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

Official title

Beyond the Joint: Enhanced Pain Relief With Ultrasound Guided Combined Submaltifidus and Sacroiliac Joint Injection - a Randomized Controlled Trial

Overview

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\[15\]

Interventions

• Procedure 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 th
• 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) a

Primary outcome measures

• Sacroiliac joint pain assessment according to Numerical rating Scale at 1month after injection. [Time frame: at one month from intervention]

Secondary outcome measures (2)

• Analgesics consumption during 6month follow-up period [Time frame: over 6 month from intection]
• Level of disability was measured by Oswestry Disability Index (ODI) scores [Time frame: 6 month after injection]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Egypt · 1 center

• Tanta University — Tanta

Identifiers

NCT: NCT07137806 · Faculty of Medicine, Tanta Uni

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗