ClinicalTrials.gg
RecruitingNCT07814729Updated Sep 25, 2026

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

An interventional study of SIJ Injection Alone and receive SIJ Injection & Sacral Submultifidus Block in Sacro Iliac Joint Pain, Low Back Pain and Sacroiliatis, sponsored by Fayoum University Hospital. Recruiting at 1 site in Egypt. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-25.

Sponsored by Fayoum University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
21 Years to 60 Years
Sex
All
01

Study 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.

Read the 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 . 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 .

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 . 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 .

Given 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 .

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.

02

Conditions studied

  • Sacro Iliac Joint Pain
  • Low Back Pain
  • Sacroiliatis

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Keywords

  • Sacroiliatis
  • sacroiliac joint injection
  • sacral submultifidus muscle
  • prolotherapy
  • pain management
03

In context

Low Back Pain

2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.

This study's planned enrollment of 54 is close to the median of 60 across 2,364 interventional studies indexed under Low Back Pain.

Browse Low Back Pain studies →

Lead sponsor

Fayoum University Hospital is the lead sponsor of 77 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1-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.

Exclusion criteria

Exclusion Criteria:

  • 1. refusal to participate. 2. Allergy or 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
54 participants (estimated)

Study arms

  • 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.

    Drug: SIJ Injection Alone

  • 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

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

Interventions

  • DrugSIJ 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

  • Drugreceive 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

06

What researchers measure

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

    Time frame: at 1 week and 1 month , 2 months , 4 months , 6 months .

Secondary outcomes

  1. 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

    Time frame: at baseline, 1 month, 3 months and 6 months

  2. 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/3): Indicate friction or missed expectations Low Scores (1 to 2): Point to severe breakdowns in communication, unaddressed comfort or pain management needs

    Time frame: immediate, at 1 month, 3 months and 6 months .

  3. Time to first postoperative analgesic dose

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

  4. Cumulative analgesic consumption

    amounts of Gabapentin XR 300 mg at 1 week, 1 month , 2 months, 4 months and 6 months after injection.

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • (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.
  • 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. PubMed 33988941 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 1,231 non-industry interventional studies with no phase under Low Back Pain, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 6 months is below that.

Counting every sponsor, half of 1,286 studies reached it within 11 months; a quarter within 5 and three quarters within 27.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2026
First posted
Sep 11, 2026
StartEst.
Sep 1, 2026
Primary completionEst.
Mar 1, 2027
CompletionEst.
Apr 1, 2027
Last update
Sep 25, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: responsible party
1 update, last Sep 25, 2026
Show all 1 update
  1. Sep 25, 2026
    Minor edits only
    + 1 other change: responsible party

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07814729
Lead sponsor
Fayoum University Hospital
Responsible party
Mohamed Ahmed Hamed (Professor, Fayoum University Hospital) — Principal investigator
First posted
Sep 11, 2026
Start date
Sep 1, 2026 (estimated)
Primary completion
Mar 1, 2027 (estimated)
Completion
Apr 1, 2027 (estimated)
Last update
Sep 25, 2026

Study contacts

Amira Emad Amin, MBBCH
Contact
aee14@fayoum.edu.eg
+201002070389
Amira Emad Amin, MBBCH
Contact
amiraemad04@gmail.com
+201002070389

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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