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

NCT04503421 | Completed

• 1 other identifier: Henry - IRB00000253
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Conditions

Bicep Tendon Rupture

Keywords

blood flow restriction; Rehabilitation; Physical therapy

Outcome Measures

Primary Outcomes (4)

• Strength

  measured via dynamometer (pounds)

  1 week post-operatively

• Strength

  measured via dynamometer (pounds)

  6 weeks post-operatively

• Strength

  measured via dynamometer (pounds)

  3 months post-operatively

• Strength

  measured via dynamometer (pounds)

  6 months post-operatively

Secondary Outcomes (20)

• Range of Motion

  1 week post-operatively

• Range of Motion

  6 week post-operatively

• Range of Motion

  3 months post-operatively

• Range of Motion

  6 months post-operatively

• Perceived Pain

  1 week post-operatively

Study Arms (2)

BFR

EXPERIMENTAL

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

Other: Blood Flow Restriction Therapy

Control (no BFR)

NO INTERVENTION

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

Interventions

Blood Flow Restriction Therapy OTHER

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

BFR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• Undergoing distal biceps tendon repair

You may not qualify if:

• 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)

Sponsors & Collaborators

• Henry Ford Health System: lead

Study Sites (1)

Health Ford Health System

Detroit, Michigan, 48202, United States

Location

Related Publications (5)

• Wernbom M, Augustsson J, Raastad T. Ischemic strength training: a low-load alternative to heavy resistance exercise? Scand J Med Sci Sports. 2008 Aug;18(4):401-16. doi: 10.1111/j.1600-0838.2008.00788.x. Epub 2008 May 3.

  PMID: 18466185 BACKGROUND

• Huynh T, Leiter J, MacDonald PB, Dubberley J, Stranges G, Old J, Marsh J. Outcomes and Complications After Repair of Complete Distal Biceps Tendon Rupture with the Cortical Button Technique. JB JS Open Access. 2019 Aug 27;4(3):e0013.1-6. doi: 10.2106/JBJS.OA.19.00013. eCollection 2019 Jul-Sep.

  PMID: 31592499 BACKGROUND

• Ohta H, Kurosawa H, Ikeda H, Iwase Y, Satou N, Nakamura S. Low-load resistance muscular training with moderate restriction of blood flow after anterior cruciate ligament reconstruction. Acta Orthop Scand. 2003 Feb;74(1):62-8. doi: 10.1080/00016470310013680.

  PMID: 12635796 BACKGROUND

• Takarada Y, Takazawa H, Ishii N. Applications of vascular occlusion diminish disuse atrophy of knee extensor muscles. Med Sci Sports Exerc. 2000 Dec;32(12):2035-9. doi: 10.1097/00005768-200012000-00011.

  PMID: 11128848 BACKGROUND

• Clark BC, Manini TM, Hoffman RL, Williams PS, Guiler MK, Knutson MJ, McGlynn ML, Kushnick MR. Relative safety of 4 weeks of blood flow-restricted resistance exercise in young, healthy adults. Scand J Med Sci Sports. 2011 Oct;21(5):653-62. doi: 10.1111/j.1600-0838.2010.01100.x. Epub 2010 Mar 11.

  PMID: 21917016 BACKGROUND

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 7, 2020
• Study Start: August 15, 2020
• Primary Completion: August 15, 2021
• Study Completion: September 15, 2021
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

US (1)