Clinical trial NCT03675620: Blood Flow Restriction Training Following Glenoid Labral Repair
Official title: Effects of Blood Flow Restriction Training Compared With Standard Rehabilitation in Patients Following Glenoid Labral Repair
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Glenoid Labrum Tear
Lead sponsor: Andrews Research & Education Foundation
Sponsor class: OTHER
First posted: 2018-09-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number generator.
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the effects of BFR training on patient reported outcome measures and shoulder muscle girth in patients following glenoid labral repair. The investigators hypothesize that participants receiving BFR with rehabilitation will have greater improvements in patient reported outcome measures and shoulder muscle girth than participants who are treated without BFR.

Detailed description: Patients between the ages of 18 and 55 who had a superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair will be screened for participation in this study. Participants will be randomized in a 1:1 ratio to receive standard physical therapy with blood flow restriction training or without blood flow restriction. Participants will receive standard of care rehabilitation for labral repair regardless of group assignment. The length of each physical therapy session will be approximately one hour. The BFR and control group will perform leg press and leg extension exercises prior to shoulder strengthening. The resistance for both groups will be set as 30% of one repetition maximum (1-RM). The goal will be for the participants to perform 4 sets of repetitions sequenced 30, 15, 15, 15 of each exercise, if this is not obtainable then the number of set/repetitions will be decreased. The lower extremity strengthening exercises for this study will be performed by all participants beginning at the first physical therapy visit post-surgery. These exercises will be performed at each physical therapy session for 6 consecutive weeks (approximately 2-3 sessions/week). Standard rehabilitation will continue at the conclusion of the 6-week intervention for all participants.

Eligibility criteria: Inclusion Criteria:

* Superior labrum anterior to posterior (SLAP) repair, anterior labral repair, anterior capsulorrhaphy, or posterior labral repair
* Willing to complete their post-operative rehabilitation at Andrews Institute Physical Therapy

Exclusion Criteria:

* Patients with prior procedures or significant injuries to the same shoulder will be excluded
* Patients with arthroscopic debridement of labral tears alone
* Patients with concomitant rotator cuff repair surgery
* Patients with Workers' Compensation or automobile insurance claim will be excluded.
* Patients who have a medical history involving any of the following medical conditions will be excluded - uncontrolled hypertension, diabetes, autoimmune disorders, rheumatoid or psoriatic arthritis, multiple sclerosis, peripheral vascular disease, peripheral neuropathy, deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke, blood disorders, disorders requiring immunosuppression, cancer, an ongoing infectious disease, use of steroids, or significant cardiovascular, renal, hepatic or pulmonary disease

Primary outcomes:
measure: Change in Pennsylvania Shoulder Score (PENN)
timeFrame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
Secondary outcomes:
measure: Change in Global Rating of Change (GROC)
timeFrame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
measure: Change in Pain Scale
timeFrame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
measure: Change in Patient Acceptable Symptom State (PASS)
timeFrame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
measure: Change in Single Assessment Numeric Evaluation (SANE)
timeFrame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
measure: Change in Patient Centered Outcome Questionnaire
timeFrame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
measure: Change in Shoulder Girth
timeFrame: Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery
Other outcomes:
Locations:
city: Gulf Breeze
country: United States
facility: Andrews Institute for Orthopaedics & Sports Medicine
state: Florida
Study officials:
affiliation: Andrews Institute for Sports Medicine and Orthopaedics
name: Adam Anz, MD
role: PRINCIPAL_INVESTIGATOR
References: