==== Front PainPainJPAINPainJOPPain0304-39591872-6623Wolters Kluwer Philadelphia, PA PAIN-D-17-0121010.1097/j.pain.000000000000121600005Research PaperEarly workplace dialogue in physiotherapy practice improved work ability at 1-year follow-up—WorkUp, a randomised controlled trial in primary care Sennehed Charlotte P. abc*Holmberg Sara cdAxén Iben eStigmar Kjerstin bfForsbrand Malin abgPetersson Ingemar F. ahGrahn Birgitta abca Department of Clinical Sciences Lund, Orthopedics, Lund University, Lund, Swedenb Epidemiology and Register Center South, Skåne University Hospital, Lund, Swedenc Department of Research and Development, Region Kronoberg, Växjö, Swedend Division of Occupational and Environmental Medicine, Institute of Laboratory Medicine, Lund University, Lund, Swedene Unit of Intervention and Implementation Research for Worker Health, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Swedenf Department of Health Sciences, Lund University, Lund, Swedeng Blekinge Center of Competence, Blekinge County Council, Karlskrona, Swedenh Skåne University Hospital, Sweden* Corresponding author. Address: Department of Research and Development, Region Kronoberg, Box 1223, 35112 Växjö, Sweden. Tel:. +46720 8312978. E-mail address: charlotte.sennehed@kronoberg.se (C.P. Sennehed).8 2018 15 3 2018 159 8 1456 1464 14 12 2017 28 2 2018 12 3 2018 Copyright © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the International Association for the Study of Pain.2018This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.An early workplace dialogue with the employer in addition to physiotherapy significantly improved work ability in comparison with structured physiotherapy only. Abstract Workplace involvement in rehabilitation for patients with musculoskeletal pain may improve work ability. Convergence Dialogue Meeting (CDM) is a model aimed at helping the patient, the care giver, and the employer to support work ability and return-to-work. Our aim was to study the effect on work ability when adding a workplace dialogue according to CDM in physiotherapy practice for patients with pain in ordinary primary care. We conducted a prospective pairwise cluster randomised controlled trial (ClinicalTrials.gov ID: NCT02609750) in primary care involving 20 primary care rehabilitation units with 1-year follow-up. Adult patients with acute/subacute neck and back pain, worked ≥4 weeks past year and not currently on sick leave or no more than 60 days of sick leave and considered at-risk of sick leave were included (n = 352). All patients received structured physiotherapy and the intervention was the addition of CDM, delivered by the treating physiotherapist. The main confirmatory outcome, work ability (defined as working at least 4 consecutive weeks at follow-up), was assessed by a weekly short text message question on number of sick leave days past week. Work ability was reached by significantly more patients in the intervention group (108/127, 85%) compared with the reference group (127/171, 74%) (P = 0.02). The intervention increased the odds of having work ability at 1-year follow-up, also after adjustment for baseline health-related quality of life (odds ratio 1.85, confidence interval 1.01-3.38). We conclude that an early workplace dialogue in addition to structured physiotherapy improved work ability significantly. Keywords: Work abilityWorkplace dialogueNeck and back painSick leavePrimary careOPEN-ACCESSTRUE ==== Body 1. Introduction Work disability due to musculoskeletal pain is one of the main causes of sick leave in western societies,5,19,53 and these patients constitute a large group seeking help in primary care.26,30 Work disability causes both personal, economic, public, and health burdens6 as well as productivity losses.11 During 2012, 20% to 30% of the total number of visits to primary care in Sweden were patients with musculoskeletal pain,49 and patients with back pain used twice as much health care resources compared with the overall population.27 The recurrence of such pain is high, about one-third of patients with previous acute back pain will have a recurrence episode within 1 year.38 The odds of a recurrence within 1 year triple when the patient experiences more than 2 previous episodes of back pain.38 Work ability is a concept that is described from different perspectives34 but in general as a relational concept, ie, that an individual's capacity must be viewed in relation to different work demands34 and can relate to either continuing work, avoiding sickness absence, or returning to work after sick leave. Reported predictors of work ability are physical demands at the workplace,45 workplace involvement and interventions,4,15,22,36,51 income level,47 urban or rural residence32 psychological factors,20 pain and disability levels, educational level and socioeconomic status, workplace factors,12,25 health-related quality of life,21 and self-prediction of possible return-to-work.12,31,35 A recent review on interventions with the intention to reduce sick leave for patients with musculoskeletal pain have shown evidence for multidomain interventions including workplace modifications.16 The SWAP study found that a vocational advice service in primary care was successful in improving work ability for patients with musculoskeletal pain.54 “Convergence Dialogue Meetings” (CDMs) were developed in Sweden for patients on sick leave due to burnout.29 The CDM model is a 3-step structured interview model where the patient, the health care provider, and the employer meet for shared discussions on concrete suggestions and actions to support sustainable work ability and, when applicable, return-to-work. The CDM model has been shown to improve return-to-work for patients on long-term sick leave due to burnout.28 The CDM model has so far not been tested for patients with musculoskeletal pain consulting in primary care. Most patients in working age with musculoskeletal pain consulting physiotherapy in primary care are in early stages of illness/disease and mostly in work. Traditionally, the treatments in primary care have focused on pain reduction and promotion of function. Despite the fact that musculoskeletal pain is a strong risk factor for disability and work loss,5,19,26,30,53 primary care has not so far focused on promoting work ability in early stages of illness. The aim was to study the effect of an early workplace intervention with CDM on work ability for patients with acute/subacute neck/back pain in ordinary primary care when added to structured physiotherapy. 2. Methods 2.1. Design We conducted a pairwise prospective cluster randomised controlled trial, with inclusion of patients from January 2013 through December 2014, ClinicalTrials.gov ID: NCT02609750. The WorkUp study was approved by the Regional Ethical Review Board in Lund Dnr 2012/497 (September 28, 2012), Dnr 2012/648, (October 30, 2012), and Dnr 2012/833 (January 9, 2013). 2.2. Outcome The predefined main confirmatory outcome was work ability measured as no days of sick leave or disability pension for 4 consecutive weeks at 1 year after baseline.23 In this study, having work ability was defined as working or being eligible to the labor market. Thus, we defined work ability as any paid work, regardless of any adjustments in work duties or of working time. Because this study includes early cases, work adjustments are expected to be few. 2.3. Setting All existing public and private primary care centers in Southern Sweden (n = 210) that were accredited and tax-financed by the county councils in Skåne, Kronoberg, and Blekinge were invited to participate in the study. Within these centers, primary care patients have open access to physiotherapy, and in Swedish health care, physiotherapy is often the first-line treatment for patients with musculoskeletal pain. Primary care physiotherapy is organised in different ways, some centers have their own physiotherapists, but most have it in common with others at primary care rehabilitation units. If the patient is unable to work, there is a need for a doctor's certificate from day 8 that confirms a diagnosis, the functional limitation, and activity restriction. In Sweden, the first 14 days of sick leave are paid by the employer, but sick leave longer than 14 days is economically compensated by the Swedish Social Insurance Agency. 2.4. Randomisation In total, 32 primary care centers corresponding to 20 primary care rehabilitation units stated an interest in participating in the WorkUp study. These rehabilitation units were classified based on size (registered population), community size of the units' location, and the patients' morbidity; Adjusted Clinical Groups13,44,52 and socioeconomic status; and Care Need Index.39,48 Primary care rehabilitation units that were as similar as possible, based on the criteria above, were matched in pairs. The randomisation process was performed by an independent statistician who used a computer-generated program (random sample uniform distribution). The primary care rehabilitation units' pairs were randomised pairwise to 10 intervention primary care rehabilitation units and 10 reference primary care rehabilitation units (Fig. 1). The primary care rehabilitation units' staff (including physiotherapists) and the patients could for obvious reasons not be blinded to allocation. Each included primary care rehabilitation unit, and all physiotherapists working at the unit were either an intervention unit or a reference unit, never mixed. Figure 1. Flowchart of inclusion and follow-up of primary care rehabilitation units. The proportion of patients who reported days on sick leave past week, by answering the text message. 2.5. Population Patients, 18 to 67 years of age, seeking physiotherapy in ordinary primary care due to acute or subacute (<12 weeks) neck and/or back pain were eligible for inclusion. It could hence be either a first episode or a recurrent episode of neck and/or back pain after a period of at least 3 months of no substantial pain. Patients not on sick leave or with no more than 60 days of sick leave and considered at-risk by scoring ≥40 points at the “ÖMPSQ-short”37 and who had been working at least 4 consecutive weeks the past year were asked to participate in the study. The cutoff for the ÖMPSQ short is normally set at ≥50 points, but we decided to lower this cutoff to ≥40 points. The lower cutoff was chosen because we wanted to include patients at-risk for work disability at an early stage and clinically relevant for treatment in primary care. Exclusion criteria were: full time disability pension, addiction diagnose, on-going medical treatment of acute disease, pregnancy, and not able to understand the Swedish language. After screening, inclusion resulted in 146 intervention patients and 206 reference patients (Fig. 1). 2.6. Procedure Patients meeting inclusion criteria were invited consecutively to participate. No record was kept regarding the number of ineligible and nonconsenting patients, or the reasons for this. Eligible and consenting patients were informed about the study verbally and in writing including the fact whether their primary care rehabilitation unit was randomised to either intervention or reference. The patients signed an informed consent. All patients were examined by a physiotherapist, red flags were considered and all patients answered a baseline questionnaire. Based on needs, contacts with other professionals could be included, such as doctor, psychologist, occupational therapist, employee, or staff manager. Further remittance to these professions was based on ordinary clinical assessments, such as red and yellow flags. The treatment was structured (including examination, assessment, diagnosis, evidence-based treatment, and follow-up as a standard procedure among physiotherapists in Sweden) and individualised in terms of content and duration in both groups according to each patient's condition. Within the framework of the study, all participants in both the intervention and the reference groups were offered visits to the physiotherapist for follow-up examinations at 3, 6, and 12 months after baseline (number not shown). The follow-ups were for monitoring and for measuring function, which will be reported in future articles. The patients had the opportunity to discuss issues relating to their pain and to get advice if needed. Both the intervention and the reference group also received a short text message every week during 52 weeks after baseline for follow-up of study outcome. The short text messages were for monitoring self-reports on sick leave. 2.7. Baseline and follow-up measurements Patients in both groups answered a baseline questionnaire regarding sex, age, marital status, education, employment, sick leave, and health-related quality of life. Health-related quality of life was measured with the EQ-5D questionnaire.21,41 We used the 5-question part of the EQ-5D, where each question has 3 options from 1 to 3, where 1 corresponds to full health-related quality of life. The answers were merged into a total score from −0.59 to 1, according to the UK tariff, where 1 corresponds to full health-related quality of life.9,10,17 Further patient-reported outcomes and clinician-reported outcomes were collected at the different follow-ups, but is to be published elsewhere. 2.8. Short text message We used a software called SMS-Track Questionnaire to collect data with short text message concerning past week's number of days on sick leave.1 Collecting self-reported weekly data using short text messages has been used in previous clinical studies and worked well with high-response rates.1–3,33 It has been shown that patient-reported outcomes, directly from patients, can provide more sensitive and specific measurements of treatment effects.40,50 All questions and answers were encrypted and stored in a secure database, accessible to the first author through the web, password, and firewall protected. The patients answered the question “Last week, how many days were you on sick leave? Please answer with a number between 0 and 7.” They responded with a number and all data were immediately collected in the database for subsequent analysis. Reminders were automatically sent to nonresponders after 2 days by sending the question a second time. If there was no answer to the second message, the database recorded it as missing. In case of missing answers also in the following week, the patient was contacted by phone and if the patient could not be reached, a reminder letter was sent. The flowchart shows the response rate (Figures 1 and 2). Figure 2. Proportion of text message answers per week after baseline, during 52 weeks, intervention n = 146 and reference n = 206. 2.9. Intervention Patients in the intervention group were offered CDM by their treating physiotherapist in addition to the structured physiotherapy care. The physiotherapist started CDM by inviting the patient to an individual interview where the patient gave her/his informed consent of contacting the employer. In the second step, the employer was invited to talk to the physiotherapist, either in person or by phone. The conversations with the patient and the employer focused on the neck/back pain in relation to work and on possible or already conducted workplace adjustments to support return-to-work or to stay at work. Finally, the patient and the employer were invited to a meeting together with the physiotherapist. This meeting aimed at a plan of action with a written record of suggested workplace changes/improvements as well as changes to the patient's daily life with the aim of strengthening the patient's work ability and/or supporting return-to-work (Fig. 3). This agreement was followed up when the patient met the physiotherapist at follow-up visits at month 3, 6, and 12 after baseline. At the intervention units, all physiotherapists were educated and trained in the CDM model by experienced personnel from the research group with background in occupational health. This training consisted of 2 half-day theoretical and practical sessions. In addition, continuous support was provided during the implementation of the study by the same personnel, who were available by telephone if matters should arise that needed discussion. Figure 3. Self-reported sick leave days per week, collected using weekly text messages, intervention n = 146, and reference n = 206. 2.10. Statistics Statistical power calculations were based on a significance level of 5% and a power of 80%. To detect a 30% reduction of sick leave in the intervention group and a 10% reduction of sick leave in the reference group and an intraclass range between 0.1 and 0.4,18 we needed a minimum of 20 clusters/primary care rehabilitation units. The estimated sample size was slightly more than 500 patients in total (259 patients per group). Age was categorised into 3 groups (≤39 years, 40-49 years, and ≥50 years). Marital status was categorised into married/cohabitation vs single. Education level was categorised into 4 groups (primary school, upper secondary school 2-3 years, university ≥3 years, and other). Diagnoses were categorised into 4 groups (cervicobrachial syndrome, cervico and lumbar syndrome, lumbago-ischias, and myalgia). Employment was categorised as yes or no. The EQ-5D score was categorised into 2 groups < and ≥0.6, based on previous findings on how health-related quality of life relates to work ability.7,8,21 Sick leave was categorised into yes or no. Descriptive statistics for baseline variables were analysed with the χ2 test for proportions. Comparisons were made between the groups over time and were analysed at baseline and at 3, 6, 9, and 12 months with the χ2 test with a significance level P < 0.05. In addition, a strict intention-to-treat analysis was performed, patients with missing data for the confirmatory outcome were allocated outcomes in accordance with baseline data, in that no sick leave at baseline was assigned as work ability at 1 year. Finally, a forward stepwise logistic regression analysis was performed to assess the odds ratio of work ability (no sick leave or disability pension) 4 consecutive weeks at 1 year after baseline. The tested independent variables were sex, education level (high/low), and health-related quality of life (EQ-5D