Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159910
• Other study ID #: JutlandRH
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: July 1, 2020

Study information

• Verified date: September 2019
• Source: Central Jutland Regional Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Behavioral:
• Shoulder-Café
Education and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit.
• Shoulder-Guidance
Home-based shoulder exercise and written counselling.

Locations

Country	Name	City	State
Denmark	Elective Surgery Centre	Silkeborg

Sponsors (4)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital	Aarhus University Hospital, Regional Hospital West Jutland, University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (11)

Anton D, Mizner RL, Hess JA. The effect of lift teams on kinematics and muscle activity of the upper extremity and trunk in bricklayers. J Orthop Sports Phys Ther. 2013 Apr;43(4):232-41. doi: 10.2519/jospt.2013.4249. Epub 2013 Jan 14. — View Citation

Borg G. Psychophysical scaling with applications in physical work and the perception of exertion. Scand J Work Environ Health. 1990;16 Suppl 1:55-8. — View Citation

Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335. — View Citation

Hurst H, Bolton J. Assessing the clinical significance of change scores recorded on subjective outcome measures. J Manipulative Physiol Ther. 2004 Jan;27(1):26-35. — View Citation

Mintken PE, Cleland JA, Whitman JM, George SZ. Psychometric properties of the Fear-Avoidance Beliefs Questionnaire and Tampa Scale of Kinesiophobia in patients with shoulder pain. Arch Phys Med Rehabil. 2010 Jul;91(7):1128-36. doi: 10.1016/j.apmr.2010.04.009. — View Citation

Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. Review. — View Citation

Rempel D, Star D, Barr A, Blanco MM, Janowitz I. Field evaluation of a modified intervention for overhead drilling. J Occup Environ Hyg. 2010 Apr;7(4):194-202. doi: 10.1080/15459620903558491. — View Citation

Schmidt S, Ferrer M, González M, González N, Valderas JM, Alonso J, Escobar A, Vrotsou K; EMPRO Group. Evaluation of shoulder-specific patient-reported outcome measures: a systematic and standardized comparison of available evidence. J Shoulder Elbow Surg. 2014 Mar;23(3):434-44. doi: 10.1016/j.jse.2013.09.029. Epub 2014 Jan 7. Review. — View Citation

van Rijn RM, Huisstede BM, Koes BW, Burdorf A. Associations between work-related factors and specific disorders of the shoulder--a systematic review of the literature. Scand J Work Environ Health. 2010 May;36(3):189-201. Epub 2010 Jan 22. Review. — View Citation

Virta L, Joranger P, Brox JI, Eriksson R. Costs of shoulder pain and resource use in primary health care: a cost-of-illness study in Sweden. BMC Musculoskelet Disord. 2012 Feb 10;13:17. doi: 10.1186/1471-2474-13-17. — View Citation

Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993 Feb;52(2):157-68. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder complaints	Monitored with the Danish version of the Oxford Shoulder Score (questionnaire).	Follow-up 3 months after end of intervention.
Primary	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.	Follow-up at end of intervention, an average of 2-3 months
Secondary	Fear Avoidance Beliefs (FABQ) about physical activity (PA)	Monitored with FABQ-PA in a version modified to the shoulder (questionnaire)	Follow-up 3 and 9 months after end of intervention.
Secondary	Patients' Global Impression of Change	Measured on a 7 point Likert scale.	Follow-up 3 months after end of intervention.
Secondary	Shoulder complaints	Monitored with the Danish version of the Oxford Shoulder Score	Follow-up 9 months after end of intervention