Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures
Primary Purpose
Shoulder Pain
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Shoulder-Café
Shoulder-Guidance
Sponsored by
About this trial
This is an interventional prevention trial for Shoulder Pain focused on measuring Shoulder Pain, Occupational Exposure, Clinical Trial
Eligibility Criteria
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
Sites / Locations
- Elective Surgery Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Shoulder-Café (intervention)
Shoulder-Guidance (control)
Arm Description
A Shoulder-Café intervention consists of three café-meetings.
The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts.
Outcomes
Primary Outcome Measures
Shoulder complaints
Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).
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.
Secondary Outcome Measures
Fear Avoidance Beliefs (FABQ) about physical activity (PA)
Monitored with FABQ-PA in a version modified to the shoulder (questionnaire)
Patients' Global Impression of Change
Measured on a 7 point Likert scale.
Shoulder complaints
Monitored with the Danish version of the Oxford Shoulder Score
Full Information
NCT ID
NCT03159910
First Posted
May 11, 2017
Last Updated
August 6, 2020
Sponsor
Central Jutland Regional Hospital
Collaborators
Regional Hospital West Jutland, Aarhus University Hospital, University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT03159910
Brief Title
Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures
Official Title
Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures: a Cluster-randomised Controlled Study (The Shoulder-Café Study)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
July 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Jutland Regional Hospital
Collaborators
Regional Hospital West Jutland, Aarhus University Hospital, University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder Pain, Occupational Exposure, Clinical Trial
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessor will be masked with respect to mechanical shoulder exposures. Statistical analyses will be performed blinded to intervention arm.
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Shoulder-Café (intervention)
Arm Type
Experimental
Arm Description
A Shoulder-Café intervention consists of three café-meetings.
Arm Title
Shoulder-Guidance (control)
Arm Type
Active Comparator
Arm Description
The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts.
Intervention Type
Behavioral
Intervention Name(s)
Shoulder-Café
Intervention Description
Education and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit.
Intervention Type
Behavioral
Intervention Name(s)
Shoulder-Guidance
Intervention Description
Home-based shoulder exercise and written counselling.
Primary Outcome Measure Information:
Title
Shoulder complaints
Description
Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).
Time Frame
Follow-up 3 months after end of intervention.
Title
Mechanical shoulder exposures
Description
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.
Time Frame
Follow-up at end of intervention, an average of 2-3 months
Secondary Outcome Measure Information:
Title
Fear Avoidance Beliefs (FABQ) about physical activity (PA)
Description
Monitored with FABQ-PA in a version modified to the shoulder (questionnaire)
Time Frame
Follow-up 3 and 9 months after end of intervention.
Title
Patients' Global Impression of Change
Description
Measured on a 7 point Likert scale.
Time Frame
Follow-up 3 months after end of intervention.
Title
Shoulder complaints
Description
Monitored with the Danish version of the Oxford Shoulder Score
Time Frame
Follow-up 9 months after end of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette Trøstrup, MsC
Organizational Affiliation
Elective Surgery Centre, Silkeborg Regional Hospital, Regional Hospital Central Jutland.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Elective Surgery Centre
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Citation
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Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures
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