[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prometei Pain Rehabilitation Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":43},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100439984","surgical-treatments-for-postamputation-pain-100439984",false,"NCT05009394","Surgical Treatments for Postamputation Pain","Inclusion Criteria:\n\n* The participant must have a major limb amputation.\n* The participant is ≥ 18 years old at the time of consent.\n* The participant must be in generally good health to undergo a surgical intervention, as per the clinical investigator's opinion.\n* Time since the last amputation must be over a year at the time of consent.\n* The participant must have an average residual limb pain score equal or greater than 4 on the Numerical Rating Scale (NRS, 0-10) after the baseline period.\n* If the participant has been prescribed pharmacological treatments for pain, there must be no variations in dosage (steady consumption) for at least 1 month before the screening visit.\n* If the participant has been prescribed non-pharmacological treatments for pain, such as spinal cord stimulation, transcutaneous electrical nerve stimulation, and mirror therapy, the treatment must have ended at least 1 month before the screening visit.\n* The participant must have a stable prosthetic fitting for at least a month before the screening visit.\n* The participant has a sufficient understanding of the language in which the assessments will be conducted, as per the clinical investigator's opinion.\n\nExclusion Criteria:\n\n* Neurological or other conditions that affect nerve regeneration for the nerve to be treated.\n* Active infection in the residual limb.\n* Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address postamputation pain.\n* Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or language difficulties that result in difficulty understanding the meaning of study participation.\n* Ongoing participation in a clinical study that the clinical investigator deems detrimental to participation in this study.","ALL","18 Years",{"count":18,"type":19},110,"ESTIMATED","INTERVENTIONAL",[22],"NA","This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years.",[25,26,27,28,29],"Residual Limb Pain","Amputation Neuroma","Phantom Limb Pain","Pain, Neuropathic","Pain, Nerve","RECRUITING","2025-01-07",{"date":33,"type":34},"2025-01-09","ACTUAL",{"date":36,"type":34},"2023-06-20",{"date":38,"type":19},"2029-06",{"name":40,"class":41},"Prometei Pain Rehabilitation Center","OTHER",9,""]