BFR After Bicep Tenodesis

NCT ID: NCT03437239

Last Updated: 2018-02-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-28
• Study Completion Date: 2020-01-31

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.

Conditions

Shoulder Pain; Bone Mineral Density; Muscle Strength

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Occlusion Training

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.

Group Type: EXPERIMENTAL

Delfi PTS II Portable Tourniquet System

Intervention Type: DEVICE

This is a portable tourniquet system that allows for occlusion of venous outflow without inhibiting arterial blood flow. This portable tourniquet system allows for rapid cuff inflation and deflation with a battery. The Delfi PTS is a purpose-built system that allows for precise control of pressure throughout training, despite the natural changes in muscle shape and length. The device has advanced pressure leak detection that monitors the tourniquet cuff, tubing, and connectors for air leaks and safely alerts staff to hazards or follow-up actions required. The device has visual and audio alarms for over and under pressure and elapsed time as well as a large, easily visible display of tourniquet pressure and elapsed time. The Delfi PTS II calibrates and self-tests on startup. It has a safety interlock that limits the normal maximum pressure and integrated tourniquet cuff testing as recommended in current AORN Standards and Recommended Practices

Non-occlusion Training

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Delfi PTS II Portable Tourniquet System

This is a portable tourniquet system that allows for occlusion of venous outflow without inhibiting arterial blood flow. This portable tourniquet system allows for rapid cuff inflation and deflation with a battery. The Delfi PTS is a purpose-built system that allows for precise control of pressure throughout training, despite the natural changes in muscle shape and length. The device has advanced pressure leak detection that monitors the tourniquet cuff, tubing, and connectors for air leaks and safely alerts staff to hazards or follow-up actions required. The device has visual and audio alarms for over and under pressure and elapsed time as well as a large, easily visible display of tourniquet pressure and elapsed time. The Delfi PTS II calibrates and self-tests on startup. It has a safety interlock that limits the normal maximum pressure and integrated tourniquet cuff testing as recommended in current AORN Standards and Recommended Practices

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brooke Army Medical Center

FED

Sponsor Role: lead

Responsible Party

Griffin Holauchock

Orthopaedic Physician Assistant Certified Resident

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Griffin M Holauchock, M.S.

Role: CONTACT

griffin.m.holauchock.mil@mail.mil

210-916-2270

Other Identifiers

C.2018.019

Identifier Type: -

Identifier Source: org_study_id