Analgesic Effect of Sacral Submultifidus Block as an Adjunct to Sacroiliac Joint Injection

NCT07814729 | Recruiting DMC

• 1 other identifier: M934
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sacro Iliac Joint Pain; Low Back Pain; Sacroiliatis

Keywords

Sacroiliatis; sacroiliac joint injection; sacral submultifidus muscle; prolotherapy; pain management

Outcome Measures

Primary Outcomes (1)

• 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 .

Secondary Outcomes (4)

• Oswestry Disability Index (ODI)

  at baseline, 1 month, 3 months and 6 months

• Patient Satisfaction Score (PSS):

  immediate, at 1 month, 3 months and 6 months .

• Time to first postoperative analgesic dose

  from completion of the sacroiliac joint injection to the patient's first request for analgesia

• Cumulative analgesic consumption

  at 1 week, 1 month , 2 months, 4 months and 6 months after injection.

Study Arms (2)

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.

Drug: SIJ Injection Alone

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. 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

Drug: SIJ Injection Alone; Drug: receive SIJ Injection & Sacral Submultifidus Block

Interventions

SIJ Injection Alone DRUG

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

group A (control group: will receive SIJ Injection Alone ) ,; group B (intervention group: will receive SIJ Injection & Sacral Submultifidus Block).

receive SIJ Injection & Sacral Submultifidus Block DRUG

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

group B (intervention group: will receive SIJ Injection & Sacral Submultifidus Block).

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Fayoum University Hospital: lead

Study Sites (1)

Fayoum university Hospitl

Al Fayyum, Egypt

RECRUITING

Related Publications (3)

• (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.

  BACKGROUND

• (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.

  BACKGROUND

• 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.

  PMID: 33988941 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Agnosia

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Central Study Contacts

Amira Emad Amin, MBBCH

CONTACT

+201002070389; aee14@fayoum.edu.eg

Amira Emad Amin, MBBCH

CONTACT

+201002070389; amiraemad04@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

EG (1)