Reducing Shoulder Complaints in Employees With High Occupational Shoulder Exposures
NCT ID: NCT03159910
Last Updated: 2020-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2017-08-14
2020-07-01
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Shoulder-Café (intervention)
A Shoulder-Café intervention consists of three café-meetings.
Shoulder-Café
Education and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit.
Shoulder-Guidance (control)
The Shoulder-Guidance intervention consists of an initial individual appointment and two e-mail contacts.
Shoulder-Guidance
Home-based shoulder exercise and written counselling.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Employed in occupations with expected high mechanical shoulder exposures (industry, construction and service)
* Shoulder complaints
* Able to read and understand Danish
Exclusion Criteria
* Breast cancer operation
* Pregnancy
* Sickness absence expected to continue into the intervention period
18 Years
65 Years
ALL
No
Sponsors
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Regional Hospital West Jutland
OTHER
Aarhus University Hospital
OTHER
University of Aarhus
OTHER
Central Jutland Regional Hospital
OTHER
Responsible Party
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Principal Investigators
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Jeanette Trøstrup, MsC
Role: PRINCIPAL_INVESTIGATOR
Elective Surgery Centre, Silkeborg Regional Hospital, Regional Hospital Central Jutland.
Locations
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Elective Surgery Centre
Silkeborg, , Denmark
Countries
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References
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Frich LH, Noergaard PM, Brorson S. Validation of the Danish version of Oxford Shoulder Score. Dan Med Bull. 2011 Nov;58(11):A4335.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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JutlandRH
Identifier Type: -
Identifier Source: org_study_id
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