Status:
UNKNOWN
BFR After Bicep Tenodesis
Lead Sponsor:
Brooke Army Medical Center
Conditions:
Shoulder Pain
Bone Mineral Density
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
A randomized controlled pilot study evaluating the effect of occlusion training on bone density and function of the upper extremity following a biceps tenodesis.
Detailed 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 j...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03437239
Start Date
February 1 2018
End Date
January 1 2020
Last Update
February 19 2018
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