Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System
Trial Parameters
Brief 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.
Eligibility Criteria
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