Clinical Trial: Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program

Brief Summary: The purpose of this randomized control study is to determine if administering neuromuscular electrical stimulation (NMES) to the thigh muscles of a below the knee amputee is more effective than the current standard of care in preserving thigh muscle strength. In addition, this study will examine the NMES treatment effects on the participant's gait, quality of life, functional performance of standing, walking, and stair climbing, and symptoms associated with residual and phantom limb pain. The primary aim is to compare NMES plus standard rehabilitation (treatment group) to the standard rehabilitation (control group) by measuring lower extremity muscle strength. The secondary aims are to compare NMES treatment group to the control group by measuring Quality of Life (QOL) and the symptoms associated with residual & phantom limb pain. In addition to the specific aims, this study will also examine the two groups for functional performance and gait patterns after prosthetic fitting.

Detailed Summary: Traumatic amputation is one of the major injuries seen as a result of Operation Iraqi and Enduring Freedom with the majority being single trans-tibial amputations (TTA). TTA experience significant reductions in thigh muscle strength of the amputated limb during the first year after amputation. The residual limb is less active in daily functions of standing and walking, resulting in progressive atrophy of the quadriceps muscles in terms of a decrease in thigh diameter which is estimated at 25% of pre-amputation diameter. An intervention that may be useful in TTA rehabilitation is neuromuscular electrical stimulation (NMES). The overall objectives of this study is to test two different approaches to prosthetic rehabilitation as potential treatments for improving muscle strength, pain and functional performance of daily activities in military personnel with TTA. Our central hypothesis is that a Nurse Managed NMES rehabilitation program will have greater improvements in muscle strength and pain as compared to the standard rehabilitation protocol alone. The rationale for this study is that NMES could have an additive effect to the Walter Reed Army Medical Center (WRAMC) standard of care program with greater improvements in muscle strength thus enhancing the performance of daily activities, Quality of Life (QOL), and decreasing disability. Such outcomes will ultimately result in decreased economic costs, accelerated rehabilitation, and potentially increase the possibility of these warriors returning to duty. The specific aims are to test Nurse Managed NMES relative to standard rehabilitation by comparing: (1) Lower extremity muscle strength; (2) QOL; and (3) Symptoms associated with phantom pain. In addition to the above aims, specific aims for the post prosthetic phase of the intervention are to compare the two groups for (4) functional performance of daily activities. After pre-testing, participants aged 18 to 55 yrs with a traumatic TTA will be randomly assigned to eit
Sponsor: University of Tennessee

Current Primary Outcome: lower extremity muscle strength and mobility [ Time Frame: Strength: 0, 3, 6-7, 9, 13 wks; Mobility 7, 13 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Quality of life and symptoms associated with residual limb and phantom pain [ Time Frame: QOL: 0, 7, 13 wks; Symptoms: 0, 3, 6-7, 9, 13 wks ]

Original Secondary Outcome: Same as current

Information By: University of Tennessee

Dates:
Date Received: July 15, 2009
Date Started: April 2009
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2015