BFR Therapy for Biceps Tendon Rupture

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Revision surgery, DVT, Neurovascular injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 16 weeks

68 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Blood Flow Restriction (BFR) Therapy for Biceps Tendon Rupture?

The research includes a case study where a college football player with a ruptured biceps muscle was successfully treated with a rehabilitation program, which included exercises and therapies similar to those in BFR Therapy. The player avoided surgery and returned to competition without reinjury, suggesting that such rehabilitation approaches can be effective. ^{1 2 3 4 5}

Is Blood Flow Restriction (BFR) Therapy generally safe for humans?

A study on exercise with low-loads and partial blood flow restriction (BFR) in females with gluteal tendinopathy suggests that this approach is feasible, indicating it may be safe for use in humans. However, more research is needed to confirm its safety across different conditions. ^{6 7 8 9 10}

What is the purpose of this trial?

The purpose of this study is to examine the effect of utilizing blood flow restriction (BFR) therapy after distal biceps tendon repair or medial patellofemoral ligament reconstruction (MPFLR) following a tear.

Research Team

Kelechi Okoroha, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults aged 18-80 who have experienced a biceps tendon tear or patellar dislocation and are undergoing repair surgery. Candidates must be able to tolerate blood flow restriction (BFR) therapy and complete physical therapy. People with a history of deep vein thrombosis, neurovascular injury, peripheral vascular disease, or those needing revision surgeries are not eligible.

Inclusion Criteria

Subjects will be recruited from our ambulatory sports medicine clinics.

You are between the ages of 18 and 80 and have torn your biceps, and are scheduled to have surgery to repair it. You may also be eligible if you have a similar knee condition called MPFLR.

Exclusion Criteria

Subjects will be withdrawn from the study if they are unable to tolerate the BFR therapy. Additionally if they suffer from any complications of the therapy they will be withdrawn immediately. This will be facilitated by describing the reasons for withdrawal to the patient prior to initiating the study and ask patients and other providers to inform the investigators if there are any issues or concerns.

You have had a previous surgery on your biceps or MPFLR, have a history of blood clot, nerve injury or poor blood circulation, cannot handle BFR treatment or physical therapy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard of care physical therapy with or without blood flow restriction (BFR) therapy following surgery

16 weeks

Regular physical therapy sessions

Follow-up

Participants are monitored for changes in strength and range of motion post-treatment

6 months

Assessments at 6 weeks, 12 weeks, 16 weeks, and 6 months

Treatment Details

Interventions

• Blood Flow Restriction (BFR) Therapy
• Physical Therapy

Trial Overview The study is testing the effectiveness of Blood Flow Restriction (BFR) Therapy when used alongside standard physical therapy after surgical repair of either the biceps tendon or medial patellofemoral ligament due to tears.

Participant Groups

Group I: Conventional rehabilitation plus blood flow restriction (BFR) therapy Experimental Treatment 1 Intervention

Following standard of care surgery, subjects will immediately be started in standard of care physical therapy. Additionally, a BFR Cuff will be applied during physical therapy.

Group II: Conventional rehabilitation Active Control 1 Intervention

Following standard of care surgery, subjects will immediately be started in standard of care physical therapy.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of a surgically repaired rupture of the distal biceps tendon in an active middle aged male: a case report. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Rehabilitation of the ruptured biceps brachii muscle of an athlete. [2008]

3. England pubmed.ncbi.nlm.nih.gov

Challenging the mechanism of distal biceps tendon rupture using a video analysis study. [2022]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

A Case Series of Symptomatic Distal Biceps Tendinopathy. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Surgical treatment of distal biceps rupture. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Use of Behavior Change Techniques Alongside Exercise in the Management of Rotator Cuff-Related Shoulder Pain: A Scoping Review. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Factors Affecting Postoperative Rehabilitation Therapy Utilization After Arthroscopic Rotator Cuff Repair: An Epidemiological Analysis. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Exercise With Low-Loads and Concurrent Partial Blood Flow Restriction Combined With Patient Education in Females Suffering From Gluteal Tendinopathy: A Feasibility Study. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Dry needling in a multimodal rehabilitation protocol following rotator cuff repair surgery: study protocol for a double-blinded randomized sham-controlled trial. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Thromboembolic Events During Weightbearing vs Nonweightbearing Accelerated Rehabilitation Protocols for Complete Achilles Tendon Ruptures. [2023]