Recruiting

Blood Flow Restriction

Sponsor:

Rush University Medical Center

Code:

NCT04113759

Conditions

Labral Tear, Glenoid

Femoral Acetabular Impingement

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Interventions

Blood Flow Restriction Rehabilitative Therapy

Sham BFR Rehabilitative Therapy

Study Details

Brief summary:

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.

Conditions

Labral Tear, Glenoid

Femoral Acetabular Impingement

Study ID

NCT04113759

Start date

Aug 1, 2023

Status verified date

Dec, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adult patients 18-40
  • English-speaking
  • Clinical and radiographic examination (MRI) consistent FAIS and/or labral pathology, and are schedule for primary hip arthroscopy
  • Written and informed consent for study participation

Exclusion Criteria:

  • Patients younger than 18 or older than 40 years of age
  • Non-native English speaker
  • Revision surgery or prior history of ipsilateral hip or knee surgery
  • Inability to comply with the proposed follow-up clinic visits
  • Patients lacking decisional capacity
  • Patients with a history of deep vein thrombosis, pulmonary embolism, or known clotting disorder or hypercoagulable state
  • Pregnant or breast-feeding women. Pregnancy as determined by a positive pregnancy test prior to procedure. Females of childbearing potential must agree to use an acceptable birth control method during study participation.
  • Worker's compensation patients
  • Any clinically significant finding that would place the patient at health risk, impact the study, or affect the completion of the study
  • Any psychiatric illness that would prevent comprehension of the details and nature of the study and interfere with follow-up clinic visits

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

placebo comparator: Control Group

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.

experimental: BFR Postoperative Rehabilitation

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

Interventions

Blood Flow Restriction Rehabilitative Therapy

BFR cuffs placed at the proximal thigh, just inferior to the greater trochanter.

Inflation time not to exceed 20 minutes. One BFR session per treatment. BFR exercise dosage: 4 sets of the following repetitions 30, 15, 15, 15, 30 second rest between sets, 1 min rest between exercises.

Progress exercise if pain <2/10 on VAS and RPE <5 on 0-10 scale. (Heerey et al), and no break down in form.

Sham BFR Rehabilitative Therapy

The schedule, type of exercises, repetition ranges, and other physical therapy interventions will be the same as the BFR experimental group - however a non-occlusive pressure will be applied with the cuff in the control group.

Primary outcome measure

  • Quadriceps Strength [ Time Frame: 3 month time point ]
  • Quadriceps Strength [ Time Frame: 6 month time point ]
  • Quadriceps Strength [ Time Frame: 12 month time point ]
  • Biodex strength testing [ Time Frame: 6 month time point ]
  • Biodex strength testing [ Time Frame: 12 month time point ]
  • Standardized circumferential leg meaurements [ Time Frame: 1 month time point ]
  • Standardized circumferential leg meaurements [ Time Frame: 3 month time point ]
  • Standardized circumferential leg meaurements [ Time Frame: 6 month time point ]
  • Standardized circumferential leg meaurements [ Time Frame: 12 month time point ]
  • Muscle size and appearance about the hip joint [ Time Frame: 6 months postoperatively ]

Central Contacts and Locations

Central contacts

Carla M. Edwards, PhD

312-563-5735carla_edwards@rush.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Carla M Edwards, PhD

312-563-5735carla_edwards@rush.edu

More Information

Sponsor

Rush University Medical Center

Last update posted

Dec 5, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2025-12-05.