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Surgical Treatments for Postamputation Pain

Sponsored by Center for Bionics and Pain Research

About this trial

Last updated 2 years ago

Study ID

2021-02346

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status

Recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting
Not yet recruiting