Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

NCT ID: NCT05134181

Last Updated: 2021-11-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-01
• Study Completion Date: 2022-12-01

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.

Conditions

Sacroiliac Joint Arthritis

Study Design

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

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

sacroiliac joint injection

Intervention Type: DRUG

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

- 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 .

Group Type: ACTIVE_COMPARATOR

sacroiliac joint injection

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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

• 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 ).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Nevert Adel

assist. prof. of anesthesia and pain management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Yahya Wahba

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Facility Contacts

yahya m wahba, assist prof.

Role: primary

adel abdel ghaffar, pof.

Role: backup

Other Identifiers

MS 20.07.1195

Identifier Type: -

Identifier Source: org_study_id