Blood Flow Restriction Therapy for Distal Radius Fracture

(ORIF DR BFR Trial)

HG
RM
Overseen ByRoxanne Miller
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The Methodist Hospital Research Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to aid recovery after wrist fracture surgery by adding blood flow restriction (BFR) therapy to regular rehab exercises. BFR therapy uses a cuff to restrict blood flow during low-intensity exercises, potentially boosting muscle growth and strength for faster, improved recovery. Individuals who recently underwent wrist fracture surgery and are experiencing muscle loss might be suitable candidates.

As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods and contribute to advancing rehabilitation science.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking any ergogenic aids (substances that enhance physical performance) or compounds banned by the NCAA, you must stop them at least one month before participating.

What prior data suggests that Blood Flow Restriction Therapy is safe for post-operative rehabilitation?

Research has shown that blood flow restriction (BFR) therapy is generally safe for people recovering from wrist fractures. One study found that BFR can reduce pain and swelling while boosting muscle strength. Another study confirmed that BFR therapy is safe and effective after surgery, but it should be customized for each person. Regular check-ups during treatment are important.

Additionally, a small study found that BFR therapy was safe and well-tolerated by patients who did not have surgery for their fractures, indicating fewer side effects and good patient tolerance. Overall, research suggests that BFR therapy is a promising option for helping patients regain strength and function with minimal risk.12345

Why are researchers excited about this trial?

Unlike the standard of care for distal radius fractures, which typically involves conventional rehabilitation exercises, Blood Flow Restriction (BFR) Therapy incorporates a novel approach that enhances muscle strength and recovery. BFR Therapy involves applying pressure to the limb to restrict blood flow during specific exercises, which can stimulate muscle growth and improve recovery outcomes with less strain. Researchers are excited about this technique because it could potentially accelerate rehabilitation times and improve functional recovery compared to traditional methods, offering a significant advantage for patients seeking faster and more effective healing.

What evidence suggests that Blood Flow Restriction Therapy is effective for improving recovery after distal radius fracture surgery?

Studies have shown that blood flow restriction (BFR) therapy can be very helpful after surgery for wrist fractures. In this trial, participants in the intervention arm will receive standard postoperative rehabilitation that incorporates BFR during certain exercises. BFR therapy can reduce pain and swelling and improve muscle strength and wrist movement. This method involves performing light exercises while gently restricting blood flow, offering benefits similar to intense workouts without heavy strain. This approach is especially useful after surgery because it helps prevent muscle loss and builds strength. Research indicates that adding BFR therapy to regular rehabilitation can lead to better recovery than traditional rehab alone, which participants in the control arm will receive.12467

Who Is on the Research Team?

SL

Shari Liberman, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need surgery (ORIF) for a broken wrist at the end of the forearm bone. It's not suitable for those with severe pain, previous injuries or surgeries to that arm, extreme obesity, diabetes type II, major organ diseases, active infections, recent cancer history, bleeding disorders, significant weight changes in the last year, inability to do rehab exercises or those on certain medications.

Inclusion Criteria

I need surgery for a broken wrist bone.

Exclusion Criteria

I have Type II diabetes.
I have heart, kidney, liver, or lung disease.
I do not have any active infections.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Initial Recovery

Participants undergo ORIF surgery for distal radius fractures and initial recovery

2 weeks
1 visit (in-person)

Rehabilitation with Blood Flow Restriction

Participants begin physical therapy with BFR exercises at two weeks post-operatively

12 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at 2 months, 6 months, and 1 year post-op

What Are the Treatments Tested in This Trial?

Interventions

  • Blood Flow Restriction (BFR) Therapy
Trial Overview The study tests if adding Blood Flow Restriction (BFR) therapy to standard post-surgery rehab can better prevent muscle loss and improve strength and recovery after wrist fracture surgery. Participants will undergo low intensity resistance exercise with BFR cuff as part of their rehabilitation routine.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - Blood Flow Restriction Therapy (BFR)Experimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The Methodist Hospital Research Institute

Lead Sponsor

Trials
299
Recruited
82,500+

Citations

The effectiveness and safety of blood flow restriction training ...In patients with DRF who underwent corrective surgery, BFR therapy effectively relieved pain and swelling, increased muscle strength and wrist ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/37505919/
The effectiveness and safety of blood flow restriction ...Conclusions: In patients with DRF who underwent corrective surgery, BFR therapy effectively relieved pain and swelling, increased muscle strength and wrist ...
The effectiveness and safety of blood flow restriction ...In patients with DRF who underwent corrective surgery, BFR therapy effectively relieved pain and swelling, increased muscle strength and wrist function, and had ...
Blood Flow Restriction Therapy to Optimize Muscle Size ...This study will assess the feasibility and effectiveness of blood flow restriction therapy in patients with tibia fractures (or lower leg bone).
The effectiveness of individualized blood flow restriction ...The results showed that the individualized blood flow restriction training was feasible and suggested promising outcomes for participants after surgery.
Blood Flow Restriction Therapy after Non-Operative ...This pilot study demonstrated BFR therapy after non-operative treatment of a distal radius fracture is safe and well tolerated, and patients may experience less ...
Blood Flow Restriction Therapy after Closed Treatment of ...Clinical relevance The addition of BFR therapy to the rehabilitative program after closed management of a distal radius fracture is safe, well tolerated by ...
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