Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-24 @ 5:49 PM
Study NCT ID:
NCT06835868
Status:
RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-02-14
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuro-Pain Provides a Dynamic and Interactive Register for the Invasvive Neuromodulatory Therapies for Different Chronic Pain Syndromes. Patients Living in Belgium and Suffering From Persistent Spinal Pain Syndromes Type 2 as Well as Suffering From Complex Regional Pain Syndromes Are Included.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062187', 'term': 'Spinal Cord Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2032-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-02-14', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain intensity after 21 days', 'timeFrame': '21 days', 'description': 'Follow-up of pain intensity (measured by the Numeric Rating Scale, with a minimum of 0 and a maximum score of 10) during the trial therapy of 21 days, together with quality of sleep and quality of ambulation (also ona NRS scale from 0 to 10).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['spinal cord stimulation', 'chronic pain', 'quality of life'], 'conditions': ['Chronic Pain Syndromes', 'CRPS']}, 'referencesModule': {'references': [{'pmid': '40791635', 'type': 'DERIVED', 'citation': 'Bernaerts L, Roelant E, Moens M, Ly HG, Buyten JV, Billet B, Bryon B, Puylaert M, Tuna T, Malone M, Theys T, Berquin A, Vangeneugden J, Hans G. Multidisciplinary Approach to Spinal Cord Stimulation for Persistent Spinal Pain Syndromes: A 65-Month Integrated Data Collection From the Belgian Neuro-Pain(R) Real-World Data Register. Pain Res Manag. 2025 Aug 4;2025:7880611. doi: 10.1155/prm/7880611. eCollection 2025.'}]}, 'descriptionModule': {'briefSummary': 'Patients suffereing from chronic pain due to persistent spinal pain syndromes or complex regional pain syndromes and living in Belgium will be included in this register once they are being considered for a treatment with invasive neuromodulation (either spinal cord stimulation either dorsal root ganglion stimulation). The screening process, the multidisciplinary evaluation, the trial therapy and the long-terl follow-up will be monitored through this register.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients suffering from chronic pain syndromes, either persistent spinal pain syndromes or complex regional pain syndromes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic pain syndromes\n\nExclusion Criteria:\n\n* acute pain syndromes'}, 'identificationModule': {'nctId': 'NCT06835868', 'briefTitle': 'Neuro-Pain Provides a Dynamic and Interactive Register for the Invasvive Neuromodulatory Therapies for Different Chronic Pain Syndromes. Patients Living in Belgium and Suffering From Persistent Spinal Pain Syndromes Type 2 as Well as Suffering From Complex Regional Pain Syndromes Are Included.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Antwerp'}, 'officialTitle': 'Nationwide Dynamic Register for Screening, Evaluation and Follow-up of Patients Suffering From Chronic Pain Syndromes and Treated by Means of Invasive Neuromodulation.', 'orgStudyIdInfo': {'id': 'Neuro-Pain'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Spinal cord stimulation', 'type': 'PROCEDURE', 'description': 'implantation of electrode which is linked to an implantable impulse generator for the treatment of chronic pain syndromes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Guy H Hans, MD, PhD', 'role': 'CONTACT', 'email': 'pijncentrum@uza.be', 'phone': '003238213000'}, {'name': 'Davina Wildemeersch, MD, PhD', 'role': 'CONTACT', 'email': 'davina.wildemeersch@uza.be'}, {'name': 'Guy H Hans, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Davina Wildemeersch, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UZA, multidisciplinary pain center', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Guy H HANS, MD, PhD', 'role': 'CONTACT', 'email': 'guy.hans@uza.be', 'phone': '003238213000', 'phoneExt': '4945'}, {'name': 'Lisa Bernaerts', 'role': 'CONTACT', 'email': 'lisa.bernaerts@uza.be', 'phone': '00323821300'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Antwerp', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}