Actively Recruiting
Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
Led by Median · Updated on 2026-01-07
20
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral major lower-limb amputation (transtibial or transfemoral)
- Persistent phantom limb pain with daily intensity of at least 3/10 on the Visual Analog Scale during baseline
- Regular daily use of a prosthetic limb for at least 4 hours
- Adequate German language skills to understand and complete study questionnaires
- Ability to provide informed consent
You will not qualify if you...
- Unstable wound or skin condition on the residual limb
- Using prosthesis less than daily or under 4 hours per day
- Poorly fitting or non-functional prosthesis as judged by study staff
- Unable to provide informed consent due to cognitive or severe psychiatric issues
- Insufficient German language skills to reliably complete study assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MEDIAN Rehab Center Wiesbaden Sonnenberg
Wiesbaden, Hesse, Germany, 65191
Actively Recruiting
Research Team
J
Johannes Schroeter, Dr. med.
CONTACT
N
Natascha Raisig, M. Sc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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