Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures

NCT03159910 | Completed

• 1 other identifier: JutlandRH
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Shoulder Pain; Occupational Exposure; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Shoulder complaints

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

  Follow-up 3 months after end of intervention.

• 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 Outcomes (3)

• Fear Avoidance Beliefs (FABQ) about physical activity (PA)

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

• Patients' Global Impression of Change

  Follow-up 3 months after end of intervention.

• Shoulder complaints

  Follow-up 9 months after end of intervention

Study Arms (2)

Shoulder-Café (intervention)

EXPERIMENTAL

A Shoulder-Café intervention consists of three café-meetings.

Behavioral: Shoulder-Café

Shoulder-Guidance (control)

ACTIVE COMPARATOR

The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts.

Behavioral: Shoulder-Guidance

Interventions

Shoulder-Café BEHAVIORAL

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

Shoulder-Café (intervention)

Shoulder-Guidance BEHAVIORAL

Home-based shoulder exercise and written counselling.

Shoulder-Guidance (control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Employed in occupations with expected high mechanical shoulder exposures (industry, construction and service)
• Shoulder complaints
• Able to read and understand Danish

You may not qualify if:

• Previous shoulder surgery
• Breast cancer operation
• Pregnancy
• Sickness absence expected to continue into the intervention period

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead
• Regional Hospital West Jutland: collaborator
• Aarhus University Hospital: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Elective Surgery Centre

Silkeborg, 8600, Denmark

Location

Related Publications (14)

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

  PMID: 22047932 BACKGROUND

• Schmidt S, Ferrer M, Gonzalez M, Gonzalez 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.

  PMID: 24406123 BACKGROUND

• 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):157-168. doi: 10.1016/0304-3959(93)90127-B.

  PMID: 8455963 BACKGROUND

• 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.

  PMID: 20599053 BACKGROUND

• 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. doi: 10.5271/sjweh.1815.

  PMID: 2345867 BACKGROUND

• 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. doi: 10.1016/j.jmpt.2003.11.003.

  PMID: 14739871 BACKGROUND

• 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.

  PMID: 22325050 BACKGROUND

• Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: diagnosis and management in primary care. BMJ. 2005 Nov 12;331(7525):1124-8. doi: 10.1136/bmj.331.7525.1124. No abstract available.

  PMID: 16282408 BACKGROUND

• 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. doi: 10.5271/sjweh.2895. Epub 2010 Jan 22.

  PMID: 20094690 BACKGROUND

• 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.

  PMID: 23321695 BACKGROUND

• 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.

  PMID: 20094939 BACKGROUND

• Trostrup J, Frost P, Dalboge A, Mikkelsen LR, Hoybye MT, Jorgensen LB, Casper SD, Klebe TM, Svendsen SW. Reducing Shoulder Complaints in Employees with High Occupational Shoulder Exposures: A Cluster-Randomised Controlled Study (The Shoulder-Cafe Study). J Occup Rehabil. 2023 Sep;33(3):473-485. doi: 10.1007/s10926-022-10086-z. Epub 2022 Dec 13.

  PMID: 36512271 DERIVED

• Trostrup J, Svendsen SW, Dalboge A, Mikkelsen LR, Hoybye MT, Jorgensen LB, Klebe TM, Frost P. Increased shoulder pain across an exercise session and subsequent shoulder exercise: a prospective cohort study. BMC Musculoskelet Disord. 2022 Jul 29;23(1):726. doi: 10.1186/s12891-022-05674-2.

  PMID: 35906579 DERIVED

• Trostrup J, Mikkelsen LR, Frost P, Dalboge A, Hoybye MT, Casper SD, Jorgensen LB, Klebe TM, Svendsen SW. Reducing shoulder complaints in employees with high occupational shoulder exposures: study protocol for a cluster-randomised controlled study (The Shoulder-Cafe Study). Trials. 2019 Nov 12;20(1):627. doi: 10.1186/s13063-019-3703-y.

  PMID: 31718683 DERIVED

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeanette Trøstrup, MsC

  Elective Surgery Centre, Silkeborg Regional Hospital, Regional Hospital Central Jutland.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be masked with respect to mechanical shoulder exposures. Statistical analyses will be performed blinded to intervention arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2017
• First Posted: May 19, 2017
• Study Start: August 14, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 7, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)