Surgical Treatments for Postamputation Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrometei Pain Rehabilitation Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Targeted Muscle Reinnervation (TMR)
Procedure/SurgerySurgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
Regenerative Peripheral Nerve Interface (RPNI)
Procedure/SurgerySurgical procedure where the the nerve is split into fascicles and wrapped in free muscle grafts.
Standard neuroma treatment, neuroma excision, and muscle burying
Procedure/SurgerySurgical procedure where the neuroma is excised and the nerve stump is buried in an adjacent deep muscle.
Treatment groups
110 Participants
are divided into 3 treatment groupsGroup A: Targeted Muscle Reinnervation (TMR)Active comparator 1 intervention
Group B: Regenerative Peripheral Nerve Interface (RPNI)Active comparator 1 intervention
Group C: Standard neuroma treatment, neuroma excision, and muscle buryingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Residual limb pain intensity
Difference in residual limb pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-month follow-up visit.
Time frame
Baseline to 12-month post-surgerySecondary outcomes
1
Neuroma pain intensity
Difference in neuroma pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-month follow-up visit.
Time frame
Baseline to 12-month post-surgery2
Phantom limb pain intensity
Difference in phantom limb pain intensity will be measured by numerical rating scale (NRS, 0-10), where 0 - no pain and 10 - worst imaginable pain, between baseline period and at the 12-months follow-up visit.
Time frame
Baseline to12-month post-surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Prometei Pain Rehabilitation Center
Lead sponsor
Vastra Gotaland Region
Collaborator
Göteborg University
Collaborator
Istituto Ortopedico Rizzoli
Collaborator
Hospital del Trabajador de Santiago
Collaborator
NHS Lothian
Collaborator
NHS Greater Clyde and Glasgow
Collaborator
NHS Grampian
Collaborator
Northwestern Memorial Hospital
Collaborator
University of Michigan
Collaborator
Massachusetts General Hospital
Collaborator
Dandenong Hospital
Collaborator
University of Alberta
Collaborator
Source ClinicalTrials.gov