Full Thickness Rotator Cuff TearEarly Phase 1CERCTNCT02750176
Rehabilitation: Closed-Chain Exercises for Rotator Cuff Tears
A Early Phase 1 study testing Closed chain exercises in people with Full Thickness Rotator Cuff Tear, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Full Thickness Rotator Cuff Tear
- What is being tested?
- Closed chain exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Jul 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Biomechanics Orthopedic and Sports Outcomes Research Laboratory
Los Angeles, California, 90089
About this study
Official title: Rehabilitation of Patients With Full-thickness Rotator Cuff Tears: Planning and Pilot Study for Feasibility and Efficacy
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.
Read the 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.
- Conditions
- Full Thickness Rotator Cuff Tear
- Being tested
- Closed chain exercises
- Keywords
- Rehabilitation, Closed chain exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed chain exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CERCT | Experimental | Closed chain exercises Receives: Other: Closed chain exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Patient Specific Functional Scale (PSFS)
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Penn Shoulder Score (Penn)
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Secondary outcomes (9)
Feasibility - retention
The goal is to retain at least 75% of the participants enrolled.
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Quick Disabilities of the Arm Shoulder Hand (QDASH) scale
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Global Rating of Change (GRoC) scale
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Numeric Pain Rating Scale (NPRS)
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
American Shoulder and Elbow Surgeon Patient-report (ASES) scale
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Shoulder pain-free active elevation range of motion
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Shoulder elevation strength
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Shoulder external rotation strength
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Patient Acceptable Symptom State (PASS) score
Measured: End of the study (Stage 2): 5 months / approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Thickness Rotator Cuff TearStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Michener, University of Southern California
- Investigators
- Lori Michener, PT, ATC, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750176
- Sponsor's protocol ID
- HS-15-00771
- Acronym
- CERCT
- Status last verified
- Oct 2018
- First submitted
- 18 Apr 2016
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation of Patients With Full-thickness Rotator Cuff Tears: Planning and Pilot Study for Feasibility and Efficacy
- ClinicalTrials.gov ID
- NCT02750176
- Acronym / sponsor ID
- CERCT / HS-15-00771
- Conditions
- Full Thickness Rotator Cuff Tear
- Keywords
- Rehabilitation, Closed chain exercises
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CERCT | Experimental | Other: Closed chain exercisesClosed chain exercises |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed chain exercisesClosed-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. | Other | CERCT |
Primary outcome
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.
Patient Specific Functional Scale (PSFS)
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Penn Shoulder Score (Penn)
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
9 secondary outcomes
Feasibility - retention
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Quick Disabilities of the Arm Shoulder Hand (QDASH) scale
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Global Rating of Change (GRoC) scale
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Numeric Pain Rating Scale (NPRS)
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
American Shoulder and Elbow Surgeon Patient-report (ASES) scale
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Shoulder pain-free active elevation range of motion
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Shoulder elevation strength
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Shoulder external rotation strength
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Patient Acceptable Symptom State (PASS) score
Time frame: End of the study (Stage 2): 5 months / approximately 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Full Thickness Rotator Cuff Tear
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Evaluation Of Outcomes Following Rotator Cuff Repair Using the REGENETEN Bioinductive Implant
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lori Michener, PT, ATC, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Closed chain exercises in people with Full Thickness Rotator Cuff Tear, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - recruitment (time frame: End of the study (Stage 2): 5 months / approximately 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.