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Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

Primary Purpose

Sacroiliac Joint Arthritis

Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
sacroiliac joint injection
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ).

Sites / Locations

  • Yahya WahbaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group MTP

- Group TMC

Arm Description

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

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 .

Outcomes

Primary Outcome Measures

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
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
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
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
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

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2021
Last Updated
November 23, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05134181
Brief Title
Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone
Official Title
Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group MTP
Arm Type
Active Comparator
Arm Description
will receive ultrasound-guided intra-articular SIJ injection with 40 mg of methylprednisolone with a uniform dose of 2 mL of 2% lidocaine hydrochloride.
Arm Title
- Group TMC
Arm Type
Active Comparator
Arm Description
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 .
Intervention Type
Drug
Intervention Name(s)
sacroiliac joint injection
Intervention Description
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
Primary Outcome Measure Information:
Title
numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
Description
numerical rating scale from 0 = no pain to 10 maximum pain
Time Frame
before injection
Title
numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
Description
numerical rating scale from 0 = no pain to 10 maximum pain
Time Frame
after 2 weeks from injection
Title
numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
Description
numerical rating scale from 0 = no pain to 10 maximum pain
Time Frame
after 1 month from injection
Title
numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
Description
numerical rating scale from 0 = no pain to 10 maximum pain
Time Frame
after 2 months from injection
Title
numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
Description
numerical rating scale from 0 = no pain to 10 maximum pain
Time Frame
after 3 months from injection
Secondary Outcome Measure Information:
Title
Quality of life
Description
Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire
Time Frame
before injection
Title
Quality of life
Description
Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire
Time Frame
after one month of injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 ).
Facility Information:
Facility Name
Yahya Wahba
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yahya m wahba, assist prof.
Phone
01211313554
Email
yahyawahba@gmail.com
First Name & Middle Initial & Last Name & Degree
adel abdel ghaffar, pof.
Phone
01210101001
Email
adelghaffar49@gmail.com

12. IPD Sharing Statement

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Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone

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