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Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03159910
Enrollment
110
Registered
2017-05-19
Start date
2017-08-14
Completion date
2020-07-01
Last updated
2020-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Shoulder Pain, Occupational Exposure, Clinical Trial

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.

Interventions

BEHAVIORALShoulder-Café

Education and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit.

BEHAVIORALShoulder-Guidance

Home-based shoulder exercise and written counselling.

Sponsors

Regional Hospital West Jutland
CollaboratorOTHER
Aarhus University Hospital
CollaboratorOTHER
University of Aarhus
CollaboratorOTHER
Central Jutland Regional Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

Outcome assessor will be masked with respect to mechanical shoulder exposures. Statistical analyses will be performed blinded to intervention arm.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Shoulder complaintsFollow-up 3 months after end of intervention.Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).
Mechanical shoulder exposuresFollow-up at end of intervention, an average of 2-3 monthsMeasured 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

MeasureTime frameDescription
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)
Patients' Global Impression of ChangeFollow-up 3 months after end of intervention.Measured on a 7 point Likert scale.
Shoulder complaintsFollow-up 9 months after end of interventionMonitored with the Danish version of the Oxford Shoulder Score

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026