About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must be a military Veteran
>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
Disqualifiers
Unstable medical conditions (e.g., uncontrolled diabetes, heart failure exacerbation)
Unstable mental illness or substance use disorder (e.g., active suicidality or psychosis)
Unable to give informed consent due to a cognitive impairment
Fibromyalgia or complex regional pain syndrome-like symptoms
Trial design
Single group
Treatments tested in this trial
Graded motor imagery mobile app
DeviceThe Graded Motor Imagery mobile app is a mobile app designed for intervention in phantom limb pain.
Treatment groups
Trial outcomes
Primary outcomes
Acceptability of Intervention Measure
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
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.
Secondary outcomes
Change from baseline Amputation Related Pain and Experiences to 6-weeks (post-test)
The Amputation Related Pain and Experiences is a measure to differentiate types of amputation-related pain and measure intensity, frequency, and pain interference with residual limb, phantom sensation, and phantom limb pain. For each section of residual limb pain, phantom sensation, and phantom limb pain, the minimum score is 0 and the maximum score is 60. A higher score indicates greater pain or sensation in each of the categories and a lower score indicates lower pain or sensation in each of the categories.
Change from 6-week post-test on the Acceptability of Intervention Measure at 3 months
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 Amputation Related Pain and Experiences to 3 months
The Amputation Related Pain and Experiences is a measure to differentiate types of amputation-related pain and measure intensity, frequency, and pain interference with residual limb, phantom sensation, and phantom limb pain. For each section of residual limb pain, phantom sensation, and phantom limb pain, the minimum score is 0 and the maximum score is 60. A higher score indicates greater pain or sensation in each of the categories and a lower score indicates lower pain or sensation in each of the categories.
Change from baseline Amputation Related Pain and Experiences to 6 months
The Amputation Related Pain and Experiences is a measure to differentiate types of amputation-related pain and measure intensity, frequency, and pain interference with residual limb, phantom sensation, and phantom limb pain. For each section of residual limb pain, phantom sensation, and phantom limb pain, the minimum score is 0 and the maximum score is 60. A higher score indicates greater pain or sensation in each of the categories and a lower score indicates lower pain or sensation in each of the categories.
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