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.
The investigators propose using standardized strength testing, serial quadriceps measurements, and MRI to assess the efficacy of BFR training in increasing muscle hypertrophy following hip arthroscopy. Investigators will perform a randomized double-blinded placebo-controlled controlled trial of patients undergoing primary hip arthroscopy. Quadriceps strength will be measured with dynamometers at 3, 6, and 12 month time points, with Biodex strength testing at 6 and 12 months, postoperatively. Additionally, standardized circumferential leg measurements to assess quadriceps hypertrophy will be performed at 1, 3, 6 and 12-month time points. Patients will also undergo a hip MRI at 6 months postoperatively to quantify muscle size and appearance about the hip joint. Patient reported outcomes including standard outcomes measures at 3, 6, and 12 months and return to work/sport data will also be collected at standard time points. Patients will also be followed longitudinally for rates of reinjury, return to work, and return to sport. This study will evaluate the efficacy of BFR therapy in the postoperative period of primary hip arthroscopy to improve muscle hypertrophy during the short-term rehabilitation period. This will be directly measured by strength testing with dynamometers and Biodex testing. Other metrics will include standard validated patient reported outcomes at 3, 6 and 12 month time points including hip disability and osteoarthritis outcome score (HOOS), Harris Hip score (HHS), visual analog scale (VAS) for pain, international hip outcome tool (iHOT-12), and Hip outcome score (HOS), and return to sport questionnaires. Standardized serial circumferential thigh measurements will also be recorded at each visit, in additional to a one time MRI at 6 months postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
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.
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.
Rush University Medical Center
Chicago, Illinois, United States
RECRUITINGQuadriceps Strength
Will be measured with dynamometer
Time frame: 3 month time point
Quadriceps Strength
Will be measured with dynamometer
Time frame: 6 month time point
Quadriceps Strength
Will be measured with dynamometer
Time frame: 12 month time point
Biodex strength testing
Isokinetic strength testing
Time frame: 6 month time point
Biodex strength testing
Isokinetic strength testing
Time frame: 12 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Time frame: 1 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Time frame: 3 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Time frame: 6 month time point
Standardized circumferential leg meaurements
To assesss quadricep hypertrophy
Time frame: 12 month time point
Muscle size and appearance about the hip joint
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To be assessed via hip MRI postoperatively
Time frame: 6 months postoperatively
Hip Disability and Osteoarthritis Outcome Score
Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.
Time frame: 3 month time point
Hip Disability and Osteoarthritis Outcome Score
Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.
Time frame: 6 month time point
Hip Disability and Osteoarthritis Outcome Score
Used to assess the patient's opinion about their hip and associated problems and to evaluate symptoms and functional limitations related to the hip during a therapeutic process.
Time frame: 12 month time point
Harris Hip Score
Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.
Time frame: 3 month time point
Harris Hip Score
Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.
Time frame: 6 month time point
Harris Hip Score
Gives a maximum of 100 points. Pain receives 44 points, function 47 points, range of motion 5 points, and deformity 4 points. Function is subdivided into activities of daily living (14 points) and gait (33 points). The higher the HHS, the less dysfunction.
Time frame: 12 month time point
Visual Analog Scale for pain
A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Time frame: 3 month time point
Visual Analog Scale for pain
A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Time frame: 6 month time point
Visual Analog Scale for pain
A 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Time frame: 12 month time point
International hip outcome tool
Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns
Time frame: 3 month time point
International hip outcome tool
Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns
Time frame: 6 month time point
International hip outcome tool
Comprised of 33 questions relating to: Symptoms and Functional Limitations Sports and Recreational Activities Job-Related Concerns Social, Emotional, and Lifestyle Concerns
Time frame: 12 month time point
Hip Outcome Score
A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.
Time frame: 3 month time point
Hip Outcome Score
A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.
Time frame: 6 month time point
Hip Outcome Score
A self-administered questionnaire with a scoring system composed of 2 sub-scales. The Activities of Daily Living (ADL) sub-scale made of 19 items and a Sports sub-scale composed of 9 items.
Time frame: 12 month time point