- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01508715
Comparison of Exercise Interventions in Adults With Subacromial Impingement Syndrome
Comparison of an Eccentric Exercise Intervention to a Concentric Exercise Intervention in Adults With Subacromial Impingement Syndrome
The purpose of this study is to compare two different physical therapy exercise programs in persons who have shoulder pain in order to determine if they have a different affect on pain level and ability to use the injured shoulder after treatment. Both exercise groups will attend physical therapy for an hour,two to three times a week, for eight weeks. The first two weeks of therapy sessions will involve learning the exercises and testing to determine what weight to use during exercises. One group will perform a traditional therapy exercise program for shoulders using hand weights. The other group will perform a version of the same shoulder exercises but with a different exercise technique. Exercises in both programs are part of the standard of care for shoulder impingement in physical therapy but one program concentrates on the lowering portion of the exercise (eccentrics) while the other emphasizes the lifting portion of the exercise (concentrics). Both groups will perform the same warm-up, stretching, and cool-down exercises. Participants will also be required to perform a daily home exercise program of stretches and range of motion that will take about 20 minutes to complete. Exercise testing will determine the hand weight resistance used by each person during their therapy sessions and re-testing will occur every two weeks to determine any changes in the weight used for the exercises to keep them challenging. Pain level, ability to use the injured arm for daily activities, strength, and amount of movement in the shoulder, will be measured at the start of physical therapy and after five and eight weeks (end of study) of the exercise treatments. A concurrent study investigating the reliability of the shoulder motion and strength measurements used in the larger study will also be performed.
Research hypotheses:
- Adults with shoulder pain who complete the eccentric progressive resistive exercise intervention will demonstrate significantly greater improvements in the outcome measures at three weeks, earlier in the intervention, than the concentric progressive resistive exercise intervention group.
- Adults with shoulder pain who perform progressive resistive exercise interventions, regardless of contraction type, will demonstrate significant improvement in the shoulder outcome measures at three and six weeks of intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Texas
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Dallas, Texas, United States, 75231
- Texas Health Resources, Presbyterian Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 18 years of age and older
- Present with clinical signs of subacromial impingement syndrome
- Have not yet initiated physical or occupational therapy treatment
Exclusion Criteria:
- Previous shoulder, cervical, or thoracic surgery.
- History of shoulder fracture, dislocation, labral tear, or full thickness rotator cuff tear
- Treatment for neoplasm in the last year
- Rheumatic disease
- Adhesive capsulitis
- Shoulder pain currently rated greater than or equal to 8/10 on the NPRS
- Cardiac, neurological, or musculoskeletal condition that precludes ability to perform upper extremity resisted exercise
- Pregnancy
- inability to understand spoken or written English
- Inability to arrange transport to evaluation or treatment sessions or not planning to stay in the area long enough to complete study
Study Plan
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 |
---|---|
Active Comparator: Concentric exercise group
The participants in this group will perform the intervention exercises by actively completing the lifting portion of the resistive shoulder exercises.
The physical therapist will then perform the lowering portion of the exercise for the participant.
|
Both groups will perform the seated "full can", sidelying internal rotation (IR), sidelying external rotation (ER) with towel roll, supine protraction at 120° of flexion, sidelying horizontal abduction, sidelying abduction, and seated pulley extension using resistance weights in the participant's pain-free shoulder motion.
One group will complete only the eccentric portion of the exercise actively, the other will complete only the concentric portion actively.
The treating physical therapist will reposition the weights to avoid active resistance occuring in the opposite direction of the desired intervention.
Both groups will use 70% of their predicted one repetition maximum (1RM), progressing to 80% with 1RM reassessed and training weight adjusted every two weeks.
|
Experimental: Eccentric exercise group
The participants in this group will actively perform the lowering portion of the resistive shoulder exercises in the intervention.
The physical therapist will perform the lifting portion of the exercise for the participant.
|
Both groups will perform the seated "full can", sidelying internal rotation (IR), sidelying external rotation (ER) with towel roll, supine protraction at 120° of flexion, sidelying horizontal abduction, sidelying abduction, and seated pulley extension using resistance weights in the participant's pain-free shoulder motion.
One group will complete only the eccentric portion of the exercise actively, the other will complete only the concentric portion actively.
The treating physical therapist will reposition the weights to avoid active resistance occuring in the opposite direction of the desired intervention.
Both groups will use 70% of their predicted one repetition maximum (1RM), progressing to 80% with 1RM reassessed and training weight adjusted every two weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Shoulder function
Time Frame: baseline, after 3 weeks and 6 weeks of intervention
|
Measured by change in numeric pain rating scale (NPRS)score for shoulder pain, change in disabilities of the arm, shoulder, and hand (DASH) self-report of function score, change in shoulder abduction and external rotation strength assessed with a hand-held dynamometer, and change in shoulder flexion and scapular plane elevation pain-free range of motion assessed with a digital inclinometer.
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baseline, after 3 weeks and 6 weeks of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intratester reliability
Time Frame: over course of study
|
A subset of participants will be tested for strength and range of motion outcomes twice at each time frame by the same examiner in order to analyze intratester reliability of the testing protocols using Intraclass Correlation Coefficients.
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over course of study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christiana L Blume, PT, PhD, OCS, Texas Woman's University, Texas Health Resources, Dallas
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16838
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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