Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

NCT05134181 | Unknown Phase 2

• 1 other identifier: MS 20.07.1195
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Joint Arthritis

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Quality of life

  before injection

• Quality of life

  after one month of injection

Study Arms (2)

Group MTP

ACTIVE COMPARATOR

will receive ultrasound-guided intra-articular SIJ injection with 40 mg of methylprednisolone with a uniform dose of 2 mL of 2% lidocaine hydrochloride.

Drug: sacroiliac joint injection

- Group TMC

ACTIVE COMPARATOR

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 .

Drug: sacroiliac joint injection

Interventions

sacroiliac joint injection 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; Group MTP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 ).

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Yahya Wahba

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Sacroiliitis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assist. prof. of anesthesia and pain management

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: November 24, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 24, 2021

Record last verified: 2021-11

Locations

EG (1)