Sacroiliac Joint DysfunctionPhase 4NCT06268704
Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection
A Phase 4 study testing Dexamethasone, Methylprednisolone and 2% Lidocaine HCl Injection in people with Sacroiliac Joint Dysfunction and Sacro-Iliac Spondylosis, run by University of New Mexico at 1 site in United States.
Trial summary
This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sacroiliac Joint Dysfunction, Sacro-Iliac Spondylosis
- What is being tested?
- Dexamethasone, Methylprednisolone and 2% Lidocaine HCl Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2024to 1 May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged >18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
- Unilateral low back/buttocks pain of at least 2 weeks.
- Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation
- Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust)
- Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician.
- 80% or more relief of index pain within first 5-15 minutes after injection
Who cannot join
- Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain
- Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
- Those involved in active litigation relevant to their pain.
- Those unable to read English and complete the assessment instruments.
- Those unable to attend follow up appointments
- The patient is incarcerated.
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- History of prior sacroiliac joint fusion
- Progressive lower extremity neurologic deficit (from active radiculopathy, unhealed radiculopathy, or neuromuscular disease)
- Sacroiliac joint steroid injection within the prior 12 months
- 2 Positive lumbar medial branch blocks within the past 12 months
- Radiofrequency ablation of the lumbar spine within the past 12 months
- Lumbar facet steroid injections within the past 12 months
- Prior epidural steroid injection within the prior 3 months in any location within the spine.
- Possible pregnancy or other reason that precludes the use of fluoroscopy.
- Allergy to steroid, contrast media, or local anesthetics.
- BMI>40.
- Systemic inflammatory arthritis (e.g., rheumatoid arthritis, ankylosing spondylitis, lupus).
- Active infection or treatment of infection with antibiotics within the past 7 days.
- Medical conditions causing significant functional disability (e.g., stroke, decompensated ---COPD, decompensated heart failure)
- Chronic widespread pain or somatoform disorder (e.g. fibromyalgia).
- Addictive behavior, severe clinical depression, or psychotic features.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of New Mexico Hospital
Albuquerque, New Mexico, 87131
Mark W Shilling, BS, 505-925-7599, mwshilling@salud.unm.edu
About this study
Official title: Particulate Versus Non-Particulate Corticosteroid in Sacroiliac Joint Injection: A Randomized Prospective Study
This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.
Read the detailed description
Patients who are screened for inclusion will be randomized into one of two groups; dexamethasone or methylprednisolone. Patients will report their pain immediately after the procedure to confirm the diagnosis of sacroiliac joint pain, then be followed for three months to compare the efficacy and safety of the two medications.
- Being tested
- Dexamethasone, Methylprednisolone, 2% Lidocaine HCl Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called Ozurdex, Maxidex, DexPak
This is a non-particulate steroid commonly used to treat SI joint pain.
Also called Solu-medrol, Depo-Medrol, Medrol
This is a particulate steroid commonly used to treat SI joint pain.
2% Lidocaine HCl InjectionDrug
Also called Lignocaine, Xylocaine
Lidocaine is a local anesthetic used in SI joint injection procedures to numb the procedure site and helps to confirm SI joint dysfunction when injected with the steroid medication into the SI joint.
| Study group | Role | What they receive |
|---|---|---|
| Non-Particulate Steroid | Experimental | Patients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 10 milligrams of dexamethasone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose. Receives: Drug: Dexamethasone; Drug: 2% Lidocaine HCl Injection |
| Particulate Steroid | Active comparator | Patients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 40 milligrams of methylprednisolone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose. Receives: Drug: Methylprednisolone; Drug: 2% Lidocaine HCl Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain using Numeric Pain Rating Score
Numeric pain rating score is an 11 point scale (0-10) filled out on a form indicating the degree to which the patient experiences pain to assess efficacy of the injection. In this scale a 0, the minimum score, indicates no pain at all with a 10, the maximum score, being the worst pain imaginable. In this study a 50% or greater reduction in numeric pain rating score is considered a successful outcome while failure to achieve at least a 50% improvement as compared to their numeric pain rating score prior to the procedure is considered a poor outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start27 Mar 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac Joint DysfunctionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, rehsanian, University of New Mexico
- Investigators
- Reza Ehsanian, MD, PhD, Principal investigator, University of New Mexico Department of Anesthesiology and Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268704
- Sponsor's protocol ID
- UNM HRRC #23-503
- Status last verified
- Nov 2025
- First submitted
- 12 Feb 2024
- Last updated
- 6 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Particulate Versus Non-Particulate Corticosteroid in Sacroiliac Joint Injection: A Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT06268704
- Acronym / sponsor ID
- UNM HRRC #23-503
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 27 Mar 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 20 Feb 2024 (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.
This study will compare two different corticosteroids (dexamethasone and methylprednisolone) for use in sacroiliac joint injections to treat SI joint pain.
Detailed description
Patients who are screened for inclusion will be randomized into one of two groups; dexamethasone or methylprednisolone. Patients will report their pain immediately after the procedure to confirm the diagnosis of sacroiliac joint pain, then be followed for three months to compare the efficacy and safety of the two medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Particulate Steroid | Experimental | Drug: Dexamethasone, Drug: 2% Lidocaine HCl InjectionPatients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 10 milligrams of dexamethasone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose. |
| Particulate Steroid | Active comparator | Drug: Methylprednisolone, Drug: 2% Lidocaine HCl InjectionPatients in this arm will receive an injection of 1 milliliter of 2% lidocaine with 40 milligrams of methylprednisolone to one or both sacroiliac joints. If participants initially achieve relief from the injection but then have a return of pain they may be offered a second injection with the same drug at the same dose. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged >18, capable of understanding and providing consent in English, capable of complying with the outcome instruments used, capable of attending all planned follow up visits
- Unilateral low back/buttocks pain of at least 2 weeks.
- Patient reported 7 day average of numeric pain rating score (NPRS) low back/buttocks pain of at least 5/10 at baseline evaluation
- Clinical diagnosis of sacroiliac joint pain as diagnosed by a board certified Physiatrist including history of low back/buttocks pain and at least 2 positive physical exam findings (including positive fortin finger sign, pain with palpation of posterior superior iliac spine, positive FABER's test, positive Gaenslan's test, positive sacral distraction, positive thigh thrust, positive lateral compression, positive sacral thrust)
- Patient consents to sacroiliac joint corticosteroid injection in a shared decision-making process with the treating physician.
Key exclusion criteria (21 listed)
- Clinical suspicion of alternative process is greater than clinical suspicion of sacroiliac joint pain
- Those receiving remuneration for their pain treatment (e.g., disability, worker's compensation).
- Those involved in active litigation relevant to their pain.
- Those unable to read English and complete the assessment instruments.
- Those unable to attend follow up appointments
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 |
|---|---|---|
| DexamethasoneAlso: Ozurdex, Maxidex, DexPakThis is a non-particulate steroid commonly used to treat SI joint pain. | Drug | Non-Particulate Steroid |
| MethylprednisoloneAlso: Solu-medrol, Depo-Medrol, MedrolThis is a particulate steroid commonly used to treat SI joint pain. | Drug | Particulate Steroid |
| 2% Lidocaine HCl InjectionAlso: Lignocaine, XylocaineLidocaine is a local anesthetic used in SI joint injection procedures to numb the procedure site and helps to confirm SI joint dysfunction when injected with the steroid medication into the SI joint. | Drug | Non-Particulate Steroid, Particulate Steroid |
Primary outcome
Pain using Numeric Pain Rating Score
Time frame: 3 months
Numeric pain rating score is an 11 point scale (0-10) filled out on a form indicating the degree to which the patient experiences pain to assess efficacy of the injection. In this scale a 0, the minimum score, indicates no pain at all with a 10, the maximum score, being the worst pain imaginable. In this study a 50% or greater reduction in numeric pain rating score is considered a successful outcome while failure to achieve at least a 50% improvement as compared to their numeric pain rating score prior to the procedure is considered a poor outcome.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Reza Ehsanian, MD, PhD principal investigator
University of New Mexico Department of Anesthesiology and Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Methylprednisolone and 2% Lidocaine HCl Injection in people with Sacroiliac Joint Dysfunction and Sacro-Iliac Spondylosis, run by University of New Mexico at 1 site in United States.
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 6 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 6 Nov 2025. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mark W Shilling, BS (505-925-7599, mwshilling@salud.unm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain using Numeric Pain Rating Score (time frame: 3 months). 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 6 Nov 2025.