[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amputation-neuroma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amputation-neuroma":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,74,101],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100639200","results-of-nerve-surgery-to-treat-postamputation-pain-100639200",false,"NCT07605754","Results of Nerve Surgery to Treat PostAmputation Pain","Results of Nerve Surgery to Treat PostAmputation Pain (TreatPAP): a Prospective Study","TreatPAP","Inclusion Criteria:\n\n* Age older than or equal to 18 years\n* Intractable postamputation pain\n\nExclusion Criteria:\n\n* Cognitive impairment or delirium at the time of inclusion\n* Having received previous radiotherapy on the affected limb\n* Patients who are unable to comprehend the informed consent form or the questionnaires used in the current study\n* Unfit for general anesthesia","ALL","18 Years",{"count":20,"type":21},98,"ESTIMATED","OBSERVATIONAL","Rationale: Postamputation pain (PAP) is frequently seen after amputations and is a severe lifelong disabling condition affecting quality of life (QoL). Different nerve surgical techniques are available to treat PAP if non-surgical treatment options are not sufficient. Multiple techniques have been described for treatment of symptomatic neuromas with varying results. Techniques described include traction neurectomy with\u002Fwithout implantation, nerve grafting, nerve capping, regenerative peripheral nerve interface, and targeted muscle reinnervation (TMR). In the Leiden University Medical Center (LUMC), the most common techniques to treat painful neuromas include TMR and fascicular split (FS). TMR involves coaptating the transected mixed nerve to functional motor nerves, showing promising results in recent studies. FS is a technique closely related to neurectomy with implantation in a functional muscle. The difference is that with FS, the nerve is split into fascicles before implantation to allow for better distribution of nerve fibers. These techniques have not yet been compared. In this study, the investigators will compare both these techniques in a prospective setting for the treatment of PAP. The hypothesis is, that after 12 months, pain will be diminished and QoL will be increased in all patients versus the pre-operative status. There will be little to no difference in outcome between the surgical techniques used.\n\nObjective: To evaluate limb pain in patients with intractable postamputation pain (residual limb pain and phantom limb pain) one year after nerve embedding surgery following the standardized workup of the LUMC.\n\nStudy design: Prospective study Study population: Patients 18 years of age or older, with a history of more than 6 months of intractable postamputation neuropathic limb pain, with no history of previous surgical intervention for pain treatment, referred to the Leiden Nerve Center.\n\nMain study parameters\u002Fendpoints: The mean difference in pain scores for phantom limb pain and residual limb pain one year postoperatively. An average pain score from the past 7 days is used for PLP and RLP individually, on the 11-point (0-10) numerical rating scale (NRS). Additionally, the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Behavior and Interference Questionnaire Short Forms (7a and 8a, respectively) are used one year postoperatively.\n\nNature and extent of the burden and risks associated with participation, benefit, and group relatedness: Both techniques are currently used in the Leiden University Medical Center (LUMC) and considered standard of care. The decision to perform either technique is solely dependent on the personal preference of the treating nerve surgeon. The results of this trial will improve the understanding of the treatment effect of both surgical techniques with a minimal patient burden. Participation requires patients to complete 3-4 non-invasive questionnaires about pain, quality of life, depression and anxiety, and mobility over a period of 2 years. The pre-operative (if applicable) and 12-month postoperative questionnaire will each take approximately 15 minutes to complete. The other two questionnaires at 18 and 24 months postoperative will take approximately 3-4 minutes to complete. Additionally, participants will fill out a daily questionnaire consisting of one to three questions about pain for 7 consecutive days at 12 months.",[25],"Amputation Neuroma",[27,28,29,30,31],"Neuroma","Amputation","pain","Targeted Muscle Reinnervation","Nerve embedding","RECRUITING","2026-05-18",{"date":35,"type":36},"2026-05-26","ACTUAL",{"date":38,"type":36},"2025-08-14",{"date":40,"type":21},"2029-08-20",{"name":42,"class":43},"Leiden University Medical Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":4},"100600835","comparison-between-digital-nerve-microanastomosis-and-traction-neurectomy-in-post-digital-amputation-pain-100600835","NCT07102654","Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain","Comparison Between Digital Nerve Microanastomosis and Traction Neurectomy in Post-Digital Amputation Pain: A Prospective Study","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients who have undergone a traumatic digital amputation\n* Patients treated with one of the two following techniques: microanastomosis of digital nerves or traction neurectomy\n* Postoperative follow-up of at least 6 months\n\nExclusion Criteria:\n\n* Patients treated with a surgical intervention other than microanastomosis of digital nerves or traction neurectomy for digital amputation\n* Non-traumatic amputations (e.g., cancer or infection)\n* Follow-up of less than 6 months\n* Patients with pre-existing peripheral neuropathy",{"count":53,"type":21},50,"The goal of this prospective observational study is to assess the post-operative pain in adults with digital amputation following two different surgical interventions: microanastomosis of digital nerves or traction neurectomy. The main questions it aims to answer are:\n\n* Which surgical intervention results in less post-operative pain?\n* Which surgical intervention leads to fewer symptoms after six months?\n* Which surgical intervention is associated with fewest post-operative complications? Participants will complete a Visual Analog Scale (VAS) to assess the pain and the Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) to evaluate the disabilities.\n\nThe researchers will assess post-operative complications during follow-up appointments.",[56,25,57,58],"Amputation Stump","Amputation, Traumatic\u002FSurgery","Amputation, Surgical",[60,61,62,63],"microanastomosis","traction neurectomy","digital amputation","digital nerve","NOT_YET_RECRUITING","2025-09-11",{"date":67,"type":36},"2025-09-15",{"date":69,"type":21},"2025-12-01",{"date":71,"type":21},"2026-07-01",{"name":73,"class":43},"Centre hospitalier de l'Université de Montréal (CHUM)",{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":44},"100305759","short-term-implanted-electrodes-following-regenerative-peripheral-nerve-surgery-for-improving-prosthetic-limb-control-signals-100305759","NCT03260400","Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals","Inclusion Criteria:\n\n* Participants must be 22 years of age or older.\n* Participants must have previously undergone an upper limb amputation proximal to the wrist.\n* For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.\n* Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).\n* Participants must have reliable transportation.\n* Participants must be able to attend at minimum 2 visits per month while electrodes remain implanted.\n* Participants must be at least 6 months post-amputation.\n\nExclusion Criteria:\n\n* Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.\n* Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.\n* Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.\n* Participants must not have used tobacco for at least one month prior to enrollment in the study.\n* Participants must agree to not use tobacco for the duration of the study.\n* Participants cannot have sustained bilateral upper extremity amputation.\n* Participants cannot be pregnant.\n* Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.\n* Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.\n* Participants must not have an autoimmune condition which is not well controlled by medication.\n* Participants will not be considered for enrollment in Primary Upper Limb Amputation with RPNI Grafts and Electrode Implantation if their amputation is a traumatic injury or cancer related","22 Years","75 Years",{"count":83,"type":21},10,"INTERVENTIONAL",[86],"NA","The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.",[25,28],[90,91],"RPNI","Regenerative Peripheral Nerve Interface","2025-08-19",{"date":94,"type":36},"2025-08-26",{"date":96,"type":36},"2017-12-11",{"date":98,"type":21},"2029-05-05",{"name":100,"class":43},"University of Michigan",{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":84,"phases":109,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100439984","surgical-treatments-for-postamputation-pain-100439984","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.",{"count":108,"type":21},110,[86],"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.",[112,25,113,114,115],"Residual Limb Pain","Phantom Limb Pain","Pain, Neuropathic","Pain, Nerve","2025-01-07",{"date":118,"type":36},"2025-01-09",{"date":120,"type":36},"2023-06-20",{"date":122,"type":21},"2029-06",{"name":124,"class":43},"Prometei Pain Rehabilitation Center",9]