RECRUITING

Surgical Treatments for Postamputation Pain

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Conditions

Residual Limb PainAmputation NeuromaPhantom Limb PainPain, NeuropathicPain, Nerve

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Surgical Treatments for Postamputation Pain

Quick Facts

Study Start:2023-06-20
Study Completion:2028-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05009394

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * The participant must have a major limb amputation.
  2. * The participant is ≥ 18 years old at the time of consent.
  3. * The participant must be in generally good health to undergo a surgical intervention, as per the clinical investigator's opinion.
  4. * Time since the last amputation must be over a year at the time of consent.
  5. * 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.
  6. * 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.
  7. * 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.
  8. * The participant must have a stable prosthetic fitting for at least a month before the screening visit.
  9. * The participant has a sufficient understanding of the language in which the assessments will be conducted, as per the clinical investigator's opinion.
  1. * Neurological or other conditions that affect nerve regeneration for the nerve to be treated.
  2. * Active infection in the residual limb.
  3. * Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address postamputation pain.
  4. * Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or language difficulties that result in difficulty understanding the meaning of study participation.
  5. * Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.

Contacts and Locations

Study Contact

Emily Pettersen, MSc
CONTACT
+46764026503
emily.pettersen@vgregion.se
Max Ortiz Catalan, PhD
CONTACT
maxortizc@outlook.com

Principal Investigator

Max Ortiz Catalan, PhD
PRINCIPAL_INVESTIGATOR
Center for Bionics and Pain Research

Study Locations (Sites)

Northwestern Memorial Hospital
Chicago, Illinois, 60611
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
University of Michigan Health System
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: Center for Bionics and Pain Research

  • Max Ortiz Catalan, PhD, PRINCIPAL_INVESTIGATOR, Center for Bionics and Pain Research

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-20
Study Completion Date2028-06

Study Record Updates

Study Start Date2023-06-20
Study Completion Date2028-06

Terms related to this study

Additional Relevant MeSH Terms

  • Residual Limb Pain
  • Amputation Neuroma
  • Phantom Limb Pain
  • Pain, Neuropathic
  • Pain, Nerve