Sacro Iliac Joint PainNCT07814729
Analgesic Effect of Sacral Submultifidus Block as an Adjunct to Sacroiliac Joint Injection
A study testing SIJ Injection Alone and receive SIJ Injection & Sacral Submultifidus Block in people with Sacro Iliac Joint Pain and Low Back Pain, run by Fayoum University Hospital at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Sacro Iliac Joint Pain, Low Back Pain, Sacroiliatis
- What is being tested?
- SIJ Injection Alone and receive SIJ Injection & Sacral Submultifidus Block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2026to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Effect of Sacral Submultifidus Block as an Adjunct to Sacroiliac Joint Injection: A Randomized Controlled Double-Blind Trial
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.
- Conditions
- Sacro Iliac Joint Pain, Low Back Pain, Sacroiliatis
- Being tested
- SIJ Injection Alone, receive SIJ Injection & Sacral Submultifidus Block
- Keywords
- Sacroiliatis, sacroiliac joint injection, sacral submultifidus muscle, prolotherapy, pain management
- Medical subject headings
- Low Back Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIJ Injection AloneDrug
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 BlockDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Drug: SIJ Injection Alone; Drug: receive SIJ Injection & Sacral Submultifidus Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 1 week and 1 month , 2 months , 4 months , 6 months .
Secondary outcomes (4)
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
Measured: at baseline, 1 month, 3 months and 6 months
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
Measured: immediate, at 1 month, 3 months and 6 months .
Time to first postoperative analgesic dose
Measured: from completion of the sacroiliac joint injection to the patient's first request for analgesia
Cumulative analgesic consumption
amounts of Gabapentin XR 300 mg at 1 week, 1 month , 2 months, 4 months and 6 months after injection.
Measured: at 1 week, 1 month , 2 months, 4 months and 6 months after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sacro Iliac Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fayoum University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Hamed, Fayoum University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814729
- Sponsor's protocol ID
- M934
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Sacral Submultifidus Block as an Adjunct to Sacroiliac Joint Injection: A Randomized Controlled Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07814729
- Acronym / sponsor ID
- M934
- Conditions
- Sacro Iliac Joint Pain, Low Back Pain, Sacroiliatis
- Keywords
- Sacroiliatis, sacroiliac joint injection, sacral submultifidus muscle, prolotherapy, pain management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Fayoum University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 11 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A (control group: will receive SIJ Injection Alone ) , | Active comparator | Drug: SIJ Injection Alonewill 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. |
| group B (intervention group: will receive SIJ Injection & Sacral Submultifidus Block). | Experimental | Drug: SIJ Injection Alone, Drug: receive SIJ Injection & Sacral Submultifidus Blockgroup 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 |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SIJ Injection Alonewill 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 | Drug | 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 Blockreceive 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 | Drug | group B (intervention group: will receive SIJ Injection & Sacral Submultifidus Block). |
Primary outcome
Pain intensity measured by Visual Analog Scale (VAS)
Time frame: at 1 week and 1 month , 2 months , 4 months , 6 months .
0: no pain 1-3 : mild pain 4-6 : moderate to severe pain 7-9 : very severe 10 :worst pain
4 secondary outcomes
Oswestry Disability Index (ODI)
Time frame: at baseline, 1 month, 3 months and 6 months
Patient Satisfaction Score (PSS):
Time frame: immediate, at 1 month, 3 months and 6 months .
Time to first postoperative analgesic dose
Time frame: from completion of the sacroiliac joint injection to the patient's first request for analgesia
Cumulative analgesic consumption
Time frame: at 1 week, 1 month , 2 months, 4 months and 6 months after injection.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Background(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: PubMed 33988941Javadov 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.
- Individual participant dataSharing planned: Undecided
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Sacro-iliac Joint Pain
Enrolling by invitationObservational study
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
Degenerative Sacroiliitis, Sacroiliac Disorder
Not yet recruiting
Postural Correction and Lumbar Stabilization vs MET for Postpartum Pain
Postpartum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SIJ Injection Alone and receive SIJ Injection & Sacral Submultifidus Block in people with Sacro Iliac Joint Pain and Low Back Pain, run by Fayoum University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira Emad Amin, MBBCH (+201002070389, aee14@fayoum.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity measured by Visual Analog Scale (VAS) (time frame: at 1 week and 1 month , 2 months , 4 months , 6 months .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07814729, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.