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

NCT ID: NCT07137806

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-20
• Study Completion Date: 2026-03-30

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

Detailed Description

Treatment of SI joint pain usually involves a multi-pronged approach, utilizing both, multi-modal medical pain control and interventional pain/surgical techniques such as local anesthetic and steroid injections, radiofrequency nerve ablation, and minimally invasive sacroiliac arthrodesis.[7] Sacroiliac (SI) joint injection is a minimally invasive procedure that involves injecting a mixture of local anesthetic and/or corticosteroid medication directly into the SI joint[8] Depending on the mixture of medications used, the duration of pain relief varies but can last anywhere from several days to months[9] Local anesthetic and corticosteroid medications are used to reduce inflammation and provide symptom relief to patients with arthritis, inflammatory conditions, and/or acute injuries[10]

The goal of SI joint injections is to provide enough pain relief to allow the patient to improve their functional status. Participation in physical therapy or exercise is encouraged, which can lead to longer-term improvements in pain and function. The number of SI joint injections required for effective pain relief can vary depending on the patient. [11, 12] 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[11, 12] 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[13] 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. Steroid injections may work well for some patients, while others may respond more positively to prolotherapy or PRP therapy[14]

Sacral Multifidus Plane Block(SMPB), a variant of paraspinal plane blocks, has been used for various surgeries in the perineal and buttock region[15]

Conditions

Pain Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

ultrasound guided sacroiliac joint injection group

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).

Group Type: ACTIVE_COMPARATOR

sacroiliac joint injection

Intervention Type: 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

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

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)

Group Type: EXPERIMENTAL

combined sacroiliac joint injection and sub maltifidous plane block

Intervention Type: 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.

Interventions

sacroiliac joint injection

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

Intervention Type: PROCEDURE

combined sacroiliac joint injection and sub maltifidous plane block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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 lack of medical treatment satisfactory response

Exclusion Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mohamed Shebl Abdelghany

UNKNOWN

Sponsor Role: collaborator

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Aliaa Muhammad Belal

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, , Egypt

Countries

Egypt

Central Contacts

Aliaa M Belal, Assistant Professor

Role: CONTACT

loloohamody@gmail.com

0201068936038

Other Identifiers

Faculty of Medicine, Tanta Uni

Identifier Type: -

Identifier Source: org_study_id