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ID
Source
Brief title
Health condition
Patients with musculoskeletal disorders (MSDs)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Limitations in specific work-related activities. The limitations in specific work-related activities in the previous week will be assessed using a patient-specific functional scale (PSFS). Patients will be asked to identify the most important work-related activity they are unable to perform or are having difficulty with as a result of their musculoskeletal problems. Patients will be asked to rate each activity on an 11-point scale indicating the current level of difficulty associated with each activity.
Pain during work. The level of pain experienced by the patient in the previous week during work will be assessed using the 11-point numeric pain rating scale (NPRS).
Secondary outcome
Limitations in general work-related activities will be assessed using a single question about the limitations experienced during work in general due to the complaints (11-point scale) [38].
General pain. The general level of pain experienced by the patient in the previous week will be assessed using the 11-point numeric pain rating scale (NPRS).
Quality of life will be assessed using the 12-item Short-Form Health Survey (SF-12) [39].
Presenteeism will be assessed using the Dutch version of the 6-item Stanford Presenteeism Scale (SPS-6) [40].
Absenteeism will be measured by asking the patient the number of days they had been out of work due to their complaints during the previous month.
Estimated risk for future work disability will be assessed using the Örebro Musculoskeletal Pain Screening Questionnaire (short form) [41].
Work-related psychosocial risk factors will be assessed using the blue flags questionnaire [42].
The degree to which health problems interfere with specific aspects of job performance and the productivity impact of these work limitations will be assessed using the Work Limitations Questionnaire [43].
Work ability will be assessed using the Work Ability Index-Single Item Scale (WAS), which is a responsive measure for work participation and highly predictive for future sickness absence [44].
The amount of attention to work participation given by the physical therapist, and the level of satisfaction of the patient with this attention will be measured using five-point Likert scales.
Other outcome measures include:
In addition, we will collect data on the attitude towards addressing work participation in physical therapy practice (five-point Likert scale), the use of other healthcare interventions (co-interventions), the number of physical therapy treatment sessions, recurrences of complaints and referrals to other occupational health professionals (including physical therapists specialised in occupational health). All participating physical therapists (in the intervention arm as well as the control arm) will receive a questionnaire about their awareness, attitude, knowledge and self-efficacy with regard to the treatment of working patients with MSDs at T0 and T2. Information about their work experience with the intervention and the use of the intervention materials will be collected at T2 (intervention group only).
Background summary
Background: Musculoskeletal disorders (MSDs) are the primary cause of disability worldwide and a major societal burden. Recent qualitative research found that although a patient’s work is considered important, physical therapists take work participation insufficiently into account as a determining factor in the treatment of patients with MSDs. Therefore, the aim of this study is to improve the effectiveness and efficiency of physical therapy (in primary healthcare) with respect to the work participation of employees with MSDs by increasing the knowledge and skills of generalist physical therapists and by improving the collaboration between generalist physical therapists and physical therapists specialised in occupational health.
Methods/Design: This trial is a two-arm non-blinded cluster randomised controlled trial. Working patients with MSDs visiting a physical therapy practice are the target group. The control group will receive normal physical therapy treatment. The intervention group will receive treatment from a physical therapist with more knowledge about work-related factors and more skills in terms of integrating work participation into the patients’ care. Data at the start of the intervention, four months after the start of the intervention and eight months after the start of the intervention. Primary outcomes are the limitations in specific work-related activities and pain during work. Secondary outcomes include limitations in general work-related activities, general pain, quality of life, presenteeism, absenteeism, estimated risk for future work disability, work-related psychosocial risk factors, job performance, and work ability. Based on a sample size calculation we need to include 221 patients in each arm (442 in total). During data analysis, each outcome variable will be analysed independently at T1 and at T2 as a dependent variable using the study group as an independent variable. In addition to the quantitative evaluation, a process evaluation will be performed by interviewing physical therapists as well as with patients.
Discussion: The trial is expected to result in a more effective and efficient physical therapy process for working patients with MSDs. This will mean a substantial reduction of costs: lower costs thanks to a more effective and efficient physical therapy process and lower costs due to less or shorter sick leave and lower presenteeism.
Study objective
Our hypothesis is that the intervention will result in better patient health and an increase in the knowledge of generalist physical therapists regarding work participation and the relevant factors that influence work participation, which will make it easier for them to integrate work participation into care and to decide when referral to or consulting with a physical therapist specialised in occupational health or another occupational health professional is appropriate.
Study design
Data will be collected at the start of the intervention (T0), four months after the start of the intervention (T1, short-term effects) and eight months after the start of the intervention (T2, long-term effects).
Intervention
Control group
Physical therapy practices randomised to the control group will provide regular physical therapy (according to the existing guidelines) to their patients. These patients will be asked to participate in the study and to fill in the baseline and follow-up questionnaires.
Intervention group
Physical therapy practices randomised to the intervention group will provide regular physical therapy (according to the existing guidelines). In addition, they are able to use all the ‘WORK TO BE DONE’ intervention components and materials. These invention components and materials are:
Symposium. At the start of the intervention, a full-day symposium will be held with presentations about the importance of work-focused healthcare, information about the trial and collaborating with other occupational health professionals. There will also be a three-hour masterclass about shared decision-making. The symposium will be video recorded for physical therapists who are unable to attend the symposium.
E-learning. Physical therapists must follow an e-learning course consisting of two parts. The first part contains general information about the importance of work-focused healthcare, the interaction between work and health, and (work-related) factors influencing participation in work. The second part contains more specific information and guidance about addressing patients’ work participation in the diagnostic and treatment phase and about working with occupational health professionals, including guidance on cooperation between generalist physical therapists and physical therapists specialised in occupational health.
Online toolkit. Physical therapists can use an online toolkit to easily find information about providing work-focused care. Using the keyword search functionality, they can find information about laws and regulations, assessment and other tools, questionnaires, and occupational health professionals. Moreover, the toolkit contains short information about all the topics covered in the e-learning course.
Network. Physical therapists will be part of a local network through which they can easily contact occupational health physical therapists, exercise therapists specialised in occupational health, and occupational therapists with additional training in occupational health.
Patient information. Physical therapists can use patient information highlighting the importance of work-focused healthcare.
Inclusion criteria
Patients will be recruited by the participating physical therapists. In order to be eligible for participation in this study, a patient must meet all of the following criteria:
1. Display one or more musculoskeletal complaints
2. Have an indication for physical therapy treatment
3. Have an employment contract or be self-employed (normally working ≥ 12 hours a week)
4. Experience symptoms during work or in their own opinion have problems performing their work (including absenteeism)
Exclusion criteria
Patients who are unable to access and fill in the online follow-up questionnaires will be excluded.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8518 |
| Other | Research Ethics Committee of the Radboud University Nijmegen Medical Center : The Research Ethics Committee of the Radboud University Nijmegen Medical Center reviewed the study protocol and has declared (declaration no. 2018-4465). |