[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627047":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":42,"locations":48,"responsibleParty":66,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":31,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":31,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":93,"whyStopped":31,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Injection of alcohol near neuroma",{"label":15,"type":6,"description":16,"interventionNames":17},"Capsaicin","Observational cohort for upper extremity amputees in which participants will receive 1.25-3.5 mL 150 micrograms\u002FmL 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.",[18],"Procedure: Injection of capsaicin 150 mcg per mL if relief with lidocaine 2%",{"label":20,"type":21,"description":22,"interventionNames":23},"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.",[24],"Procedure: Lidocaine 2% injection",[26,32,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Injection of alcohol near neuroma","Injection of 98-100% alcohol over painful neuromas after lidocaine 2% injected.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Lidocaine 2% injection","Injection of Lidocaine 2% followed by normal saline",[20],[37],"Blinded control arm for alcohol neurolysis",{"type":27,"name":39,"description":40,"armGroupLabels":41,"otherNames":31},"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.",[15],[43],{"name":44,"role":45,"phone":46,"phoneExt":31,"email":47},"Steven Paul Cohen, MD","CONTACT","1-312-695-2500","steven.cohen@northwestern.edu",[49],{"facility":50,"status":31,"city":51,"state":31,"zip":31,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"First Lviv Medical Union","Lviv","Ukraine","UA",{"type":55,"coordinates":56},"Point",[57,58],24.02324,49.83826,{"lat":58,"lon":57},[61,65],{"name":62,"role":45,"phone":63,"phoneExt":31,"email":64},"Roman Smolynets, MD","380-967037175","smoroman9@gmail.com",{"name":31,"role":45,"phone":31,"phoneExt":31,"email":64},{"type":67,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[69],{"name":50,"class":70},"UNKNOWN","100627047","alcohol-neurolysis-and-capsaicin-for-postamputation-pain-pap-100627047",false,"NCT07443553","Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)","Randomized Controlled and Observational Studies Evaluating Alcohol Neurolysis and Capsaicin for Postamputation Pain (PAP)","Inclusion Criteria:\n\n* 1\\. Age \\>\u002F= 18 years 2. At least 1 lower extremity amputation 3. Pain duration \\>\u002F= 1 month 4. Either average RLP or PLP in one or both (for those who have 2 lower limbs enrolled) amputated extremities \\>\u002F=4\u002F10 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)\n\nExclusion Criteria:\n\n* 1\\. Very poorly controlled psychiatric condition (e.g., PCL-5 score \\> 60, \\> 15 on the anxiety and\u002For 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","ALL","18 Years",{"count":81,"type":82},120,"ESTIMATED","INTERVENTIONAL",[85],"NA","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.\n\nNeurolysis 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\u002For tibial; obturator and\u002F or lateral femoral cutaneous when pain is in those distributions) in individuals with RLP and PLP.\n\nFor 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).",[88],"Postamputation Pain",[90,91,92],"Postamputation pain","phantom limb pain","residual limb pain","NOT_YET_RECRUITING","2026-08-14",{"date":96,"type":97},"2026-08-18","ACTUAL",{"date":99,"type":82},"2026-10-31",{"date":101,"type":82},"2029-12-31",{"name":5,"class":6},1]