Clinical trial NCT00942890: Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
Official title: Strength, Pain and Function in Operation Iraqi Freedom/Operation Enduring Freedom Amputees: A Nurse-Managed Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Amputation
Keywords: Case Management
Amputation
Muscle strength
phantom limb pain
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: Walter Reed National Military Medical Center
name: United States Naval Medical Center, San Diego
First posted: 2009-07-21
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 description: 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 either the 1) Nurse Managed NMES rehabilitation program (n=30); or 2) WRAMC Amputee Protocol (n=30). Those in the NMES group will receive 12 weeks of electrical muscle stimulation 15 min/day, 5 days a week for 12 weeks. Both groups will receive the standard 12-week Walter Reed Army Medical Center rehabilitation protocol. Generalized Estimating Equation methods will be used to build regression models for statistical analysis of the longitudinal data. The significance of this research is that Nurse Managed NMES may be very important for accelerating the rehabilitation of amputees so they can achieve functional independence and regain lost muscle strength in preparation for return to duty.

Eligibility criteria: Inclusion Criteria:

1. Unilateral trans-tibial amputee;
2. Military service member at the time of injury (Active Duty, Reserves or National Guard);
3. Age ≥18 and ≤55 years; and
4. Able to provide freely given informed consent.

Exclusion Criteria:

1. A significant co-morbid medical condition (such as severe uncontrolled hypertension (over 160/100 mmHg) or neurological disorders such as epilepsy) where NMES strength training is contraindicated and/or participation would pose a safety threat or impair their ability to participate;
2. Unable to speak and read English;
3. Implanted cardiac pacemaker or defibrillator;
4. Vision impairment where participant is classified as legally blind (we define legally blind both clinically and functionally. Clinically, it is central visual acuity of 20/200 or less in the better eye with corrective glasses. Functionally, the participant is not able to see the digital numbers on the NMES device with corrective glasses);
5. Unwillingness to accept random assignment;
6. Currently participating in another research study with an intervention that would potentially confound the outcome variables of this study (we will also instruct participants that joining a study after being enrolled in this protocol is also not allowed); and
7. Conflicting co-morbidities including traumatic brain injury (score \< 14 on glasgow coma scale), and a contralateral lower extremity injury that causes antalgic gait, pain \> 5/10 consistently on the contralateral limb and/or a grade of \< 4+/5 in lower extremity.

Primary outcomes:
measure: Lower Extremity Muscle Strength- Extension
timeFrame: 0, 3, 6, 9, 12 wks
measure: Lower Extremity Muscle Strength- Flexion
timeFrame: 0, 3, 6, 9, 12 wks
measure: Lower Extremity Mobility-Distance
timeFrame: 6, 12 wks
measure: Lower Extremity Mobility- Up and Go
timeFrame: 6, 12 wks
measure: Lower Extremity Mobility- Stair Climb
timeFrame: 6, 12 wks
measure: Lower Extremity Mobility-Chair Rise
timeFrame: 6, 12 wks
Secondary outcomes:
measure: Pain Severity
timeFrame: 0, 3, 6, 9, 12 wks
measure: Pain Interference
timeFrame: 0, 3, 6, 9, 12 wks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Navy Medical Center
state: California
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Memphis
country: United States
facility: University of Tennessee Health Science Center
state: Tennessee
Study officials:
affiliation: UTHSC
name: Laura A Talbot, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Reed National Military Medical Center
name: Michelle Kane, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Navy Medical Center San Diego
name: Michael Rosenthal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Talbot LA, Brede E, Price M, Metter EJ. Health-related quality of life in active duty military: A secondary data analysis of two randomized controlled trials. Nurs Outlook. 2017 Sep-Oct;65(5S):S53-S60. doi: 10.1016/j.outlook.2017.07.010. Epub 2017 Jul 25.
citation: Talbot LA, Brede E, Metter EJ. Effects of Adding Neuromuscular Electrical Stimulation to Traditional Military Amputee Rehabilitation. Mil Med. 2017 Jan;182(1):e1528-e1535. doi: 10.7205/MILMED-D-16-00037.