Clinical trial NCT03055117: Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders: a Randomised Controlled Trial
Official title: Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Pain
Keywords: Shoulder pain
Physiotherapy
Rehabilitation
Exercise
Lead sponsor: Regional Hospital West Jutland
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Central Denmark Region
First posted: 2017-02-16
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)
timeFrame: 6 monhts
Secondary outcomes:
measure: Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
timeFrame: 6 months
measure: Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments
timeFrame: 6 months
measure: Pain intensity
timeFrame: 6 months
measure: Patients impression of change of overall shoulder condition
timeFrame: 6 months
measure: Patient Acceptable Symptom State (PASS)
timeFrame: 6 months
measure: Well-being wil be assessed by the WHO-5 Well-being Index questionnaire
timeFrame: 6 months
measure: Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation
timeFrame: 6 months
measure: Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire
timeFrame: 6 months
measure: Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
timeFrame: 3 months
measure: Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
timeFrame: 3 months
measure: Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: David H Christiansen
state: Central Denmark Region
Study officials:
affiliation: Occupational Medicine Regional Hospital West Jutland University Research Clinic
name: David H Christiansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Christiansen DH, Hjort J. Group-based exercise, individually supervised exercise and home-based exercise have similar clinical effects and cost-effectiveness in people with subacromial pain: a randomised trial. J Physiother. 2021 Apr;67(2):124-131. doi: 10.1016/j.jphys.2021.02.015. Epub 2021 Mar 17.