Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:33 PM
Study NCT ID:
NCT01104051
Status:
COMPLETED
Last Update Posted:
2015-07-29
First Post:
2010-04-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-27', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in pain', 'timeFrame': '6 months', 'description': '• To evaluate the clinical efficacy of RF lesioning of sensory innervation of the sacroiliac region as a long term treatment for pain associated with SI joint dysfunction as measured by the reduction in VAS scale and the use of pain alleviating therapies'}], 'secondaryOutcomes': [{'measure': 'Economic outcomes', 'timeFrame': '1 year', 'description': '• To evaluate the economic and cost benefits of radiofrequency as a treatment for chronic pain associated with SI joint pain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sacroiliac Joint Dysfunction']}, 'descriptionModule': {'briefSummary': 'Trial will enroll qualified subjects at a 2:1 ration to receive radiofrequency ablation or sham. At six weeks follow up they will be unblinded; sham subjects will then be given option to receive treatment.\n\nSubjects will be followed after procedure for data collection for economic outcomes and efficacy of treatment.', 'detailedDescription': 'Patients presenting with low back pain associated with SIJD for longer than 6 months, and who have not had positive responsive to the conservative treatments:\n\n* Pharmacologic Management\n* Therapies; physical, acupuncture, massage etc…\n* Other alternative treatments\n\nEnrollment, Treatment/Sham Procedure, Follow-up at 3 weeks, 6 weeks with unblinding, 4, 6, 9 months. Un-blinding occurring at 6 weeks with crossover option to receive treatment. Total visits 7 with enrollment approximately over a period of 9 months. Trial extension optional for phone contact at year 1, 2. Sham subjects receiving treatment will be followed at months 6 weeks, 4, and 6 months with phone calls at year 1, 2.\n\nPatients who complete at least 50% of their patient diaries, and miss no more 2 consecutive office visits. Data will be used if patients have remained enrolled thru 4 month visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients presenting with low back pain associated with SIJD for longer than 6 months, and who have not had positive responsive to the conservative treatments:\n\n* Pharmacologic Management\n* Therapies; physical, acupuncture, massage etc…\n* Other alternative treatments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. 18 years old, or older 2. Unilateral or Bilateral LBP or Buttocks Pain for greater than six months with a 3 day average VAS greater or equal to 4 on a 1-10 scale 3. Tenderness over the SI joint 4. 75% or greater relief of pain (with return to baseline) during the local anesthetic phase of two separate, one fluoroscopically guided intra-articular SI joint injection and one lateral branch block (see Appendix A) 5. Stable medications for pain for the last seven days 6. Have used at least 3 alternative treatments for pain without success (se 7. BMI less than 35.0\n\nExclusion Criteria:\n\n1. Focal Neurologic Signs\n2. Any component of pain related to Lumbar Z-joints at L4-5 and/or L5-S1 as determined by one set of medial branch blocks\n3. Previous radiofrequency procedure within the last 6 months\n4. Moderate or greater spinal stenosis\n5. Greater than Grade 2 listhesis\n6. Foraminal Stenosis; marked to severe\n7. Previous Lumbar Spine Surgery\n8. Unstable Medical or Psychological Conditions as determined by the investigator\n9. Concomitant cervical or thoracic pain greater than 2/10 on VAS\n10. Workers compensation, disability or litigation\n11. Pregnancy, breast feeding or planning on becoming pregnant during the trial\n12. Subject unwillingness to complete study related activities\n13. Current Smoker; unless quit greater than 6 months -'}, 'identificationModule': {'nctId': 'NCT01104051', 'briefTitle': 'Radiofrequency Nerve Ablation Versus Sham to Treat Chronic Low Back Pain Caused by Sacroiliac Joint Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Coastal Orthopedics & Sports Medicine'}, 'officialTitle': 'A Prospective, Single Center, Double Blind, Randomized, Sham Controlled, Crossover Study to Evaluate the Clinical Efficacy of Radiofrequency Nerve Ablation Using Simplicity III Versus Sham for the Treatment of Chronic Low Back Pain Associated With Sacroiliac Joint Dysfunction', 'orgStudyIdInfo': {'id': 'RBSI001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Radiofrequency Ablation', 'description': 'The treatment to be used in this trial is radiofrequency nerve ablation of lateral branches from S1 - S4 using radiofrequency treatments; Simplicity lll Electrode, a single RF electrode with a single percutaneous entry point.'}, {'label': 'Sham', 'description': 'subjects to be blinded,to receive sham procedure; The treatment to be used in this trial is radiofrequency nerve ablation of lateral branches from S1 - S4 using radiofrequency treatments; Simplicity lll Electrode, a single RF electrode with a single percutaneous entry point.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34209', 'city': 'Bradenton', 'state': 'Florida', 'country': 'United States', 'facility': 'Coastal Orthopedics & Sports Medicine', 'geoPoint': {'lat': 27.49893, 'lon': -82.57482}}], 'overallOfficials': [{'name': 'Richard Bundschu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Coastal Orthopedics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Coastal Orthopedics & Sports Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}