Stimulation for Amputation Pain Management (NCT07759219) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Stimulation for Amputation Pain Management
United States40 participantsStarted 2026-09-01
Plain-language summary
The goal of this clinical trial is to see if electrical stimulation applied through the application of a wearable suit improves pain and function among adults with lower-limb amputation who report pain in two or more body regions. The main questions this study seeks to answer are:
* Does the suit provide a viable treatment option for pain management?
* Does the intensity of electrical stimulation matter? Researchers will compare two different intensities of electrical stimulation applied through application of a wearable suit to see the immediate, sustained and cumulative effects on pain and function among adults with lower-limb amputation.
Participants will:
* Fill out questionnaires online.
* Undergo two onsite clinical examinations.
* Complete 10 treatment sessions over 2-3 weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* English-speaking and reading to enable informed consent and participation
* Report of pain in 2/more body regions for at least 3 months duration per site • Report of at least moderate intensity pain over the past 7 days
Exclusion Criteria:
* An amputation of the contralateral lower-limb \> toe-level
* Do not currently use a prosthesis to ambulate
* Diagnosed cognitive impairment (e.g., dementia, traumatic brain injury)
* Severe vision (e.g., blind) or hearing loss (e.g., deaf)
* Are currently pregnant
* Active cancer/malignancy
* Open wound in any area that is covered by the suit
* An acute infection or injury (e.g., fracture)
* Deep vein thrombosis
* Bowel and/or bladder incontinence
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain Intensity
Timeframe: Immediately following treatment sessions 2-3 weeks post-baseline
2
Pain Interference
Timeframe: Immediately following treatment sessions 2-3 weeks post-baseline
3
Global Rating of Change
Timeframe: Immediately following treatment sessions 2-3 weeks post-baseline