An interventional study of Injection of alcohol near neuroma and Lidocaine 2% injection in Postamputation Pain, sponsored by Northwestern University. Not yet recruiting at 1 site in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Northwestern University · Not applicable, Interventional, and Treatment
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).
Up to 130 patients with lower extremity amputations and PAP will be randomized by a computer-generated randomization table in a 1:1 ratio in blocks of 20 to receive peri-neuroma injections of either lidocaine 2% + 100% ethyl alcohol, or lidocaine 2% + saline, around the following neuromas: 1) Femoral, or saphenous nerve below the adductor canal; 2) sciatic, or common peroneal and/or posterior tibial beneath the popliteal fossa; 3) obturator (in above the knee amputees); and 4) lateral femoral cutaneous (in above the knee amputees). The painful neuromas to be treated will be determined by physical exam (e.g., Tinel's sign, pain reproduction during palpation or use of a prosthesis), and PLP patterns correlating with nerve distributions (e.g., a person with only foot PLP will not have the obturator or lateral femoral cutaneous neuromas injected; a patient who perceives phantom pain only in the top of their foot, or the lateral side of their ankle, may require only neurolysis of the common peroneal nerve or saphenous nerve, respectively). Those with bilateral lower extremity amputations who meet inclusion criteria for both limbs will be suballocated to have an alcohol injection on one side and a lidocaine injection on the other, in random order (estimated 10-20 patients). The side that receives local anesthetic alone and the side that receives local anesthetic and alcohol will be determined by a computer-generated random number table.
The location of the painful neuromas will be identified by physical exam and confirmed via either ultrasound or electrical stimulation (e.g., using a radiofrequency machine or nerve stimulator, with concordant stimulation in the painful area(s) ideally noted at \< 0.5 volts). Patients with unilateral lower extremity amputations who meet selection criteria will be allocated via a computer-generated randomization table in blocks of 20 to receive either: 1) an injection of 2 mL lidocaine 2% at each painful neuroma over 5 minutes, followed by 1.5 mL saline within 5 minutes; or 2) 2 mL lidocaine 2% at each painful neuroma over 5 minutes followed by 1.25-3.5 mL 98-100% dehydrated ethyl alcohol (the volume depends on the voltage threshold, i.e., thresholds > 0.5 mL may warrant the 23.5 mL higher volume ). For those suballocated with bilateral lower extremity amputations, both painful sides will receive an injection of 2 mL lidocaine 2% per neuroma site over 5 minutes. Then after approximately 5 minutes, the side allocated to receive alcohol with have that side injected with 1.25-3.5 mL of 98-100% alcohol while the other side will receive 1.5 mL of normal saline; the lidocaine is given first because the alcohol can burn when injected, and normal saline has been shown to provide some therapeutic effect by washing out inflammatory cytokines and breaking up adhesive scar tissue, both of which may mediate neuroma-related pain. The injections will be performed with 20-22-gauge needles or stimulating needles (when a nerve stimulator is used), depending on the means for neuroma location.
After 6 weeks (primary endpoint) in the randomized double-blind portion, those with a negative categorical outcome (\< 30% pain relief or \< 4/7 on the Patient Global Impression of Change (PGIC) scale) will be unblinded to receive alternative treatments. The next follow-up for those with a successful 6-week outcome will be 12 weeks. For those with a successful 12-week outcome, the final follow-up will occur at 6 months.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 120 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Injection of 2 mL lidocaine 2% at each painful neuroma over 5 minutes, followed by 1.25-3.5 mL 98-100% dehydrated ethyl alcohol (the volume depends on the voltage threshold, i.e., thresholds \> 0.5 mL may warrant the higher volume). In those with bilateral lower extremity amputations, one leg will receive this treatment.
Procedure: Injection of alcohol near neuroma
Observational cohort for upper extremity amputees in which participants will receive 1.25-3.5 mL 150 micrograms/mL of capsaicin if they experience greater or equal to 30% pain relief after injection of 2 mL of lidocaine 2% at sites of painful neuromas.
Procedure: Injection of capsaicin 150 mcg per mL if relief with lidocaine 2%
Injection of 2 mL lidocaine 2% at each painful neuroma over 5 minutes, followed by 1.5 mL saline within 5 minutes.
Procedure: Lidocaine 2% injection
Injection of 98-100% alcohol over painful neuromas after lidocaine 2% injected.
Injection of Lidocaine 2% followed by normal saline
Also known as: Blinded control arm for alcohol neurolysis
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.
Average phantom limb pain
Average phantom limb pain on 0-10 numerical rating scale (NRS)
Time frame: 6 weeks
Average residual limb pain
Residual limb pain on 0-10 numerical rating scale (NRS)
Time frame: 6 weeks after treatment
Phantom limb pain
Average and worst phantom limb pain on 0-10 NRS
Time frame: 2 weeks
Residual limb pain
Average and worst residual limb pain on 0-10 NRS
Time frame: 2 weeks
Worst residual limb pain
Worst residual limb pain on 0-10 NRS
Time frame: 6 weeks
Worst phantom limb pain
Worst phantom limb pain on 0-10 NRS
Time frame: 6 weeks
Phantom limb pain
Average and worst phantom limb pain on 0-10 NRS
Time frame: 12 weeks
Residual limb pain
Average and worst residual limb pain on 0-10 NRS
Time frame: 12 weeks
Phantom limb pain
Average and worst phantom limb pain on 0-10 NRS
Time frame: 6 months
Residual limb pain
Average and worst residual limb pain on 0-10 NRS
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
0-21 scale measuring anxiety and depression (higher scores indicate greater disease burden, each component is measured from 0-21)
Time frame: 2 weeks
Hospital Anxiety and Depression Scale (HADS)
0-21 scale measuring anxiety and depression (higher scores indicate greater disease burden, each component is measured from 0-21)
Time frame: 6 weeks
Hospital Anxiety and Depression Scale (HADS)
0-21 scale measuring anxiety and depression (higher scores indicate greater disease burden, each component is measured from 0-21)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
0-21 scale measuring anxiety and depression (higher scores indicate greater disease burden, each component is measured from 0-21)
Time frame: 6 months
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Time frame: 2 weeks
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Time frame: 6 weeks
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Time frame: 12 weeks
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Time frame: 6 months
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Time frame: 2 weeks
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Time frame: 6 weeks
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Time frame: 12 weeks
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Time frame: 6 months
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Time frame: 2 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Time frame: 6 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Time frame: 12 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Time frame: 6 months
European Quality of Life (EuroQoL) 5D-5L
EuroQol group instrument measuring quality of life, on 5 dimensions (Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression) with 5 severity levels. Each segment is measured from 1-5 (5 indicates greater disease burden).
Time frame: 2 weeks
European Quality of Life (EuroQoL) 5D-5L
EuroQol group instrument measuring quality of life, on 5 dimensions (Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression) with 5 severity levels. Each segment is measured from 1-5 (5 indicates greater disease burden).
Time frame: 6 weeks
European Quality of Life (EuroQoL) 5D-5L
EuroQol group instrument measuring quality of life, on 5 dimensions (Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression) with 5 severity levels. Each segment is measured from 1-5 (5 indicates greater disease burden).
Time frame: 12 weeks
European Quality of Life (EuroQoL) 5D-5L
EuroQol group instrument measuring quality of life, on 5 dimensions (Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression) with 5 severity levels. Each segment is measured from 1-5 (5 indicates greater disease burden).
Time frame: 6 months
Patient Global Impression of Change (PGIC) scale
1-7 Likert scale graded from 1 (the same or worse) through 7 (a great deal better). A score of 4 (somewhat better) accompanied by at least 30% pain relief designates a positive outcome.
Time frame: 2 weeks
Patient Global Impression of Change (PGIC) scale
1-7 Likert scale graded from 1 (the same or worse) through 7 (a great deal better). A score of 4 (somewhat better) accompanied by at least 30% pain relief designates a positive outcome.
Time frame: 6 weeks
Patient Global Impression of Change (PGIC) scale
1-7 Likert scale graded from 1 (the same or worse) through 7 (a great deal better). A score of 4 (somewhat better) accompanied by at least 30% pain relief designates a positive outcome.
Time frame: 12 weeks
Patient Global Impression of Change (PGIC) scale
1-7 Likert scale graded from 1 (the same or worse) through 7 (a great deal better). A score of 4 (somewhat better) accompanied by at least 30% pain relief designates a positive outcome.
Time frame: 6 months
Binary categorical outcome (positive or negative)
Positive outcome designated as at least 30% pain relief coupled with a PGIC score of at least 4. This will be designated for the two primary outcomes, residual limb and phantom pain.
Time frame: 2 weeks
Binary categorical outcome (positive or negative)
Positive outcome designated as at least 30% pain relief coupled with a PGIC score of at least 4. This will be designated for the two primary outcomes, residual limb and phantom pain.
Time frame: 6 weeks
Binary categorical outcome (positive or negative)
Positive outcome designated as at least 30% pain relief coupled with a PGIC score of at least 4. This will be designated for the two primary outcomes, residual limb and phantom pain.
Time frame: 12 weeks
Binary categorical outcome (positive or negative)
Positive outcome designated as at least 30% pain relief coupled with a PGIC score of at least 4. This will be designated for the two primary outcomes, residual limb and phantom pain.
Time frame: 6 months
Plan to share: Undecided — Contingent on case-by-case approval by Ministry of Health
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