Use of Blood Flow Restriction (BFR) Therapy in Post-operative Rehabilitation Following Distal Biceps Tendon Repair
NCT ID: NCT04503421
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
64 participants
INTERVENTIONAL
2020-08-15
2021-09-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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) 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
Blood Flow Restriction Therapy
Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
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) 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
No interventions assigned to this group
Interventions
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Blood Flow Restriction Therapy
Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
Eligibility Criteria
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Inclusion Criteria
* Undergoing distal biceps tendon repair
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Henry Ford Health System
OTHER
Responsible Party
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Charles S Day
Orthopedic Surgeon
Locations
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Health Ford Health System
Detroit, Michigan, United States
Countries
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References
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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.
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.
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.
Other Identifiers
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Henry - IRB00000253
Identifier Type: -
Identifier Source: org_study_id