Sacro-Iliac SpondylosisPhase 4NCT03166761
Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Injection
A Phase 4 study testing Dexamethasone and Triamcinolone Acetonide in people with Sacro-Iliac Spondylosis, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in sacroiliac joint injections Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sacro-Iliac Spondylosis
- What is being tested?
- Dexamethasone and Triamcinolone Acetonide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2017to 28 Feb 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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.
Show all 21Show fewer
- 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.
About this study
Official title: Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection
Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in sacroiliac joint injections
Read the detailed description
Patients eligible for a sacroiliac joint injection will be randomized to receive one of two different steroids, dexamethasone or triamcinolone. The response immediately after injection will be assessed to confirm the diagnosis, and then they will be followed for three month to assess the degree of pain relief experienced
- Conditions
- Sacro-Iliac Spondylosis
- Being tested
- Dexamethasone, Triamcinolone Acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Also called decadron
Dexamethasone injection into the sacroiliac joint
Triamcinolone AcetonideDrug
Also called Kenalog
Triamcinolone injection into the sacroiliac joint
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | dexamethasone injected into the sacroiliac joint Receives: Drug: Dexamethasone |
| Triamcinolone | Active comparator | triamcinolone injected into the sacroiliac joint Receives: Drug: Triamcinolone Acetonide |
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, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported.
Measured: Baseline to 3 months; Average value at month 3 reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start14 Sep 2017
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Why it stopped: recruitment and staffing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sacro-Iliac SpondylosisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byron Schneider, Vanderbilt University Medical Center
- Investigators
- Byron Schneider, Principal investigator, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166761
- Sponsor's protocol ID
- SCHNEIBJ03152017153735
- Status last verified
- Jul 2024
- First submitted
- 16 May 2017
- Last updated
- 10 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Study of Particulate Corticosteroid Versus Non-particulate Corticosteroid for Sacroiliac Joint Steroid Injection
- ClinicalTrials.gov ID
- NCT03166761
- Acronym / sponsor ID
- SCHNEIBJ03152017153735
- Conditions
- Sacro-Iliac Spondylosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment and staffing
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 25 May 2017 (actual)
- Results
- Posted 10 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparing two different corticosteroids (dexamethasone and triamcinolone) for use in sacroiliac joint injections
Detailed description
Patients eligible for a sacroiliac joint injection will be randomized to receive one of two different steroids, dexamethasone or triamcinolone. The response immediately after injection will be assessed to confirm the diagnosis, and then they will be followed for three month to assess the degree of pain relief experienced
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasonedexamethasone injected into the sacroiliac joint |
| Triamcinolone | Active comparator | Drug: Triamcinolone Acetonidetriamcinolone injected into the sacroiliac joint |
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: decadronDexamethasone injection into the sacroiliac joint | Drug | Dexamethasone |
| Triamcinolone AcetonideAlso: KenalogTriamcinolone injection into the sacroiliac joint | Drug | Triamcinolone |
Primary outcome
Pain Using Numeric Pain Rating Score
Time frame: Baseline to 3 months; Average value at month 3 reported
Numeric pain rating score, 11 point scale (0-10) filled out on a form indicating the degree of relief/discomfort after the injection. Pain was assessed monthly from baseline to 3 months following the injection. The average value at month 3 is reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Sacro-Iliac Spondylosis
Not yet recruiting
PRP Injection Into the Sacroiliac Joint After Ipsilateral THA: Effects on Early Recovery and Function (SIJ-THA Randomized Trial)
Osteoarthitis, Sacro Iliac Joint Pain
RecruitingPhase 4
Particulate vs. Non-Particulate Steroid for Sacroiliac Joint Injection
Sacroiliac Joint Dysfunction, Sacro-Iliac Spondylosis
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.
Byron Schneider principal investigator
Assistant professor
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 and Triamcinolone Acetonide in people with Sacro-Iliac Spondylosis, run by Vanderbilt University Medical Center 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: stopped early, as of the sponsor's last update on 10 Jul 2024. 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?
Yes. Results are posted in the registry (first posted 10 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Using Numeric Pain Rating Score (time frame: Baseline to 3 months; Average value at month 3 reported). 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 10 Jul 2024.