Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
Recruiting now · Not applicable
Conditions studied: Phantom Limb Pain After Amputation, Lower Limb Amputation Above Knee, Lower Limb Amputation Below Knee, Lower Limb Amputation Knee
In brief
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.
Key facts
- Study ID
- NCT07324109
- Run by
- Median
- People needed
- 20
- Starts
- 2025-04-01
- Expected to finish
- 2026-07-31
- Last updated by the study team
- 2026-01-07
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- MEDIAN Rehab Center Wiesbaden Sonnenberg — Wiesbaden, Hesse, Germany (enrolling)
Full record on ClinicalTrials.gov
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