[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655659":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":40,"studyPopulation":24,"armGroups":41,"interventions":54,"overallOfficials":24,"centralContacts":64,"locations":72,"responsibleParty":88,"collaborators":24,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":24,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":101,"enrollmentInfo":102,"targetDuration":24,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":75,"whyStopped":24,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Fayoum University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":24},[9],{"measure":10,"description":11,"timeFrame":12},"Pain intensity measured by Visual Analog Scale (VAS)","0: no pain 1-3 : mild pain 4-6 : moderate to severe pain 7-9 : very severe 10 :worst pain","at 1 week and 1 month , 2 months , 4 months , 6 months .",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Oswestry Disability Index (ODI)","0% to 20% (Minimal Disability) 21% to 40% (Moderate Disability) 41% to 60% (Severe Disability) 61% to 80% (Crippled) 81% to 100%: You are mostly bed-bound","at baseline, 1 month, 3 months and 6 months",{"measure":19,"description":20,"timeFrame":21},"Patient Satisfaction Score (PSS):","High Scores (e.g., 4 to 5 on a 5-point scale, or 80%+): Suggest that patients feel respected, communication is clear Moderate Scores (Neutral\u002F3): Indicate friction or missed expectations Low Scores (1 to 2): Point to severe breakdowns in communication, unaddressed comfort or pain management needs","immediate, at 1 month, 3 months and 6 months .",{"measure":23,"description":24,"timeFrame":25},"Time to first postoperative analgesic dose",null,"from completion of the sacroiliac joint injection to the patient's first request for analgesia",{"measure":27,"description":28,"timeFrame":29},"Cumulative analgesic consumption","amounts of Gabapentin XR 300 mg at 1 week, 1 month , 2 months, 4 months and 6 months after injection.","at 1 week, 1 month , 2 months, 4 months and 6 months after injection.",{"allocation":31,"interventionModel":32,"interventionModelDescription":24,"primaryPurpose":33,"observationalModel":24,"timePerspective":24,"maskingInfo":34},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":35,"maskingDescription":24,"whoMasked":36},"TRIPLE",[37,38,39],"PARTICIPANT","INVESTIGATOR","OUTCOMES_ASSESSOR","Sacroiliac joint (SIJ) pain is an under-recognized significant contributor to chronic low back pain, with estimates indicating that it accounts for approximately 10-30% of mechanical low back pain presentations . The SIJ is a complex diarthrodial-amphiarthrodial articulation between the sacrum and ilium that functions within the weight-bearing system of the pelvis and lumbosacral spine, stabilized by a dense ligamentous network and influenced by surrounding musculature . Pain originating from the SIJ often manifests as deep aching discomfort that can radiate to the buttocks, groin, or lower extremity and may be difficult to differentiate from lumbar or hip pathology based on clinical features alone .\n\nThe intricate innervation of the SIJ contributes to diagnostic challenges. Abundant anatomical evidence suggests that pain signals from both intra-articular and extra-articular structures, including the posterior sacroiliac ligaments and dorsal sacral rami, converge to produce symptomatology, underscoring the potential utility of targeted neural blockade . Image-guided intra-articular injections with local anesthetic and corticosteroids are commonly used for both diagnostic confirmation and therapeutic pain relief, yet responses to these interventions are variable and often short-lived . Systematic reviews have demonstrated modest analgesic effects of SIJ injections overall and highlight significant heterogeneity in procedural techniques and outcomes, emphasizing the ongoing need for optimized interventional strategies .\n\nGiven the limitations of conventional SIJ injections, interest has grown in adjunctive regional blockade techniques that more comprehensively target periarticular neural pathways . Fascial plane and lateral branch blocks aimed at disrupting nociceptive input from the posterior sacral nerve supply have shown physiological efficacy in cadaver and clinical studies, though high-quality randomized data remain limited . The sacral submultifidus block is a novel regional anesthetic technique that targets the dorsal rami beneath the multifidus muscle, potentially augmenting pain control when combined with SIJ injection by addressing extra-articular and posterior nociceptive sources .\n\nSo addition of ultrasound-guided sacral submultifidus block to SIJ injection produces superior pain relief and functional improvement compared with SIJ injection alone .\n\nSome 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 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 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.",[42,48],{"label":43,"type":44,"description":45,"interventionNames":46},"group A (control group: will receive SIJ Injection Alone ) ,","ACTIVE_COMPARATOR","will receive SIJ Injection Alone :The sacroiliac joint will be identified under real-time ultrasound guidance. low- frequency curvilinear transducer is used, The transducer is placed transversely over the lower part of the sacrum (at the level of the sacral hiatus), and the lateral edge of the sacrum is identified. Then the transducer is moved laterally and cephalad till the bony contour of the ileum is clearly identified. The cleft seen between the medial border of the ileum and the lateral sacral edge represents the SI joint, and the inferior-most point is targeted. needle is then inserted at the medial end of the transducer and advanced laterally under direct vision in plane with the ultrasound beam, Following skin infiltration with a small volume of local anesthetic (e.g., lidocaine 1%), a 22-25G spinal needle 50mm block needle (SONOTAP, Pajunk , Geisingen ,Germany ),will be advanced toward the inferior third of the sacroiliac joint under direct sonographic visualization.",[47],"Drug: SIJ Injection Alone",{"label":49,"type":50,"description":51,"interventionNames":52},"group B (intervention group: will receive SIJ Injection & Sacral Submultifidus Block).","EXPERIMENTAL","group B (intervention group: will receive SIJ Injection \\& Sacral Submultifidus Block).:2.Sacral Submultifidus Block (group A and group B): After completion of the SIJ injection, patients in the intervention group will receive an ultrasound-guided sacral submultifidus block (device used is GE healthcare model LOGIQ P7). A low-frequency curvilinear transducer will be placed longitudinally over the sacrum to identify key anatomical landmarks, including the median sacral crest, intermediate sacral crest, and overlying multifidus muscle.\n\nA 22G block needle will be inserted using an in-plane technique in a cranial-to-caudal or lateral-to-medial direction, targeting the fascial plane between the multifidus muscle and the underlying sacral lamina. After careful aspiration to exclude intravascular placement, 8 mL of local anesthetic (e.g., bupivacaine .25%) combined with 8 mg dexamethasone ( 2 ml) and the total volume will be 10 ml , will be injected incrementally. Proper spread will be visual",[47,53],"Drug: receive SIJ Injection & Sacral Submultifidus Block",[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":24},"DRUG","SIJ Injection Alone","will receive SIJ Injection Alone ) , will receive SIJ Injection Alone :The sacroiliac joint will be identified under real-time ultrasound guidance. low- frequency curvilinear transducer is used, The transducer is placed transversely over the lower part of the sacrum (at the level of the sacral hiatus), and the lateral edge of the sacrum is identified. Then the transducer is moved laterally and cephalad till the bony contour of the ileum is clearly identified. The cleft seen between the medial border of the ileum and the lateral sacral edge represents the SI joint, and the inferior-most point is targeted. needle is then inserted at the medial end of the transducer and advanced laterally under direct vision in plane with the ultrasound beam, Following skin infiltration with a small volume of local anesthetic (e.g., lidocaine 1%), a 22-25G spinal needle 50mm block needle (SONOTAP, Pajunk , Geisingen ,Germany ),will be advanced toward the inferior third of the sacroiliac j",[43,49],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":24},"receive SIJ Injection & Sacral Submultifidus Block","receive SIJ Injection \\& Sacral Submultifidus Block). group B (intervention group: will receive SIJ Injection \\& Sacral Submultifidus Block).:2.Sacral Submultifidus Block (group A and group B): After completion of the SIJ injection, patients in the intervention group will receive an ultrasound-guided sacral submultifidus block (device used is GE healthcare model LOGIQ P7). A low-frequency curvilinear transducer will be placed longitudinally over the sacrum to identify key anatomical landmarks, including the median sacral crest, intermediate sacral crest, and overlying multifidus muscle. A 22G block needle will be inserted using an in-plane technique in a cranial-to-caudal or lateral-to-medial direction, targeting the fascial plane between the multifidus muscle and the underlying sacral lamina. After careful aspiration to exclude intravascular placement, 8 mL of local anesthetic (e.g., bupivacaine .25%) combined with 8 mg dexamethasone ( 2 ml) and the total volume will b",[49],[65,70],{"name":66,"role":67,"phone":68,"phoneExt":24,"email":69},"Amira Emad Amin, MBBCH","CONTACT","+201002070389","aee14@fayoum.edu.eg",{"name":66,"role":67,"phone":68,"phoneExt":24,"email":71},"amiraemad04@gmail.com",[73],{"facility":74,"status":75,"city":76,"state":24,"zip":24,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Fayoum university Hospitl","RECRUITING","Al Fayyum","Egypt","EG",{"type":80,"coordinates":81},"Point",[82,83],30.8418,29.30995,{"lat":83,"lon":82},[86],{"name":87,"role":67,"phone":24,"phoneExt":24,"email":24},"fayou",{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Mohamed Ahmed Hamed","Professor","100655659","analgesic-effect-of-sacral-submultifidus-block-as-an-adjunct-to-sacroiliac-joint-injection-100655659",false,"NCT07814729","Analgesic Effect of Sacral Submultifidus Block as an Adjunct to Sacroiliac Joint Injection","Analgesic Effect of Sacral Submultifidus Block as an Adjunct to Sacroiliac Joint Injection: A Randomized Controlled Double-Blind Trial","Inclusion Criteria:\n\n1-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 Positive SI provocative tests: usually \\> 3 positive tests ... 2-Failure of conservative therapy .3-Radiological exclusion of lumbar pathology. 4- Diagnostic SIJ block producing ≥75% pain relief.\n\nExclusion Criteria:\n\n* 1\\. refusal to participate. 2. Allergy or contraindication to local anesthetics. 3. Coagulation disorders or ongoing anticoagulant therapy. 4. Infection at the block injection site. 5. Chronic opioid use or substance abuse. 6. Neurological or psychiatric disorders affecting pain assessment. 7. Pregnancy.","ALL","21 Years","60 Years",{"count":103,"type":104},54,"ESTIMATED","INTERVENTIONAL",[107],"NA","The aim of this study is to assess whether the addition of sacral submultifidus block to standard image-guided SIJ injection provides superior analgesia and functional improvement compared with SIJ injection alone in patients with chronic SIJ-mediated pain.",[110,111,112],"Sacro Iliac Joint Pain","Low Back Pain","Sacroiliatis",[112,114,115,116,117],"sacroiliac joint injection","sacral submultifidus muscle","prolotherapy","pain management","2026-09-22",{"date":120,"type":121},"2026-09-25","ACTUAL",{"date":123,"type":104},"2026-09-01",{"date":125,"type":104},"2027-04-01",{"name":5,"class":6},1]