Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Behavioral: Shoulder-Café; Behavioral: Shoulder-Guidance

• Registration Number: NCT03159910
• Lead Sponsor: Central Jutland Regional Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-05-11
• Study First Submitted QC: 2017-05-18
• Study First Posted: 2017-05-19
• Study Start: 2017-08-14
• Status Verified: 2019-09
• Primary Completion: 2020-07-01
• Study Completion: 2020-07-01
• Last Update Submitted: 2020-08-06
• Last Update Posted: 2020-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shoulder-Café (intervention)	Shoulder-Café	A Shoulder-Café intervention consists of three café-meetings.
Shoulder-Guidance (control)	Shoulder-Guidance	The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts.

Primary Outcome Measures

Name	Time	Method
Shoulder complaints	Follow-up 3 months after end of intervention.	Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).
Mechanical shoulder exposures	Follow-up at end of intervention, an average of 2-3 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Elective Surgery Centre; 🇩🇰 Silkeborg, Denmark