Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

Overview

Intra-articular steroids have been also practiced since a long time. These agents have a better and safer profile as compared to oral drugs in terms of adverse effects/contraindications of the later. Moreover, Intra-articular steroids impart a better pain relief by delivering and also delays any surgical intervention thereby improving the patient's quality of life. Without imaging, intra-articular injection has been shown in only 22% of patients so ultrasound, fluoroscopic imaging and computerized tomographic (CT) are required to ensure accuracy. Comparing to other guidance, ultrasound guided injection provides easy, safe, accurate, non-invasive, inexpensive imaging and lacking exposure to radiation.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: August 1, 2022

Detailed Description

Technique of ultrasound-guided intra-articular SIJ injection: On arrival to recovery room, an IV line will be secured, ringer solution will be infused, O2 mask with 3l/min oxygen will be supplemented and RBS will be measured. Intervention will be done at complete aseptic conditions by ultrasound at frequency of 4-5 MHz patient in prone position. The ultrasound transducer will be oriented in a transverse orientation at the level of the sacral hiatus. Here the sacral cornuae are identified. Moving the transducer laterally from here, the lateral edge of the sacrum is now identified. This bony edge is followed in a cephalad direction with the transducer maintained in a transverse orientation. A second bony contour, the ileum, is now identified. The cleft between both bony contours represented the sacroiliac joint. This will be found at 4.5 cm depth. Real-time imaging will be used to direct a 22G spinal needle into the SIJ, where 2% lidocaine and triamcinolone or methylprednisolone will be injected under direct vision.The needle will be removed, a sterile dressing will be applied .then patient lay down at supine position at least 30 minutes with blood pressure ,pulse ,O2 saturation and adverse effect monitoring . If the pain will be ≥ 4, NSAID will be given to control the pain in the form of 20 mg piroxicam once daily after meal.

Interventions

  • Drug: sacroiliac joint injection
    • Intervention will be done at complete aseptic conditions by ultrasound at frequency of 4-5 MHz patient in prone position. The ultrasound transducer will be oriented in a transverse orientation at the level of the sacral hiatus. Here the sacral cornuae are identified. Moving the transducer laterally from here, the lateral edge of the sacrum is now identified. This bony edge is followed in a cephalad direction with the transducer maintained in a transverse orientation. A second bony contour, the ileum, is now identified. The cleft between both bony contours represented the sacroiliac joint. This will be found at 4.5 cm depth. Real-time imaging will be used to direct a 22G spinal needle into the SIJ, where 2% lidocaine and triamcinolone or methylprednisolone will be injected under direct vision.The needle will be removed, a sterile dressing will be applied

Arms, Groups and Cohorts

  • Active Comparator: Group MTP
    • will receive ultrasound-guided intra-articular SIJ injection with 40 mg of methylprednisolone with a uniform dose of 2 mL of 2% lidocaine hydrochloride.
  • Active Comparator: – Group TMC
    • will receive ultrasound-guided intra-articular SIJ injection with 40 mg of Triamcinolone acetonide with a uniform dose of 2 mL of 2% lidocaine hydrochloride .

Clinical Trial Outcome Measures

Primary Measures

  • numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
    • Time Frame: before injection
    • numerical rating scale from 0 = no pain to 10 maximum pain
  • numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
    • Time Frame: after 2 weeks from injection
    • numerical rating scale from 0 = no pain to 10 maximum pain
  • numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
    • Time Frame: after 1 month from injection
    • numerical rating scale from 0 = no pain to 10 maximum pain
  • numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
    • Time Frame: after 2 months from injection
    • numerical rating scale from 0 = no pain to 10 maximum pain
  • numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
    • Time Frame: after 3 months from injection
    • numerical rating scale from 0 = no pain to 10 maximum pain

Secondary Measures

  • Quality of life
    • Time Frame: before injection
    • Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire
  • Quality of life
    • Time Frame: after one month of injection
    • Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire

Participating in This Clinical Trial

Inclusion Criteria

  • Age between 50 – 70 years of both gender, – sacroiliac pain with at least 3 of the 5 provocative tests are positive, – pain did not relieved by the conservative therapy (rest, ice/heat, topical menthol, lidocaine patch, pelvic belt, physical therapy and NSIAD) for 4 weeks, – positive diagnostic test 2 ml lidocaine 2% intra-articular SIJ injection one day before the procedure are included in this study. Exclusion Criteria:

  • The exclusion criteria are patient refusal, – history of immunosuppression diseases, – bleeding or coagulation disorders, – sacroiliac pain of multiple sources, – local skin infection, – septic joint, osteomyelitis, – renal patients (Serum Creatinine >1.8 ), – decompensated liver diseases, – local malignancy, – psychiatric disorders affecting co-operation, – previous history of chronic opioid use, – intra articular sacroiliac injection within previous three months, – negative diagnostic test, – allergy or hypersensitivity to any of the study medications – diabetes mellitus, type II with history of poor glycemic control – morbid obesity ( BMI> 40 ).

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Nevert Adel, assist. prof. of anesthesia and pain management – Mansoura University

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