Effectiveness of standardized ultrasound guided percutaneous treatment of lateral epicondylitis with application of autologous blood, dextrose or perforation only on pain: a study protocol for a multi-center, blinded, randomized controlled trial with a 1 year follow up.

BACKGROUND: In the treatment of Lateral Epicondylitis (LE) no single intervention concerning injection therapies has been proven to be the most effective with regard to pain reduction. In this trial 3 injection therapies (perforation with application of autologous blood, perforation with application of dextrose and perforation only) will be compared in a standardized and ultrasound guided way. The objective is to assess the effectiveness of these 3 injection therapies on pain, quality of life and functional recovery. By conducting this study, we hope to make a statement on the effectiveness of injection therapy in the treatment of LE. Hereby, unnecessary treatments can be avoided, a more universal method of treatment can be established and the quality of the treatment can be improved. METHODS/DESIGN: A multicenter, randomized controlled trial with a superiority design and 12 months follow-up will be conducted in four Dutch hospitals. One hundred sixty five patients will be recruited in the age of 18 to 65 years, with chronic symptomatic lateral epicondylitis lasting longer than 6 weeks, which have concordant pain during physical examination. Patients will be randomized by block randomization to one of the three treatment arms. The treatment will be blinded for patients and outcome assessors. The following three injection therapies are compared: perforation with application of autologous blood, perforation with application of dextrose and perforation only. Injections will be performed ultrasound guided in a standardized and automated way. The primary endpoint is: pain (change in 'Visual Analogue Scale'). Secondary endpoints are quality of life and functional recovery. These measurements are collected at baseline, 8 weeks, 5 months and 1 year after treatment. DISCUSSION: When completed, this trial will provide evidence on the effectiveness of injection therapy in the treatment of lateral epicondylitis on pain, quality of life and functional recovery. In current literature proper comparison of the effectiveness of injectables for LE is questionable, due to the lack of standardization of the treatment. This study will overcome bias due to manually performed injection therapy. TRIAL REGISTRATION: This study is registered in the Trial Register ( www.trialregister.nl ) of the Dutch Cochrane centre. Trial ID; NTR4569. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4569.

Evaluation of a randomized controlled trial on the effect on return to work with coaching combined with light therapy and pulsed electromagnetic field therapy for workers with work-related chronic stress.

BACKGROUND: Chronic work-related stress is quite prevalent in the working population and is in some cases accompanied by long-term sick leave. These stress complaints highly impact employees and are costly due to lost productivity and medical expenses. A new treatment platform with light therapy plus Pulsed Electro Magnetic Fields (PEMF) in combination with coaching was used to assess whether more positive effects on return to work, stress, work-related fatigue, and quality of life could be induced compared to coaching alone. METHODS: A placebo-controlled trial was executed after inclusion of 96 workers, aged 18-65 with work-related chronic stress complaints and who were on sick leave (either part-time or full-time). Participants were divided into three arms at random. Group 1 (n = 28) received the treatment and coaching (Intervention group), group 2 (n = 28) received the treatment with the device turned off and coaching (Placebo group) and group 3 (n = 28) received coaching only (Control group). The data were collected at baseline, and after 6, 12 and 24 weeks. The primary outcome was % return to work, and secondary outcomes were work-related fatigue (emotional exhaustion and need for recovery after work), stress (distress and hair cortisol), and quality of life (SF-36 dimensions: vitality, emotional role limitation, and social functioning). RESULTS: Eighty-four workers completed all measurements, 28 in each group. All groups improved significantly over time in the level of return to work, as well as on all secondary outcomes. No statistical differences between the three groups were found either on the primary outcome or on any of the secondary outcomes. CONCLUSIONS: Light therapy with Pulsed Electro Magnetic Fields PEMF therapy has no additional effect on return to work, stress, fatigue, and quality of live compared to coaching alone. TRIAL REGISTRATION: NTR4794 , registration date: 18-sep-2014.

Design of a randomized controlled trial on the effect on return to work with coaching plus light therapy and pulsed electromagnetic field therapy for workers with work-related chronic stress.

BACKGROUND: Work-related chronic stress is a common problem among workers. The core complaint is that the employee feels exhausted, which has an effect on the well-being and functioning of the employee, and an impact on the employer and society. The employee's absence is costly due to lost productivity and medical expenses. The usual form of care for work-related chronic stress is coaching, using a cognitive-behavioural approach whose primary aim is to reduce symptoms and improve functioning. Light therapy and pulsed electromagnetic field therapy are used for the treatment of several mental and physical disorders. The objective of this study is to determine whether coaching combined with light therapy plus pulsed electromagnetic field therapy is an effective treatment for reducing absenteeism, fatigue and stress, and improving quality of life compared to coaching alone. METHODS/DESIGN: The randomized placebo-controlled trial consists of three arms. The population consists of 90 participants with work-related chronic stress complaints. The research groups are: (i) intervention group; (ii) placebo group; and (iii) control group. Participants in the intervention group will be treated with light therapy/pulsed electromagnetic field therapy for 12 weeks, twice a week for 40 min, and coaching (once a fortnight for 50 min). The placebo group receives the same treatment but with the light and pulsed electromagnetic field switched to placebo settings. The control group receives only coaching for 12 weeks, a course of six sessions, once a fortnight for 50 min. The primary outcome is the level of return to work. Secondary outcomes are fatigue, stress and quality of life. Outcomes will be measured at baseline, 6 weeks, 12 and 24 weeks after start of treatment. DISCUSSION: This study will provide information about the effectiveness of coaching and light therapy plus pulsed electromagnetic field therapy on return to work, and secondly on fatigue, stress and quality of life in people with work-related chronic stress. TRIAL REGISTRATION: NTR4794 , registration date 18-sept-2014.

Cost-effectiveness of 40-hour versus 100-hour vocational rehabilitation on work participation for workers on sick leave due to subacute or chronic musculoskeletal pain: study protocol for a randomized controlled trial.

BACKGROUND: Although vocational rehabilitation is a widely advocated intervention for workers on sick leave due to subacute or chronic nonspecific musculoskeletal pain, the optimal dosage of effective and cost-effective vocational rehabilitation remains unknown. The objective of this paper is to describe the design of a non-inferiority trial evaluating the effectiveness and cost-effectiveness of 40-h multidisciplinary vocational rehabilitation compared with 100-h multidisciplinary vocational rehabilitation on work participation for workers on sick leave due to subacute or chronic musculoskeletal pain. METHODS/DESIGN: A non-inferiority study design will be applied. The study population consists of workers who are on part-time or full-time sick leave due to subacute or chronic nonspecific musculoskeletal pain. Two multidisciplinary vocational rehabilitation programs following the bio-psychosocial approach will be evaluated in this study: 40-h vocational rehabilitation and 100-h vocational rehabilitation, both delivered over a maximum of 15 weeks. The 100-h vocational rehabilitation comprises five modules: work participation coordination, graded activity, cognitive behavioral therapy, group education, and relaxation. The 40-h vocational rehabilitation comprises work participation coordination and a well-reasoned choice from the other four modules. Four rehabilitation centers will participate in this study, each delivering both interventions. Patients will be randomized into one of the interventions, stratified for the duration of sick leave (<6 weeks or ≥ 6 weeks) and type of sick leave (part-time or full-time). The primary outcome is work participation, measured by self-reported sick leave days, and will be assessed at baseline, mid-term, discharge, and at 2, 4, 6, 8, 10, and 12 months follow-up. Secondary outcomes are work ability, disability, quality of life, and physical functioning and will be assessed at baseline, discharge, and at 6 and 12 months follow-up. Cost outcomes are absenteeism, presenteeism, healthcare usage, and travelling costs. Cost-effectiveness will be evaluated from the societal and employer perspectives. DISCUSSION: The results obtained from this study will be useful for vocational rehabilitation practice and will provide stakeholders with relevant insights into two versions of vocational rehabilitation. TRIAL REGISTRATION: Dutch Trial Register identifier: NTR4362 (registered 17 March 2014).

What promotes sustained return to work of employees on long-term sick leave? Perspectives of vocational rehabilitation professionals.

OBJECTIVES: The aim of this study was to (i) explore promoting factors for sustained return to work (RTW), according to vocational rehabilitation professionals (VRP) that are amenable to change for employees who have been on sick leave >18 months and (ii) gain insight into crucial aspects of interventions. METHODS: Semi-structured interviews were carried out with 23 VRP. All interviews were transcribed fully verbatim. An inductive analysis of the transcripts was performed, using a process of identifying, coding, and categorizing the primary patterns in the data. RESULTS: Key influenceable promoting factors for sustained RTW by long-term sick-listed employees include: employee-based vocational guidance; integral, effective communication between the sick-listed employee and all RTW stakeholders; personal factors; a supportive work environment; and a stimulating social environment. Crucial aspects of interventions include: gathering information and setting priorities; improving qualifications; influencing cognitions; monitoring the sick-listed employee through the rehabilitation process; offering tailor-made interventions at different stages within a personal time-bound action plan; and preparing the employee and the work environment for RTW. CONCLUSIONS: Sustained RTW for long-term sick-listed employees can be achieved by focusing on the influenceable promoting factors for RTW. The use of combined interventions in a holistic approach involving the worker and his environment is considered the best way to address the multicausality of work disability and could help maximize RTW outcomes.

Evaluation of effective return-to-work treatment programs for sick-listed patients with non-specific musculoskeletal complaints: a systematic review.

OBJECTIVE: This systematic review seeks to gain insight into the effectiveness of return-to-work treatment programs among sick-listed patients with non-specific musculoskeletal complaints. The focus here lies on the composition of effective treatment programs, itemized for regional non-specific musculoskeletal complaints. METHODS: A systematic literature search was performed and methodological quality criteria were applied. RESULTS: Eighteen high quality articles were selected, which reported on a combined total of 22 treatment programs, including a total of 3,579 participants. Of these 22 treatments programs, seven experimental treatments (32%) resulted in faster return to work compared to the control treatment. None of the studies reviewed reported negative findings. What appeared to be essential to effective treatment was knowledge conditioning, psychological, physical and work conditioning, possibly supplemented with relaxation exercises. Most of the high quality studies (64%) reported on a low back pain population. CONCLUSION: The findings were inconsistent regarding the effectiveness of treatment programs in enabling sick-listed patients with non-specific musculoskeletal disorders to return to work. Except for low back pain, none of the studies explicitly itemized the effects of treatment programs on return to work by regional musculoskeletal disorders, such as upper extremity musculoskeletal disorders.