Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

Sponsor
Mansoura University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05134181
Collaborator
(none)
45
1
2
16
2.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: sacroiliac joint injection
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone
Actual Study Start Date :
Aug 1, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

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

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 .

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

Outcome Measures

Primary Outcome Measures

  1. numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking) [before injection]

    numerical rating scale from 0 = no pain to 10 maximum pain

  2. numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking) [after 2 weeks from injection]

    numerical rating scale from 0 = no pain to 10 maximum pain

  3. numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking) [after 1 month from injection]

    numerical rating scale from 0 = no pain to 10 maximum pain

  4. numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking) [after 2 months from injection]

    numerical rating scale from 0 = no pain to 10 maximum pain

  5. numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking) [after 3 months from injection]

    numerical rating scale from 0 = no pain to 10 maximum pain

Secondary Outcome Measures

  1. Quality of life [before injection]

    Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire

  2. Quality of life [after one month of injection]

    Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 ).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yahya Wahba Mansoura Egypt

Sponsors and Collaborators

  • Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nevert Adel, assist. prof. of anesthesia and pain management, Mansoura University
ClinicalTrials.gov Identifier:
NCT05134181
Other Study ID Numbers:
  • MS 20.07.1195
First Posted:
Nov 24, 2021
Last Update Posted:
Nov 24, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 24, 2021