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

Trial Summary

What is the purpose of this trial?

This study will be a prospective randomized, double-blinded, placebo-controlled trial of patients undergoing primary hip arthroscopy for FAIS and/or labral pathology. All patients who sign the consent form will be enrolled in the study and randomized to one of the two treatment arms. Follow-up will take place at 1-month, 3-months, 6-months, and 1-year.

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 data supports the effectiveness of the treatment Blood Flow Restriction Therapy for hip pain?

Blood flow restriction therapy has shown benefits in improving strength, endurance, and reducing pain for various musculoskeletal injuries, which suggests it might be helpful for hip pain as well. ^{1 2 3 4 5}

Is Blood Flow Restriction Therapy safe for humans?

Blood Flow Restriction Therapy is generally considered safe for healthy individuals, but it may cause increased blood pressure and other cardiovascular issues. It requires caution for people with existing health conditions like heart disease, diabetes, or those who are pregnant, as it could increase the risk of blood clots and other complications. ^{1 2 6 7 8}

How is Blood Flow Restriction Therapy different from other treatments for hip pain?

Blood Flow Restriction Therapy is unique because it involves restricting blood flow to muscles during low-load exercises, which can enhance muscle strength and reduce pain without the need for heavy weights. This approach is different from traditional treatments that may rely on high-load resistance training or medication. ^{1 2 3 4 9}

Research Team

Jorge Chahla, MD, PhD

Principal Investigator

Rush University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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) 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]

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]

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 (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]

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]

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]

References

1. India pubmed.ncbi.nlm.nih.gov

Survey of blood flow restriction therapy for rehabilitation in Sports Medicine patients. [2023]

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

The Safety of Blood Flow Restriction Training as a Therapeutic Intervention for Patients With Musculoskeletal Disorders: A Systematic Review. [2020]

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

Efficacy and Safety of Blood Flow Restriction Training in Patients With Knee Osteoarthritis: A Systematic Review and Meta-Analysis. [2022]

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

Perioperative Blood Flow Restriction Rehabilitation in Patients Undergoing ACL Reconstruction: A Systematic Review. [2022]

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

Blood Flow Restriction Training in Clinical Rehabilitation: Occlusion Pressure Methods Relative to the Limb Occlusion Pressure. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Perceived Barriers to Blood Flow Restriction Training. [2022]

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

Blood Flow Restriction Therapy: From Development to Applications. [2020]

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

A Useful Blood Flow Restriction Training Risk Stratification for Exercise and Rehabilitation. [2022]

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

Use of Blood Flow Restriction Training for Postoperative Rehabilitation. [2019]