[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"painful-diabetic-neuropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:painful-diabetic-neuropathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,72,123],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100414613","phase-2-low-dose-naltrexone-for-the-treatment-of-painful-diabetic-neuropathy-100414613",false,"NCT04678895","Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy","Low-Dose Naltrexone for the Treatment of Painful Diabetic Neuropathy, a Small, Randomized, Double-blind, Placebo-controlled Crossover Trial","Inclusion Criteria:\n\n1. Diagnosis of Painful Diabetic Neuropathy (PDN) for \\>6 months\n2. Has failed at least one prior standard treatment for PDN (Gabapentin, duloxetine, etc)\n3. No other known causes of lower extremity neuropathic pain\n4. Subjects capable of giving informed consent\n5. Greater than 18 years of age\n6. Stable on all current non-opioid pain medication for at least 1 month\n7. English as primary language\n\nExclusion Criteria:\n\n1. Known allergy to naltrexone or naloxone\n2. Presence of known causes of lower extremity neuropathic pain not attributed to PDN\n3. Active substance use disorder or alcohol use disorder as defined by DSM-V (The Diagnostic and Statistical Manual of Mental Disorders)\n4. Current treatment for substance use disorder or alcohol use disorder\n5. Current opioid therapy or on opioid therapy within the past 1 month","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Diabetes affects more than 30 million people in the United States and is a leading cause of morbidity. Over 25% diabetics also suffer from debilitating painful diabetic neuropathy in the lower legs and feet. This pain can be severe, difficult to control, and have a significant negative impact on quality of life. Opioid medications have historically been a mainstay of treatment for this pain, despite the risks. As the death toll from the U.S. opioid epidemic continues to rise, the need for quality alternative non-opioid medications to treat pain becomes more urgent. One of these potential medications is Low-Dose Naltrexone (LDN). This drug is reported to work by enhancing the body's natural pain relieving mechanisms and decreases inflammation by targeting specific cells called microglia which have been shown to influence chronic pain. LDN has been shown to be a safe medication with minimal side effects. Its efficacy has been demonstrated in other painful conditions but has never been fully studied for treating painful diabetic neuropathy. The goal of this randomized, placebo-controlled trial is to determine if LDN is effective for treating the pain caused by diabetic neuropathy. LDN's mechanism of action is well suited to treating painful diabetic neuropathy, and LDN shows significant promise as a safe, non-opioid alternative that can decrease pain and improve quality of life for those suffering from this painful condition.",[26],"Painful Diabetic Neuropathy",[28,26],"Low-Dose Naltrexone","RECRUITING","2026-05-01",{"date":32,"type":33},"2026-05-06","ACTUAL",{"date":35,"type":33},"2020-12-22",{"date":37,"type":20},"2026-12",{"name":39,"class":40},"Dartmouth-Hitchcock Medical Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":41},"100553030","scs-for-patient-with-painful-diabetic-neuropathy-and-peripheral-arterial-disease-100553030","NCT06480786","SCS for Patient With Painful Diabetic Neuropathy and Peripheral Arterial Disease","Spinal Cord Stimulation for Patients With Painful Diabetic Neuropathy and Peripheral Arterial Disease: Mechanistic Insights From a Single-center, Randomized, Blinded, Sham-controlled Cross-over Proof-of-concept Trial","Inclusion Criteria:\n\n* 19 years to 89 years old\n* Diagnosed diabetes mellitus\n* Signs or symptoms of neuropathy and maximum baseline visual-analog pain scale ≥ 5 cm and peripheral arterial disease (diagnosed by ankle-brachial index \\\u003C 0.90 or vascular imaging studies) with claudication and exertion-induced visual-analog pain scale ≥ 6 cm for a minimum of 3 months\n* Successful spinal cord stimulator (SCS) trial (\\>50% relief of chronic lower extremity pain) and will have a new permanent SCS placed prior to study intervention\n\nExclusion Criteria:\n\n* Uncontrolled psychological or psychiatric disorder\n* Inability to hold antithrombotic therapy per the American Society of Regional Anesthesia guidelines\n* Non-healing wounds\n* Gangrene\n* Critical limb ischemia\n* Prior lower extremity amputation\n* Inability to adhere to study follow-up\n* Mechanical spine instability based on flexion\u002Fextension radiographs of the lumbar spine\n* Prior or current spinal cord stimulator implant","19 Years","89 Years",{"count":52,"type":20},15,[54],"NA","Peripheral arterial disease (PAD) affects over 230 million adults worldwide and is a highly morbid, costly, and disabling condition. Ischemic leg pain drives disability in PAD patients and results from oxygen supply-demand mismatch, autonomic dysfunction, and muscle breakdown. This leg pain, which is unresponsive to traditional pharmacotherapy, limits the patient's tolerance to exercise, which is an important disease-modifying intervention. Spinal cord stimulation is a well-established therapy for medically intractable pain, including painful diabetic neuropathy (PDN) and ischemic pain, but is not part of the standard-of-care for PAD despite limited promising clinical data. Early studies used first-generation, tonic stimulation devices, but with these it was impossible to perform sham-controlled trials to test the treatment. Since then, new types of waveform treatments, including high-frequency spinal cord stimulation (SCS), have been shown to be more effective in the treatment of intractable pain. While high-frequency SCS is approved for PDN treatment, it has never been tested in the treatment of claudication pain from PAD.\n\nThis study will enroll up to 15 participants between the ages of 19 and 89 who have PAD and PDN and are successfully implanted with a permanent SCS. Twelve weeks after SCS implantation, participants will receive two weeks of stimulation and two weeks of sham intervention, in random starting order. Blood flow, blood pressure, skin oxygen levels, and participant reported pain int the lower extremities will be assessed before SCS implantation, 12 weeks after SCS implantation and during each of the treatment periods. Participants will also complete a quality of life survey at the same time points. Comparisons of these measurements with the baseline and post-implantation measurements to determine the effects of SCS.",[57,26,58,59,60,61,62],"Peripheral Arterial Disease","Diabetes Mellitus, Type 2","Chronic Pain","Spinal Cord Stimulation","Chronic Pain Syndrome","Limb Pain","2025-10-21",{"date":65,"type":33},"2025-10-22",{"date":67,"type":33},"2024-12-18",{"date":69,"type":20},"2027-07",{"name":71,"class":40},"University of Nebraska",{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":104,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":41},"100497203","assessing-symptom-and-mood-dynamics-in-pain-using-the-smartphone-application-soma-100497203","NCT05754190","Assessing Symptom and Mood Dynamics in Pain Using the Smartphone Application SOMA","INCLUSION CRITERIA \\[General study\\]\n\n* Chronic pain group:\n\n  * Age above 18\n  * Access to a personal smartphone and a stable internet connection\n  * Average pain intensity score of greater than 3 in the past week or\n  * Average pain interference score of greater than 3 in the past week or\n  * Average pain distress score of greater than 3 in the past week\n  * Pain duration: greater than 6 months\n* Acute pain group:\n\n  * Age above 18\n  * Access to a personal smartphone and a stable internet connection\n  * Average pain intensity score of greater than 3 in the past week\n\n    ○ or\n  * Average pain interference score of greater than 3 in the past week\n\n    ○ or\n  * Average pain distress score of greater than 3 in the past week\n  * Pain duration: less than 3 months\n  * Pain cause: Due to recent surgery, injury, acute illness, or childbirth (within the past 3 months)\n* Healthy control group:\n\n  * Age above 18\n  * Access to a personal smartphone and a stable internet connection\n  * Average pain intensity score of less than 3 in the past week\n  * Average pain interference score of less than 3 in the past week\n  * Average pain distress score of less than 3 in the past week\n  * No surgery, injury, acute illness, or childbirth (within the past 3 months)\n* In person EEG testing \\[Sub-Study only\\]:\n\n  * Same as in General App Study Above and additionally:\n  * Current diagnosis of Fibromyalgia, Chronic Low Back Pain or Failed Back Surgery Syndrome OR\n  * No current or prior history of chronic pain\n  * If participant has chronic low back pain or failed back surgery syndrome: are they planning to have either a radio-frequency ablation, back surgery, or spinal cord stimulation implant in the next few months\n  * If participant has chronic low back pain or failed back surgery syndrome: have they received insurance approval for the procedure?\n  * Ok with EEC\u002FECG measures\n\nEXCLUSION CRITERIA \\[General study\\]\n\n* Chronic pain group:\n\n  * recent injury or surgery unrelated to the pain in the past 3 months\n  * difficulty participating for technical\u002Flogistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);\n  * Not fluent in English (difficulty understanding questions)\n  * Current primary or metastatic cancer (organic cause of pain)\n* Acute pain group:\n\n  * History of Chronic Pain (Pain lasting for more than 6 months)\n  * difficulty participating for technical\u002Flogistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);\n  * Not fluent in English (difficulty understanding questions)\n  * Current primary or metastatic cancer (organic cause of pain)\n* Healthy control group:\n\nHistory of Chronic Pain (Pain lasting for more than 6 months)\n\n* difficulty participating for technical\u002Flogistical issues (e.g., no computer, incompatible smartphone, can't commit to 4 months study participation);\n* Not fluent in English (difficulty understanding questions)\n\n  -In person EEG testing \\[Sub-study only\\]: \\[will interfere with EEG data collection safety or quality\\]:\n* Same as in General App Study Above and additionally:\n* Baldness\n* Pregnancy\n* Dreadlocks\n* Left-handedness\n* Use of a wheelchair\n* Heart failure diagnosis\n* Current or prior experience with acute psychosis or mania\n* implanted pacemaker, neurostimulator or any other head or heart implants\n* require a hearing aid to hear properly\n* claustrophobia\n* metal fragments in the body",true,{"count":80,"type":20},800,"OBSERVATIONAL","This study relies on the use of a smartphone application (SOMA) that the investigators developed for tracking daily mood, pain, and activity status in acute pain, chronic pain, and healthy controls over four months.The primary goal of the study is to use fluctuations in daily self-reported symptoms to identify computational predictors of acute-chronic pain transition, pain recovery, and\u002For chronic pain maintenance or flareups. The general study will include anyone with current acute or chronic pain, while a smaller sub-study will use a subset of patients from the chronic pain group who have been diagnosed with chronic low back pain, failed back surgery syndrome, or fibromyalgia. These sub-study participants will first take part in one in-person EEG testing session while completing simple interoception and reinforcement learning tasks and then begin daily use of the SOMA app. Electrophysiologic and behavioral data from the EEG testing session will be used to determine predictors of treatment response in the sub-study.",[59,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,26,100,101,102,61,103],"Acute Pain","Post Operative Pain","Fibromyalgia, Primary","Fibromyalgia, Secondary","Fibromyalgia","Irritable Bowel Syndrome","Chronic Headache Disorder","Chronic Migraine","Chronic Pelvic Pain Syndrome","Temporomandibular Joint Disorders","Endometriosis-related Pain","Arthritis","Chronic Low-back Pain","Failed Back Surgery Syndrome","Post Herpetic Neuralgia","Neuropathic Pain","Painful Bladder Syndrome","Trauma-related Wound","Trauma, Multiple","Chronic Shoulder Pain",[105,106,107,108,109,110,111,112,113],"digital health","e-health","smartphone application","chronic pain","acute pain","symptom tracking","experience sampling methodology","ecological momentary assessment","pain self-management","2025-09-16",{"date":116,"type":33},"2025-09-19",{"date":118,"type":33},"2023-06-20",{"date":120,"type":20},"2026-05-30",{"name":122,"class":40},"Brown University",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":4,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":41},"100416213","peripheral-nerve-block-in-patients-with-painful-diabetic-polyneuropathy-100416213","NCT04699734","Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy","Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Probably diabetic neuropathy confirmed using the Toronto criteria in a \"conservative manner\", i.e. three out of three symptoms\u002Fsigns of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes) 7.\n* Definite or probable neuropathic pain for minimum the last 6 months\n* Mean pain intensity at \\> 4 NRS the last week17.\n\nSince we expect a large effect of the block it is not necessary to discontinue pain medication.\n\nExclusion Criteria:\n\n* Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain.\n* Unable to understand and speak Danish.\n* Non-cooperative.\n* Warfarin or other medication that contraindicate regional anesthesia.\n* Infection in the injection area.\n* Allergy to lidocaine.\n* Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception).\n* Severe psychiatric disease e.g. severe depression during the last 6 months.\n* Alcohol or drug abuse.",{"count":131,"type":20},16,[54],"The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy",[26,99,135],"Neuropathy;Peripheral","2021-01-06",{"date":138,"type":33},"2021-01-07",{"date":140,"type":33},"2020-09-08",{"date":142,"type":20},"2026-12-31",{"name":144,"class":40},"University of Aarhus"]