Postamputation PainNCT07443553
Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)
A study testing Injection of alcohol near neuroma, Lidocaine 2% injection and Injection of capsaicin 150 mcg per mL if relief with lidocaine 2% in people with Postamputation Pain, run by Northwestern University at 1 site in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postamputation Pain
- What is being tested?
- Injection of alcohol near neuroma, Lidocaine 2% injection and Injection of capsaicin 150 mcg per mL if relief with lidocaine 2%
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUkraine
- Study dates
- 31 Oct 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ukraine1 site
First Lviv Medical Union
Lviv
Roman Smolynets, MD, 380-967037175, smoroman9@gmail.com
smoroman9@gmail.com
About this study
Official title: Randomized Controlled and Observational Studies Evaluating Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)
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).
Read the detailed description
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.
- Conditions
- Postamputation Pain
- Being tested
- Injection of alcohol near neuroma, Lidocaine 2% injection, Injection of capsaicin 150 mcg per mL if relief with lidocaine 2%
- Keywords
- Postamputation pain, phantom limb pain, residual limb pain
- Medical subject headings
- Phantom Limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of alcohol near neuromaProcedure or surgery
Injection of 98-100% alcohol over painful neuromas after lidocaine 2% injected.
Lidocaine 2% injectionProcedure or surgery
Also called Blinded control arm for alcohol neurolysis
Injection of Lidocaine 2% followed by normal saline
Injection of capsaicin 150 mcg per mL if relief with lidocaine 2%Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Alcohol neurolysis | Experimental | 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. Receives: Procedure: Injection of alcohol near neuroma |
| Capsaicin | Other | 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. Receives: Procedure: Injection of capsaicin 150 mcg per mL if relief with lidocaine 2% |
| Lidocaine only | Active comparator | Injection of 2 mL lidocaine 2% at each painful neuroma over 5 minutes, followed by 1.5 mL saline within 5 minutes. Receives: Procedure: Lidocaine 2% injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average phantom limb pain
Average phantom limb pain on 0-10 numerical rating scale (NRS)
Measured: 6 weeks
Average residual limb pain
Residual limb pain on 0-10 numerical rating scale (NRS)
Measured: 6 weeks after treatment
Secondary outcomes (36)
Phantom limb pain
Average and worst phantom limb pain on 0-10 NRS
Measured: 2 weeks
Residual limb pain
Average and worst residual limb pain on 0-10 NRS
Measured: 2 weeks
Worst residual limb pain
Worst residual limb pain on 0-10 NRS
Measured: 6 weeks
Worst phantom limb pain
Worst phantom limb pain on 0-10 NRS
Measured: 6 weeks
Phantom limb pain
Average and worst phantom limb pain on 0-10 NRS
Measured: 12 weeks
Residual limb pain
Average and worst residual limb pain on 0-10 NRS
Measured: 12 weeks
Phantom limb pain
Average and worst phantom limb pain on 0-10 NRS
Measured: 6 months
Residual limb pain
Average and worst residual limb pain on 0-10 NRS
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Measured: 2 weeks
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Measured: 6 weeks
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Measured: 12 weeks
Somatic Symptom Scale (SSS-8)
Measure of somatic symptoms from 0-32, with higher scores indicating greater disease burden
Measured: 6 months
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Measured: 2 weeks
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Measured: 6 weeks
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Measured: 12 weeks
Athens Insomnia Scale
Instrument measuring sleep quality scored from 0-24 with higher scores indicating greater dysfunction
Measured: 6 months
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Measured: 2 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Measured: 6 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Measured: 12 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Instrument measuring PTSD symptoms from 0-80 with higher scores indicating greater disease burden
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start31 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postamputation PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- First Lviv Medical Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07443553
- Sponsor's protocol ID
- UNBROKEN-1
- Other IDs
- Neu-92-13337
- Status last verified
- Aug 2026
- First submitted
- 24 Feb 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Contingent on case-by-case approval by Ministry of Health
Publications
Campbell CM, Diamond E, Schmidt WK, Kelly M, Allen R, Houghton W, Brady KL, Campbell JN. A randomized, double-blind, placebo-controlled trial of injected capsaicin for pain in Morton's neuroma. Pain. 2016 Jun;157(6):1297-1304. doi: 10.1097/j.pain.0000000000000544.
PubMed 26963851Zhang X, Xu Y, Zhou J, Pu S, Lv Y, Chen Y, Du D. Ultrasound-guided alcohol neurolysis and radiofrequency ablation of painful stump neuroma: effective treatments for post-amputation pain. J Pain Res. 2017 Feb 3;10:295-302. doi: 10.2147/JPR.S127157. eCollection 2017.
PubMed 28223839
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled and Observational Studies Evaluating Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)
- ClinicalTrials.gov ID
- NCT07443553
- Acronym / sponsor ID
- UNBROKEN-1
- Conditions
- Postamputation Pain
- Keywords
- Postamputation pain, phantom limb pain, residual limb pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- First Lviv Medical Union
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alcohol neurolysis | Experimental | Procedure: Injection of alcohol near neuromaInjection 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. |
| Capsaicin | Other | Procedure: Injection of capsaicin 150 mcg per mL if relief with lidocaine 2%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. |
| Lidocaine only | Active comparator | Procedure: Lidocaine 2% injectionInjection of 2 mL lidocaine 2% at each painful neuroma over 5 minutes, followed by 1.5 mL saline within 5 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of alcohol near neuromaInjection of 98-100% alcohol over painful neuromas after lidocaine 2% injected. | Procedure or surgery | Alcohol neurolysis |
| Lidocaine 2% injectionAlso: Blinded control arm for alcohol neurolysisInjection of Lidocaine 2% followed by normal saline | Procedure or surgery | Lidocaine only |
| 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. | Procedure or surgery | Capsaicin |
Primary outcome
Average phantom limb pain
Time frame: 6 weeks
Average phantom limb pain on 0-10 numerical rating scale (NRS)
Average residual limb pain
Time frame: 6 weeks after treatment
Residual limb pain on 0-10 numerical rating scale (NRS)
36 secondary outcomes
Phantom limb pain
Time frame: 2 weeks
Residual limb pain
Time frame: 2 weeks
Worst residual limb pain
Time frame: 6 weeks
Worst phantom limb pain
Time frame: 6 weeks
Phantom limb pain
Time frame: 12 weeks
Residual limb pain
Time frame: 12 weeks
Phantom limb pain
Time frame: 6 months
Residual limb pain
Time frame: 6 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 2 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 6 months
Somatic Symptom Scale (SSS-8)
Time frame: 2 weeks
Somatic Symptom Scale (SSS-8)
Time frame: 6 weeks
Somatic Symptom Scale (SSS-8)
Time frame: 12 weeks
Somatic Symptom Scale (SSS-8)
Time frame: 6 months
Athens Insomnia Scale
Time frame: 2 weeks
Athens Insomnia Scale
Time frame: 6 weeks
Athens Insomnia Scale
Time frame: 12 weeks
Athens Insomnia Scale
Time frame: 6 months
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Time frame: 2 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Time frame: 6 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Time frame: 12 weeks
PTSD (posttraumatic symptom disorder) checklist (PCL-5)
Time frame: 6 months
European Quality of Life (EuroQoL) 5D-5L
Time frame: 2 weeks
European Quality of Life (EuroQoL) 5D-5L
Time frame: 6 weeks
European Quality of Life (EuroQoL) 5D-5L
Time frame: 12 weeks
European Quality of Life (EuroQoL) 5D-5L
Time frame: 6 months
Patient Global Impression of Change (PGIC) scale
Time frame: 2 weeks
Patient Global Impression of Change (PGIC) scale
Time frame: 6 weeks
Patient Global Impression of Change (PGIC) scale
Time frame: 12 weeks
Patient Global Impression of Change (PGIC) scale
Time frame: 6 months
Binary categorical outcome (positive or negative)
Time frame: 2 weeks
Binary categorical outcome (positive or negative)
Time frame: 6 weeks
Binary categorical outcome (positive or negative)
Time frame: 12 weeks
Binary categorical outcome (positive or negative)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 26963851Campbell CM, Diamond E, Schmidt WK, Kelly M, Allen R, Houghton W, Brady KL, Campbell JN. A randomized, double-blind, placebo-controlled trial of injected capsaicin for pain in Morton's neuroma. Pain. 2016 Jun;157(6):1297-1304. doi: 10.1097/j.pain.0000000000000544.
- Background: PubMed 28223839Zhang X, Xu Y, Zhou J, Pu S, Lv Y, Chen Y, Du D. Ultrasound-guided alcohol neurolysis and radiofrequency ablation of painful stump neuroma: effective treatments for post-amputation pain. J Pain Res. 2017 Feb 3;10:295-302. doi: 10.2147/JPR.S127157. eCollection 2017.
- Individual participant dataSharing planned: Undecided. Contingent on case-by-case approval by Ministry of Health
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection of alcohol near neuroma, Lidocaine 2% injection and Injection of capsaicin 150 mcg per mL if relief with lidocaine 2% in people with Postamputation Pain, run by Northwestern University at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven Paul Cohen, MD (1-312-695-2500, steven.cohen@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average phantom limb pain (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07443553, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.