Clinical trial NCT05134181: Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone
Official title: Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Sacroiliac Joint Arthritis
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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 ).

Primary outcomes:
measure: numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
timeFrame: before injection
measure: numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
timeFrame: after 2 weeks from injection
measure: numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
timeFrame: after 1 month from injection
measure: numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
timeFrame: after 2 months from injection
measure: numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
timeFrame: after 3 months from injection
Secondary outcomes:
measure: Quality of life
timeFrame: before injection
measure: Quality of life
timeFrame: after one month of injection
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Yahya Wahba
Study officials:
References: