Clinical trial NCT03437239: BFR After Bicep Tenodesis
Official title: Blood Flow Restriction Training After Bicep Tenodesis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Pain
Bone Mineral Density
Muscle Strength
Keywords: Bicep tenodesis
Lead sponsor: Brooke Army Medical Center
Sponsor class: FED
First posted: 2018-02-19
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Operative Forearm Bone Density
timeFrame: 24 weeks
measure: Total Body Bone Density
timeFrame: 24 weeks
measure: Elbow Flexion Strength
timeFrame: 18 weeks
measure: Forearm Supination Strength
timeFrame: 18 weeks
measure: Grip Strength
timeFrame: 18 weeks.
Secondary outcomes:
measure: Femoral Neck Bone Density
timeFrame: 24 weeks
measure: Lumbar Spine Bone Density
timeFrame: 24 weeks
measure: Pain
timeFrame: 24 weeks
measure: Disability of the Arm, Shoulder, and Hand
timeFrame: 24 weeks
measure: Functional Scale
timeFrame: 24 weeks
Other outcomes:
Locations:
Study officials:
References: