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NCT03055117 Clinical Trial

Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders: a Randomised Controlled Trial

Shoulder Pain Clinical Trial

Official title:
Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03055117
Other study ID # 1-10-72-178-16
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 16, 2017
Est. completion date August 27, 2018

Study information
Verified date March 2019
Source Regional Hospital West Jutland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Degenerative shoulder disorders are frequent in the Danish population and often cause disability and sick leave. After hospital discharge patients are often referred to physiotherapy rehabilitation as part of the treatment, and it is often assumed that one-on-one sessions will yield better results than group-based sessions, because individual needs can be better meet and targeted

The project aims to evaluate the effect and cost-effectiveness of group- based exercise rehabilitation as compared to individual exercise rehabilitation in patients with degenerative shoulder disorders.

Description:

The study is a three-armed controlled randomized trial in which a total of 180 patients referred to the municipal rehabilitation after hospital treatment due to shoulder disorders in 6 municipalities in Region Midtjylland expected to participate. Patients will be allocated to either 1) Group-based rehabilitation 2) Individual rehabilitation or 3) Home exercise.

Recruitment information / eligibility
Status Completed
Enrollment 180
Est. completion date August 27, 2018
Est. primary completion date August 27, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years and above, ability to speak and understand Danish and referred to physiotherapy rehabilitation after hospital conservative or surgical treatment under diagnose of rotator cuff/shoulder impingement or acromioclavicular osteoarthritis (International Classification of Diseases 10th revision [ICD-10] group M75.1-M75.8, M19.8).

Exclusion Criteria:

- Influence of co-morbidity, psychiatric illness, pregnancy, fullthickness rotator cuff tear, rotator cuff repair surgery, traumatic lesion, rheumatoid arthritis, frozen shoulder, glenohumeral osteoarthritis.

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Group-based exercise rehabilitation
Group- based physiotherapy-led exercise rehabilitation
• Individual exercise rehabilitation
Individual physiotherapy-led exercise rehabilitation
• Home exercise
Supervised home exercise

Locations
Country Name City State
Denmark David H Christiansen Herning Central Denmark Region

Sponsors (3)
Lead Sponsor Collaborator
Regional Hospital West Jutland Central Denmark Region, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH) Sum score 0-100 6 monhts
Secondary Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire Quality of life scale EQ-5D-5L will be used to calculate quality adjusted life years (QALYs) used in the health economic evaluation 6 months
Secondary Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments Register 6 months
Secondary Pain intensity Numeric scale (0-10) 6 months
Secondary Patients impression of change of overall shoulder condition Single item question 6 months
Secondary Patient Acceptable Symptom State (PASS) Single item question. The highest level of symptom at which patients find their condition acceptable 6 months
Secondary Well-being wil be assessed by the WHO-5 Well-being Index questionnaire Sum score of 5 items 0-100 6 months
Secondary Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation Register number of contacts 6 months
Secondary Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire Sumscore 0-20 6 months
Secondary Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire Single item question. 3 months
Secondary Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire Single item question. 3 months
Secondary Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire Single item question. 3 months
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