Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

Sacroiliac Joint Arthritis Clinical Trial

Official title:

Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05134181
• Other study ID #: MS 20.07.1195
• Status: Recruiting
• Phase: Phase 2
• Start date: August 1, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ).

Related Conditions & MeSH terms

• Sacroiliac Joint Arthritis
• Sacroiliitis

Intervention

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

Locations

Country	Name	City	State
Egypt	Yahya Wahba	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)	numerical rating scale from 0 = no pain to 10 maximum pain	before injection
Primary	numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)	numerical rating scale from 0 = no pain to 10 maximum pain	after 2 weeks from injection
Primary	numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)	numerical rating scale from 0 = no pain to 10 maximum pain	after 1 month from injection
Primary	numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)	numerical rating scale from 0 = no pain to 10 maximum pain	after 2 months from injection
Primary	numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)	numerical rating scale from 0 = no pain to 10 maximum pain	after 3 months from injection
Secondary	Quality of life	Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire	before injection
Secondary	Quality of life	Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire	after one month of injection