Back to resultsExercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome
Primary Purpose
Shoulder Impingement Syndrome
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation
Eligibility Criteria
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
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Shoulder disability
Secondary Outcome Measures
Patient satisfaction
Quality of life
Pain with rest, normal activities, and strenuous activities
Patient perceived global rating of effect
Additional healthcare utilization and medication use
Full Information
NCT ID
NCT00632996
First Posted
March 3, 2008
Last Updated
December 18, 2015
Sponsor
Virginia Commonwealth University
Collaborators
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation), University of North Florida, Arcadia University
1. Study Identification
Unique Protocol Identification Number
NCT00632996
Brief Title
Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome
Official Title
Effectiveness of Rehabilitation for Subacromial Impingement Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Athletic Trainers' Association Research & Education Foundation (NATA Foundation), University of North Florida, Arcadia University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Impingement Syndrome
Keywords
shoulder pain, shoulder impingement syndrome, manual therapy, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Rehabilitation
Other Intervention Name(s)
Physical Therapy, Manual Therapy
Intervention Description
Exercise, manual therapy, patient education, posture, home exercise program
Primary Outcome Measure Information:
Title
Shoulder disability
Time Frame
6 week and 3, 6, 12 months
Secondary Outcome Measure Information:
Title
Patient satisfaction
Time Frame
6 weeks and 3, 6, 12 months
Title
Quality of life
Time Frame
6 weeks and 3, 6, 12 months
Title
Pain with rest, normal activities, and strenuous activities
Time Frame
6 weeks and 3, 6, 12 months
Title
Patient perceived global rating of effect
Time Frame
6 weeks and 3 months
Title
Additional healthcare utilization and medication use
Time Frame
6 weeks and 3, 6, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori A Michener, PhD, PT, ATC
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phillip W McClure, PhD, PT
Organizational Affiliation
Arcadia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela R Tate, PhD, PT
Organizational Affiliation
Arcadia University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ian A Young, PT
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Study Chair
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20710088
Citation
Tate AR, McClure PW, Young IA, Salvatori R, Michener LA. Comprehensive impairment-based exercise and manual therapy intervention for patients with subacromial impingement syndrome: a case series. J Orthop Sports Phys Ther. 2010 Aug;40(8):474-93. doi: 10.2519/jospt.2010.3223.
Results Reference
derived
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Exercise and Manual Therapy for Shoulder Subacromial Impingement Syndrome
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