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

Bicep Tendon Rupture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503421
• Other study ID #: Henry - IRB00000253
• Status: Completed
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: December 2023
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 15, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bicep Tendon Rupture
• Rupture

Intervention

Other:
• Blood Flow Restriction Therapy
Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy

Locations

Country	Name	City	State
United States	Health Ford Health System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Strength	measured via dynamometer (pounds)	1 week post-operatively
Primary	Strength	measured via dynamometer (pounds)	6 weeks post-operatively
Primary	Strength	measured via dynamometer (pounds)	3 months post-operatively
Primary	Strength	measured via dynamometer (pounds)	6 months post-operatively
Secondary	Range of Motion	via goniometer (degrees)	1 week post-operatively
Secondary	Range of Motion	via goniometer (degrees)	6 week post-operatively
Secondary	Range of Motion	via goniometer (degrees)	3 months post-operatively
Secondary	Range of Motion	via goniometer (degrees)	6 months post-operatively
Secondary	Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	1 week post-operatively
Secondary	Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	6 week post-operatively
Secondary	Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	3 months post-operatively
Secondary	Perceived Pain	via visual analog scale (VAS) pain scale: (scale 0 - 10, higher score indicates more pain)	6 months post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	1 week post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	1 week post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	1 week post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	6 week post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	6 week post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	6 week post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	3 months post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	3 months post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	3 months post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) score	6 months post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Pain (P) score	6 months post-operatively
Secondary	Patient reported outcome scores	via Patient-Reported Outcomes Measurement Information System (PROMIS) Depression (D) score	6 months post-operatively