- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02750176
Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears (CERCT)
Rehabilitation of Patients With Full-thickness Rotator Cuff Tears: Planning and Pilot Study for Feasibility and Efficacy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Closed-chain exercises have been used extensively in rehabilitation approaches to treat a diverse range of musculoskeletal diagnoses. The closed-chain approach theoretically facilitates co-contraction to improve joint mobility, stability and motor control, as well as decreasing potential compression of the RC tendons in the subacromial space. The closed-chain exercises are performed with the hands in contact with the floor/table, while the shoulder joint moves and gravity provides resistance. This approach may prevent tear progression and improve joint mechanics, shoulder pain, and function.
STAGE 1 - Physical therapy
Participants will be provided closed-chain exercises in the physical therapy treatment by a licensed physical therapist. The length of each session will be 1 hour. Participants will attend 2 sessions per week, for a minimum of 12 sessions. The maximum number of sessions to complete Stage I of the protocol is 24. Each physical therapy session will consist of closed-chain strengthening, along with stretching and aerobic exercises.
During the closed-chain strengthening portion, participants will be asked to perform 6 exercises focusing on the shoulder girdle. Closed-chain strengthening will be performed with the shoulder moving over a fixed hand. Resistance will be provided by body weight against gravity. To off-load and progress the amount of body-weight resistance, elastic bands will be used to support body weight. The elastic bands will be attached to support frame used for the exercises. As the patient improves, less elastic band support will be provided to allow increased resistance via the patient's body weight. The criteria for determining if the resistance is too high or the exercise is too difficult will be based on 2 criteria: 1.) after the exercise is completed, the participant rates their shoulder pain > 2/10 increase as compared to baseline pain taken at the start of that day's treatment session, on the numeric pain rating scale, and 2.) BORG scale > 3 (moderate difficulty) and an inability of the participant to maintain proper exercise form and full range of motion. If these criteria are met then the physical therapist will modify the exercise so the subject can perform similar movement pattern without pain. The goal will be for the participant to perform 2 sets of 20 repetitions, of each exercise. When the participant is able to perform 24 repetitions with the given load, over 2 successive treatment sessions, then the resistance will be increased.
The investigators recognize that there is limited evidence regarding the effectiveness and safety of closed-chain exercises in patients with full-thickness rotator cuff tears. Therefore, the investigators are employing several steps to assure safety. At the beginning of each session, each patient will fill out a questionnaire to assess for adverse effects of exercises (such as severe joint pain). After each exercise, participants will rate their shoulder pain level and their perceived difficulty with the exercise. This information will be used to tailor the intervention according to the response to the intervention. Furthermore, it will allow for monitoring for adverse outcomes of the intervention.
Participants will perform aerobic exercises of a stationary bike, elliptical, and treadmill. Aerobic exercise will last about 10 to 15 minutes each session. Intensity of aerobic exercises will be adjusted throughout stage I. The target is to exercise at least at a 4 level (somewhat hard) on the BORG scale.
STAGE 2 - Gym program
Participants will be enrolled in a gym program following discharge from Stage 1. The Gym Program will be provided by a health care professionals trained in the delivery of exercise. Each session will be 1 hour. Participants will attend 2 sessions per week, for 8- 12 weeks depending on when they are discharged from Stage I. Each session will consist of closed-chain strengthening, stretching, and aerobic exercises.
During the closed-chain strengthening portion, participants will execute the same six-strengthening exercises as stage I. The next phase involves progressing to a moderate resistance load that will allow the participant to complete 2 sets of 8 to 12 repetitions of a given exercise. When the participant is able to perform more than 12 repetitions with a given load, over the course of 2 successive training sessions, then the resistance will be incrementally increased. The maximum resistance will be against body weight (no support from bands).
Participants will perform aerobic exercises alternating each session between a stationary bike, elliptical, and treadmill. Aerobic exercise will last about 15 to 20 minutes each session. Intensity of aerobic exercises will be adjusted throughout stage II. The target will be to exercise at least at a 4 level (somewhat hard) on the BORG scale.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90089
- Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Full-thickness rotator cuff tears - confirmed by ultrasound (US) or magnetic resonance imagining (MRI)
- Symptomatic for > 3 months
- Reduction in shoulder function:
Patient satisfaction with use of their shoulder: ≤ 7/10 (10 = fully satisfied) OR Penn Function Subscale Score ≤ 40/60 (60 = full function)
Exclusion Criteria:
- Physical therapy for current shoulder symptoms within last 3 months
- Previous shoulder surgery on the involved shoulder
- Cervical radiculopathy
- Undergoing treatment for active cancer
- Cardiovascular, pulmonary, neurological disease with physician limitations on exercise
- Uncontrolled high blood pressure (> systolic above 90, diastolic above 140)
- Unstable shoulder - primary diagnosis
- Unable to complete up to 5 months of treatment at the clinic
Study Plan
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: CERCT
Closed chain exercises
|
Closed-chain strengthening will be performed with the shoulder moving over a fixed hand.
Resistance will be provided by body weight against gravity.
To off-load and progress the amount of body-weight resistance, elastic bands will be used to support body weight using a exercise frame.
Patients will perform 6 exercises.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - recruitment
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
|
Recruit 65% of the patients with rotator cuff tears that come to the USC PT Associate clinic for physical therapy treatment or patients that are seen at the physician office and are referred for physical therapy treatment.
|
End of the study (Stage 2): 5 months / approximately 24 weeks
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Patient Specific Functional Scale (PSFS)
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
|
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Penn Shoulder Score (Penn)
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility - retention
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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The goal is to retain at least 75% of the participants enrolled.
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End of the study (Stage 2): 5 months / approximately 24 weeks
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Quick Disabilities of the Arm Shoulder Hand (QDASH) scale
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
|
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Global Rating of Change (GRoC) scale
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
|
End of the study (Stage 2): 5 months / approximately 24 weeks
|
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Numeric Pain Rating Scale (NPRS)
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
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American Shoulder and Elbow Surgeon Patient-report (ASES) scale
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
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Shoulder pain-free active elevation range of motion
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
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Shoulder elevation strength
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
|
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Shoulder external rotation strength
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
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End of the study (Stage 2): 5 months / approximately 24 weeks
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Patient Acceptable Symptom State (PASS) score
Time Frame: End of the study (Stage 2): 5 months / approximately 24 weeks
|
End of the study (Stage 2): 5 months / approximately 24 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Lori Michener, PT, ATC, PhD, University of Southern California
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 (Actual)
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
- HS-15-00771
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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