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

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Group-based exercise rehabilitation
Individual exercise rehabilitation
Home exercise
Sponsored by
Regional Hospital West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Shoulder pain, Physiotherapy, Rehabilitation, Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • David H Christiansen

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Group-based exercise rehabilitation

Individual exercise rehabilitation

Home exercise

Arm Description

Group-based rehabilitation: Group-based sessions (4-8 patients per group) with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).

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

Home exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
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
Register
Pain intensity
Numeric scale (0-10)
Patients impression of change of overall shoulder condition
Single item question
Patient Acceptable Symptom State (PASS)
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
Sum score of 5 items 0-100
Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation
Register number of contacts
Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire
Sumscore 0-20
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Single item question.

Full Information

First Posted
February 3, 2017
Last Updated
March 25, 2019
Sponsor
Regional Hospital West Jutland
Collaborators
University of Aarhus, Central Denmark Region
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1. Study Identification

Unique Protocol Identification Number
NCT03055117
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
February 16, 2017 (Actual)
Primary Completion Date
August 27, 2018 (Actual)
Study Completion Date
August 27, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital West Jutland
Collaborators
University of Aarhus, Central Denmark Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Shoulder pain, Physiotherapy, Rehabilitation, Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group-based exercise rehabilitation
Arm Type
Experimental
Arm Description
Group-based rehabilitation: Group-based sessions (4-8 patients per group) with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Arm Title
Individual exercise rehabilitation
Arm Type
Active Comparator
Arm Description
Individual rehabilitation: One-on-one sessions with physiotherapist and home training for 8 weeks (maximum of 12 training sessions).
Arm Title
Home exercise
Arm Type
Active Comparator
Arm Description
Home exercise: Instruction in home exercise by physiotherapist, with maximum of 4 follow-up consultations over a period of 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Group-based exercise rehabilitation
Intervention Description
Group- based physiotherapy-led exercise rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Individual exercise rehabilitation
Intervention Description
Individual physiotherapy-led exercise rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Home exercise
Intervention Description
Supervised home exercise
Primary Outcome Measure Information:
Title
Disability wil be assessed by The Disabilities of the Arm, Shoulder and Hand questionnaire - shortened version (Quick DASH)
Description
Sum score 0-100
Time Frame
6 monhts
Secondary Outcome Measure Information:
Title
Cost-effectiveness across study arms measured by the EuroQol (EQ-5D) questionnaire
Description
Quality of life scale EQ-5D-5L will be used to calculate quality adjusted life years (QALYs) used in the health economic evaluation
Time Frame
6 months
Title
Time off work (weeks) assessed by the Danish Register of Sickness absence compensation benefits and Social transfer payments
Description
Register
Time Frame
6 months
Title
Pain intensity
Description
Numeric scale (0-10)
Time Frame
6 months
Title
Patients impression of change of overall shoulder condition
Description
Single item question
Time Frame
6 months
Title
Patient Acceptable Symptom State (PASS)
Description
Single item question. The highest level of symptom at which patients find their condition acceptable
Time Frame
6 months
Title
Well-being wil be assessed by the WHO-5 Well-being Index questionnaire
Description
Sum score of 5 items 0-100
Time Frame
6 months
Title
Re-presentations after discharge from rehabilitation will be obtained by Danish National Rehabilitation
Description
Register number of contacts
Time Frame
6 months
Title
Fear avoidance Beliefs and risk of chronicity the Orebro Musculoskeletal Pain Screening Questionnaire
Description
Sumscore 0-20
Time Frame
6 months
Title
Confidence will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Description
Single item question.
Time Frame
3 months
Title
Safety will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Description
Single item question.
Time Frame
3 months
Title
Satisfaction will be assessed by one item from the Danish Cancer Society PREM (Barometer) Questionnaire
Description
Single item question.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H Christiansen, PhD
Organizational Affiliation
Occupational Medicine Regional Hospital West Jutland University Research Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
David H Christiansen
City
Herning
State/Province
Central Denmark Region
ZIP/Postal Code
7400
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33744191
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.
Results Reference
derived

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

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