar spine. No complications	
Lord et al 1996 15	RCT	12/12	Cervical spine. Sensory disturbances, in 5/12 patients after RF denervation. Koebner's phenomenon in 1 patient	
van Kleef et al 1999 101	RCT	15/16	Lumbar spine. No complications	
Leclair et al 2001 93	RCT	36/34	
van Wijk et al 96 2005	RCT	40/41	Lumbar spine. No significant differences in the incidence of pain, sensory disturbances, and motor deficit	
Tekin et al 2007 97	RCT	20/20	Lumbar spine. No complications	
Nath et al 2008 89	RCT	20/20	
Cohen et al 98 2008a	RCT	14/14	Sacroiliac joint. Sensory disturbances in 1/14 patients	
Patel et al 2012 99	RCT	34/17	Sacroiliac joint. No complications	

.

In an observational study 168 with 26,151 interventions (181 medial branch blocks, 86 RF denervations), 11 procedures were terminated prematurely. 5 vasovagal syncopes were observed when performing medial branch blocks. Neurological complications and bleeding events did not occur. Another observational study 200 observed pain or neuropathic pain for more than 2 weeks in 1% of the patients (116 RF denervations). These complications are usually self-limiting and classified as mild. Other complications did not occur. In a review by Engel et al 201 on RF denervations of the cervical spine with evaluation of the literature according to GRADE criteria, 4 observational studies were evaluated regarding risks. With low-quality evidence, no serious complications were found (Table 22).Table 22. Literature Review of Observational Studies Investigating Complications in the Lumbar Spine.

Study	Design	Population /Control	Results	
Carr et al 168 2016	Retrospective observational study	86	5 vasovagal syncopes during medial branch blocks	
Kornick et al 200 2004	Retrospective observational study	92	Pain or neuropathic pain for more than 2 weeks in 1% of the patients	

The studies show that prolonged pain is the most common complication after RF denervation96,200 followed by sensory disturbances.15,96,98 Neuropathic pain has already been described by Bogduk 202 in a case report. In the case of denervation of the “Third Occipital Nerve” (TON), ataxia is mentioned as a typical temporary side effect,203,204 and temporary sensory disturbances or dysesthesia 203 are described in many patients. In a study by Gazelka et al 205 neuralgia after RF denervation of the TON was reported in 12 of 64 patients without neurological deficits.

Dreyfuss et al 206 were able to demonstrate diffuse atrophy of the multifidus muscle in 5 patients after 17 to 26 months after unilateral RF denervation. However, the 3 blinded radiologists were only able to correctly identify the side and level of the lesion in 1 patient. Clinical consequences of the atrophy were not found. Smuck et al 207 found no significant difference in the area of the multifidus muscle or negative changes in the facet joints in 27 patients after RF denervation, but increased degeneration of the intervertebral discs. Another study 208 examined the proportion of fat tissue in the multifidus muscle before and at least 6 months after RF denervation. A difference in relation to fatty degeneration could not be determined.

Skin burns due to the lesion extending too far, 209 the neutral electrode 210 or a malfunction of the RF generator 211 are conceivable and described as case reports in the literature.212,213 There may be an increased risk with cooled-RF due to the larger lesion 214 and with strip electrodes. 209

Injuries to the lumbar spinal nerves are rare. A single case report describes radicular L5 pain and sensory disturbances after RF denervation. 215 Bogduk et al. 216 describe 2 unpublished spinal cord injuries after cervical RF denervation, 1 with the development of Brown-Séquard syndrome and 1 infarction with probably coagulation of an artery supplying the spinal cord in the foramen. Donohue and White 217 describe a thoracic spinal cord change after an RF denervation of the thoracic spine, without being able to clarify the mechanism of the injury.Recommendations and statements20.1 Serious complications are very rare after RF denervations (only single cases in the literature). (Quality of Evidence: low)

20.2 It is important to include existing imaging (particularly MRI) for anatomical variants (eg, course of the vertebral artery) in planning for RF denervation of the cervical spine. (Recommendation: EC)

20.3 It is important to inform patients prior to RF denervation of the possibility of a transient increase in pain or of prolonged pain and dysesthesia. Pain that lasts longer than 2 weeks is very rare. (Recommendation: EC)

Discussion

Unlike standards that offer little room for deviation, guidelines tend to be more flexible and allow for variations based on physician judgment and unique patient characteristics. For areas of medicine with there is a lack of high-quality clinical trials to guide treatment and a consensus regarding best practices, the development of inclusive guidelines becomes even more important.

A multidisciplinary expert group formulated a national clinical guideline for RF denervation of the facet joints and the SI joint. These guidelines were developed to serve as a roadmap for physicians who treat cervical, lumbar, and sacral joint pain and for interested patients. There can be wide variations in the conclusions of experts from different specialties on the effectiveness of pain management procedures. Reasons for incongruities include conscious and unconscious bias, differences in patient selection and in the technical implementation of the RF denervation.

Strengths of this national clinical guideline include the interdisciplinary chairmanship by the German Spine Society (DWG), the rigorous adherence to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach for assessing the overall quality of evidence, and the rigorous adherence to relevant scientific standards. Furthermore, the guideline working group were composed of clinicians and academic researchers with a range of professional backgrounds, as well as relevant professional societies. Finally, the guidelines were peer-reviewed by the Association of the Scientific Medical Societies of Germany (AWMF) who provided detailed comments which resulted in revisions and clarifications prior to release of the final report. All participating organizations approved the document.

The main weakness of this work relates to the limited scientific evidence for some recommendations due to the lack of published clinical trials in some areas; therefore, the recommendations are mostly based on low quality of evidence. We chose 20 key questions to address in these guidelines, but this list is by no means exhaustive. In many cases, the answers to the questions we addressed will be controversial because there are gaps in the literature. Areas of controversy include all aspects of lumbar facet joint arthropathy, such as the value of history and physical examination and imaging, how to perform and interpret diagnostic injections, and technical aspects of the RF denervation.

Conclusion

Clinical trials evaluating RF denervation are characterized by widely disparate outcomes, and there is enormous variation in selecting patients and performing procedures. A multidisciplinary working group developed a national clinical guideline for RF denervation of the spine and the SI joint in adult patients. These multi-society guidelines have been developed to improve outcomes, enhance safety, and minimize unnecessary tests and procedures.

The recommendations are based on limited evidence or on consensus but are well aligned with recommendations from similar international guidelines. The guideline working groups strongly recommend that research efforts in relation to all aspects of the management of LBP and RF denervation be intensified.

ORCID iDs

Stephan Klessinger https://orcid.org/0000-0003-1180-9908

Martin Vazan https://orcid.org/0000-0003-3245-1941

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Potential conflicts of interest have been declared by all involved partners and made publicly available on the webpage of The Association of the Scientific Medical Societies of Germany (AWMF): https://register.awmf.org/de/leitlinien/detail/004-151. No member of the guideline developing group had a high risk of conflict of interest.

Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.

Publication: The national clinical guideline on radiofrequency denervation of the spine and the sacroiliac joint has been published and is electronically available at https://register.awmf.org/de/leitlinien/detail/004-151.
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