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

Not Applicable

Completed

• Conditions: Shoulder Pain
• Interventions: Behavioral: Individual exercise rehabilitation; Behavioral: Group-based exercise rehabilitation; Behavioral: Home exercise

• Registration Number: NCT03055117
• Lead Sponsor: Regional Hospital West Jutland

Brief 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.

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Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-13
• Study Start: 2017-02-16
• Study First Posted: 2017-02-16
• Primary Completion: 2018-08-27
• Study Completion: 2018-08-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-25
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual exercise rehabilitation	Individual exercise rehabilitation	Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Individual exercise rehabilitation	Home exercise	Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Group-based exercise rehabilitation	Group-based exercise rehabilitation	Group-based rehabilitation: Group-based sessions (4-8 patients per group) with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Home exercise	Home exercise	Home exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks.
Group-based exercise rehabilitation	Home exercise	Group-based rehabilitation: Group-based sessions (4-8 patients per group) with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).

Primary Outcome Measures

Name	Time	Method
Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)	6 monhts	Sum score 0-100

Secondary Outcome Measures

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

Trial Locations

Locations (1)

David H Christiansen; 🇩🇰 Herning, Central Denmark Region, Denmark