BFR After Bicep Tenodesis

NCT03437239 | Unknown

• 1 other identifier: C.2018.019
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Pain; Bone Mineral Density; Muscle Strength

Keywords

Bicep tenodesis

Outcome Measures

Primary Outcomes (5)

• Operative Forearm Bone Density

  Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance

  24 weeks

• Total Body Bone Density

  Bone Density will be measured using the GE Lunar Dual Energy X-ray Absorptiometry (iDXA) device maintained and operated by the Nuclear Medicine clinic at SAMMC in accordance with the International Society for Clinical Densitometry (ISCD) Best Practices for dual energy x-ray absorptiometry guidance

  24 weeks

• Elbow Flexion Strength

  Elbow Flexion Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination

  18 weeks

• Forearm Supination Strength

  Forearm Supination Strength will be assessed using the BTE PrimusRS dynamometer after the completion of the rehabilitation protocol, approximately 18 weeks postoperative. The patient will be seated with a lap belt to perform testing, to include isokinetic measurements of elbow flexion and forearm supination. The patient will perform 3 trials of one repetition on both the operative forearm and the contralateral arm of both elbow flexion and supination. The PrimusRS will generate a number of pounds of force used, which will be averaged for each side and used for analysis to represent strength. The BTE PrimusRS has been validated for measuring strength and used in numerous studies for various joints and movements to include elbow flexion and forearm supination

  18 weeks

• Grip Strength

  Grip strength will be assessed using the JAMAR Hand Dynamometer. It has been selected for use in this study as per the recommendation by the American Society for the Surgery of the Hand and American Society of Hand Therapists ASHT) as the tool of choice to measure grip strength. Studies have shown that the JAMAR dynamometer has high instrument and test-retest reliability. Grip strength will be tested according to the testing position and procedure recommended by the ASHT. The mean of three successive trials will be recorded. There are established normative data for grip strength by both age and hand dominance.

  18 weeks.

Secondary Outcomes (5)

• Femoral Neck Bone Density

  24 weeks

• Lumbar Spine Bone Density

  24 weeks

• Pain

  24 weeks

• Disability of the Arm, Shoulder, and Hand

  24 weeks

• Functional Scale

  24 weeks

Study Arms (2)

Occlusion Training

EXPERIMENTAL

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.

Device: Delfi PTS II Portable Tourniquet System

Non-occlusion Training

NO INTERVENTION

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).

Interventions

Delfi PTS II Portable Tourniquet System 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

Occlusion Training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Brooke Army Medical Center: lead

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Griffin M Holauchock, M.S.

CONTACT

210-916-2270; griffin.m.holauchock.mil@mail.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Physician Assistant Certified Resident

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: February 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: February 19, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share