Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection

NCT07137806 | Not Yet Recruiting DMC

• 1 other identifier: Faculty of Medicine, Tanta Uni
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Sacroiliitis is not the same as SI joint dysfunction. Sacroiliitis is specific to an inflammatory processes present in the SI joint and the pain sensed is a direct result of those inflammatory processes, whereas sacroiliac joint dysfunction is a condition caused by abnormal motion or slight mispositioning of the SI joint. Sacroiliac joint syndrome is a condition that is difficult to diagnose and is often overlooked by physicians and physiotherapist

Conditions

Pain Management

Outcome Measures

Primary Outcomes (1)

• Sacroiliac joint pain assessment according to Numerical rating Scale at 1month after injection.

  at one month from intervention

Secondary Outcomes (2)

• Analgesics consumption during 6month follow-up period

  over 6 month from intection

• Level of disability was measured by Oswestry Disability Index (ODI) scores

  6 month after injection

Study Arms (2)

ultrasound guided sacroiliac joint injection group

ACTIVE COMPARATOR

patients included in this group will receive SIJ injection alone.The injectate includes 40 mg of methylprednisolone acetate diluted in 2 mL of bupivacaine 0.25% with epinephrine 1:200,000 (total 3 mL injectate).

Procedure: sacroiliac joint injection

combined ultrasound guide sacroiliac joint injection and submaltifidous plan (combined block group):

EXPERIMENTAL

patients included in this group will receive combined SMPB and SIJ injection twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests)

Procedure: combined sacroiliac joint injection and sub maltifidous plane block

Interventions

sacroiliac joint injection PROCEDURE

Ultrasound-guided injection of the SI joints The patient is placed in a prone position to receive this injection treatment. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified. The cleft between the bony contours of the sacrum and ileum represents the posterior aspect of the SI joint. By tilting the transducer in a caudal direction, the lower one third of the SI joint is identified. Because of its synovial component, the lower one third of the SI joint is the portion of the entire SI joint in which the injection should be performed. The medial to lateral approach and intraarticular deposition is preferred for the ultrasound-guided SI joint

ultrasound guided sacroiliac joint injection group

combined sacroiliac joint injection and sub maltifidous plane block PROCEDURE

patients will be positioned prone. A 6-13 MHz linear array ultrasound transducer was placed in the parasagittal orientation with the second sacral foramen (SF-2) in the field. A 21G short bevel needle is inserted in-plane approach from the cephalad to the caudad direction. After hitting the underlying bone, twenty millilitres of local anaesthetic solution (1:1 mixture of lidocaine 2% and bupivacaine 0.25%) will be injected. An anechoic LA spread in the plane between the multifidus muscle (MFM) and the hyperechoic bony area (between the median and intermediate sacral crests) will be confirmed. The Curvilinear transducer is placed in a transverse orientation to identify the sacral hiatus first. After identifying the sacral cornu, the transducer is moved in a lateral direction until the lateral edge of the sacrum is observed. With the transducer maintained in the transverse orientation, it is then moved in a cephalad or upward direction until the bony contour of the ileum is identified.

combined ultrasound guide sacroiliac joint injection and submaltifidous plan (combined block group):

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 lack of medical treatment satisfactory response

You may not qualify if:

• Patient refusal. Patients who have any allergies to local anesthetics or have had a reaction to contrast dyes in the past.
• Patients who are unable to describe their pain (e.g., language barrier or neuropsychiatric disorder).
• Patients with history of bleeding diathesis

Sponsors & Collaborators

• Tanta University: lead
• Mohamed Shebl Abdelghany: collaborator

Study Sites (1)

Tanta University

Tanta, Egypt

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Aliaa M Belal, Assistant Professor

CONTACT

0201068936038; loloohamody@gmail.com

Study Design

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

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 22, 2025
• Study Start: August 20, 2025
• Primary Completion: March 20, 2026
• Study Completion: March 30, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)