Using blood flow restriction therapy for rotator cuff tears
Use of Blood Flow Restriction (BFR) Therapy in Patients With Rotator Cuff Tears Treated Nonoperatively or Operatively: a Randomized Controlled Trial
This study is testing if blood flow restriction therapy can help people with rotator cuff tears get stronger and avoid muscle loss during their recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Henry Ford Health System Academic / other |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT04384120 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of blood flow restriction (BFR) therapy on patients with rotator cuff tears, both those treated non-operatively and operatively. Patients will be randomly assigned to either a BFR group or a traditional therapy group after a shared decision-making process with their orthopedic surgeon. The goal is to assess whether BFR can enhance strength gains and prevent muscle atrophy during rehabilitation. Participants will undergo baseline testing and follow a structured rehabilitation protocol tailored to their treatment plan.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have suffered a rotator cuff tear and are either undergoing surgical repair or nonoperative treatment.
Not a fit: Patients with a history of deep vein thrombosis, neurovascular injury, or those unable to tolerate BFR treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery and improved strength for patients with rotator cuff tears.
How similar studies have performed: Previous studies have shown promising results with blood flow restriction therapy in various rehabilitation settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients aged 18-80 who suffered a rotator cuff tear * Patients undergoing arthroscopic rotator cuff repair * Patients undergoing nonoperative treatment with physical therapy Exclusion Criteria: * o Subjects will be excluded if they are undergoing revision rotator cuff repair, history of DVT, neurovascular injury, unable to tolerate BFR treatment, unable to complete physical therapy, peripheral vascular disease
Where this trial is running
Detroit, Michigan
- Henry Ford Health Systems — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Lafi S Khalil, MD — Henry Ford Health System
- Study coordinator: Lafi S Khalil, MD
- Email: lkhalil2@hfhs.org
- Phone: 313-932-5657
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.