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Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System

RecruitingNAAges 18 Years - anyAllMedian
NCT07324109 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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
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What it tests

  • Vibrotactile sensory feedback
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Where

1 site
MEDIAN Rehab Center Wiesbaden Sonnenberg
Wiesbaden, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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