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

Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04503421

Enrollment

Registered

2020-08-07

Start date

2020-08-15

Completion date

2021-09-15

Last updated

2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bicep Tendon Rupture

Keywords

blood flow restriction, Rehabilitation, Physical therapy

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

Interventions

OTHERBlood Flow Restriction Therapy

Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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)

Design outcomes

Primary

Measure	Time frame	Description
Strength	1 week post-operatively	measured via dynamometer (pounds)

Secondary

Measure	Time frame	Description
Range of Motion	1 week post-operatively	via goniometer (degrees)
Perceived Pain	1 week post-operatively	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)
Patient reported outcome scores	1 week post-operatively	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026