Clinical trial NCT04503421: Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair
Official title: Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal: A Prospective Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bicep Tendon Rupture
Keywords: blood flow restriction
Rehabilitation
Physical therapy
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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)

Primary outcomes:
measure: Strength
timeFrame: 1 week post-operatively
measure: Strength
timeFrame: 6 weeks post-operatively
measure: Strength
timeFrame: 3 months post-operatively
measure: Strength
timeFrame: 6 months post-operatively
Secondary outcomes:
measure: Range of Motion
timeFrame: 1 week post-operatively
measure: Range of Motion
timeFrame: 6 week post-operatively
measure: Range of Motion
timeFrame: 3 months post-operatively
measure: Range of Motion
timeFrame: 6 months post-operatively
measure: Perceived Pain
timeFrame: 1 week post-operatively
measure: Perceived Pain
timeFrame: 6 week post-operatively
measure: Perceived Pain
timeFrame: 3 months post-operatively
measure: Perceived Pain
timeFrame: 6 months post-operatively
measure: Patient reported outcome scores
timeFrame: 1 week post-operatively
measure: Patient reported outcome scores
timeFrame: 1 week post-operatively
measure: Patient reported outcome scores
timeFrame: 1 week post-operatively
measure: Patient reported outcome scores
timeFrame: 6 week post-operatively
measure: Patient reported outcome scores
timeFrame: 6 week post-operatively
measure: Patient reported outcome scores
timeFrame: 6 week post-operatively
measure: Patient reported outcome scores
timeFrame: 3 months post-operatively
measure: Patient reported outcome scores
timeFrame: 3 months post-operatively
measure: Patient reported outcome scores
timeFrame: 3 months post-operatively
measure: Patient reported outcome scores
timeFrame: 6 months post-operatively
measure: Patient reported outcome scores
timeFrame: 6 months post-operatively
measure: Patient reported outcome scores
timeFrame: 6 months post-operatively
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Health Ford Health System
state: Michigan
Study officials:
References:
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.
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.
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.
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.
citation: 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.