[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-neuropathic-pain-in-the-low-back-and-legs\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-neuropathic-pain-in-the-low-back-and-legs":26},{"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":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":38,"leadSponsor":40,"locationsCount":5},"100573077","phase-3-mechanisms-of-stimulation-for-pain-alleviation-100573077",false,"NCT06741579","Mechanisms of Stimulation for Pain Alleviation","M-SPA","Inclusion criteria for study participants\n\nAdults aged 18 or older with clinically diagnosed unilateral CNP in the lower back, pelvis, or lower extremities, defined (per IASP classification) as persistent or recurrent neuropathic pain caused by a peripheral nerve lesion, history of a plausible nerve trauma, pain onset in temporal relation to the trauma, and pain distribution within the innervation territory of a peripheral nerve (or nerves).14 Negative and positive sensory symptoms or signs must be compatible with the innervation territory of the affected nerve. Can be post-traumatic, post-surgical, nerve compression, nerve ischemia, peripheral nerve injury, painful scar, nerve entrapment, mononeuropathy with or without loss of motor function\n\nPatients enrolled in this study must already have been referred for or have an existing order for PNS therapy (either Nalu or SPR SPRINT), prior to consent and enrollment in this study, as part of their routine medical care. Patients cannot receive a referral for PNS device as part of the study procedures.\n\nPositive response (at least 50% pain relief) to diagnostic nerve block(s) at the suspected site(s) of CNP.\n\nChronic (at least 6 months duration), intractable peripheral neuropathic pain; any nociceptive pain must be less prominent than the neuropathic pian.\n\nFluent in English writing, reading, and speaking\n\nAbility and willingness to complete online assessments\n\nWilliness to refrain from physical activity for at least 7 days post-lead placement.\n\nWillingness to refrain from physical activity or exercise causing muscle and\u002For joint soreness for 48 hours prior to QST, illicit drugs (marijuana) for 12 hours, as-needed (PRN) pain medications (e.g., NSAIDs, acetaminophen, opioids) for 12 hours prior to QST, and alcohol and nicotine on the day of QST prior to testing\\*\n\nExclusion Criteria:\n\nConditions causing inability to complete assessments (education, cognitive ability, mental status, medical status)\n\nActive cancer diagnosis, active malignant neoplasm (metastatic or local) or evidence of paraneoplastic syndrome\n\nPainful polyneuropathy (e.g., metabolic, autoimmune, familial, infectious disease, environmental toxins, treatment with neurotoxic drug)\n\nChronic central neuropathic pain (e.g., spinal cord injury, brain injury, multiple sclerosis)\n\nPeripheral vascular disease\n\nDiabetic neuropathy\n\nAnother pain diagnosis affecting the CNP site that could interfere with study procedures, accurate reporting and\u002For could confound evaluation of study endpoints (e.g., post-herpetic neuralgia)\n\nOther active implantable devices (e.g., implantable cardioverter defibrillator, spinal cord stimulator, dorsal root ganglion stimulator, sacral nerve stimulator, deep brain stimulator, intrathecal pump)\n\nPregnancy, breastfeeding, or planning to conceive\n\nSystemic infection or local infection at the anticipated PNS implant site\n\nImmunocompromised state\n\nCoagulation disorder, bleeding diathesis, platelet dysfunction, active anticoagulation\n\nInterventional procedure and\u002For surgery to treat CNP in the last 30 days (subjects should be enrolled 30 days after last procedure, for prior ablative treatment must be enrolled at least 3 months after last procedure)\n\nUntreated substance use disorder\n\nParticipating in another clinical trial with an active treatment arm\n\nNumbness or loss of sensation at the bilateral thumbnails, peripheral neuropathy in the hands, circulatory or sensory problem in the hands\\*\n\nParticipants with a history of Raynaud's Syndrome\\*\n\nParticipants with SBP ≥150 and\u002For DBP ≥100\\*\n\n\\*QST Inclusion\u002FExclusion Criteria. Participants can still be enrolled iif they have the QST-only exclusionary criteria have the QST-only exclusionary criteria, but QST will be modified based on responses\n\nAdditional Exclusion Criteria for Subjects receiving PET\u002FMRI and PET\u002FCT imaging at Stanford:\n\nPrior radiation exposure of \\>2 rem total within the last 12 months\n\nStandard contraindications that would preclude MRI including pacemakers or other electronic implants, metal foreign objects or fragments in the eye or body, and aneurysm clips.\n\nClaustrophobia\n\nInability to understand and communicate with the investigators to complete the study related questionnaires\n\nFemales with positive pregnancy test.","ALL","18 Years",{"count":19,"type":20},148,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a mechanistic randomized controlled trial of patients with chronic neuropathic pain (CNP) in the lower back, pelvis, and lower extremities, randomized to conventional medical management (CMM) or combined CMM and peripheral nerve stimulation therapy (PNS+CMM). Our goal is to compare treatment outcomes and trial response rate across the control and interventional device groups.",[26,27,28],"Chronic Neuropathic Pain in the Low Back and Legs","Peripheral Nerve Stimulation","Chronic Neuropathic Pain",[30,31],"SPRINT PNS","NALU PNS","RECRUITING","2025-09-26",{"date":35,"type":36},"2025-10-02","ACTUAL",{"date":33,"type":36},{"date":39,"type":20},"2028-11-01",{"name":41,"class":42},"Stanford University","OTHER"]