Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair

Henry Ford Health

Status: Completed

Conditions: Bicep Tendon Rupture

Treatments: Other: Blood Flow Restriction Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04503421

Henry - IRB00000253

Details and patient eligibility

About

The goal of this investigation is to determine if using BFR during postoperative therapy would lead to increased and expedited strength gains. Additionally, the investigators would like to determine if BFR is beneficial in preventing muscle atrophy and fatty infiltration in the setting of bicep tendon tears, due to the altered tension-length relationship following surgery. The study will also look at patient reported outcomes metrics and pain scores to determine if BFR has a significant impact on the patient experience surrounding distal biceps tear and surgical repair

Enrollment: 64 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-80
• Undergoing distal biceps tendon repair

Exclusion criteria

• Revision Biceps tendon repair,
• Irrepairable tendon injury,
• Biceps repairs with biologic augmentation,
• Patients with concomitant neurovascular injury,
• Inability to tolerate BFR treatment,
• Unable to complete full course of physical therapy,
• Peripheral vascular disease,
• History of Venous thromboembolism (VTE)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

BFR

Experimental group

Description:

Patient will use the following rehabilitation protocol while incorporating blood flow restriction therapy: * Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only * Sling immobilization with active wrist and shoulder ROM * Active extension of biceps to 30 degrees, No active flexion * 6-9 weeks full active extension in brace * Maintain wrist and shoulder flexibility * Begin rotator cuff/deltoid isometrics, progress active extension in brace * Weeks 9-12: Gently advance ROM to tolerance * Discontinue sling * Begin active flexion and extension against gravity. * Advance strength to light resistance, maintain flexibility/ROM * Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated

Treatment:

Other: Blood Flow Restriction Therapy

Control (no BFR)

No Intervention group

Description:

patients will use following rehabilitation protocol without the use of blood flow restriction therapy: * Post-op weeks 0-6: Passive shoulder and wrist Range of Motion (ROM) only * Sling immobilization with active wrist and shoulder ROM * Active extension of biceps to 30 degrees, No active flexion * 6-9 weeks full active extension in brace * Maintain wrist and shoulder flexibility * Begin rotator cuff/deltoid isometrics, progress active extension in brace * Weeks 9-12: Gently advance ROM to tolerance * Discontinue sling * Begin active flexion and extension against gravity. * Advance strength to light resistance, maintain flexibility/ROM * Weeks 12-6 months: Gradual return to full ROM and pain free o Begin gradual flexion strengthening and advance as tolerated