Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

Study Overview
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Brief Summary
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Aim: To evaluate the effectiveness of Shoulder-Café (intervention) compared to Shoulder-Guidance (control intervention) with respect to shoulder exposures and shoulder complaints. Hypothesis: The Shoulder-Café, which unifies education, diagnostic clarification, supervised and home-based shoulder exercises, and advice from a health and safety consultant on workplace interventions, will reduce shoulder exposures and shoulder complaints more effectively than an individual-oriented control intervention with home-based shoulder exercises and written general advice on workplace interventions.

Detailed Description
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Introduction: Shoulder complaints prevail in the working age population and constitute a common cause of contacts with general practitioners. In occupations with high mechanical shoulder exposures, these complaints are especially frequent. Persons with high occupational mechanical shoulder exposures and shoulder complaints seem an obvious target group for secondary prevention efforts, and more research on interventions targeting shoulder complaints in occupations with high shoulder exposures is needed. The aim is to develop and evaluate a Shoulder-Café intervention to reduce high occupational mechanical shoulder exposures and prolonged shoulder complaints. The specific objectives are: I. To evaluate the effectiveness of the Shoulder-Café as compared to the control-intervention, the Shoulder-Guidance, measured on reductions in shoulder complaints. II. To evaluate the effectiveness of the Shoulder-Café as compared to the Shoulder-Guidance measured on reductions in occupational mechanical shoulder exposures. III. To identify the influence of shoulder exercises and reduced occupational mechanical shoulder exposures, respectively, on shoulder complaints. The hypothesis is that the Shoulder-Café will reduce shoulder exposures and shoulder complaints more effectively than the Shoulder-Guidance. Furthermore, a hypothesis is that fear avoidance beliefs is reduced and the degree to which the participants feel informed about the nature of their complaints and their remedies is increased more effectively with the Shoulder-Café compared to the control intervention. Method: The project consists of a two-armed, cluster-randomised controlled trial with randomisation at company level (objectives I and II) and a prospective cohort study based on the cluster-randomised study (objective III). Follow-up: A questionnaire 3 and 9 months after end of intervention with e.g. OSS.

Official Title
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Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures: a Cluster-randomised Controlled Study (The Shoulder-Café Study)

Conditions
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Shoulder Pain

Intervention / Treatment
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* Behavioral: Shoulder-Café
* Behavioral: Shoulder-Guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Employed in occupations with expected high mechanical shoulder exposures (industry, construction and service) Shoulder complaints Able to read and understand Danish Exclusion Criteria: Previous shoulder surgery Breast cancer operation Pregnancy Sickness absence expected to continue into the intervention period

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shoulder-Café (intervention)<br>A Shoulder-Café intervention consists of three café-meetings. | Behavioral: Shoulder-Café<br>* Education and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit.<br>|
| Active Comparator: Shoulder-Guidance (control)<br>The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts. | Behavioral: Shoulder-Guidance<br>* Home-based shoulder exercise and written counselling.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder complaints | Monitored with the Danish version of the Oxford Shoulder Score (questionnaire). | Follow-up 3 months after end of intervention. | 
| Mechanical shoulder exposures | Measured during 1-5 working days in terms of % time with the arm elevated at different angles and shoulder angular velocity (°/s) using an Axivity accelerometer. Degree of exertion for the arms monitored with Borg CR10 (questionnaire). Participants will fill out questions in Borg CR 10 when they are using the Axivity accelerometer. | Follow-up at end of intervention, an average of 2-3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear Avoidance Beliefs (FABQ) about physical activity (PA) | Monitored with FABQ-PA in a version modified to the shoulder (questionnaire) | Follow-up 3 and 9 months after end of intervention. | 
| Patients' Global Impression of Change | Measured on a 7 point Likert scale. | Follow-up 3 months after end of intervention. | 
| Shoulder complaints | Monitored with the Danish version of the Oxford Shoulder Score | Follow-up 9 months after end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Pain, Occupational Exposure, Clinical Trial