Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-08 @ 12:50 PM
Study NCT ID:
NCT04039633
Status:
RECRUITING
Last Update Posted:
2025-07-08
First Post:
2019-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Cord Stimulation for Refractory Pain in Erythromelalgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004916', 'term': 'Erythromelalgia'}], 'ancestors': [{'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '1st blinding: patients will be blinded to the actual treatment allocation during the different study periods (first blinding). 2nd: surgeons and all study personnel involved in handling the patients and collecting the study data (except those who perform the actual setting of the device) will be blinded to the actual treatment allocation. 3rd: All study personnel evaluating end point measures will be blinded to the actual treatment. 4th All the tables and figures to be presented from the study will be settled before any data from the study is evaluated in order to avoid selective presentation of findings according to statistical results. 5th The statistician performing the statistical procedures on the outcome of the study will be blinded. The data will only show treatment allocation as treatment A and treatment B. Then the tables and figures are filled in.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'During 6 months following implantation of a pulse generator, all patients will undergo 4 six-week long periods with either burst spinal cord stimulation (SCS) or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2019-07-30', 'studyFirstSubmitQcDate': '2019-07-30', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in pain', 'timeFrame': '6 months', 'description': 'assessed with a 0 -to-10 numerical rating scale (NRS)'}], 'secondaryOutcomes': [{'measure': 'Change in generic health-related quality of life', 'timeFrame': '6 months', 'description': 'Assessed with the Euro-Qol-5D (5L)'}, {'measure': 'Oswestry disability index (ODI) score', 'timeFrame': '6 months', 'description': 'questionnaire originally designed to quantify disability for degenerative conditions of the lumbar spine, possibly a relevant outcome measure also in patients with erythromelalgia as it covers intensity of pain, ability to care for oneself, ability to walk, ability to sit, ability to lift, sexual function, ability to stand, social life, sleep quality, and ability to travel. The index is scored from 0 to 100. Zero means no disability and 100 reflects maximum disability.'}, {'measure': 'Daily physical activity', 'timeFrame': '6 months', 'description': "measured by use of a body-worn accelerometer (activPALs from PAL Technologies Ltd., Glasgow, United Kingdom) attached by a waterproof tape to the midpoint of the patients' anterior right thigh"}, {'measure': 'Severity of erythema', 'timeFrame': '6 months', 'description': "assessed using the Patient's Self-Assessment (PSA) scale"}, {'measure': "Health Care Provider's Costs", 'timeFrame': '6 months', 'description': 'Cost-effectiveness (cost per gained quality-adjusted life year)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal Cord Stimulation'], 'conditions': ['Erythromelalgia']}, 'referencesModule': {'references': [{'pmid': '34854473', 'type': 'DERIVED', 'citation': "O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2."}]}, 'descriptionModule': {'briefSummary': 'Erythromelalgia is a rare disorder characterized by red, warm, and painful extremities, which is often precipitated by warm conditions. The pathophysiology is incompletely understood. The management of pain in erythromelalgia is challenging as no single therapy has been found to be effective. Response to pharmacotherapy varies, meaning that the physician has to take a stepwise trial and error approach with each patient. Consequently, this disorder is often associated with poorer health-related quality of life. There is currently no consensus or guideline on management of pain in erythromelalgia. Spinal cord stimulation is a widely applied therapy to treat severe chronic pain of various origin. Case reports and anecdotal evidence suggest that this therapy might alleviate refractory pain in patients with erythromelalgia.\n\nThe aim of this trial is to evaluate the efficacy of spinal cord stimulation for refractory pain in erythromelalgia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A diagnosis of primary or idiopathic erythromelalgia\n2. Patients ≥18 years who have developed chronic pain that has remained refractory to medical treatment for ≥6 months.\n3. Minimum pain intensity of 5/10 on a numeric rating scale NRS at baseline.\n4. Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in pain NRS from baseline). This means patients will experience paresthesia during the trial period of spinal cord stimulation.\n\nExclusion Criteria:\n\n1. Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy).\n2. History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.\n3. Abnormal pain behavior and/or unresolved psychiatric illness.\n4. Unresolved issues of secondary gain or inappropriate medication use.\n5. Unfit for participation for any other reason as judged by the study physician.'}, 'identificationModule': {'nctId': 'NCT04039633', 'briefTitle': 'Spinal Cord Stimulation for Refractory Pain in Erythromelalgia', 'organization': {'class': 'OTHER', 'fullName': 'St. Olavs Hospital'}, 'officialTitle': 'Spinal Cord Stimulation for Refractory Pain in Erythromelalgia', 'orgStudyIdInfo': {'id': '2019/159'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Burst spinal cord stimulation (SCS)', 'description': 'following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.', 'interventionNames': ['Procedure: Burst Spinal Cord Stimulation', 'Procedure: Sham spinal cord stimulation']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham spinal cord stimulation (SCS)', 'description': 'following implantation of a generator that sends pulses to a thin wire (lead), which delivers pulses to nerves along the spinal cord, the patients will initially undergo four six-week long periods with either burst SCS or no stimulation (sham) in a randomized order. During this period all patients will undergo two periods of SCS and sham stimulation.', 'interventionNames': ['Procedure: Burst Spinal Cord Stimulation', 'Procedure: Sham spinal cord stimulation']}], 'interventions': [{'name': 'Burst Spinal Cord Stimulation', 'type': 'PROCEDURE', 'description': 'Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode', 'armGroupLabels': ['Burst spinal cord stimulation (SCS)', 'sham spinal cord stimulation (SCS)']}, {'name': 'Sham spinal cord stimulation', 'type': 'PROCEDURE', 'description': 'A pulse generator is implanted, but no spinal cord stimulation is provided', 'armGroupLabels': ['Burst spinal cord stimulation (SCS)', 'sham spinal cord stimulation (SCS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halden', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Alexandros L Stefou, md', 'role': 'CONTACT'}], 'facility': 'Halden Dermatology Center', 'geoPoint': {'lat': 59.12478, 'lon': 11.38754}}, {'city': 'Strømmen', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Mari S Kvernebo, md', 'role': 'CONTACT'}], 'facility': 'Aleris', 'geoPoint': {'lat': 59.95063, 'lon': 11.01009}}, {'city': 'Tromsø', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Øystein Grimstad, md phd', 'role': 'CONTACT'}], 'facility': 'Universitetssykehuset nord-norge hf', 'geoPoint': {'lat': 69.6489, 'lon': 18.95508}}, {'city': 'Trondheim', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Sasha Gulati, md phd', 'role': 'CONTACT'}, {'name': 'Sozaburo Hara, md', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Agnete M Gulati, md', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jan Jørgensen, md', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'St Olavs Hospital', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'centralContacts': [{'name': 'Sasha Gulati, md prof', 'role': 'CONTACT', 'email': 'sasha.gulati@ntnu.no', 'phone': '+47 73592020'}, {'name': 'Sven M Carlsen, md prof', 'role': 'CONTACT', 'email': 'sven.carlsen@ntnu.no', 'phone': '+47 91769528'}], 'overallOfficials': [{'name': 'Sasha Gulati, md prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Olavs Hospital'}, {'name': 'Geir Bråthen, md prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St. Olavs Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Olavs Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}