NCT05009394 Surgical Treatments for Postamputation Pain
| NCT ID | NCT05009394 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Prometei Pain Rehabilitation Center |
| Condition | Residual Limb Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2023-06-20 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 110 participants in total. It began in 2023-06-20 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years.
Eligibility Criteria
Inclusion Criteria: * The participant must have a major limb amputation. * The participant is ≥ 18 years old at the time of consent. * The participant must be in generally good health to undergo a surgical intervention, as per the clinical investigator's opinion. * Time since the last amputation must be over a year at the time of consent. * The participant must have an average residual limb pain score equal or greater than 4 on the Numerical Rating Scale (NRS, 0-10) after the baseline period. * If the participant has been prescribed pharmacological treatments for pain, there must be no variations in dosage (steady consumption) for at least 1 month before the screening visit. * If the participant has been prescribed non-pharmacological treatments for pain, such as spinal cord stimulation, transcutaneous electrical nerve stimulation, and mirror therapy, the treatment must have ended at least 1 month before the screening visit. * The participant must have a stable prosthetic fitting for at least a month before the screening visit. * The participant has a sufficient understanding of the language in which the assessments will be conducted, as per the clinical investigator's opinion. Exclusion Criteria: * Neurological or other conditions that affect nerve regeneration for the nerve to be treated. * Active infection in the residual limb. * Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address postamputation pain. * Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or language difficulties that result in difficulty understanding the meaning of study participation. * Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.
Contact & Investigator
Max Ortiz Catalan, PhD
PRINCIPAL INVESTIGATOR
Prometei Pain Rehabilitation Center
Frequently Asked Questions
Who can join the NCT05009394 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Residual Limb Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05009394 currently recruiting?
Yes, NCT05009394 is actively recruiting participants. Contact the research team at maxortizc@outlook.com for enrollment information.
Where is the NCT05009394 trial being conducted?
This trial is being conducted at Chicago, United States, Boston, United States, Ann Arbor, United States, Melbourne, Australia and 5 additional locations.
Who is sponsoring the NCT05009394 clinical trial?
NCT05009394 is sponsored by Prometei Pain Rehabilitation Center. The principal investigator is Max Ortiz Catalan, PhD at Prometei Pain Rehabilitation Center. The trial plans to enroll 110 participants.