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Completed

NCT Number: NCT03159910

Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elective Surgery Centre

Silkeborg, 8600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoulder-Café

Behavioral

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

Shoulder-Guidance

Behavioral

Home-based shoulder exercise and written counselling.

Primary outcomes

  1. Shoulder complaints

    Time frame: Follow-up 3 months after end of intervention.

    Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).

  2. Mechanical shoulder exposures

    Time frame: 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 outcomes

  1. Fear Avoidance Beliefs (FABQ) about physical activity (PA)

    Time frame: Follow-up 3 and 9 months after end of intervention.

    Monitored with FABQ-PA in a version modified to the shoulder (questionnaire)

  2. Patients' Global Impression of Change

    Time frame: Follow-up 3 months after end of intervention.

    Measured on a 7 point Likert scale.

  3. Shoulder complaints

    Time frame: Follow-up 9 months after end of intervention

    Monitored with the Danish version of the Oxford Shoulder Score

Sponsors and collaborators

Lead sponsor

Central Jutland Regional Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Regional Hospital West Jutland
  • University of Aarhus

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 19, 2017
Registry last updated
Aug 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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