NCT06106984 Home-based Rehabilitation Intervention for Phantom Limb Pain in Veterans With Lower Limb Amputations
| NCT ID | NCT06106984 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Phantom Limb Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2024-04-01 |
| Primary Completion | 2028-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 36 participants in total. It began in 2024-04-01 with a primary completion date of 2028-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Contact & Investigator
Tonya L Rich, PhD MA BS
PRINCIPAL INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Frequently Asked Questions
Who can join the NCT06106984 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Phantom Limb Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06106984 currently recruiting?
Yes, NCT06106984 is actively recruiting participants. Contact the research team at Tonya.Rich@va.gov for enrollment information.
Where is the NCT06106984 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT06106984 clinical trial?
NCT06106984 is sponsored by VA Office of Research and Development. The principal investigator is Tonya L Rich, PhD MA BS at Minneapolis VA Health Care System, Minneapolis, MN. The trial plans to enroll 36 participants.