Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears (CERCT)
Primary Purpose
Full Thickness Rotator Cuff Tear
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Closed chain exercises
Sponsored by
About this trial
This is an interventional treatment trial for Full Thickness Rotator Cuff Tear focused on measuring Rehabilitation, Closed chain exercises
Eligibility Criteria
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
Sites / Locations
- Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CERCT
Arm Description
Closed chain exercises
Outcomes
Primary Outcome Measures
Feasibility - recruitment
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.
Patient Specific Functional Scale (PSFS)
Penn Shoulder Score (Penn)
Secondary Outcome Measures
Feasibility - retention
The goal is to retain at least 75% of the participants enrolled.
Quick Disabilities of the Arm Shoulder Hand (QDASH) scale
Global Rating of Change (GRoC) scale
Numeric Pain Rating Scale (NPRS)
American Shoulder and Elbow Surgeon Patient-report (ASES) scale
Shoulder pain-free active elevation range of motion
Shoulder elevation strength
Shoulder external rotation strength
Patient Acceptable Symptom State (PASS) score
Full Information
NCT ID
NCT02750176
First Posted
April 18, 2016
Last Updated
October 23, 2018
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT02750176
Brief Title
Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears
Acronym
CERCT
Official Title
Rehabilitation of Patients With Full-thickness Rotator Cuff Tears: Planning and Pilot Study for Feasibility and Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A single arm design will be used to assess the feasibility and preliminary efficacy of a closed-chain rehabilitation protocol for patients with full thickness rotator cuff tears of the shoulder. Full thickness rotator cuff tears will be documented using MRI or ultrasound images. 30 participants will be recruited for this study. The rehabilitation protocol will include two stages: stage 1, physical therapy, and stage 2, gym program. Stage I will include a total number of session between 12 and 24. The number of session included in stage 2, will depend on the total number of session completed during stage 1. The total duration of both stages will 5 months.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Rotator Cuff Tear
Keywords
Rehabilitation, Closed chain exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CERCT
Arm Type
Experimental
Arm Description
Closed chain exercises
Intervention Type
Other
Intervention Name(s)
Closed chain exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility - recruitment
Description
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.
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Patient Specific Functional Scale (PSFS)
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Penn Shoulder Score (Penn)
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Secondary Outcome Measure Information:
Title
Feasibility - retention
Description
The goal is to retain at least 75% of the participants enrolled.
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Quick Disabilities of the Arm Shoulder Hand (QDASH) scale
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Global Rating of Change (GRoC) scale
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Numeric Pain Rating Scale (NPRS)
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
American Shoulder and Elbow Surgeon Patient-report (ASES) scale
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Shoulder pain-free active elevation range of motion
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Shoulder elevation strength
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Shoulder external rotation strength
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
Title
Patient Acceptable Symptom State (PASS) score
Time Frame
End of the study (Stage 2): 5 months / approximately 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori Michener, PT, ATC, PhD
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears
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