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Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

C

Central Jutland Regional Hospital

Status

Completed

Conditions

Shoulder Pain

Treatments

Behavioral: Shoulder-Guidance
Behavioral: Shoulder-Café

Study type

Interventional

Funder types

Other

Identifiers

NCT03159910
JutlandRH

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

110 participants in 2 patient groups

Shoulder-Café (intervention)
Experimental group
Description:
A Shoulder-Café intervention consists of three café-meetings.
Treatment:
Behavioral: Shoulder-Café
Shoulder-Guidance (control)
Active Comparator group
Description:
The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts.
Treatment:
Behavioral: Shoulder-Guidance

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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