Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders: a Randomised Controlled Trial
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|ClinicalTrials.gov Identifier: NCT03055117|
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : April 11, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain||Behavioral: Group-based exercise rehabilitation Behavioral: Individual exercise rehabilitation Behavioral: Home exercise||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||180 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders|
|Actual Study Start Date :||February 16, 2017|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
Experimental: 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).
Behavioral: Group-based exercise rehabilitation
Group- based physiotherapy-led exercise rehabilitationBehavioral: Home exercise
Supervised home exercise
Active Comparator: Individual exercise rehabilitation
Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Behavioral: Individual exercise rehabilitation
Individual physiotherapy-led exercise rehabilitationBehavioral: Home exercise
Supervised home exercise
Active Comparator: Home exercise
Home exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks.
Behavioral: Home exercise
Supervised home exercise
- Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH) [ Time Frame: 6 monhts ]Sum score 0-100
- Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire [ Time Frame: 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
- Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments [ Time Frame: 6 months ]Register
- Pain intensity [ Time Frame: 6 months ]Numeric scale (0-10)
- Patients impression of change of overall shoulder condition [ Time Frame: 6 months ]Single item question
- Patient Acceptable Symptom State (PASS) [ Time Frame: 6 months ]Single item question. The highest level of symptom at which patients find their condition acceptable
- Well-being wil be assessed by the WHO-5 Well-being Index questionnaire [ Time Frame: 6 months ]Sum score of 5 items 0-100
- Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation [ Time Frame: 6 months ]Register number of contacts
- Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire [ Time Frame: 6 months ]Sumscore 0-20
- Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 3 months ]Single item question.
- Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 3 months ]Single item question.
- Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire [ Time Frame: 3 months ]Single item question.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055117
|Contact: David H Christiansen, PhD||+45 email@example.com|
|David H Christiansen||Recruiting|
|Herning, Central Denmark Region, Denmark, 7400|
|Contact: David H Christiansen, PhD +4521688431 david.Christiansen@vest.rm.dk|
|Principal Investigator:||David H Christiansen, PhD||Department of Occupational Medicine Regional Hospital West Jutland University Research Clinic|