Blood Flow Restriction Following Hip Arthroscopy

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Rush University Medical Center
Study ID
NCT04113759
Status
Recruiting

Conditions

  • Femoral Acetabular Impingement
  • Labral Tear, Glenoid

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Blood Flow Restriction Rehabilitative Therapy — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Aug 1, 2023
Status verified
Dec 2025
Primary completion
Nov 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
56 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

Quadriceps Strength [ Time Frame: 3 month time point ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rush University Medical CenterChicagoIllinois60612
Carla M Edwards, PhD
312-563-5735

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