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

Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03055117
Enrollment
180
Registered
2017-02-16
Start date
2017-02-16
Completion date
2018-08-27
Last updated
2019-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Shoulder pain, Physiotherapy, Rehabilitation, Exercise

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.

Interventions

BEHAVIORALGroup-based exercise rehabilitation

Group- based physiotherapy-led exercise rehabilitation

BEHAVIORALIndividual exercise rehabilitation

Individual physiotherapy-led exercise rehabilitation

BEHAVIORALHome exercise

Supervised home exercise

Sponsors

University of Aarhus
CollaboratorOTHER
Central Denmark Region
CollaboratorOTHER
Regional Hospital West Jutland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)6 monhtsSum score 0-100

Secondary

MeasureTime frameDescription
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire6 monthsQuality 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 payments6 monthsRegister
Pain intensity6 monthsNumeric scale (0-10)
Patients impression of change of overall shoulder condition6 monthsSingle item question
Patient Acceptable Symptom State (PASS)6 monthsSingle item question. The highest level of symptom at which patients find their condition acceptable
Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation6 monthsRegister number of contacts
Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire6 monthsSumscore 0-20
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire3 monthsSingle item question.
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire3 monthsSingle item question.
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire3 monthsSingle item question.
Well-being wil be assessed by the WHO-5 Well-being Index questionnaire6 monthsSum score of 5 items 0-100

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026