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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how blood flow restriction (BFR) therapy aids recovery after surgery for a torn biceps tendon or knee ligament repair. BFR therapy uses a cuff to restrict blood flow to muscles during physical therapy, potentially accelerating recovery. Participants will join one of two groups: one will receive standard physical therapy plus BFR, while the other will receive only standard physical therapy. This trial suits individuals who have recently undergone surgery to repair a biceps tear or certain knee ligament injuries.

As an unphased trial, it provides participants the chance to explore innovative recovery methods that could enhance their rehabilitation experience.

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 prior data suggests that blood flow restriction (BFR) therapy is safe for post-surgical rehabilitation?

Research has shown that blood flow restriction (BFR) therapy is generally safe for rehabilitation. A review of 20 studies found that BFR therapy improves movement and strength in muscles and joints, indicating that most patients tolerate the therapy well.

One study found that patients using BFR therapy after certain surgeries had better outcomes than those who did not, experiencing less pain and improved movement, which suggests positive safety outcomes.

However, not all studies agree. Some show mixed results, particularly for tendon issues. Despite this, BFR therapy is widely used in rehabilitation settings, indicating that serious side effects are rare.

Overall, current research supports BFR therapy as a generally safe option, with improvements in recovery and few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Blood Flow Restriction (BFR) Therapy for biceps tendon rupture because it offers a unique way to enhance muscle recovery. Unlike standard physical therapy that focuses solely on exercise, BFR therapy involves applying a specialized cuff to partially restrict blood flow during rehabilitation exercises. This technique can stimulate muscle growth and strength more effectively, potentially leading to faster recovery times. By combining BFR with conventional rehabilitation, there's hope for improved outcomes, setting it apart from traditional methods that do not incorporate this innovative approach.

What evidence suggests that this trial's treatments could be effective for biceps tendon rupture?

Research shows that blood flow restriction (BFR) therapy, a treatment under study in this trial, can aid recovery after surgeries like biceps tendon repairs. Studies have found that BFR therapy strengthens and enlarges muscles. It also enhances recovery by improving mobility and reducing pain. For instance, a college football player successfully recovered from a biceps tendon injury using BFR therapy. Overall, patients have reported less pain and improved movement with BFR therapy. Participants in this trial will receive either conventional rehabilitation plus BFR therapy or conventional rehabilitation alone. ^{2 3 5 6 7}

Who Is on the Research Team?

Kelechi Okoroha, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-025-08734-5

The impact of blood flow restriction training on tendon ... Additionally, five case reports using BFRT demonstrated improvements in functional outcomes and pain [35, 48,49,50,51]. However, one study ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0972978X23000624

Survey of blood flow restriction therapy for rehabilitation in ... Blood flow restriction (BFR) therapy has demonstrated benefits across a spectrum of musculoskeletal injuries, including improved strength, endurance, function, ...

3. withpower.com withpower.com/trial/phase-medial-patellofemoral-ligament-tear-5-2022-c3dd9

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 ...

4. mdpi.com mdpi.com/2674-0621/3/1/3

Blood Flow Restriction Training for Tendinopathy ... Despite the intervention being short-term, all patients improved clinical outcomes (pain and function), strength (dynamometry), and tendon vascularity ( ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9083008/

Blood Flow Restriction Resistance Training in Tendon ... For example, BFRT has been found to be an efficacious method for increasing strength gains and muscle hypertrophy in rehabilitation following surgery for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12096532/

The impact of blood flow restriction training on tendon ... BRFT produced significantly better results compared to LLRT-sham for all primary outcomes and at 6 and 12weeks. Patients in BRFT group had ...

7. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2022.879860/full

Blood Flow Restriction Resistance Training in Tendon ... A variety of outcomes were assessed, including pain, function, strength, and tendon morphological and mechanical properties, particularly changes in tendon ...