Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07443553
NA

Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)

Sponsor: Northwestern University

View on ClinicalTrials.gov

Summary

Postamputation pain is a complex condition that includes phantom limb pain (PLP), stump pain and residual limb pain (RLP), the latter of which may be referred from joints, the spine and inflamed bursa and tendons. PLP may have peripheral, spinal and central etiologies. The evidence of peripheral mechanisms includes the relief of both PLP and RLP during local anesthetic (LA) infusions, the relief of PLP and RLP with sympathetic blocks and neuroma injections, and the development of phantom radicular pain in amputees with a herniated disc. Neurolysis and defunctionalization are long-lasting treatments for pain when LA blocks provide temporary benefit, being most commonly used for cancer pain (e.g., celiac plexus neurolysis). Neurolysis has also been used to treat PAP, with uncontrolled studies showing benefit for both RLP and PLP. However, there are no controlled studies demonstrating efficacy. In this small study, we will evaluate the effectiveness of alcohol neurolysis of lower extremity neuromas (femoral or saphenous; sciatic or common peroneal and/or tibial; obturator and/ or lateral femoral cutaneous when pain is in those distributions) in individuals with RLP and PLP. For individuals with upper extremity amputation in whom non-selective neurolysis may affect the ability to use certain prosthetics that depend on functioning nerve and muscle signals, high-concentration capsaicin will be injected in an observational arm. The investigators will also examine factors associated with treatment outcome in a subset of patients (e.g., functional MRI, quantitative sensory testing).

Official title: Randomized Controlled and Observational Studies Evaluating Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-02-15

Completion Date

2029-03-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

PROCEDURE

Injection of alcohol near neuroma

Injection of 98-100% alcohol over painful neuromas after lidocaine 2% injected.

PROCEDURE

Lidocaine 2% injection

Injection of Lidocaine 2% followed by normal saline

PROCEDURE

Injection of capsaicin 150 mcg per mL if relief with lidocaine 2%

Painful upper neuroma neuromas will be injected if patients experience at least 30% pain relief with lidocaine. These patients (upper extremity amputees) are an observational cohort.

Locations (1)

First Lviv Medical Union

Lviv, Ukraine