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

March 25, 2019 updated by: David H Christiansen, Regional Hospital West Jutland

Individual Versus Group-based Exercise Rehabilitation for Shoulder Disorders

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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Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Denmark Region
      • Herning, Central Denmark Region, Denmark, 7400
        • David H Christiansen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 rehabilitation
Behavioral: 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: Home exercise
Supervised home exercise
Behavioral: Individual exercise rehabilitation
Individual physiotherapy-led exercise rehabilitation
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

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)
Time Frame: 6 monhts
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
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
6 months
Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments
Time Frame: 6 months
Register
6 months
Pain intensity
Time Frame: 6 months
Numeric scale (0-10)
6 months
Patients impression of change of overall shoulder condition
Time Frame: 6 months
Single item question
6 months
Patient Acceptable Symptom State (PASS)
Time Frame: 6 months
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
Time Frame: 6 months
Sum score of 5 items 0-100
6 months
Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation
Time Frame: 6 months
Register number of contacts
6 months
Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire
Time Frame: 6 months
Sumscore 0-20
6 months
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time Frame: 3 months
Single item question.
3 months
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time Frame: 3 months
Single item question.
3 months
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Time Frame: 3 months
Single item question.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regional Hospital West Jutland

Collaborators

University of Aarhus
Central Denmark Region

Investigators

  • Principal Investigator: David H Christiansen, PhD, Occupational Medicine Regional Hospital West Jutland University Research Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Actual)

August 27, 2018

Study Completion (Actual)

August 27, 2018

Study Registration Dates

First Submitted

February 3, 2017

First Submitted That Met QC Criteria

February 13, 2017

First Posted (Actual)

February 16, 2017

Study Record Updates

Last Update Posted (Actual)

March 26, 2019

Last Update Submitted That Met QC Criteria

March 25, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-178-16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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