- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00632996
Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome
December 18, 2015 updated by: Virginia Commonwealth University
Effectiveness of Rehabilitation for Subacromial Impingement Syndrome
The purposes of this study are to:
- determine if a rehabilitation program that consists of exercise and manual therapy reduces pain and improves quality of life in patients with shoulder subacromial impingement syndrome;
- determine which patients are likely to respond to this rehabilitation program and which patients are not likely to respond to this rehabilitation program
The hypotheses are:
- the rehabilitation treatment program will result in significant changes in pain and quality of life
- there will be items from the history and examination that will identify those patients who respond favorably and those who do not respond favorably to rehabilitation at 6 weeks, 3, 6 and 12 months.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Subacromial impingement syndrome (SAIS) is the most frequent cause of shoulder pain.
A variety of non-surgical treatments have been advocated to correct the impairments associated with SAIS.
Clinical trials support the use of therapeutic exercise and joint mobilizations to improve pain and functional disability associated with SAIS.
However, not all patients in these trials had a favorable outcome.
Moreover, the effect sizes in these trials were small to moderate.
Thus the purposes of this study are to 1. determine the effect of a multi-modal rehabilitation program consisting of strengthening, stretching, manual therapy to the shoulder and spine, patient education, posture, and functional re-training; and 2. identify those patients who are and who are not likely to respond to rehabilitation at the start of care.
Study Type
Interventional
Enrollment (Actual)
162
Phase
- Phase 2
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
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
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 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Diagnosis of shoulder impingement syndrome as evidence by all 5 criteria:
- Reproduction of symptoms with impingement test: either Hawkins-Kennedy or Neer Test
- Pain during active shoulder elevation at or above 60 degrees
- Weakness of rotator cuff or pain during the Empty Can test or during resisted shoulder external rotation
- Shoulder disability: greater than or equal to 20/100 (0 = no disability)
- Able to understand written and spoken English
Exclusion Criteria:
- Severe pain; pain is > or equal to 7/10 on NPRS (0 = no pain)
- Shoulder surgery on affected shoulder
- Traumatic shoulder dislocation within the past 3 months
- Previous rehabilitation for this episode of shoulder pain
- Reproduction of shoulder pain with active or passive cervical motion
- Systemic inflammatory joint disease
- Global loss of passive shoulder ROM, indicative of adhesive capsulitis
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
Exercise, manual therapy, patient education, posture, home exercise program
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Shoulder disability
Time Frame: 6 week and 3, 6, 12 months
|
6 week and 3, 6, 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient satisfaction
Time Frame: 6 weeks and 3, 6, 12 months
|
6 weeks and 3, 6, 12 months
|
Quality of life
Time Frame: 6 weeks and 3, 6, 12 months
|
6 weeks and 3, 6, 12 months
|
Pain with rest, normal activities, and strenuous activities
Time Frame: 6 weeks and 3, 6, 12 months
|
6 weeks and 3, 6, 12 months
|
Patient perceived global rating of effect
Time Frame: 6 weeks and 3 months
|
6 weeks and 3 months
|
Additional healthcare utilization and medication use
Time Frame: 6 weeks and 3, 6, 12 months
|
6 weeks and 3, 6, 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lori A Michener, PhD, PT, ATC, Virginia Commonwealth University
- Principal Investigator: Phillip W McClure, PhD, PT, Arcadia University
- Study Director: Angela R Tate, PhD, PT, Arcadia University
- Study Chair: Ian A Young, PT, Virginia Commonwealth University
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, 2008
Primary Completion (Actual)
January 1, 2014
Study Completion (Actual)
January 1, 2014
Study Registration Dates
First Submitted
March 3, 2008
First Submitted That Met QC Criteria
March 10, 2008
First Posted (Estimate)
March 11, 2008
Study Record Updates
Last Update Posted (Estimate)
December 21, 2015
Last Update Submitted That Met QC Criteria
December 18, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HM10320
- Proposal #:PT101875
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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-
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