- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01054326
Effects of Supervised Physical Therapy With Early Activation of the Rotator Cuff Versus Home Exercises in Patients After Arthroscopic Subacromial Decompression
January 21, 2010 updated by: Linkoeping University
The objective of this study was to evaluate and compare two different post-surgical rehabilitation strategies, Rehabilitation supervised by a physical therapist including exercises with progressive early activation of the rotator cuff versus basic home exercises regarding shoulder function, pain, health related quality of life and return to work after arthroscopic subacromial decompression.
Study Overview
Detailed Description
Patients scheduled for surgery (arthroscopic subacromial decompression)and in the age 25-65 were offered to participate in the study.
After surgery they were randomized to either Supervised Physical therapy with early activation of the rotator cuff (PT-group) or to home exercises (H-group).
Patients in the PT group met the physical therapist twice a week for exercises and in between these visits they did their exercises at home daily.
The H-group did home exercises daily.
Shoulder function and pain(primary outcomes)and health related quality of life, returning to work(secondary outcomes)were assessed before surgery, one week after(baseline), 1,2,3 and 6 months after surgery by an independent physical therapist.
Study Type
Interventional
Enrollment (Actual)
45
Phase
- Not Applicable
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
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Subacromial impingement verified with Neer impingement test
- At least 6 month duration of pain
- Treated in primary care without satisfactory results for at least three months.
- Typical history and pain location. Scheduled for surgery (subacromial decompression)
Three of these four tests must be positive:
- Neer impingement test
- Hawkins-Kennedy impingement sign Jobe supraspinatus test
- Painful arc 60-120 degree
Exclusion Criteria:
- Radiological findings of malignancy osteoarthritis, fractures
- Polyarthritis or fibromyalgia
- Pathological hyper laxity
- Lack of communication skills that prevent the use of outcome measurements
- Cervical spine pathology
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 physical therapy focusing of rotatorcuff exercises
Patients did specific exercises supervised by a physical therapists twice a week during two months.
Focus was on early activation of rotator cuff and scapula stabilizers following different phases in a rehabilitation program Assessments before surgery,1 week after as well as 1,2,3 and 6 months after surgery.
|
|
Active Comparator: Home exercises
Patients did home exercises following a programme during three months.
Assessment considering shoulder function and pain was done before surgery, 1w after as well as 1,2,3 and 6 months after surgery,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder function and pain
Time Frame: before surgery, 1 w (baseline, 1,2,3 and 6 month after surgery
|
before surgery, 1 w (baseline, 1,2,3 and 6 month after surgery
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health related quality of life and returning to work
Time Frame: before surhery and 1 w(baseline)1,2,3 and 6 months after surgery
|
before surhery and 1 w(baseline)1,2,3 and 6 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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, 2003
Primary Completion (Actual)
January 1, 2006
Study Completion (Actual)
January 1, 2007
Study Registration Dates
First Submitted
January 21, 2010
First Submitted That Met QC Criteria
January 21, 2010
First Posted (Estimate)
January 22, 2010
Study Record Updates
Last Update Posted (Estimate)
January 22, 2010
Last Update Submitted That Met QC Criteria
January 21, 2010
Last Verified
January 1, 2006
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DNR 02-37
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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