Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorVA Office of Research and Development

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Graded motor imagery mobile app

    Device

    The Graded Motor Imagery mobile app is a mobile app designed for intervention in phantom limb pain.

Treatment groups

36 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6-week post-test
2

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.

Time frame
6 month follow up (an average of 24 weeks from 6-week post test)

Secondary outcomes

1

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.

Time frame
Baseline, 6-week Post-Test
2

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.

Time frame
3 month follow up (an average of 12 weeks after baseline)
3

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.

Time frame
Baseline, 3 month follow up (an average of 12 weeks from baseline)
4

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.

Time frame
Baseline, 6 month follow up (an average of 24 weeks from baseline)

Other outcomes

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