Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Acceptability of Intervention Measure
研究概览
简要总结
Nearly 60-85% of Veterans with amputations experience pain at the location of the amputated limb called phantom limb pain (PLP). PLP is a major problem and can have a profound impact on Veteran's daily function and ability to fully participate in life. Although several rehabilitation interventions are promising, advances in novel rehabilitation interventions are limited. The objective of this project is to refine a mobile app for graded motor imagery in 12 Veterans with amputations and test the mobile app with 36 Veterans with amputations. For this pilot project, the investigators will measure the preliminary feasibility and acceptability of the intervention. Knowledge from this project will provide evidence to guide future larger studies of this graded motor imagery intervention. Developing novel strategies for chronic pain in this population will positively impact quality of life for Veterans with amputations.
详细描述
Background: Phantom Limb Pain (PLP) is a form of unpredictable neuropathic pain in Veterans with amputation. Current non-medication treatments for PLP are limited and more interventions are needed that take into consideration the unique needs of the Veteran population. PLP significantly impairs rehabilitation outcomes and community participation. One non-medication intervention is graded motor imagery (GMI). GMI consists of sequentially progressing from limb laterality training, to motor imagery, and then mirror therapy (i.e., observing movement using the visual illusion of an intact limb in a mirror). Although clinicians report benefit from use of the technique, barriers exist to supporting at-home use of the intervention.
Research Questions (Objectives) - This VA Career Development Award-2 proposal focuses on refining a mobile app for GMI (VA-GMI) (Aim 1) and then pilot testing serial sessions of mobile app use in a sample of Veterans with lower limb amputation and moderate to severe PLP in their home setting (Aim 2).
Relevance to VA - There is a growing population of Veterans with amputation in the VA system. Many of whom will experience amputation pain, like phantom limb pain, and other amputation-related experiences. There are currently limited non-drug treatment options for phantom limb pain. Graded Motor Imagery could be one tool as a part of a comprehensive treatment plan for phantom limb pain. With the support of the expert mentor team in place, this work will incorporate Veteran input into the design of a novel intervention with high translational value. This work will lead to future investigations of optimized GMI intervention for the reduction of PLP in Veterans with amputations.
Number of Research Participants (Sample Size) - For Aim 1 that involves refining the mobile app, the investigators will recruit 12 Veterans. For Aim 2 that involves the clinical trial, the investigators will recruit 36 Veterans with unilateral below knee amputation to participate in the pilot testing of serial sessions.
Participating Sites - Minneapolis VA Health Care System
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a military Veteran
- •At least 18 years old;
- •>1 year since unilateral below knee amputation;
- •Moderate or severe (NRS score 4 on a 0-10 scale) PLP;
- •Stable medications over the past 2 weeks;
- •Willing and able to give informed consent; and
- •Able to participate in the telehealth study activities with a personal device.
排除标准
- •Unstable medical conditions (e.g., uncontrolled diabetes, heart failure exacerbation);
- •Unstable mental illness or substance use disorder (e.g., active suicidality or psychosis); and
- •Unable to give informed consent due to a cognitive impairment.
- •Fibromyalgia or complex regional pain syndrome-like symptoms
结局指标
主要结局
Acceptability of Intervention Measure
时间窗: 6-week post-test
The Acceptability of Intervention Measure is a measure of the acceptability of the intervention sessions and if acceptability changes over time. This measure will evaluate the acceptability of using a mobile app with a telehealth platform. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention, a lower score indicates lower acceptability of the intervention.
Change from 6-week post-test on the Acceptability of Intervention Measure to 6 months
时间窗: 6 month follow up (an average of 24 weeks from 6-week post test)
The Acceptability of Intervention Measure is a measure of the acceptability of the intervention sessions and if acceptability changes over time. This measure will evaluate the acceptability of using a mobile app with a telehealth platform. Minimum score: 12, maximum score: 60. A higher score indicates greater acceptability of the intervention, a lower score indicates lower acceptability of the intervention.
次要结局
- Change from baseline Amputation Related Pain and Experiences to 6-weeks (post-test)(Baseline, 6-week Post-Test)
- Change from 6-week post-test on the Acceptability of Intervention Measure at 3 months(3 month follow up (an average of 12 weeks after baseline))
- Change from 6-week post-test Amputation Related Pain and Experiences to 3 months(Baseline, 3 month follow up (an average of 12 weeks from baseline))
- Change from baseline Amputation Related Pain and Experiences to 6 months(Baseline, 6 month follow up (an average of 24 weeks from baseline))