Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2025-12-31 @ 11:24 AM
Study NCT ID:
NCT07137806
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 62}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-15', 'studyFirstSubmitDate': '2025-08-15', 'studyFirstSubmitQcDate': '2025-08-15', 'lastUpdatePostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sacroiliac joint pain assessment according to Numerical rating Scale at 1month after injection.', 'timeFrame': 'at one month from intervention'}], 'secondaryOutcomes': [{'measure': 'Analgesics consumption during 6month follow-up period', 'timeFrame': 'over 6 month from intection'}, {'measure': 'Level of disability was measured by Oswestry Disability Index (ODI) scores', 'timeFrame': '6 month after injection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Management']}, 'descriptionModule': {'briefSummary': 'Sacroiliitis is not the same as SI joint dysfunction. Sacroiliitis is specific to an inflammatory processes present in the SI joint and the pain sensed is a direct result of those inflammatory processes, whereas sacroiliac joint dysfunction is a condition caused by abnormal motion or slight mispositioning of the SI joint.\n\nSacroiliac joint syndrome is a condition that is difficult to diagnose and is often overlooked by physicians and physiotherapist', 'detailedDescription': "Treatment of SI joint pain usually involves a multi-pronged approach, utilizing both, multi-modal medical pain control and interventional pain/surgical techniques such as local anesthetic and steroid injections, radiofrequency nerve ablation, and minimally invasive sacroiliac arthrodesis.\\[7\\] Sacroiliac (SI) joint injection is a minimally invasive procedure that involves injecting a mixture of local anesthetic and/or corticosteroid medication directly into the SI joint\\[8\\] Depending on the mixture of medications used, the duration of pain relief varies but can last anywhere from several days to months\\[9\\] Local anesthetic and corticosteroid medications are used to reduce inflammation and provide symptom relief to patients with arthritis, inflammatory conditions, and/or acute injuries\\[10\\]\n\nThe goal of SI joint injections is to provide enough pain relief to allow the patient to improve their functional status. Participation in physical therapy or exercise is encouraged, which can lead to longer-term improvements in pain and function. The number of SI joint injections required for effective pain relief can vary depending on the patient. \\[11, 12\\] Some patients may only require one injection, while others may require several injections. As a general guideline, injections may be administered once every 2 weeks, and no more than 3 injections may be given per year\\[11, 12\\] In general, if the first injection provides significant relief, additional injections may be recommended. However, the exact timing can vary based on the doctor's guidance, the patient's response to the treatment, and the type of injection\\[13\\] The long-term outcomes of SI joint injections can vary depending on a number of factors, including the underlying cause of the pain, the patient's overall health, the patient's response to the injection, and the type of injection used. Steroid injections may work well for some patients, while others may respond more positively to prolotherapy or PRP therapy\\[14\\]\n\nSacral Multifidus Plane Block(SMPB), a variant of paraspinal plane blocks, has been used for various surgeries in the perineal and buttock region\\[15\\]"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged above 21 years, both genders diagnosed with chronic sacroiliac joint pain with a rating on the numeric pain rating scale (NPRS) of at least 5, without radiculopathy lasting 3 months or longer, and lack of medical treatment satisfactory response\n\nExclusion Criteria:\n\nPatient refusal. Patients who have any allergies to local anesthetics or have had a reaction to contrast dyes in the past.\n\nPatients who are unable to describe their pain (e.g., language barrier or neuropsychiatric disorder).\n\nPatients with history of bleeding diathesis'}, 'identificationModule': {'nctId': 'NCT07137806', 'briefTitle': 'Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Beyond the Joint: Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection - a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Faculty of Medicine, Tanta Uni'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ultrasound guided sacroiliac joint injection group', 'description': 'patients included in this group will receive SIJ injection alone.The injectate includes 40 mg of methylprednisolone acetate diluted in 2 mL of bupivacaine 0.25% with epinephrine 1:200,000 (total 3 mL injectate).', 'interventionNames': ['Procedure: sacroiliac joint injection']}, {'type': 'EXPERIMENTAL', 'label': 'combined ultrasound guide sacroiliac joint injection and submaltifidous plan (combined block group):', 'description': 'patients included in this group will receive combined SMPB and SIJ injection twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests)', 'interventionNames': ['Procedure: combined sacroiliac joint injection and sub maltifidous plane block']}], 'interventions': [{'name': 'sacroiliac joint injection', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided injection of the SI joints The patient is placed in a prone position to receive this injection treatment. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified. The cleft between the bony contours of the sacrum and ileum represents the posterior aspect of the SI joint. By tilting the transducer in a caudal direction, the lower one third of the SI joint is identified. Because of its synovial component, the lower one third of the SI joint is the portion of the entire SI joint in which the injection should be performed. The medial to lateral approach and intraarticular deposition is preferred for the ultrasound-guided SI joint', 'armGroupLabels': ['ultrasound guided sacroiliac joint injection group']}, {'name': 'combined sacroiliac joint injection and sub maltifidous plane block', 'type': 'PROCEDURE', 'description': 'patients will be positioned prone. A 6-13 MHz linear array ultrasound transducer was placed in the parasagittal orientation with the second sacral foramen (SF-2) in the field. A 21G short bevel needle is inserted in-plane approach from the cephalad to the caudad direction. After hitting the underlying bone, twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected. An anechoic LA spread in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests) will be confirmed. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified.', 'armGroupLabels': ['combined ultrasound guide sacroiliac joint injection and submaltifidous plan (combined block group):']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tanta', 'country': 'Egypt', 'facility': 'Tanta University', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}], 'centralContacts': [{'name': 'Aliaa M Belal, Assistant Professor', 'role': 'CONTACT', 'email': 'loloohamody@gmail.com', 'phone': '0201068936038'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual issues'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mohamed Shebl Abdelghany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Aliaa Muhammad Belal', 'investigatorAffiliation': 'Tanta University'}}}}