Ignite Creation Date:
2025-12-24 @ 2:08 PM
Ignite Modification Date:
2026-02-06 @ 12:26 AM
Study NCT ID:
NCT03957395
Status:
UNKNOWN
Last Update Posted:
2019-05-29
First Post:
2019-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055111', 'term': 'Failed Back Surgery Syndrome'}, {'id': 'D020918', 'term': 'Complex Regional Pain Syndromes'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001342', 'term': 'Autonomic Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-27', 'studyFirstSubmitDate': '2019-05-17', 'studyFirstSubmitQcDate': '2019-05-20', 'lastUpdatePostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale', 'timeFrame': '12 months', 'description': 'Change from baseline in VAS for back and leg pain'}, {'measure': 'Oswestry Disability Index', 'timeFrame': '12 months', 'description': 'Change from baseline in functionality using the ODI score'}, {'measure': 'Adverse Events', 'timeFrame': '12 months', 'description': 'Number of AE through the study'}, {'measure': 'Number of pain medication', 'timeFrame': '12months', 'description': 'List of pain medication taken by patient'}, {'measure': 'Quality of life scale', 'timeFrame': '12months', 'description': 'Quality of life assessed by EuroQol group - 5 Dimensions (EQ-5D)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FBSS', 'CRPS', 'SCS', 'Burst', 'Tonic', 'High-frequency'], 'conditions': ['Failed Back Surgery Syndrome', 'CRPS (Complex Regional Pain Syndromes)']}, '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': 'Spinal cord stimulation (SCS) is one of the most commonly undertaken neuromodulatory surgery techniques in the treatment of neuropathic pain. The indication for SCS is an ineffective conservative treatment of chronic pain syndromes. The effectiveness of SCS in the case of neuropathic pain is high. The positive result of SCS treatment is the reduction of previous painful symptoms by min. 50% and / or a reduction in the amount of taken analgesics and an improvement in the quality of life including sleep quality. Long-term studies estimate that in a properly selected group of patients more than 50% of patients achieve pain reduction by the required 50% and about 60% - 70% have an improvement in the quality of life and a reduction of pain.\n\nThe efficacy of SCS in different modes of stimulation is evaluated. Patients receive four different types of stimulation for 2-week period - not knowing what kind of stimulation it is. It is said that in one type of stimulation they would feel parestesias and in other three they would not. Patients are not informed that beside tonic, burst and high frequency stimulation, the fourth is an off stimulation to check for placebo effect. The test is double-blinded', 'detailedDescription': 'Patients with FBSS and CRPS are evaluated for VAS,, dissability scale, Quality of Life (QoL), sleep disorders and mental disorders.\n\nAll patients undergo percutaneus (1 or 2) 8-contact SCS electrode implantation with trial.\n\nAll patients are blindly randomized to tonic or burst or high frequency or off stimulation. After 2-week period each participant is adequately switched to another type of stimulation for next 2 weeks. Alltogether crossover takes 8 weeks: four 2-week periods of tonic, burst, HF and off stimulation. At the end of trial period patients are subjected to the mode of stimulation which is the most efficent. The final 2-week stimulation is performed with final renewed evaluation for VAS, amount of taken medications, dissability scale, Quality of Life (QoL), sleep disorders and mental disorders. Follow-up observation will last up to 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. FBSS, CRPS patients with neuropathic and mixed pain in low-back and/or legs refractory to conservative therapy\n2. Chronic pain as a result of FBSS that exists for at least 6 months\n3. ≥ 18 years of age\n4. Written consent of the patient to participate in study procedures.\n\nExclusion Criteria:\n\n1. Active malignancy\n2. Addiction to any of the following: drugs, alcohol and/or medication\n3. Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator\n4. Local infection or other skin disorder at site of surgical incision\n5. Pregnancy'}, 'identificationModule': {'nctId': 'NCT03957395', 'briefTitle': 'Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Jan Biziel University Hospital No 2 in Bydgoszcz'}, 'officialTitle': 'Comparison of Effectiveness of Tonic, High Frequency and Burst Spinal Cord Stimulation in Chronic Pain Syndromes: a Double-blind, Randomised, Cross-over, Placebo Controlled Trial', 'orgStudyIdInfo': {'id': 'JBUH-NN-SCS-2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'scs high-frequency', 'description': 'high-frequency stimulation', 'interventionNames': ['Device: Device: Precision Novi™ system Neurostimulation procedures']}, {'type': 'EXPERIMENTAL', 'label': 'scs tonic', 'description': 'tonic stimulation', 'interventionNames': ['Device: Device: Precision Novi™ system Neurostimulation procedures']}, {'type': 'EXPERIMENTAL', 'label': 'scs burst', 'description': 'burst stimulation', 'interventionNames': ['Device: Device: Precision Novi™ system Neurostimulation procedures']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'scs off', 'description': 'off stimulation', 'interventionNames': ['Device: Device: Precision Novi™ system Neurostimulation procedures']}], 'interventions': [{'name': 'Device: Precision Novi™ system Neurostimulation procedures', 'type': 'DEVICE', 'otherNames': ['SCS'], 'description': 'SCS with Device: Precision Novi™ system', 'armGroupLabels': ['scs burst', 'scs high-frequency', 'scs off', 'scs tonic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85-168', 'city': 'Bydgoszcz', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Paweł Sokal, Ph.D.', 'role': 'CONTACT', 'email': 'pawel.sokal@cm.umk.pl', 'phone': '+48600954415'}, {'name': 'Agnieszka Malukiewicz, M.D.', 'role': 'CONTACT', 'email': 'agnieszka.malukiewicz@gmail.com', 'phone': '+48 604 892 763\u202c'}, {'name': 'Agnieszka Malukiewicz', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Neurosurgery and Neurology University Hospital nr 2 Collegium Medicum Nicolaus Copernicus University', 'geoPoint': {'lat': 53.1235, 'lon': 18.00762}}], 'centralContacts': [{'name': 'Pawel Sokal, Ph.D.', 'role': 'CONTACT', 'email': 'pawel.sokal@cm.umk.pl', 'phone': '+48600954415'}], 'overallOfficials': [{'name': 'Paweł Sokal', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jan Biziel University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jan Biziel University Hospital No 2 in Bydgoszcz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Department of Neurosurgery and Neurology', 'investigatorFullName': 'Pawel Sokal', 'investigatorAffiliation': 'Jan Biziel University Hospital No 2 in Bydgoszcz'}}}}