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

NCT ID: NCT03055117

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-16

Study Completion Date

2018-08-27

Brief Summary

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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

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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.

Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

Group-based exercise rehabilitation

Intervention Type BEHAVIORAL

Group- based physiotherapy-led exercise rehabilitation

Home exercise

Intervention Type BEHAVIORAL

Supervised home exercise

Individual exercise rehabilitation

Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).

Group Type ACTIVE_COMPARATOR

Individual exercise rehabilitation

Intervention Type BEHAVIORAL

Individual physiotherapy-led exercise rehabilitation

Home exercise

Intervention Type BEHAVIORAL

Supervised 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 Type ACTIVE_COMPARATOR

Home exercise

Intervention Type BEHAVIORAL

Supervised home exercise

Interventions

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Group-based exercise rehabilitation

Group- based physiotherapy-led exercise rehabilitation

Intervention Type BEHAVIORAL

Individual exercise rehabilitation

Individual physiotherapy-led exercise rehabilitation

Intervention Type BEHAVIORAL

Home exercise

Supervised home exercise

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Central Denmark Region

OTHER

Sponsor Role collaborator

Regional Hospital West Jutland

OTHER

Sponsor Role lead

Responsible Party

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David H Christiansen

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David H Christiansen, PhD

Role: PRINCIPAL_INVESTIGATOR

Occupational Medicine Regional Hospital West Jutland University Research Clinic

Locations

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David H Christiansen

Herning, Central Jutland, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 33744191 (View on PubMed)

Other Identifiers

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1-10-72-178-16

Identifier Type: -

Identifier Source: org_study_id

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