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

Not Applicable

Completed

• Conditions: Bicep Tendon Rupture

• 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

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-07
• Study Start: 2020-08-15
• Primary Completion: 2021-08-15
• Study Completion: 2021-09-15
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-01
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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