[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intractable-pain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intractable-pain":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,73,104,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100249200","phase-1-periganglionic-resiniferatoxin-for-the-treatment-of-intractable-pain-due-to-cancer-induced-bone-pain-100249200",false,"NCT02522611","Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain","An Open-Label, Phase 1b Safety and Efficacy Trial of Periganglionic Resiniferatoxin for the Treatment of Intractable Pain Due to Cancer-induced Bone Pain","-INCLUSION CRITERIA:\n\n1. Male or female subjects must be at least 18 years of age or older.\n2. Must be diagnosed with histologically-confirmed cancer-induced bone pain producing intractable chronic pain in the target area (mid thoracic or chest level down to lower extremities) which was poorly responsive to conservative therapies based on patient report, such as analgesic medication management with potent opioids with or without prior radiotherapy, bisphosphonates, or radioisotope therapy. Additionally, pain that is non-responsive to non-opioid drugs in situations where opioids were not tolerated. Conservative therapies do not include invasive treatments, such as neurolytic procedure, including surgical neurolysis, percutaneous regional or neuraxial continuous infusions (whether opioid or local anesthetic), and peripheral neuromodulation or spinal cord stimulation, but may include temporary diagnostic or therapeutic procedures.\n3. Not currently seeking or receiving potentially curative therapies for cancer (e.g., chemotherapy or immunotherapy). Curative cancer therapy may be sought after the Outpatient Follow Up visit 14 (D14). Palliative anti-tumor therapy is allowed as long as the subject was established on that therapy prior to enrollment.\n4. Must have moderate to severe pain that is not relieved by standard treatments. Mean daily worst pain NRS score of greater than or equal to 6 for pain at or below the T6 dermatome (level of the chest) that is associated with a malignant disease. The mean score must be derived from recordings on at least 4 of 7 consecutive days within 3 weeks preceding treatment.\n5. The subject must agree to undergo a diagnostic periganglionic injection(s) with a long-acting local anesthetic (e.g., bupivacaine) under fluoroscopic guidance which resulted in at least a 30% temporary pain reduction in the targeted pain region lasting for the expected duration of the local anesthetic used.\n6. Must be healthy enough to tolerate study procedures in the judgment of the investigator.\n7. Subjects taking aspirin, non-steroidal anti-inflammatory medications, or vitamin supplements that include vitamin E or any prophylactic anticoagulant (including but not limited to Coumadin, heparin, or Xarelto) will be counseled either to stop taking these at least 7 days before surgery or be given instructions on dosing changes if applicable. In addition, if patients are currently taking a Factor Xa inhibitor (such as Xarelto) a hematology consult will be obtained. Subjects must be willing to comply with this requirement, which is standard clinical practice when undergoing elective surgical procedures to avoid surgical and post-surgical bleeding complications.\n8. Formal review of the subject s medical records and written approval for his\u002Fher inclusion in the study by 3 separate persons:\n\n   * Principal Investigator (PI) or an Associate Investigator (AI).\n   * Medical oncologist or oncologic surgeon.\n   * A member of the Pain and Palliative Care Service (PPCS) at the NIH.\n9. For women of childbearing potential and men with partners of childbearing potential, the ability and willingness use an effective method of contraception during the study.\n\n   Effective methods of birth control include:\n   * hormonal contraception (birth control pills, injected hormones, or vaginal ring).,\n   * intrauterine device.\n   * barrier methods (condom or diaphragm) combined with spermicide\n   * surgical sterilization (hysterectomy, tubal ligation, or vasectomy).\n10. Medical clearance from referring physician consisting of a statement indicating an adequate recovery period from other previous trials\u002Fmedication if known.\n11. Must be able and willing to undergo an eye examination.\n12. Must be able to read, speak and understand English and willing to complete the study tools and forms.\n13. Subjects must have provided written informed consent which includes signing the institutional review board (IRB)-approved consent form prior to participating in any study-related activity.\n14. Must have the capacity to provide informed consent.\n15. Must have a responsible adult to provide assistance with activities of daily living as needed for the subject through the Day 14 visit.\n16. Must have abilityAbility to assign a Durable Power of Attorney (DPA) for research and medical care at NIH.\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded from the study if they meet any of the following criteria:\n\n1. Subject must not have primary pain source from anatomical regions at T5 dermatome or above.\n2. Subject must not have pain due to causes other than cancer or its treatment that is moderate to severe in intensity.\n3. Subjects must not be undergoing or have plans to undergo any active treatment for their cancer during the study until after the day 14 assessment timepoint, after the RTX injection.\n4. Subject must not be anticipating initiation of palliative anti-tumor therapy or significant changes to current palliative anti-tumor therapy before completion of the Day 14 visit.\n5. Subject must not have an ECG abnormality of which the baseline QTc interval exceeds 450 milliseconds.\n6. Subjects must not have an allergy or hypersensitivity to chili peppers, capsaicin or radiographic contrast agents.\n7. Subject must not have an anatomic abnormality or pathology of the spinal cord and\u002For PG space on magnetic resonance imaging (MRI) that could increase the risk of adverse effects of placement of the needle.\n8. Subject must not have a contraindication to MRI or MRI contrast..\n9. Subjects must not have evidence of a coagulopathy or hemostasis problem as\n\n   evidenced by the following blood laboratory values within the week prior to the planned injection:\n   * PT\u002FINR (prothrombin time\u002FInternational normalized ratio) \\> 1.5 times upper limit of normal range (ULN).\n   * PTT (partial thromboplastin time) \\> 35 seconds.\n10. Subjects must not have a platelet count \\\u003C50,000\u002Fmm3. Platelets will be transfused as necessary to raise the platelet count to greater than or equal to 100,000\u002Fmm3 prior to dosing.\n11. Subjects must not have a total neutrophil count (TNC) \\\u003C1500. The US Clinical Practice Guideline for lumbar puncture is a platelet count of 50,0000, which is higher risk for hemorrhage than periganglionic infection. Patients with TNC\\\u003C1500 (neutropenia) may be eligible later if their TNC level becomes greater than 1500 spontaneously or after use of medications stimulating granulocyte production, such as Neupogen (granulocyte colony stimulating factor: G-CSF).\n12. Subjects must not have abnormal electrolyte levels (i.e. low potassium) that cannot be corrected.\n13. Subjects must not be febrile or have other evidence of an infection within 7 days of the planned periganglionic injection.\n14. Subjects must not have an allergy or hypersensitivity to chili peppers, capsaicin, or radiographic contrast agents.\n15. Female subjects must not be pregnant or breastfeeding.\n16. Subjects with any medical condition that, in the Investigator s opinion, could adversely impact the subject s participation or safety, conduct of the study, or interfere with the pain assessment, such as poorly controlled diabetes or hypertension. Patients can be re-assessed for eligibility if these conditions can be controlled medically.\n17. Subjects may not have a history of heart failure or unexplained fainting (syncope).\n18. Subjects may not have a known family history of long QT syndrome.\n19. Subjects who participated in a clinical trial of an investigational drug or device within 30 days of screening visit or are scheduled to receive an investigational product within 14 days of RTX injection.\n20. Subjects must not have received invasive treatments, such as a neurolytic procedure, including surgical neurolysis, percutaneous regional or neuraxial continuous infusions (whether opioid or local anesthetic), peripheral neuromodulation or spinal cord stimulation.","ALL","18 Years","99 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","Background:\n\nCancer-induced bone pain (CIBP) is common in people with cancer. Bone cancer can also lead to anxiety, depression, and reduced mobility and quality of life. Researchers believe a research drug called resiniferatoxin (RTX) may be able to help.\n\nObjective:\n\nTo learn whether RTX is safe and can reduce cancer induced bone pain.\n\nEligibility:\n\nPeople ages 18 and older with CIBP that is not relieved by standard treatments\n\nDesign:\n\nParticipants will have up to 6 outpatient visits over about 7 months. These will include:\n\nMedical history\n\nPhysical exam\n\nBlood and urine tests.\n\nThermal testing: a disk placed on the skin to test ability to sense temperature in and around the area of pain\n\nChest x-ray\n\nEKG: stickers are placed on the chest to measure heart signals\n\nECG: measures electrical activity of the heart\n\nParticipants will have 1 inpatient visit lasting 2-4 days. This will include:\n\nCatheter inserted into a vein in the arm. They are given anesthesia, sedation, and x-ray contrast.\n\nA needle is passed through the skin of the back to inject the RTX.\n\nParticipants will keep a log of the pain medications they take after surgery.\n\nParticipants will be called 1 week and 2, 3, and 4 months after the injection.\n\nParticipants will be mailed surveys and questionnaires to complete 2, 3, and 4 months after the injection.",[28,29],"Intractable Pain","Palliative Care",[29,31,32,33],"Adults","Cancer Pain","Quality of Life","NOT_YET_RECRUITING","2026-06-13",{"date":37,"type":38},"2026-06-16","ACTUAL",{"date":40,"type":21},"2026-06-27",{"date":42,"type":21},"2026-12-01",{"name":44,"class":45},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100118154","phase-1-resiniferatoxin-to-treat-severe-pain-associated-with-advanced-cancer-100118154","NCT00804154","Resiniferatoxin to Treat Severe Pain Associated With Advanced Cancer","A Phase I Study of the Intrathecal Administration of Resiniferatoxin for Treating Severe Refractory Pain Associated With Advanced Cancer","* INCLUSION CRITERIA:\n\nSubject inclusion criteria are based on inadequate control of pain despite best efforts, including appropriate use of analgesic medications. To be enrolled in the study, subjects must meet all of the following criteria:\n\n1. Age 18 years or older.\n2. Clinical and histological diagnosis of cancer with disease that has not adequately responded to standard therapies. A pathology report documenting malignancy is required.\n3. Subject not currently seeking or receiving potentially curative therapies for cancer (e.g., chemotherapy or immunotherapy). Curative cancer therapy may be sought after the Day 15 clinic visit, and palliative anti-tumor therapy is allowed as long as the subject was established on that therapy prior to enrollment (see exclusion criterion 6).\n4. Mean daily worst pain NRS score of greater than or equal to 6 for pain at or below the T6 dermatome (level of the chest) that is associated with a malignant disease. The mean score must be derived from recordings on at least 4 of 7 consecutive days within 3 weeks preceding treatment.\n5. Alternative methods of pain control are not sufficiently effective, not indicated, not tolerated, and\u002For refused by the subject, as determined by the Pain and Palliative Care Service (PPCS). Alternative methods of pain control include, but are not limited to, the following:\n\n   -Opioids (all routes of administration including neuraxial infusions)\n\n   -Adjuvant pain medications such as antidepressants, corticosteroids, local anesthetics, and antiseizure medications\n\n   -Procedures such as catheter or implantable pump placement for delivery of analgesic medication\n   * Prior neurolytic interventions (including intercostal, superior hypogastric, or celiac plexus blocks)\n   * Complementary medicine approaches\n   * Transcutaneous electric nerve stimulation\n   * Radiation therapy\n6. Reasonable expectation that the subject will be able to complete the study through the 30-day follow-up.\n7. Medical clearance from referring physician consisting of a statement indicating an adequate recovery period from other previous trials\u002Fmedication.\n8. Formal review of the subject s medical records and written approval for his\u002Fher inclusion in\n\nthe study by 3 separate persons:\n\n* Principal Investigator (PI) or an Associate Investigator (AI)\n* Medical oncologist or oncologic surgeon.\n* A member of the PPCS at the NIH or institution s equivalent at other sites.\n\n  10\\. International normalized ratio (INR; from prothrombin time \\[PT\\]) \\\u003C 1.5 and partial thromboplastin time (PTT) less than or equal to the upper limit of the reference range. The INR and PTT may be corrected (e.g., by administration of blood products, vitamin K, etc.), provided a repeat blood draw confirms that the values meet this inclusion criterion.\n\n  10\\. Platelet count greater than or equal to 50,000\u002Fmm\\^3. Platelets will be transfused as necessary to raise the platelet count to greater than or equal to 100,000\u002Fmm\\^3 prior to dosing.\n\n  11\\. Ability to stop any anticoagulant (e.g., Coumadin) and antiplatelet therapies (e.g., aspirin) before and during IT catheter placement according to accepted medical guidelines.1\n\n  12\\. Ability and willingness to undergo an eye examination.\n\n  13\\. Ability to read, speak, and understand English, and willingness to complete the study tools and forms.\n\n  14\\. For women of childbearing potential and men with partners of childbearing potential, the ability and willingness to use an effective method of contraception during the study. Effective methods of birth control include:\n* hormonal contraception (birth control pills, injected hormones, or vaginal ring),\n* intrauterine device,\n* barrier methods (condom or diaphragm) combined with spermicide, or\n* surgical sterilization (hysterectomy, tubal ligation, or vasectomy).\n\n  15\\. Availability of a responsible adult to assist with activities of daily living as needed for the subject through the Day 15 visit.\n\n  16\\. Ability to assign a Durable Power of Attorney (DPA) for research and medical care at NIH\n\nEXCLUSION CRITERIA:\n\nSubjects will be excluded from the study if they meet any of the following criteria:\n\n1. Primary pain source from anatomical regions at T5 dermatome or above.\n2. Pain due to causes other than cancer or its treatment that is moderate to severe in intensity.\n3. Anatomic abnormality or pathology of the spinal cord and\u002For IT space on magnetic resonance imaging (MRI) that could increase the risk of adverse effects of catheter placement or interfere with CSF flow.\n4. Evidence of advanced brain pathology or elevated intracranial pressure as determined by symptoms, history, physical examination (including neurological and eye examination), and\u002For MRI.\n5. Presence of an IT shunt device (e.g., ventriculo-peritoneal and ventriculo-atrial shunts).\n6. Anticipating initiation of palliative anti-tumor therapy or significant changes to current palliative anti-tumor therapy before completion of the Day 15 visit.\n7. Documented allergy to chili peppers or capsaicin (e.g., hives, wheal).\n8. Contraindication to MRI or MRI contrast.\n9. Female subjects who are pregnant or lactating.\n10. Clinically significant disorder or condition that might interfere with study participation or greatly increase safety risk to the subject, as judged by a study investigator.\n11. Planned use of another investigational agent, therapy, or device within 30 days after dosing.\n12. Have a history of heart failure or unexplained fainting (syncope).\n13. Have an EKG abnormality in which the baseline QTc interval exceeds 450 milliseconds.\n14. Have a known family history of long QT syndrome.\n15. Have abnormal electrolyte levels (i.e., low potassium) that cannot be corrected.\n16. Have urinary retention that does not resolve with medical or surgical treatment.\n17. Have skin ulceration that does not resolve with medical or surgical treatment.\n18. Have a history of seizure activity in the previous month.\n19. Have experienced symptoms of opioid toxicity in the past month (i.e. myoclonus, seizures, and\u002For hallucinations)",{"count":55,"type":21},45,[24],"This study will examine the safety of giving the experimental drug, resiniferatoxin (RTX), to treat severe pain in patients with advanced cancer. RTX is a chemical extracted from a cactus-like plant. It is similar to capsaicin, the active ingredient in hot pepper. RTX has relieved pain and reduced the need for pain medication in several animal experiments. It works by destroying nerves that transmit pain information.\n\nPeople at least 18 years of age with severe pain from advanced cancer at or below the level of the chest that cannot be controlled with standard treatments may be eligible for this study. Participants undergo the following procedures:\n\nPretreatment Visit\n\nBefore beginning treatment with RTX, patients give a medical history and undergo a physical examination that includes:\n\n* Electrocardiogram (EKG)\n* Blood draw\n* Urinalysis\n* Neurological examinations\n* Peak expiratory flow rate (PEFR)\n* Eye examination\n* MRI\n* Urology assessment\n* Pregnancy test, when appropriate\n* Questionnaires to collect information on health, personality, mood, pain levels and symptoms.\n\n  2-Day Hospitalization\n\nPatients are hospitalized for 2 days for RTX injection and monitoring, as follows:\n\n* RTX injection: RTX is injected in the operating room under general anesthesia. It is given through a catheter placed in the patient s spine. The catheter is also used to obtain samples of cerebrospinal fluid (CSF) the clear fluid that bathes the spinal cord. The fluid is examined to assess drug effects and side effects, chemical changes in the content of the CSF associated with RTX, and how RTX is handled by the body.\n* Post-injection monitoring, including:\n* Surveys about symptoms such as pain or weakness\n* Neurological examinations\n* Blood and CSF sampling\n* EKG\n* AEs\n\nOutpatient followup\n\n* Vitals\n* Blood draw, Urinalysis, neurological and sensory testing, EKG on days 7, 14 and 30 after the injection\n* MRI scans of the head and back, Urology assessment and PEFR on day 15 after the injection\n* Eye examination\n* Follow-up phone calls monthly for 6 months",[28,29],[60,61,32,62],"Vanilloid","Capsaicin","Nerve Block","RECRUITING","2026-06-05",{"date":66,"type":38},"2026-06-08",{"date":68,"type":38},"2009-08-14",{"date":70,"type":21},"2027-02-07",{"name":72,"class":45},"National Institute of Dental and Craniofacial Research (NIDCR)",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":92,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":103},"100607611","managing-pain-using-optimized-sequences-by-adjusting-parameters-with-independent-current-control-100607611","NCT07190807","Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control","Managing Pain Using Optimized Sequences by Adjusting Parameters With Independent Current Control (MOSAIC Study)","MOSAIC","Key Inclusion Criteria:\n\n* Persistent spinal pain syndrome (PSPS) Type I (or non-surgical refractory back pain), or PSPS Type II (Failed Back Surgery Syndrome, FBSS) diagnosis.\n* Diagnosed with chronic pain of the trunk and\u002For limbs for at least 6 months.\n* 18 years of age or older when written informed consent is obtained\n* Able to independently read and complete all questionnaires and assessments provided in English.\n* Signed a valid, IRB or EC approved informed consent form (ICF) provided in English.\n\nKey Exclusion Criteria:\n\n* Any pain-related diagnosis, medical or psychological condition that, in the Investigator's judgment might confound reporting of study outcomes (e.g., vascular or neurogenic claudication, osteoarthritis, plantar fasciitis, pelvic pain, anginal pain, chronic migraine, acute herniated disc, malignancy, untreated major depression, injury claim).\n* Significant cognitive impairment at Screening and Baseline visit that, in the opinion of the Investigator, would reasonably be expected to impair the study candidate's ability to participate in the study\n* A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.\n* Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.",{"count":82,"type":21},70,[84],"NA","Study to evaluate the effectiveness of time variant pulse (TVP)-SCS in patients with chronic pain using commercially approved Boston Scientific SCS Systems per local Instructions for use (IFU).\n\nIn addition, to compile real-world clinical outcomes in subjects with chronic, intractable low back and\u002For leg pain.",[87,28,88,89,90,91],"Chronic Pain","Low Back Pain","Chronic Low-back Pain","Chronic Leg Pain","Leg Pain",[93],"Spinal Cord Stimulation","2026-06-04",{"date":64,"type":38},{"date":97,"type":38},"2025-11-07",{"date":99,"type":21},"2029-05",{"name":101,"class":102},"Boston Scientific Corporation","INDUSTRY",7,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":112,"targetDuration":114,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":127},"100631956","post-market-evaluation-of-real-world-outcomes-and-durability-to-support-implantable-inceptiv-spinal-cord-stimulation-therapy-100631956","NCT07507422","Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy","Post Market Evaluation of Real World Outcomes and Durability to Support Implantable SCS Therapy (PERSIST) Addendum - Inceptiv™ Spinal Cord Stimulation (SCS) Therapy","PERSIST","Inclusion Criteria:\n\n1. 18 years of age or older\n2. Patient must be SCS therapy naïve\n3. A clinical decision was made for the patient to receive an Inceptiv™ SCS system (pending satisfactory results from a Medtronic SCS trial) limited to on-label leads based on the specific geography for an on-label indication prior to enrollment in the study.\n4. Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable\n5. Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat\n6. Patient must have an on-label indication specific to geography.\n\n   * NOTE: Patients may be enrolled if they have upper limb radicular limb pain, related or unrelated to spine surgery\n   * NOTE: In the US, patients experiencing chronic back pain without a history of spine surgery and not eligible for spine surgery are on-label candidates for SCS if the pain is associated with degenerative disc disease, herniated disc, or radicular pain syndrome. Radicular pain syndrome (with or without prior spine surgery) is an approved indication for SCS implant.\n7. Diagnosis of chronic back and\u002For limb pain for an on-label indication lasting at least six months.\n\nExclusion Criteria:\n\n1. Has any existing or is planning to have a new active implantable neuromodulation device or system during the 5 year follow up period (e.g., peripheral nerve stimulation, sacral neuromodulation, intrathecal drug delivery system, a second SCS system)\n2. Has a complex pain pattern that involves both upper and lower limbs or back and upper limb\n3. Has a planned major medical procedure within 6 months before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator\n4. Has a planned interventional procedure within 6 weeks (+\u002F- 2 weeks) before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator\n5. Major untreated or unstable psychiatric comorbidity, such as suicidal ideations, personality disorders, schizophrenia etc., that could interfere with accurate pain reporting, study procedures, and\u002For confound evaluation of study, as determined by the Investigator\n6. Subjects with PCS total score \\>30 are not eligible unless ALL of the following are met:\n\n   1. Absence of uncontrolled major psychiatric disorder or active suicidality based on clinical evaluation.\n   2. Investigator documentation of adequate understanding of therapy, realistic expectations, and anticipated compliance with protocol follow-up\n7. Major non-indicated, untreated or refractory progressive disease (e.g., neurodegenerative disease {not including Diabetic Peripheral Neuropathy}, heart failure, cancer, osteoarthritis, fibromyalgia, chronic fatigue syndrome), or injury (e.g., fall resulting in hip fracture) that could interfere with accurate pain reporting, study procedures, and\u002For confound evaluation of study as determined by the Investigator\n8. Has inpatient or outpatient admissions for drug or alcohol dependency within past 12 months or current\u002Fongoing substance abuse\n9. Has a current prescription of ≥90 morphine milligram equivalents (MME) per day\n10. Has predominant mechanical back pain arising from facet or sacroiliac joint pain as the main cause of chronic low-back pain if low-back pain is the predominant pain condition, as determined by the Investigator\n11. Has mechanical spine instability (eg. Spondylolisthesis grade 2) as determined by the Investigator\n12. Has an active systemic or local infection that would delay trial or implant\n13. Is pregnant or planning on becoming pregnant\n14. Has a life expectancy of less than 1 year\n15. Involved in an injury claim, under current litigation, beneficiary of an injury claim, receiving worker's compensation, or planning any future litigation\n16. Has a condition that the Investigator determines would significantly increase perioperative risk (e.g., unstable or severe cardiac disease, liver disease, uncontrolled diabetes, kidney disease)\n\nPatients enrolled into the study with Diabetic Peripheral Neuropathy, Complex Regional Pain Syndrome and Upper Limb pain are required to meet further inclusion\u002Fexclusion criteria in order to contribute to the analysis for that particular condition. These criteria are designed to ensure that the patient's condition aligns with the standard diagnostic criteria set by applicable clinical guidelines.\n\nPainful Diabetic Peripheral Neuropathy (DPN) Inclusion Criteria\n\n* Clinical diagnosis of diabetes mellitus according to the American Diabetes Association guidelines (ADA).\n* Predominant pain condition being treated by SCS is lower-limb pain due to DPN\n* Hemoglobin A1c (HbA1c) must be \\\u003C8% within 6 months of enrollment for inclusion or have completed a preoperative risk assessment if \\>8%\n* Presence of either numbness or at least one sensory disturbance (e.g., increased or decreased sensitivity, burning, pricking\u002Fstabbing, aching, \"pins and needle\" sensation) in the foot\u002Ffeet.\n\nPainful DPN Exclusion Criteria\n\n* Lower-limb pain not associated with DPN or that cannot be distinguished from DPN (e.g., mononeuropathies, proximal neuropathies, nonneuropathic pain, peripheral vascular disease)\n* History of lower-limb amputation or planned lower-limb amputations due to diabetes\n* Large (≥3cm) and\u002For gangrenous ulcers or active infection of the lower limbs\n\nComplex Regional Pain Syndrome (CRPS) Inclusion Criteria\n\n* Meets diagnostic criteria for CRPS (International Association for the Study of Pain \"Budapest Criteria\")\n* Disease that is clinically restricted to one hand or foot and affects the entire hand, foot or lower extremity\n* CRPS is the predominant pain condition that SCS is intended to treat\n\nCRPS Exclusion Criteria\n\n* Presence of Reynaud's disease\n* Current or previous neurologic abnormalities unrelated to CRPS\n* Another condition affecting the function of the diseased or contralateral extremity\n* Dystonia as a predominant component of their presentation\n\nUpper Limb Pain (ULP) - non CRPS Inclusion Criteria\n\n* Be diagnosed with radicular pain syndrome, or be diagnosed with radicular pain secondary to failed back surgery or herniated disk\n\nULP - non CRPS Exclusion Criteria\n\n* Has significant cervical stenosis, as determined by the Investigator\n* Failed treatments of carpal tunnel syndrome and\u002For cubital tunnel syndrome\n* Has mechanical neck pain (e.g., facet spondylosis), as determined by the Investigator\n* Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine\n* Has brachial plexus injury as predominant cause of pain",{"count":113,"type":21},970,"5 Years","OBSERVATIONAL","The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR). The purpose of PERSIST is to generate long-term evidence for the Inceptiv™ Spinal Cord Stimulation therapy.",[87,28],"2026-04-28",{"date":120,"type":38},"2026-05-04",{"date":122,"type":38},"2026-04-17",{"date":124,"type":21},"2034-01-11",{"name":126,"class":102},"Medtronic",3,{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":136,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":46},"100623701","mri-evaluation-of-spinal-cord-edema-after-ct-guided-percutaneous-cordotomy-in-cancer-pain-patients-100623701","NCT07400055","MRI Evaluation of Spinal Cord Edema After CT-Guided Percutaneous Cordotomy in Cancer Pain Patients","Evaluation of Medulla Spinalis Edema After CT-Guided Percutaneous Cervical Cordotomy Using Magnetic Resonance Imaging and Its Association With Postprocedural Clinical Outcomes in Patients With Cancer Pain","CORD-MRI","Inclusion Criteria:\n\nAdults aged 18 years and older\n\nPatients with cancer-related pain refractory to medical treatment\n\nPatients scheduled to undergo CT-guided percutaneous cervical cordotomy as part of routine clinical care\n\nAbility to provide informed consent\n\nAvailability for postoperative MRI follow-up on day 1 and at 1 month\n\nExclusion Criteria:\n\nPatients younger than 18 years\n\nPatients without an indication for percutaneous cervical cordotomy\n\nInability to undergo MRI (e.g., incompatible implants, severe claustrophobia)\n\nPatients who decline participation or withdraw consent\n\nIncomplete clinical or imaging follow-up data",{"count":137,"type":21},15,"This observational study aims to evaluate changes in the spinal cord following CT-guided percutaneous cervical cordotomy performed for the treatment of intractable cancer-related pain. Cordotomy is a routine clinical procedure used to relieve severe pain in selected cancer patients. After the procedure, some patients may develop temporary neurological symptoms that are thought to be related to spinal cord edema.\n\nIn this study, magnetic resonance imaging (MRI) will be performed as part of routine clinical follow-up on postoperative day 1 and at 1 month to assess the presence and extent of spinal cord edema. Clinical outcomes, including pain intensity and possible postprocedural symptoms, will be recorded and compared with MRI findings.\n\nThe goal of this research is to better understand the relationship between imaging changes in the spinal cord and clinical outcomes after cordotomy, which may help improve patient care and postoperative management in the future.",[32,28,140,141],"Spinal Cord Edema","Neuropathic Pain",[143,144,145,146,147,148],"Percutaneous Cordotomy","CT-guided Cordotomy","Cervical Cordotomy","Spinal Cord MRI","Radiofrequency Ablation","Postprocedural Complications","2026-02-03",{"date":151,"type":38},"2026-02-10",{"date":153,"type":21},"2026-03-01",{"date":155,"type":21},"2027-04-01",{"name":157,"class":158},"Mersin University","OTHER"]