Sacroiliac Joint ArthritisPhase 2NCT05134181
Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone
A Phase 2 study testing sacroiliac joint injection in people with Sacroiliac Joint Arthritis, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac Joint Arthritis
- What is being tested?
- sacroiliac joint injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 1 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 16Show fewer
- 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 ).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Yahya Wahba
Al Mansurah
yahya m wahba, assist prof., 01211313554, yahyawahba@gmail.com
adel abdel ghaffar, pof., 01210101001, adelghaffar49@gmail.com
About this study
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.
Read the 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
- Being tested
- sacroiliac joint injection
- Medical subject headings
- Sacroiliitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sacroiliac joint injectionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Drug: sacroiliac joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after 3 months from injection
Secondary outcomes (2)
Quality of life
Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire
Measured: before injection
Quality of life
Euroqol group 5 dimension 5 level (EQ-5D-5L) questionnaire
Measured: after one month of injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint ArthritisStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevert Adel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05134181
- Sponsor's protocol ID
- MS 20.07.1195
- Status last verified
- Nov 2021
- First submitted
- 12 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Intra-sacroiliac Joint Injection: Methylprednisolone Versus Triamcinolone
- ClinicalTrials.gov ID
- NCT05134181
- Acronym / sponsor ID
- MS 20.07.1195
- Conditions
- Sacroiliac Joint Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group MTP | Active comparator | Drug: sacroiliac joint injectionwill receive ultrasound-guided intra-articular SIJ injection with 40 mg of methylprednisolone with a uniform dose of 2 mL of 2% lidocaine hydrochloride. |
| - Group TMC | Active comparator | Drug: sacroiliac joint injectionwill receive ultrasound-guided intra-articular SIJ injection with 40 mg of Triamcinolone acetonide with a uniform dose of 2 mL of 2% lidocaine hydrochloride . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- The exclusion criteria are patient refusal,
- history of immunosuppression diseases,
- bleeding or coagulation disorders,
- sacroiliac pain of multiple sources,
- local skin infection,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sacroiliac joint injectionIntervention 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 | Drug | - Group TMC, Group MTP |
Primary outcome
numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking)
Time frame: before injection
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)
Time frame: after 2 weeks from injection
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)
Time frame: after 1 month from injection
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)
Time frame: after 2 months from injection
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)
Time frame: after 3 months from injection
numerical rating scale from 0 = no pain to 10 maximum pain
2 secondary outcomes
Quality of life
Time frame: before injection
Quality of life
Time frame: after one month of injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sacroiliac joint injection in people with Sacroiliac Joint Arthritis, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
numerical rating scale at rest and during motion (standing up from a seated position, during stair climbing and walking) (time frame: before injection). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.