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

NCT06106984 | Recruiting

• 1 other identifier: B4805-W
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Phantom Limb Pain

Keywords

Amputation; Rehabilitation; Phantom limb pain; Pain

Outcome Measures

Primary Outcomes (2)

• 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.

  6-week post-test

• 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.

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

Secondary Outcomes (4)

• 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)

Study Arms (1)

Intervention

EXPERIMENTAL

Veterans will trial the Graded Motor Imagery mobile application.

Device: Graded motor imagery mobile app

Interventions

Graded motor imagery mobile app DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

MeSH Terms

Conditions

Phantom Limb; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Tonya L Rich, PhD MA BS

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tonya L Rich, PhD MA BS

CONTACT

(612) 467-5463; Tonya.Rich@va.gov

Andrew H Hansen, PhD

CONTACT

(612) 467-2910; andrew.hansen2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The investigators will conduct pilot testing of serial sessions of Graded Motor Imagery with Veterans using telehealth to their home environment.

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: April 1, 2024
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)