- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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 (1). 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 (2). 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 (3).
The 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 (4). 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 (5). 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 (6).
Given the limitations of conventional SIJ injections, interest has grown in adjunctive regional blockade techniques that more comprehensively target periarticular neural pathways (7). 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 (4). 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 (8).
So addition of ultrasound-guided sacral submultifidus block to SIJ injection produces superior pain relief and functional improvement compared with SIJ injection alone .
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 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amira Emad Amin, MBBCH
- Phone Number: +201002070389
- Email: aee14@fayoum.edu.eg
Study Contact Backup
- Name: Amira Emad Amin, MBBCH
- Phone Number: +201002070389
- Email: amiraemad04@gmail.com
Study Locations
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Al Fayyum, Egypt
- Recruiting
- Fayoum university Hospitl
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Contact:
- fayou
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-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 1.Compression : While lying on your side, downward pressure is applied to the top of your pelvis. 2.Distraction : While lying on your back, outward pressure is applied to the front of your pelvic bones. 3.Thigh thrust: Lying near the edge of the table, one leg is pulled to your chest while the other is allowed to hang off, creating pelvic torsion. 4.Gaenslen: (Lying near the edge of the table, one leg is pulled to your chest while the other is allowed to hang off, creating pelvic torsion). 5.FABER: (Flexion, Abduction, External Rotation) *Failure of conservative therapy * Radiological exclusion of lumbar pathology. * Diagnostic SIJ block producing ≥75% pain relief.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: group A (control group: 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 joint under direct sonographic visualization.
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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
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Experimental: group B (intervention group: will 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 be 10 ml , will be injected incrementally. Proper spread will be visual |
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
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Pain intensity measured by Visual Analog Scale (VAS)
Time Frame: at 1 week and 1 month , 2 months , 4 months , 6 months .
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at 1 week and 1 month , 2 months , 4 months , 6 months .
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Oswestry Disability Index (ODI)
Time Frame: at baseline, 1 month, 3 months and 6 months
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at baseline, 1 month, 3 months and 6 months
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Patient Satisfaction Score (PSS):
Time Frame: immediate, at 1 month, 3 months and 6 months .
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immediate, at 1 month, 3 months and 6 months .
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Time to first postoperative analgesic dose
Time Frame: from completion of the sacroiliac joint injection to the patient's first request for analgesia
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from completion of the sacroiliac joint injection to the patient's first request for analgesia
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Cumulative analgesic consumption
Time Frame: at 1 week, 1 month , 2 months, 4 months and 6 months after injection.
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amounts of Gabapentin XR 300 mg at 1 week, 1 month , 2 months, 4 months and 6 months after injection.
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at 1 week, 1 month , 2 months, 4 months and 6 months after injection.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Javadov A, Ketenci A, Aksoy C. The Efficiency of Manual Therapy and Sacroiliac and Lumbar Exercises in Patients with Sacroiliac Joint Dysfunction Syndrome. Pain Physician. 2021 May;24(3):223-233.
- (7) Aranke, Mayank et al. 2022. "Minimally Invasive and Conservative Interventions for the Treatment of Sacroiliac Joint Pain: A Review of Recent Literature." Orthopedic Reviews 14(2). https://orthopedicreviews.openmedicalpublishing.org/article/31915-minimally-invasive-and-conservative-interventions-for-the-treatment-of-sacroiliac-joint-pain-a-review-of-recent-literature. (8) Nair et al. 2025. "Ultrasound-Guided Sacral Multifidus Plane Block for Perioperative Analgesia: A Comprehensive Systematic Review, Meta-Analysis, and Trial Sequential Analysis." Indian Journal of Anaesthesia 69(12): 1341-58. https://journals.lww.com/10.4103/ija.ija_1066_25. (9) Tantawy, Mostafa F., and Wael M. Nazim. 2024. "Comparison between Intra-Articular and Combined Intra- and Periarticular Sacroiliac Injection: A Prospective Randomized Controlled Clinical Trial." Journal of Neurosurgical Sciences. (10) Ostelo, R. W., Deyo, R. A., Stratford, P., Waddell, G., Croft, P., Von Korff, M., Bouter, L. M., & de Vet, H. C. (2008). Interpreting change scores for pain and functional status in low back pain: towards international consensus and standardized approaches. Spine, 33(1), 90-94. (11) Ab Aziz, S. N. F., Zakaria Mohamad, Z., Karupiah, R. K., Che Ahmad, A., & Omar, A. S. (2022). Efficacy of sacroiliac joint injection with anesthetic and corticosteroid: A prospective observational study. Cureus, 14(4), e24039. https://doi.org/10.7759/cureus.24039 Faul, F., Erdfelder, E., Lang, A.-G., & Buchner, A. (2007). G*Power 3: A Protocol Patients and Methods flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behavior Research Methods, 39(2), 175-191. https://doi.org/10.3758/bf03193146 https://doi.
- (2) alowski, Steven et al. 2020. "A Review and Algorithm in the Diagnosis and Treatment of Sacroiliac Joint Pain." Journal of Pain Research Volume 13: 3337-48. https://www.dovepress.com/a-review-and-algorithm-in-the-diagnosis-and-treatment-of-sacroiliac-jo-peer-reviewed-article-JPR. (3) Buchanan, Patrick et al. 2021. "Successful Diagnosis of Sacroiliac Joint Dysfunction." Journal of Pain Research Volume 14: 3135-43. https://www.dovepress.com/successful-diagnosis-of-sacroiliac-joint-dysfunction-peer-reviewed-fulltext-article-JPR (4) Dreyfuss, Paul et al. 2009. "The Ability of Multi-Site, Multi-Depth Sacral Lateral Branch Blocks to Anesthetize the Sacroiliac Joint Complex." Pain Medicine 10(4): 679-88. https://academic.oup.com/painmedicine/article-lookup/doi/10.1111/j.1526-4637.2009.00631.x. (5) Li, Li, Xiaofan Dou, Xueliang Song, and Fengxian Wang. 2025. "The Current Status and Future Prospects of Intra-Articular Injection Therapy for Hip Osteoarthritis: A Review." Current Pain and Headache Reports 29(1): 64. https://link.springer.com/10.1007/s11916-025-01378-z. (6) Ruffilli, A. et al. 2024. "Injective Treatments for Sacroiliac Joint Pain: A Systematic Review and Meta-Analysis." Indian Journal of Orthopaedics 58(6): 637-49. https://link.springer.com/10.1007/s43465-024-01164-w.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- M934
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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