Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair
- Conditions
- Bicep Tendon Rupture
- Interventions
- Other: Blood Flow Restriction Therapy
- Registration Number
- NCT04503421
- Lead Sponsor
- Henry Ford Health System
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Age 18-80
- Undergoing distal biceps tendon repair
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BFR Blood Flow Restriction Therapy 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
- Primary Outcome Measures
Name Time Method Strength 6 months post-operatively measured via dynamometer (pounds)
- Secondary Outcome Measures
Name Time Method Patient reported outcome scores 6 months post-operatively via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score
Range of Motion 6 months post-operatively via goniometer (degrees)
Perceived Pain 6 months post-operatively via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Trial Locations
- Locations (1)
Health Ford Health System
🇺🇸Detroit, Michigan, United States