Blood flow restriction therapy for shoulder injuries
Blood Flow Restriction Therapy Following Acute Shoulder Injury Patients: Assessment of Efficacy in Return to Activity
This study tests if using blood flow restriction therapy during rehab can help people with acute shoulder injuries recover better than those who don’t receive the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT06223373 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of blood flow restriction (BFR) therapy on patients with acute shoulder injuries, specifically focusing on non-operative rotator cuff and biceps tendinopathy. BFR therapy involves applying a pressurized tourniquet to the injured limb during rehabilitation to limit muscle atrophy while performing strength training. The study aims to clarify the impact of BFR on ligamentous and tendinous injuries in the upper extremity, an area that has not been extensively researched. Participants will be compared against a sham BFR group to assess the effectiveness of the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18 to 55 with a formal diagnosis of non-operative rotator cuff or biceps tendinopathy.
Not a fit: Patients with prior upper extremity surgeries or those with other significant injuries that affect rehabilitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could significantly reduce muscle atrophy and improve recovery outcomes for patients with shoulder injuries.
How similar studies have performed: While several studies have explored BFR therapy, this specific application for upper extremity injuries remains largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * injured patient with clinical and magnetic resonance imaging (MRI) consistent with a formal diagnosis of non-operative rotator cuff and/or biceps tendinopathy * no prior upper extremity ipsilateral procedures or history of deep vein thrombosis * those willing to be part of the study Exclusion Criteria: * patients younger than 18 or older than 55 years of age * a history of revision surgery or prior ipsilateral upper extremity surgery * concomitant ligamentous, tendinous, or cartilage injury that would alter postoperative rehabilitation protocol * inability to comply with the proposed follow-up clinic visits * patients lacking decisional capacity
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Kristen Nicholson, MD — Wake Forest University Health Sciences
- Study coordinator: Edward Beck, MD
- Email: ecbeck@wakehealth.edu
- Phone: 630.9678844
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.