Blood Flow Restriction Training Following Glenoid Labral Repair

NCT03675620 | Withdrawn FDA Device

• 1 other identifier: 1309802
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Glenoid Labrum Tear

Outcome Measures

Primary Outcomes (1)

• Change in Pennsylvania Shoulder Score (PENN)

  The Penn Shoulder Score contains a visual analog scale pain score for pain at rest, pain with everyday activities, and pain with strenuous activities. The maximum possible score is 100 points.

  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 (6)

• Change in Global Rating of Change (GROC)

  Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery

• Change in Pain Scale

  Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery

• Change in Patient Acceptable Symptom State (PASS)

  Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery

• Change in Single Assessment Numeric Evaluation (SANE)

  Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery

• Change in Patient Centered Outcome Questionnaire

  Baseline (prior to surgery), 1 week, 6 weeks, 16 weeks, 20 weeks, discharge from physical therapy, 1-year, and 2-years post-surgery

Study Arms (2)

Standard Rehabilitation (Control Group)

ACTIVE COMPARATOR

All participants will perform traditional post-operative shoulder rehabilitation exercises. Participants randomized to this group will begin with lower extremity strengthening exercises (prior to shoulder strengthening) 2-3 times per week for for the first 6 weeks of post-operative care. Standard rehabilitation will continue until discharge.

Other: Standard Rehabilitation

Blood Flow Restriction (BFR)

EXPERIMENTAL

All participants will perform traditional post-operative shoulder rehabilitation exercises. Participants randomized to the BFR group will begin combining BFR with lower extremity strengthening exercises (prior to shoulder strengthening) 2-3 times per week for the first 6 weeks post-operative care. Standard rehabilitation will continue until discharge.

Device: BFR

Interventions

BFR DEVICE

Delfi's Personalized Tourniquet System for Blood Flow Restriction will be used with leg extension and leg press exercises. Bilateral thigh cuffs will be applied to the participants and occlusion pressure will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each participant will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions) with resistance of 30% 1-repetition maximum. The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between exercises. Sets and repetitions will remain constant for each participant; however, resistance will be incrementally increased.

Blood Flow Restriction (BFR)

Standard Rehabilitation OTHER

The control group will perform perform 4 sets of leg extensions and leg press (1 set of 30 repetitions followed by 3 sets of 15 repetitions) with resistance of 30% 1-repetition maximum. Sets and repetitions will remain constant for each participant; however, resistance will be incrementally increased.

Standard Rehabilitation (Control Group)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrews Research & Education Foundation: lead

Study Sites (1)

Andrews Institute for Orthopaedics & Sports Medicine

Gulf Breeze, Florida, 32561, United States

Location

Study Officials

• Adam Anz, MD

  Andrews Institute for Sports Medicine and Orthopaedics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Investigators recording data and the patients physician will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: January 31, 2019
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)