What this study is
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.
What's being tested
- Graded motor imagery mobile app
Intervention · DEVICE
The Graded Motor Imagery mobile app is a mobile app designed for intervention in phantom limb pain.
Study details
- Sponsor
- VA Office of Research and Development
- Conditions
- Phantom Limb Pain
- Enrolling
- 36 people
- Starts
- 2024-04-01
- Est. completion
- 2029-03-31
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 89 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
- Willing and able to give informed consent
- Able to participate in the telehealth study activities with a personal device
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openMinneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
- Tonya L Rich, PhD MA BS · Contact(612) 467-5463Tonya.Rich@va.gov
- Andrew H Hansen, PhD · Contact(612) 467-2910andrew.hansen2@va.gov
- Tonya L Rich, PhD MA BS · Principal investigator
Recruiting
Study team
Sponsor
VA Office of Research and Development
Study ID B4805-W
Principal investigator
Tonya L Rich, PhD MA BS
Minneapolis VA Health Care System, Minneapolis, MN
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.