Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System (NCT07324109) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
Germany20 participantsStarted 2025-04-01
Plain-language summary
This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. If pain improves, the study team will help participants apply for insurance coverage to keep using the system long-term. The goal is to offer a simple, non-drug option that may help ease chronic pain and improve daily function for amputees. Participation is voluntary and can be stopped anytime without affecting medical care.
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:
* Unilateral major lower-limb amputation (transtibial or transfemoral)
* Presence of persistent phantom limb pain, defined as daily pain intensity ≥ 3/10 on the Visual Analog Scale (VAS) during the baseline period
* Regular daily use of a prosthetic limb (minimum 4 hours/day)
* Adequate German language proficiency to understand and complete study questionnaires and follow study procedures
* Ability to provide informed consent
Exclusion Criteria:
* Unstable wound or skin condition at the residual limb
* Inconsistent prosthetic use (less than daily or \< 4 hours/day)
* Poorly fitting or non-functional prosthesis (as determined by study team)
* Incapacity to provide informed consent (e.g., due to cognitive impairment or severe psychiatric illness)
* Insufficient German language skills to comprehend study materials or complete assessments reliably
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
Visual Analogue Scale (VAS)
Timeframe: Baseline (t1), end of 3-week intervention (t3), and 3-week follow-up (t4) - assessed via daily VAS entries averaged per time point.