Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP) (NCT07443553) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)
Ukraine120 participantsStarted 2026-02-15
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. Age \>/= 18 years 2. At least 1 lower extremity amputation 3. Pain duration \>/= 1 month 4. Either average RLP or PLP in one or both (for those who have 2 lower limbs enrolled) amputated extremities \>/=4/10 5. Stable analgesic regimen over the past 10 days 6. Failure of physical therapy and at least 2 pharmacological treatments 7. At least 1 suspected painful neuroma, identified by Tinel's sign or pain with pressure or prosthetic use, referred pain in the distribution of the severed nerve, and neuropathic-type symptoms (tingling, shooting or lancinating pain)
Exclusion Criteria:
* 1\. Very poorly controlled psychiatric condition (e.g., PCL-5 score \> 60, \> 15 on the anxiety and/or depression section of HADS) 2. Poorly controlled medical condition that would preclude participation (e.g., heart failure, uncontrolled diabetes) 3. Patients in whom targeted muscle reinnervation or a similar procedure is being considered 4. Systemic infection or infection overlying the stump 5. Clinically-relevant injury to nerve fibers proximal to the amputation 6. Pregnancy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.