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

Study Overview
=================
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. .

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.

Official Title
-----------------
Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders

Conditions
-----------------
Shoulder Pain

Intervention / Treatment
-----------------
* Behavioral: Group-based exercise rehabilitation
* Behavioral: Individual exercise rehabilitation
* Behavioral: Home exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-based exercise rehabilitation<br>Group-based rehabilitation: Group-based sessions (4-8 patients per group) with physiotherapist and home training for 8 weeks (maximum of 12 training sessions). | Behavioral: Group-based exercise rehabilitation<br>* Group- based physiotherapy-led exercise rehabilitation<br>Behavioral: Home exercise<br>* Supervised home exercise<br>|
| Active Comparator: Individual exercise rehabilitation<br>Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions). | Behavioral: Individual exercise rehabilitation<br>* Individual physiotherapy-led exercise rehabilitation<br>Behavioral: Home exercise<br>* Supervised home exercise<br>|
| Active Comparator: Home exercise<br>Home exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks. | Behavioral: Home exercise<br>* Supervised home exercise<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments | Register | 6 months | 
| Pain intensity | Numeric scale (0-10) | 6 months | 
| Patients impression of change of overall shoulder condition | Single item question | 6 months | 
| Patient Acceptable Symptom State (PASS) | Single item question. The highest level of symptom at which patients find their condition acceptable | 6 months | 
| Well-being wil be assessed by the WHO-5 Well-being Index questionnaire | Sum score of 5 items 0-100 | 6 months | 
| Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation | Register number of contacts | 6 months | 
| Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire | Sumscore 0-20 | 6 months | 
| Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire | Single item question. | 3 months | 
| Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire | Single item question. | 3 months | 
| Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire | Single item question. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder pain, Physiotherapy, Rehabilitation, Exercise