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

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

Study Overview

• Status: Completed
• Conditions: Bicep Tendon Rupture
• Intervention / Treatment: Other: Blood Flow Restriction Therapy

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Health Ford Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BFR; 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) onlySling immobilization with active wrist and shoulder ROMActive extension of biceps to 30 degrees, No active flexion; 6-9 weeks full active extension in braceMaintain wrist and shoulder flexibilityBegin rotator cuff/deltoid isometrics, progress active extension in brace; Weeks 9-12: Gently advance ROM to toleranceDiscontinue slingBegin 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; Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
No Intervention: Control (no BFR); 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) onlySling immobilization with active wrist and shoulder ROMActive extension of biceps to 30 degrees, No active flexion; 6-9 weeks full active extension in braceMaintain wrist and shoulder flexibilityBegin rotator cuff/deltoid isometrics, progress active extension in brace; Weeks 9-12: Gently advance ROM to toleranceDiscontinue slingBegin 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Range of Motion	via goniometer (degrees)	1 week post-operatively
Range of Motion	via goniometer (degrees)	6 week post-operatively
Range of Motion	via goniometer (degrees)	3 months post-operatively
Range of Motion	via goniometer (degrees)	6 months post-operatively
Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	1 week post-operatively
Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	6 week post-operatively
Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	3 months post-operatively
Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	6 months post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	1 week post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	1 week post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	1 week post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	6 week post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	6 week post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	6 week post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	3 months post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	3 months post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	3 months post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	6 months post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	6 months post-operatively
Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	6 months post-operatively

Collaborators and Investigators

• Sponsor: Henry Ford Health System

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Actual): August 15, 2021
• Study Completion (Actual): September 15, 2021

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; Physical therapy; blood flow restriction
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: Henry - IRB00000253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No