Ignite Creation Date:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-31 @ 2:32 PM
Study NCT ID:
NCT03564106
Status:
COMPLETED
Last Update Posted:
2021-01-20
First Post:
2018-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-16', 'studyFirstSubmitDate': '2018-06-02', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain intensity', 'timeFrame': 'up to 6 months', 'description': 'Numeric Rating Scale (NRS)'}], 'secondaryOutcomes': [{'measure': 'Patient Impression', 'timeFrame': 'up to 6 months', 'description': 'Patient Global Impression of Change Scale (PGIC)'}, {'measure': 'Pain Disability', 'timeFrame': 'up to 6 months', 'description': 'Pain Disability Index ( PDI)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic sacroilitis,radiofrequancy,intraarticular steroids injection'], 'conditions': ['Pain Management']}, 'referencesModule': {'references': [{'pmid': '17014598', 'type': 'BACKGROUND', 'citation': 'Bogduk N. Pulsed radiofrequency. Pain Med. 2006 Sep-Oct;7(5):396-407. doi: 10.1111/j.1526-4637.2006.00210.x. No abstract available.'}, {'pmid': '18996232', 'type': 'BACKGROUND', 'citation': 'Borowsky CD, Fagen G. Sources of sacroiliac region pain: insights gained from a study comparing standard intra-articular injection with a technique combining intra- and peri-articular injection. Arch Phys Med Rehabil. 2008 Nov;89(11):2048-56. doi: 10.1016/j.apmr.2008.06.006.'}, {'pmid': '21055873', 'type': 'BACKGROUND', 'citation': 'Choi WJ, Hwang SJ, Song JG, Leem JG, Kang YU, Park PH, Shin JW. Radiofrequency treatment relieves chronic knee osteoarthritis pain: a double-blind randomized controlled trial. Pain. 2011 Mar;152(3):481-487. doi: 10.1016/j.pain.2010.09.029. Epub 2010 Nov 4.'}, {'pmid': '27738191', 'type': 'BACKGROUND', 'citation': 'Do KH, Ahn SH, Jones R, Jang SH, Son SM, Lee DG, Cho HK, Choi GS, Cho YW. A New Sacroiliac Joint Injection Technique and Its Short-Term Effect on Chronic Sacroiliac Region Pain. Pain Med. 2016 Oct;17(10):1809-1813. doi: 10.1093/pm/pnw003. Epub 2016 Feb 25.'}]}, 'descriptionModule': {'briefSummary': 'The sacroiliac joint is Located between the pelvis and base of the spine, the sacroiliac joints are strong, stable joints that allow for little movement. While these joints do not bend like a knuckle or knee, they are susceptible to degenerative arthritis. Sacroiliac joint pain is one of the most common causes of chronic low back pain, accounting for 10% to 27% of patients with chronic lower back pain. It is known to be caused by abnormal motion in this joint, namely, too much motion or too little motion. Patients with pain experience various degrees of pain in the low back, groin, buttock, or posterior thigh.', 'detailedDescription': 'The pain starts when the Sacroiliac joint gets inflamed. There are several reasons it could happen. It could be hurt when playing sports or if fall down.\n\nSometimes start hurting when the ligaments that hold the SI joint together are damaged, which may make the joint move abnormally. The pain associated with sacroiliitis most commonly occurs in the buttocks and lower back. It can also affect the legs, groin and even the feet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients must have chronic pain more than 6 months and have failed medical treatment.\n\nExclusion Criteria:\n\n* Infection at the site of injection\n* Opioids addiction\n* Coagulopathy or another bleeding diathesis\n* Those who refuse to participate in the study\n* Ankylosing Spondylitis patients'}, 'identificationModule': {'nctId': 'NCT03564106', 'briefTitle': 'Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Comparison Between Intra-articular Pulsed Radiofrequency With Steroids Injection Versus Intra-articular Steroids Injection in Chronic Sacroiliac Joint Arthritis', 'orgStudyIdInfo': {'id': '17200203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'group A', 'description': 'receive intraarticular radiofrequency + methylprednisolone (30 mg)', 'interventionNames': ['Drug: intraarticular radiofrequency + intraarticular methylprednisolone']}, {'type': 'EXPERIMENTAL', 'label': 'group C', 'description': 'receive intraarticular methylprednisolone (30 mg)', 'interventionNames': ['Drug: intraarticular methylprednisolone']}], 'interventions': [{'name': 'intraarticular radiofrequency + intraarticular methylprednisolone', 'type': 'DRUG', 'description': 'intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)', 'armGroupLabels': ['group A']}, {'name': 'intraarticular methylprednisolone', 'type': 'DRUG', 'description': 'intraarticular methylprednisolone (30 mg)', 'armGroupLabels': ['group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut governorate', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ghada Mohammed AboelFadl', 'investigatorAffiliation': 'Assiut University'}}}}