Blood Flow Restriction Therapy for Hip Pain

Overseen By Carla M. Edwards, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Rush University Medical Center

Disqualifiers: Age, Non-English, Pregnancy, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 12 months

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new rehab therapy called Blood Flow Restriction (BFR) for individuals with hip pain undergoing hip arthroscopy, a type of surgery. The goal is to determine if BFR exercises improve recovery more effectively than regular exercises. Participants will be divided into two groups: one will receive real BFR therapy, while the other receives a placebo version. Individuals diagnosed with hip joint issues like FAIS or labral problems and scheduled for hip surgery might be suitable for this trial.

As an unphased trial, this study provides a unique opportunity to explore innovative recovery methods that could enhance post-surgery rehabilitation.

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 study team or your doctor.

What prior data suggests that Blood Flow Restriction Therapy is safe for hip pain rehabilitation?

Research has shown that blood flow restriction (BFR) therapy is generally safe for rehabilitation. One study found that patients who began BFR therapy 2-3 weeks after ACL surgery did not experience major safety issues. This finding suggests that BFR could also be safe for recovery after other surgeries, such as those for hip pain.

BFR therapy involves using a tight band or cuff to reduce blood flow to a limb, which can help build muscle strength and speed up recovery. Although it might sound intense, studies have demonstrated its safety when performed correctly. Following a therapist's instructions ensures the best results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Blood Flow Restriction (BFR) Therapy for hip pain because it offers a unique approach compared to traditional treatments like physical therapy, pain medications, or surgery. Unlike these standard methods, BFR Therapy involves applying a specialized cuff to restrict blood flow, which can enhance muscle strength and recovery without the need for heavy weights or intense exercise. This method could potentially reduce recovery time and improve outcomes for patients dealing with hip pain, making it a promising alternative or supplement to conventional care strategies.

What evidence suggests that Blood Flow Restriction Therapy is effective for hip pain?

Research has shown that blood flow restriction (BFR) therapy can reduce pain and strengthen muscles. One study found that BFR improved daily activities and sports performance in people with knee osteoarthritis. This therapy uses a special cuff to gently limit blood flow, aiding muscle recovery and growth. Early findings also suggest that BFR might benefit bones and connective tissues. While most research has focused on knees, these benefits could extend to other joints, such as the hip. In this trial, participants will either receive BFR postoperative rehabilitation or join a control group receiving sham BFR therapy to evaluate its effectiveness for hip pain. ^{1 3 6 7 8}

Who Is on the Research Team?

Jorge Chahla, MD, PhD

Principal Investigator

Rush University Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-40 who have been diagnosed with FAIS or labral pathology in the hip, confirmed by clinical and MRI examination, and are scheduled for primary hip arthroscopy. They must be able to provide written informed consent.

Inclusion Criteria

You need to agree in writing to take part in the study.

You can speak English.

I am scheduled for a hip surgery due to issues seen in my MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo BFR or sham BFR exercises following hip arthroscopy

12 months

Visits at 1, 3, 6, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Follow-up assessments at 1, 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Blood Flow Restriction Rehabilitative Therapy
• Sham BFR Rehabilitative Therapy

Trial Overview The study compares two post-surgery treatments: Blood Flow Restriction (BFR) Rehabilitative Therapy versus a sham version of BFR therapy. It's randomized and double-blinded, meaning patients are assigned randomly to either group and neither they nor the researchers know which treatment they're getting.

How Is the Trial Designed?

Group I: BFR Postoperative Rehabilitation Experimental Treatment 1 Intervention

The experimental group will receive BFR postoperative rehabilitation, which will involve performing a series of blood flow restriction exercises identical to the control group.

Group II: Control Group Placebo Group 1 Intervention

The control group will receive sham BFR, in which a non-occlusive pressure is applied with the cuff. The exercises performed will be identical to the BFR group.

Blood Flow Restriction Rehabilitative Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Blood Flow Restriction Therapy for:

• Post-operative rehabilitation
• Muscle strengthening
• Pain relief
• Pre-surgical strengthening
• Arthritis
• Tendinitis
• ACL/meniscal tears
• Non-union fractures
• IT band issues

Approved in European Union as Blood Flow Restriction Therapy for:

• Post-operative rehabilitation
• Muscle strengthening
• Pain relief
• Pre-surgical strengthening
• Arthritis
• Tendinitis
• ACL/meniscal tears
• Non-union fractures
• IT band issues

Who Is Running the Clinical Trial?

Rush University Medical Center

Lead Sponsor

Trials

448

Recruited

247,000+

Published Research Related to This Trial

A survey of 250 orthopedic surgeons revealed that 59.8% currently use blood flow restriction (BFR) therapy, primarily for rehabilitation after anterior cruciate ligament reconstruction (ACLR), indicating its growing acceptance in clinical practice.

BFR therapy is typically applied 2-3 times per week, allowing patients to achieve benefits similar to high-intensity training while using lighter weights, which can be particularly useful for those recovering from musculoskeletal injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. Castle, JP., Tramer, JS., Turner, EHG., et al.[2023]

Blood flow restriction (BFR) training is effective for increasing muscle size and strength, making it a promising option for treating musculoskeletal issues and aiding in postoperative recovery.

The article highlights the need for more research on BFR's applications in rehabilitation, while also sharing the authors' practical experiences with its use after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. Wilkinson, BG., Donnenwerth, JJ., Peterson, AR.[2019]

Low-load blood flow restriction (BFR) training, when combined with standard rehabilitation, showed significant improvements in muscle endurance and blood flow in patients undergoing anterior cruciate ligament reconstruction (ACLR), particularly noted in a preoperative study with a significant increase in muscle isometric endurance and blood flow to the vastus lateralis.

Postoperative BFR training demonstrated notable benefits in muscle hypertrophy and strength compared to traditional low-load resistance training, indicating that BFR could enhance recovery outcomes after ACLR, although more research is needed to confirm these findings due to the limited number of studies available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. Lu, Y., Patel, BH., Kym, C., et al.[2022]

Blood flow restriction training (BFRT) does not show significantly greater efficacy than conventional resistance training for treating knee osteoarthritis, based on a meta-analysis of 5 studies with low to moderate risk of bias.

BFRT may have a lower incidence of adverse events compared to high-load resistance training, suggesting it could be a safer option for patients with knee osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. Wang, HN., Chen, Y., Cheng, L., et al.[2022]

Blood flow restriction (BFR) therapy can enhance skeletal muscle adaptations, making it a beneficial method for both civilian and military populations during rehabilitation.

BFR therapy allows patients to safely start strength training earlier in their recovery, potentially leading to quicker returns to activity and improved military readiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Therapy: From Development to Applications. Anderson, AB., Owens, JG., Patterson, SD., et al.[2020]

In a study involving 75 participants, it was found that using 130% of resting brachial systolic blood pressure can effectively estimate the occlusion needed for blood flow restriction (BFR) training, achieving similar effects to 100% limb occlusion pressure (LOP).

Applying arbitrary restriction values of 200 and 300 mm Hg can exceed safe occlusion levels, potentially increasing risks during BFR exercise, while using 100 mm Hg or resting brachial systolic pressure is safer and results in pressures between 60% and 80% LOP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood Flow Restriction Training in Clinical Rehabilitation: Occlusion Pressure Methods Relative to the Limb Occlusion Pressure. Chulvi-Medrano, I., Cortell-Tormo, JM., Hernández-Sánchez, S., et al.[2023]

Blood flow restriction (BFR) training is gaining popularity for its ability to enhance muscle mass, strength, and cardiovascular function, making it a valuable tool in fitness and rehabilitation.

Despite its benefits, practitioners face challenges in implementing BFR training, such as determining appropriate pressure levels, ensuring access to technology, conducting thorough medical screenings, and managing the perceived discomfort of the training to encourage long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Barriers to Blood Flow Restriction Training. Rolnick, N., Kimbrell, K., Cerqueira, MS., et al.[2022]

Blood flow restriction training (BFRT) is generally safe for patients with musculoskeletal disorders, with a systematic review of 19 studies involving 322 participants showing that most did not report adverse events.

While some rare adverse events were noted, such as deep vein thrombosis and rhabdomyolysis, individuals undergoing BFRT did not experience more adverse events compared to those doing regular exercise, indicating its potential as a safe strengthening method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. Minniti, MC., Statkevich, AP., Kelly, RL., et al.[2020]

Blood flow restriction training (BFRT) can be beneficial for rehabilitation but poses risks such as increased blood pressure and adverse cardiovascular responses, especially in individuals with pre-existing conditions like hypertension and diabetes.

To ensure safety, a risk stratification tool is recommended for clinicians to assess patients' medical histories and identify those who may be at higher risk for complications when undergoing BFRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. Nascimento, DDC., Rolnick, N., Neto, IVS., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8811521/

Blood Flow Restriction Therapy and Its Use for ... Blood flow restriction (BFR) is an expanding rehabilitation modality that uses a tourniquet to reduce arterial inflow and occlude venous outflow.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1466853X25000744

Blood flow restriction training compared to conventional ... Blood flow restriction training can significantly reduce short-term knee pain. No significant effects on knee function or strength were identified.

3. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1220758/full

Effectiveness of blood flow restriction versus traditional ... BFR training enhanced muscle strength, reduced pain, and improved daily living and sports activities in patients with KOA, compared to WB training alone.

4. arthroscopysportsmedicineandrehabilitation.org arthroscopysportsmedicineandrehabilitation.org/article/S2666-061X(21)00215-7/fulltext

Blood Flow Restriction Enhances Rehabilitation and ... In addition to local and systemic impacts on muscle, recent pilot data indicate that BFR-LIX may have a positive impact on bone and possibly connective tissue.

5. nm.org nm.org/conditions-and-care-areas/treatments/blood-flow-restriction-training

Blood Flow Restriction Training in Rehabilitation Restricting your blood flow speeds up the process of your muscles swelling, getting tired and using up oxygen. BFR training can: Speed up recovery. Strengthen ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25000220

Blood flow restriction therapy for revolutionizing ... Blood flow restriction therapy could offer a potent strategy for accelerating muscle growth and strength enhancement, as well as overall fitness improvements.

7. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2022.808622/full

A Useful Blood Flow Restriction Training Risk Stratification ... A previous study demonstrated safety in rehabilitation 2–3 weeks after anterior cruciate ligament surgery using BFRT (Hughes et al., 2019). Another study ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT04809714?term=AREA%5BConditionSearch%5D(Hip%20Fractures)%20AND%20AREA%5BOverallStatus%5D(ACTIVE_NOT_RECRUITING)&rank=8

The Role of Blood Flow Restriction Therapy in ... The investigators aim to study the use of blood flow restriction therapy (BFR) to augment routine post-operative physical therapy in elderly patients (age >= 65 ...