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10.1136/bmjopen-2023-082272
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Protocol
Complementary Medicine
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Protocol for systematic review and meta-analysis on the efficacy and safety of acupuncture for residual low back pain after percutaneous kyphoplasty in patients with osteoporotic vertebral compression fracture
http://orcid.org/0000-0001-7283-5902
Liu Xuhao 10806411567@qq.com

Liu Hongyan 10986996769@qq.com

Dong Yuanwei 10499082791@qq.com

Yang Xiaolong 1804111601@qq.com

Zou Jinwen 11428138755@qq.com

Ren Liangjuan 1450310677@qq.com

Liao Tiannan 12015397878@qq.com

Gou Xin 1280967392@qq.com

1 Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

None declared.

TiannanLiao; 2015397878@qq.com
XL, HL and YD are joint first authors.

2024
29 8 2024
14 8 e08227218 11 2023
22 7 2024
Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
2024
https://creativecommons.org/licenses/by-nc/4.0/ This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

ABSTRACT

Introduction

Osteoporotic vertebral compression fracture (OVCF) is a common complication in elderly patients with osteoporosis. Despite undergoing percutaneous kyphoplasty (PKP) treatment, a significant percentage of OVCF patients (1.8% to 31.9%) continue to experience residual low back pain. While acupuncture has shown promise in relieving this pain, there is currently no systematic review on its efficacy specifically for residual low back pain after PKP in OVCF patients. This project aims to evaluate the effectiveness and safety of acupuncture as a treatment for this condition.

Methods and analysis

A comprehensive search will be conducted, including manual and electronic searches of literature published. Various databases such as MEDLINE, PubMed, EMBASE, Web of Science, Cochrane Library, International Clinical Trial Registration Platform, China National Knowledge Network, China Biomedical Literature Database, China Scientific Journal Database and Wan-fang Database will be explored. Additional sources like bibliographies and meeting minutes will also be searched. All randomised controlled clinical trials related to acupuncture for treating residual low back pain after PKP in OVCF patients will be included. Two researchers will independently perform study selection, data extraction and quality assessment. The primary outcome measure will be pain relief assessed using a visual analogue scale (VAS) or other validated scales. Secondary outcomes include effectiveness, Oswestry dysfunction index (ODI), quality of life questionnaire (QUALEFFO-41), follow-up relapse rate and adverse events. If feasible, a meta-analysis using RevMan V.5.3 software will be conducted. Otherwise, descriptive or subgroup analyses will be performed. Database searches will commence after the publication of this agreement, with an estimated commencement date of 1 August 2024.

Ethics and dissemination

Ethical approval is not required since this review does not involve individual patient data. The findings will be disseminated through peer-reviewed journals or relevant conferences.

PROSPERO registration number

CRD42023478838.

China
Chronic Pain
COMPLEMENTARY MEDICINE
Rehabilitation medicine
Back pain
Spine
the Key R&D projects of the Sichuan Provincial Department of Science and Technology No. 2018SZ0084 Sichuan Provincial Cadre Health Research Project No：CGB2024512 Sichuan Provincial Administration of Traditional Chinese Medicine Special Research Project of Traditional Chinese Medicine No. 2021MS003 Chengdu Science and Technology Bureau Key R&D support program technology innovation R&D project No. 2022-YF05-02035-SN
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pmcStrengths and limitations of this study

By qualitatively estimating and quantitatively synthesising subjective and objective outcome indicators, this review aims to comprehensively evaluate the effectiveness and safety of acupuncture in treating residual low back pain after percutaneous kyphoplasty in osteoporotic vertebral compression fracture patients.

We will conduct extensive and comprehensive searches of relevant randomised controlled trials on multiple electronic databases in both Chinese and English.

The limited number of studies ultimately included in the analysis was a major limitation of our study.

Due to the specific nature of acupuncture, conducting double-blind studies is challenging, which may introduce potential bias.

Considerable heterogeneity may arise from the different types of acupuncture treatments used in the included studies.

Introduction

Description of the condition

As the ageing society continues to rapidly develop, the incidence of osteoporosis (OP) is also increasing annually, and its detrimental effects are worsening.1 OP not only leads to a decrease in bone mass and degeneration of bone structure, but it also increases bone fragility and reduces bone strength.2 Consequently, older patients face an elevated risk of fractures, even with minor or no external force.3 The most common complication is osteoporotic vertebral compression fracture (OVCF), which is closely associated with race, gender and age.4 OVCF often results in persistent low back pain that hampers mobility and impairs normal function, significantly reducing overall quality of life.5

Currently, the main treatment methods for OVCF in clinical practice are non-surgical treatment and surgical treatment; non-surgical treatment primarily involves bed rest, analgesic medication, physical therapy and active anti-OP treatment to achieve fracture healing and pain relief.6 However, this treatment approach has a lengthy cycle, and prolonged bed rest can lead to further bone loss, increasing the risk of fractures in other areas such as the femoral neck; additionally, complications like bedsores, lung infections and lower extremity vascular embolism may arise.7 Lee et al found that the pain improvement rate of OVCF patients treated non-surgically was only 65%, indicating unsatisfactory therapeutic outcomes.8

Given the challenges presented by non-surgical treatment, minimally invasive vertebral augmentation, specifically percutaneous vertebroplasty (PVP) and PKP, has become the primary clinical treatments for OVCF; both surgical techniques offer advantages such as reduced trauma, faster recovery and high safety, making them widely used in clinical practice.9 However, compared with PKP, PVP is less effective in correcting kyphotic deformity and carries a relatively higher risk of bone cement leakage after surgery.10 Consequently, PKP gradually becomes the preferred choice for OVCF treatment.

Although the clinical efficacy of vertebral augmentation surgery for OVCF is well-documented, studies have indicated that approximately 1.8%–31.9% of patients treated with this procedure experience residual low back pain requiring clinical intervention.11 The extent and severity of residual low back pain after PKP in OVCF patients varies among individuals, which may result from multiple factors.12 Some researchers have suggested that the amount of bone cement injected, the timing of injection and the injury to the lower back muscles at the fracture site may contribute to residual low back pain after PKP.13 The complex pathogenic mechanism further complicates clinical treatment; residual low back pain after vertebral augmentation not only prolongs the postoperative recovery time but also increases the likelihood of related complications.14 It also reduces patient satisfaction and trust in the treatment.

Modern medicine aims to relieve pain and improve mobility, function and quality of life in interventions for residual low back pain after PKP in OVCF patients, so non-surgical first-line treatment options, including anti-inflammatory drugs, physical therapy, education and epidural steroid injections, are recommended.15 However, the efficacy of pain relief varies, and these drugs carry varying degrees of side effects. Therefore, combining other complementary and alternative therapies with the treatment of OVCF combined with PKP residual low back pain is necessary to achieve better therapeutic outcomes.16

Description of the intervention

Historically, acupuncture has been widely recognised and used as a complementary and alternative therapy, which has shown significant clinical results in the treatment of a variety of conditions, including but not limited to chronic pain syndrome (Vickers et al),17 postoperative pain (Sun et al),18 migraines (Linde et al),19 osteoarthritis (Corbett et al)20 and nausea/vomiting associated with chemotherapy (Ezzo et al).21 Acupuncture relieves pain, tension and stress by inserting fine needles into the skin to stimulate nerves, muscles and connective tissues throughout the body with very rare serious side effects (Patil et al).22

Since 1980, WHO has recommended acupuncture as an alternative therapy for 43 different diseases.23 Studies have shown that approximately 8 million Americans have received acupuncture treatment for chronic pain such as arthritis, lower back pain and migraines; consequently, acupuncture is often used as a complementary therapy alongside conventional medication for pain in the United States.24

How the intervention might work?

According to traditional Chinese medicine, pain arises from the disharmony of Zang-fu, meridians, Qi and blood circulation, resulting in disrupted functioning. Acupuncture treatment aims to restore balance in Zang-fu organs by stimulating and warming acupuncture points, thereby unblocking and promoting the flow of Qi and blood. This helps improve the condition of diseased areas, restore the balance of Qi, blood and Yin and Yang and alleviate pain.

Modern research suggests that apart from the pain centre in the central nervous system, there exists a ‘pain modulation system’ at all levels of the central system that can inhibit pain transmission to the centre.25 After acupuncture signals enter the central system, they activate numerous neurons at different levels ranging from the spinal cord and brainstem to the brain.26 This activation stimulates the body’s analgesic system, leading to increased secretion of analgesic substances like 5-hydroxytryptamine and acetylcholine.27 Acupuncture activates endogenous opioid mechanisms, enhances endogenous opiates such as enkephalins, dynorphins and endorphins, and releases corticosteroids to enhance the healing process (Kaptchuk),28 ultimately producing noticeable analgesic effects.

Objectives

The main objectives of this study are to evaluate the efficacy and safety of acupuncture in treating residual low back pain after PKP in patients with OVCF.

Methods and analysis

Study registration

This protocol report adheres to the guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) statement.29 The study has been registered in PROSPERO with the registration number CRD42023478838. We will follow the PRISMA guidelines and the recommendations outlined in the Cochrane Handbook for Systematic Reviews of Interventions.30 31 Any procedural refinements made during the study will be updated in the PROSPERO record and disclosed in future publications related to this study.

Inclusion criteria for study selection

Types of study

This review will include all randomised controlled trials (RCTs) that meet the inclusion criteria and investigate the use of acupuncture in the treatment of residual low back pain after percutaneous kyphoplasty (PKP) in patients with osteoporotic vertebral compression fractures (OVCF). Articles in languages other than English and Chinese, conference abstracts and other informal publications, secondary literature, news reports, case reports and other research materials and literature for which the full text of the study is not available will not be included.

Types of participants

Participants aged 60 years or older with a diagnosis of OVCF and residual low back pain after PKP will be included regardless of gender, race, education or economic status. The diagnostic criteria are as follows：

Cases by the Chinese Expert Consensus on Osteoporosis Diagnosis (Third Draft, 2014 Edition)32 and the OVCF treatment guidelines,33 and who had previously undergone surgical treatment with PKP.

Significant postoperative low back pain remained and the patient had a VAS score of ≥3.

Diagnostic criteria are defined by the authors or defined by the clinician.

Participants self-reported low back pain.

The exclusion criteria are as follows:

Those who develop other complications after surgery.

Those with other causes of low back pain.

Those with the presence of significant medical conditions.

Those with incomplete case data to evaluate the efficacy of the treatment.

Types of intervention

The experimental group in the included studies will receive acupuncture treatment targeting residual low back pain following PKP in patients with OVCF. The acupuncture techniques employed may encompass diverse approaches such as body acupuncture, electroacupuncture, scalp acupuncture, abdominal acupuncture, acupoint burying thread, warm acupuncture and other relevant acupuncture techniques. The control group will receive no intervention, sham acupuncture intervention, placebo intervention or nonsteroidal drugs (NSAIDs) therapy as a comparison method.

The following treatment comparisons will be investigated:

Acupuncture compared with no intervention;

Acupuncture compared with sham acupuncture intervention;

Acupuncture compared with placebo intervention;

Acupuncture compared with NSAID therapy.

We will evaluate and compare acupuncture based on factors such as acupuncturists’ training and education, clinical experience, total number of acupuncture sessions, treatment time and frequency, etc.

Types of outcome measures

Primary outcomes

VAS for pain assessment

ODI for functional impairment assessment.

QUALEFFO-41 for assessing quality of life

Secondary outcomes

Changes in serum levels of amino-terminal prolonging peptide (P1NP), bone alkaline phosphatase (BALP) and cross-linked C-terminal peptide (β-CTX) of type I collagen.

Relapse rate during follow-up.

Adverse events, including haematoma, syncope, infection and dropout rate.

Search methods for identification of studies

Data sources

We expect to begin a comprehensive search of all RCTs of acupuncture for residual low back pain after PKP in patients with OVCF in the following database on 1 August 2024. The search will include both electronic and manual methods, without restrictions on publication status or language. The following databases will be searched: PubMed, EMBASE, Web of Science, Cochrane Library, WHO International Clinical Trial Registration Platform, Traditional Chinese Medicine Database, China National Knowledge Network, China Biomedical Literature Database, China Scientific Journal Database and Wan-fang Database. Additionally, other sources such as bibliographies of identified publications and meeting minutes will also be searched.

Search strategy

The search strategy will adhere to the PRISMA guidelines. The key search terms used in the strategy are ("chronic low back pain" "back pain" OR "lumbar pain" OR "residual low back pain") AND ("acupuncture" OR "electro-acupuncture" OR "traditional Chinese acupuncture therapy" OR "complementary acupuncture therapy" OR "warm needle") AND ("osteoporosis" OR "osteoporotic vertebral compression fracture" OR "osteoporotic fractures" OR "PKP" OR "percutaneous kyphoplasty" OR "PVP" OR "percutaneous vertebroplasty") AND ("randomized"). The search strategy will be adjusted according to the specific requirements of each database. The search strategy is presented in the online supplemental appendix 1online supplemental appendix 1.

Data collection and analysis

Selection of studies

Before commencing the formal literature search, all reviewers will receive training on the background and purpose of the review research. EndNote software (V.X8) will be used for document management and screening of retrieved documents. Two review authors (XL and YD) will independently screen all retrieved studies based on the title, abstract and keywords, following the inclusion criteria. We will assess whether the original article meets the criteria of a RCT using the Consolidated Standards of Reporting Trials 2010 checklist. Excluded studies will be recorded, and reasons for exclusion will be noted. In case of any disagreements during the selection process, they will be resolved through discussion between the two authors (XL and YD) or with the involvement of a third author (XG) if necessary. If needed, contact will be made with the authors of the trials for clarification. The main selection process will be presented in a PRISMA flowchart (figure 1).

Figure 1 Flow diagram of studies identified.

Data extraction and management

The two authors (XL and YD) will independently extract data from the included literature and complete a data extraction form. General information, participant characteristics, methods, interventions, outcomes, adverse events, conflicts of interest, ethical endorsements and other relevant information will be collected. In cases where the literature data is incomplete or unclear, the corresponding author will be contacted via email or telephone for additional information. Any disagreements between the two authors regarding data extraction will be discussed and resolved. If necessary, the third author (XG) will be consulted for arbitration.

Management of missing data

If any preliminary results data are missing or incomplete, efforts will be made to contact the corresponding author to obtain the missing information. If the missing data cannot be obtained, the literature will be excluded from the analysis.

Assessment of risk of bias and reporting of study quality

Risk of bias assessment for all included literature will be conducted by the authors (XY and JZ) using the Cochrane Collaboration’s risk of bias assessment tool. The domains assessed include sequence generation, allocation concealment, blinding of participants, personnel and outcome assessors, incomplete outcome data, selective outcome reporting and other sources of bias. The risk of bias will be categorised as low (L), unclear (U) or high (H). Disagreements between the two authors will be resolved by the third author (XG). Bias risk assessment information will be summarised in tabular form, and critical discussions on the results and implications will be provided. If necessary, contact with the study authors will be attempted for clarification. In cases of replicated articles, only the original text will be selected.

Statistical analysis

Data analysis and quantitative data synthesis will be performed using RevMan V.5.3 software. We will use the mean difference (MD) or standard mean difference (SMD) as the measure of treatment effect for continuous data. Additionally, 95% CI will be provided. In cases where there is no significant heterogeneity among the continuous data, MD or SMD will be used. In the presence of significant heterogeneity, a random effects model will be employed. In the context of this study, heterogeneity could arise due to clinical heterogeneity and methodological heterogeneity factors, such as patient characteristics, intervention types, or study design. The χ2 test will be used to check for heterogeneity, the I2 statistic will reflect the degree of heterogeneity. The I2>50% indicates considerable heterogeneity among the studies. To determine the specific reasons for heterogeneity, we will explore potential sources through subgroup analyses and sensitivity analyses. For binary data, the risk ratio (RR) with a 95% CI will be used for analysis.

Assessment of reporting bias

If more than 10 trials are included, reporting bias will be assessed using funnel plots. If asymmetry is detected in the funnel plot, the Egger method will be used to assess the potential for publication bias. However, it’s important to note that while the Egger method can help detect publication bias, it may not necessarily identify the specific cause of heterogeneity. All eligible studies, regardless of methodological quality, will be included in the analysis. Assessment of clinical heterogeneity: by describing differences in study participants, interventions, measurements and study settings, we will assess whether these differences affect the interpretation of study results and discuss their possible implications. Assessment of methodological heterogeneity: by describing the study design, risk of bias assessment, data extraction methods and statistical analysis strategies, we will discuss how these methodological differences affect the reliability of the interpretation of results.

Subgroup analysis

In our research analysis, we will use both stratified and subgroup analyses to ensure a comprehensive and scientific evaluation of acupuncture treatments for residual lower back pain following PKP. First, the experimental group will be stratified based on different acupuncture techniques (such as body acupuncture, electroacupuncture, scalp acupuncture, etc.) to study their effects on alleviating residual lower back pain after PKP. The control group will be categorised based on the type of intervention received, including no intervention, sham acupuncture, placebo or NSAID treatment, to ensure effective comparative analysis. Additionally, factors such as the acupuncturist’s training background, clinical experience, number of acupuncture sessions, treatment duration and frequency will be integrated to ensure the scientific reliability of the study results.

To account for the significant differences in the studies, we will perform subgroup analyses to investigate the possible reasons behind this variation. These analyses will group studies based on clinical and methodological factors, including demographic characteristics (such as age, gender and baseline pain severity), duration of postoperative residual lower back pain and the methodological quality of the studies. In evaluating the impact of different acupuncture techniques (eg, electroacupuncture, body acupuncture and warm needle acupuncture), treatment frequency and duration on therapeutic efficacy, we will compare treatment outcomes across different subgroups to more accurately assess the role of specific factors in observed heterogeneity.

Through this integrated approach, we aim to comprehensively evaluate the effects of different interventions on lower back pain symptoms, while ensuring the scientific rigour and reliability of the study design and data analysis.

Sensitivity analysis

we will conduct sensitivity analyses to examine the impact of excluding studies with certain characteristics or methodological limitations. First, we will evaluate the influence of excluding studies with a high risk of bias or studies with a small sample size on the pooled effect estimates. Furthermore, we will investigate the impact of different statistical models, such as fixed-effects and random-effects models, on the overall treatment effect estimates. Finally, we will also be performed to assess the influence of different data imputation methods for missing data or the exclusion of studies with incomplete outcome data. These will help us understand whether particular studies disproportionately affect the overall treatment effect, potentially contributing to heterogeneity.

Grading the quality of evidence

The quality of evidence for all findings will be assessed using the recommended methodology of the Grading of Recommendations, Assessment, Development and Evaluation Working Group. The aspects that will be evaluated include risk of bias, consistency, directness, accuracy and publication bias. The ratings will be categorised as high, medium, low or very low.

Patient and public involvement

Patients and/or the public were not involved in the design, conduct, reporting or dissemination plans of this research.

Discussion

OVCF is a common complication of OP in the elderly, leading to persistent back and lower back pain. This significantly impacts the mobility and quality of life of elderly patients and even poses a threat to their lives. Although PKP surgery has shown promising clinical treatment effects, some patients still experience residual low back pain. In response to this issue, Western medicine primarily relies on anti-inflammatory analgesia and oral nonsteroidal anti-inflammatory drugs. However, long-term use of these drugs can cause significant damage to the gastrointestinal tract.34 Therefore, there is an increasing interest among clinicians in studying complementary and alternative therapies. Acupuncture, an integral part of traditional Chinese medicine, has been widely used in various diseases and has demonstrated remarkable clinical efficacy, gaining popularity among both Chinese and Western clinicians.

Clinical trials investigating acupuncture for the treatment of residual low back pain after PKP in OVCF patients have yielded varying conclusions due to differences in observational indicators and clinical efficacy measures. To address the inconsistencies and provide additional clinical evidence for treating residual low back pain after PKP in OVCF patients, we conducted a systematic review and meta-analysis. Following the Cochrane method and combining domestic and foreign clinical RCT evidence, we searched and screened major electronic literature databases to identify relevant studies. The systematic review process involved literature identification, inclusion criteria, data extraction and comprehensive analysis of the data. We aim to provide clinicians with compelling evidence for the treatment of residual low back pain after PKP in OVCF patients.

Ethics and communication

Since we are not directly targeting individuals or extracting data without privacy, formal ethical approval is not required. The research findings will be disseminated through peer-reviewed publications or conference presentations.

supplementary material

10.1136/bmjopen-2023-082272 online supplemental file 1

Acknowledgements

We would like to express our gratitude to all authors for their contributions to this paper, as well as to the reviewers for their valuable criticisms and corrections.

Review Process File
29 08 2024

Funding: This work was supported by the Chengdu Science and Technology Bureau Key R&D support programme technology innovation R&D project (No. 2022-YF05-02035-SN), the Sichuan Provincial Administration of Traditional Chinese Medicine Special Research Project of Traditional Chinese Medicine (No. 2021MS003) and the Key R&D projects of the Sichuan Provincial Department of Science and Technology (No. 2018SZ0084) and Sichuan Provincial Cadre Health Research Project (No. CGB2024512).

Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2023-082272).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Not applicable.

Patient and public involvement: Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
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