BFR After Bicep Tenodesis

Brooke Army Medical Center

Status: Unknown

Conditions: Shoulder Pain; Muscle Strength; Bone Mineral Density

Treatments: Device: Delfi PTS II Portable Tourniquet System

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03437239

C.2018.019

Details and patient eligibility

About

A randomized controlled pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis.

Full description

Blood flow restriction training, resistance exercise performed with a specialized venous tourniquet, leads to beneficial changes in muscle strength at low resistance and minimal stress on the nearby joint. Early research further indicates that it improves systemic bone mineral density with change in bone turnover markers. This novel resistance training has the potential to improve muscle strength and bone density in individuals who are medically unable to perform high resistance exercises typically required to improve these attributes. Our study will examine the effect of occlusion training on bone density and function of the upper extremity following a bicep tenodesis. The primary objective of the intervention is to achieve improved bone density and accelerated recovery of upper extremity function as assessed using measures such as validated questionnaires, functional outcome testing, strength testing, and dual energy x-ray absorptiometry.

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Selected to undergo a unilateral bicep tenodesis
• Males and females age 18-65
• DoD beneficiaries
• Must be able to read and write in English in order to consent

Exclusion criteria

• Contralateral upper extremity involvement resulting in less than normal range of motion, muscle strength, or daily pain greater than 1/10.
• Rehabilitation protocol with prohibited muscle strengthening greater than 6 weeks post-operation.
• Current metallic implants that contraindicate or significantly affect the sensitivity of DEXA scan
• Current implanted defibrillator or pacemaker
• Pregnancy - per patient self-report. Due to the expected small number of pregnant individuals and resulting inability to account for its effect on resulting outcomes, these patients will not be included in this study.
• Recent history of deep vein thrombosis within the 12 months or on active treatment with anticoagulants
• Currently taking medications that are known to affect bone density to include heparin, warfarin, glucocorticoids, medroxyprogesterone acetate, cancer treatment medications, bisphosphonates or other osteoporosis treatment medications, and thyroid hormone.
• History of hyperparathyroidism
• History of upper quadrant lymph node dissection
• Patient endorsement of easy bruising
• History of an upper extremity amputation
• Active infection in the operative extremity
• Cancer (current diagnosis per medical record)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Occlusion Training

Experimental group

Description:

Patients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy to include occlusion training.

Treatment:

Device: Delfi PTS II Portable Tourniquet System

Non-occlusion Training

No Intervention group

Description:

Patients undergoing a biceps tenodesis that are expected to begin a rehabilitation protocol with strength training by 6 weeks postoperatively for a continued 12 weeks course of 2-3 times per week of occupational therapy without occlusion training (standard of care).