Blood Flow Restriction Training Following Glenoid Labral Repair

Andrews Research & Education Foundation

Status: Withdrawn

Conditions: Glenoid Labrum Tear

Treatments: Other: Standard Rehabilitation; Device: BFR

Study type: Interventional

Funder types: Other

Identifiers

NCT03675620

1309802

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Standard Rehabilitation (Control Group)

Active Comparator group

Description:

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.

Treatment:

Other: Standard Rehabilitation

Blood Flow Restriction (BFR)

Experimental group

Description:

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.

Treatment:

Device: BFR