- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257113
Supervised Exercise Therapy vs Home Exercises for Patients With Subacromial Impingement
November 20, 2019 updated by: Norwegian University of Science and Technology
Is Supervised Exercise Therapy a Better Option Than Home Exercises for Patients With Subacromial Impingement When Looking at Pain and Function?
The purpose of this study is to determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with shoulder pain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Shoulder pain is common in the population.
Various treatment modalities are used.
According to the literature, it is equally good results for home exercises and for guided exercise therapy.
The purpose of this study is to look at this again and determine whether there are any difference between supervised exercise therapy and homebased exercise when looking at pain and function for patients with subacromial impingement.
Study Type
Interventional
Enrollment (Actual)
46
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
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Trondheim, Norway, 7006
- Tverrfaglig Poliklinikk, rygg-nakke-skulder. Fys.Med. og rehab., St.Olavs Hospital
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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 to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pain in one shoulder
- Had the condition for more than 12 weeks
- Pain at abduction (must be present in some part between 60 and 120 degrees)
- Pain/ weakness in isometric external rotation
- Positive Hawkins test
Exclusion Criteria:
- Instability
- Labral pathology
- Acromioclavicular joint (AC-joint) pathology
- Complete rupture in the rotatorcuff
- Glenohumeral osteoarthritis
- Previously operated on current shoulder
- The pain comes from neck pathology
- Rheumatoid arthritis or other serious physical or mental illness
- Lack of Norwegian language
- Unable to start
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: supervised exercise
The group gets 10 supervised exerciseclasses at the physiotherapy clinic in addition to homebased exercises
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This group will receive 10 classes of supervised exercise in the 6 weeks intervention.
In this classes the patients will be with a physiotherapist that will adjust their home-exercise program and make sure they do the exercises in a good way.
They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day.
If necessary, they should also do stretching exercises
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Experimental: homebased exercises
The group gets 1 supervised exerciseclass before they do all their exercises at home
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This group will receive 1 class of supervised exercise at the beginning of the 6 weeks intervention.
In this class the patients will be with a physiotherapist that will put together a home-exercise program and make sure they do the exercises in a good way.
They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day.
If necessary, they should also do stretching exercises
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain and function 1
Time Frame: Baseline
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Shoulder Pain and Disability Index
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Baseline
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Pain and function 2
Time Frame: At 6 weeks
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Shoulder Pain and Disability Index
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At 6 weeks
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Pain and function 3
Time Frame: At 6 months
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Shoulder Pain and Disability Index
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At 6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fear avoidance 1
Time Frame: Baseline
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Fear-Avoidance Beliefs Questionnaire.
Modified version with questions about shoulder instead of back
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Baseline
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Fear avoidance 2
Time Frame: At 6 weeks
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Fear-Avoidance Beliefs Questionnaire.
Modified version with questions about shoulder instead of back.
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At 6 weeks
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Quality of life 1
Time Frame: Baseline
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The Short-Form 36 questionnaire
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Baseline
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Quality of life 2
Time Frame: At 6 weeks
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The Short-Form 36 questionnaire
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At 6 weeks
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Pain the last week
Time Frame: Baseline and once a week for 6 weeks
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Numeric pain rating scale
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Baseline and once a week for 6 weeks
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Active range of motion 1
Time Frame: Baseline
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Abduction, flexion, external rotation and internal rotation measured with inclinometer
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Baseline
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Active range of motion 2
Time Frame: At 6 weeks
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Abduction, flexion, external rotation and internal rotation measured with inclinometer
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At 6 weeks
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Impingement tests 1
Time Frame: Baseline
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Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
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Baseline
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Impingement tests 2
Time Frame: At 6 weeks
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Hawkins test, painful arc test and isometric external rotation test is beeing conducted and scored positive or negative
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At 6 weeks
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Work status 1
Time Frame: Baseline
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Registration of the patients work status
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Baseline
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Work status 2
Time Frame: At 6 weeks
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Registration of the patients work status
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At 6 weeks
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Work status 3
Time Frame: At 6 months
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Registration of the patients work status
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At 6 months
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Patient satisfaction
Time Frame: At 6 weeks
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2 questions, one question about benefit and one about satisfaction
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At 6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ottar Vasseljen, Dr.Philos, Norwegian University of Science and Technology
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.
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
January 1, 2011
Primary Completion (Actual)
December 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
December 8, 2010
First Submitted That Met QC Criteria
December 8, 2010
First Posted (Estimate)
December 9, 2010
Study Record Updates
Last Update Posted (Actual)
November 21, 2019
Last Update Submitted That Met QC Criteria
November 20, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/2591
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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