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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedian

About this trial

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

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Vibrotactile sensory feedback

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators