Rotator Cuff TearsNCT04470570
The Effect of Cross-Education on Shoulder Arthroscopy
A study testing Cross-Education and Blood-Flow Restriction Training in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured upper extremity either alone or with the addition of blood flow restriction (BFR) training on subjects who have undergone shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries, Rotator Cuff Repair
- What is being tested?
- Cross-Education and Blood-Flow Restriction Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2020to 30 Oct 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older
- Diagnosed with rotator cuff injury
- Scheduled for rotator cuff surgery via shoulder arthroscopy
Who cannot join
- Less than 18 years old
- History of previous contra-lateral surgery or injury
- Previous ipsi-lateral upper extremity surgery
- History of shoulder osteoarthritis
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Kerlan-Jobe Institute
Los Angeles, California, 90045
About this study
Official title: The Effects of Cross-Education and Blood Flow Restriction Study on Patients Undergoing Shoulder Arthroscopy
The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured upper extremity either alone or with the addition of blood flow restriction (BFR) training on subjects who have undergone shoulder arthroscopy.
Read the detailed description
The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured limb either alone or with the addition of blood flow restriction (BFR) training on the status of the injured limb post shoulder arthroscopy. Patients will be randomized into one of three standardized physical therapy (PT) groups after shoulder arthroscopy: Control group (CON), Strength Training on the uninvolved shoulder (STR), strength training with the BFR on the uninvolved shoulder (BFR). All three patient groups will follow a standardized PT rehab protocol that is usual standard of care on the involved shoulder. The STR and BFR group will follow a typical standard of care rehab protocol to the uninvolved side to investigate the potential effects of cross-education. Isometric strength will be assessed utilizing handheld dynamometry (HHD) at Kerlan-Jobe during their regularly scheduled pre-operative and follow-up visits. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 14 weeks. 2 weeks to allow for a pre-op baseline strength assessment and 12 weeks post-op for the final assessment during the patients routine follow-up visit. Physical Therapy will be standardized for all three groups in terms of frequency and rehabilitation protocol. The only exercises that will be added will be to the intervention groups on the uninvolved side. Patients will present to physical therapy 2-3 times/week during the duration of the study regardless of their group allocation.
- Being tested
- Cross-Education, Blood-Flow Restriction Training
- Keywords
- biceps tenodesis, Cross-Education, Blood-Flow Restriction Training
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cross-EducationOther
- Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.
Blood-Flow Restriction TrainingOther
- Blood Flow Restriction: A type of resistance training using a blood-pressure like cuff that partially occludes venous blood flow to induce various neurohormonal effects and allows strength gains to be achieved at very low loads of resistance.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | This group will undergo a standardized rehabilitation protocol of the involved shoulder only. |
| Cross-Education Group | Experimental | This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side. Receives: Other: Cross-Education |
| Cross-Education + Blood-Flow Restriction Group | Experimental | This group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side with blood-flow restriction simultaneously. Receives: Other: Cross-Education; Other: Blood-Flow Restriction Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in strength of the shoulder at 6 weeks and 12 weeks
Strength of the shoulder will be assessed via hand-held dynamometer
Measured: pre-operative visit, 6 week post-operative visit, 12-week post-operative visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start13 Jul 2020
- Primary completion30 Sep 2020
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Banffy, MD, Cedars-Sinai Medical Center
- Investigators
- Michael B Banffy, MD, Principal investigator, Cedars-Sinai Kerlan-Jobe Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470570
- Sponsor's protocol ID
- STUDY00000737
- Status last verified
- Feb 2024
- First submitted
- 7 Jul 2020
- Last updated
- 8 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cross-Education and Blood Flow Restriction Study on Patients Undergoing Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT04470570
- Acronym / sponsor ID
- STUDY00000737
- Keywords
- biceps tenodesis, Cross-Education, Blood-Flow Restriction Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 13 Jul 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 14 Jul 2020 (actual)
- 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.
The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured upper extremity either alone or with the addition of blood flow restriction (BFR) training on subjects who have undergone shoulder arthroscopy.
Detailed description
The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured limb either alone or with the addition of blood flow restriction (BFR) training on the status of the injured limb post shoulder arthroscopy. Patients will be randomized into one of three standardized physical therapy (PT) groups after shoulder arthroscopy: Control group (CON), Strength Training on the uninvolved shoulder (STR), strength training with the BFR on the uninvolved shoulder (BFR). All three patient groups will follow a standardized PT rehab protocol that is usual standard of care on the involved shoulder. The STR and BFR group will follow a typical standard of care rehab protocol to the uninvolved side to investigate the potential effects of cross-education. Isometric strength will be assessed utilizing handheld dynamometry (HHD) at Kerlan-Jobe during their regularly scheduled pre-operative and follow-up visits. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 14 weeks. 2 weeks to allow for a pre-op baseline strength assessment and 12 weeks post-op for the final assessment during the patients routine follow-up visit. Physical Therapy will be standardized for all three groups in terms of frequency and rehabilitation protocol. The only exercises that will be added will be to the intervention groups on the uninvolved side. Patients will present to physical therapy 2-3 times/week during the duration of the study regardless of their group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –This group will undergo a standardized rehabilitation protocol of the involved shoulder only. |
| Cross-Education Group | Experimental | Other: Cross-EducationThis group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side. |
| Cross-Education + Blood-Flow Restriction Group | Experimental | Other: Cross-Education, Other: Blood-Flow Restriction TrainingThis group will undergo a standardized rehabilitation protocol of the involved shoulder with the addition of upper extremity strengthening exercises to the uninvolved side with blood-flow restriction simultaneously. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Diagnosed with rotator cuff injury
- Scheduled for rotator cuff surgery via shoulder arthroscopy
Key exclusion criteria (4 listed)
- Less than 18 years old
- History of previous contra-lateral surgery or injury
- Previous ipsi-lateral upper extremity surgery
- History of shoulder osteoarthritis
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 |
|---|---|---|
| Cross-Education1) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity. | Other | Cross-Education + Blood-Flow Restriction Group, Cross-Education Group |
| Blood-Flow Restriction Training1) Blood Flow Restriction: A type of resistance training using a blood-pressure like cuff that partially occludes venous blood flow to induce various neurohormonal effects and allows strength gains to be achieved at very low loads of resistance. | Other | Cross-Education + Blood-Flow Restriction Group |
Primary outcome
Change in strength of the shoulder at 6 weeks and 12 weeks
Time frame: pre-operative visit, 6 week post-operative visit, 12-week post-operative visit
Strength of the shoulder will be assessed via hand-held dynamometer
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 8 Feb 2024.
- Individual participant dataSharing planned: Yes
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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.
Michael B Banffy, MD principal investigator
Cedars-Sinai Kerlan-Jobe Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cross-Education and Blood-Flow Restriction Training in people with Rotator Cuff Tears and Rotator Cuff Injuries, run by Cedars-Sinai Medical Center 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 3 inclusion and 4 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 8 Feb 2024. 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.
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?
Change in strength of the shoulder at 6 weeks and 12 weeks (time frame: pre-operative visit, 6 week post-operative visit, 12-week post-operative visit). 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 8 Feb 2024.