SpondylarthropathyEarly Phase 1NCT00829543
Unguided Sacroiliac Injection: Effect on Refractory Buttock Pain in Patients With Spondyloarthropathies
A Early Phase 1 study testing guide-free sacroiliac corticosteroid injection in people with Spondylarthropathy, run by Tabriz University at 1 site in Iran.
Trial summary
This study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Spondylarthropathy
- What is being tested?
- guide-free sacroiliac corticosteroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteIran
- Study dates
- Sep 2004to Feb 2009
- Phase
- Early Phase 1
- 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 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients had to fulfill the European Spondylarthropathy Study Group criteria for SpA.
- The presence of inflammatory buttock pain for at least 4 months (typical night pain and morning stiffness) despite of receiving NSAIDs, corticosteroid and DMARDs (Disease Modifying Anti-Rheumatic Drugs) such as: methotrexate, sulfasalazin and azathioprine.
- Tenderness over sacroiliac joint: pain over the sacroiliac sulcus with 4-5 kg/cm2 direct pressure.
Who cannot join
- Spinal infections (such as Brucellosis).
- Local infection in the site of injection.
- Sacroiliac ankylosis based on pelvic X-Ray (sacroilitis grade IV).
- Patients who had received anti TNF, corticosteroid pulse or an investigational drugs during 4 months before.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Tabriz Medical University, Rheumatology Department
Tabriz, East Azarbayjan, +989123355170
About this study
Official title: Guide-Free Sacroiliac Injection in Spondyloarthropathies
This study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies.
Read the detailed description
A 20 weeks open-label clinical trial study of 35 patients, with different subtypes of spondyloarthropathies, is conducted In spondyloarthropathy's patients with refractory inflammatory buttock pain (fulfilling inclusion criteria), we performed outpatient guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each joint. Patient (pain, stiffness, sleep disturbance) and Clinician assessments (sacroiliac tenderness, Finger to floor and Schober tests ) are recorded at baseline and every 4 weeks until the end of the study. MRI scoring of sacroiliac joint is recorded according to the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) index for scoring inflammatory lesions in the sacroiliac joints, at baseline and in the end of the study.
- Conditions
- Spondylarthropathy
- Being tested
- guide-free sacroiliac corticosteroid injection
- Keywords
- Spodyloarthropathy, Guide-free sacroiliac injection
- Medical subject headings
- Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guide-free sacroiliac corticosteroid injectionProcedure or surgery
Also called Unguided sacroiliac injection
guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint
| Study group | Role | What they receive |
|---|---|---|
| sacroiliac injection | Experimental | an open label study designed to evaluate the efficacy and safety of guide-free sacroiliac injection in refractory sacroiliac pain due to spondyloarthropathies Receives: Procedure: guide-free sacroiliac corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Refractory inflammatory sacroiliac pain
Measured: 8 months
Secondary outcomes (4)
ESR, CRP
Measured: 8 months
Patient's assessment of: pain, sleep disturbance, morning stiffness
Measured: 8 months
Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm)
Measured: 8 months
MRI SIJ inflammatory scoring
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2009 (estimated)
- Study startSep 2004
- Primary completionJan 2007
- Study completionFeb 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylarthropathyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabriz University
- Sponsor type
- University, hospital or other
- Investigators
- Shahram Sadreddini, Rheumatology, Study director, Tabriz medical university (Rheumatology Department)Shahram Sadreddini, Rheumatology, Study chair, Assistant professor of Tabriz medical universityMahshid Molaeefard, MD, Principal investigator, Tehran medical universitySeyed-Kazem Shakouri, Physiatrist, Principal investigator, Assistant professor of Tabriz medical universityMorteza Ghojazadeh, Physiologist, Principal investigator, Assistant professor of Tabriz medical universityHamid Noshad, Nephrologist, Principal investigator, Assistant professor of Tabriz medical universityMohammad-Reza Ardalan, Nephrologist, Principal investigator, Assistant professor of Tabriz medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00829543
- Sponsor's protocol ID
- 8715
- Status last verified
- Feb 2009
- First submitted
- 26 Jan 2009
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guide-Free Sacroiliac Injection in Spondyloarthropathies
- ClinicalTrials.gov ID
- NCT00829543
- Acronym / sponsor ID
- 8715
- Conditions
- Spondylarthropathy
- Keywords
- Spodyloarthropathy, Guide-free sacroiliac injection
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Tabriz UniversityUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Feb 2009 (estimated)
- First posted
- 27 Jan 2009 (estimated)
- 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 is designed to evaluate the efficacy and safety of guide-free sacroiliac joint (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies.
Detailed description
A 20 weeks open-label clinical trial study of 35 patients, with different subtypes of spondyloarthropathies, is conducted In spondyloarthropathy's patients with refractory inflammatory buttock pain (fulfilling inclusion criteria), we performed outpatient guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each joint. Patient (pain, stiffness, sleep disturbance) and Clinician assessments (sacroiliac tenderness, Finger to floor and Schober tests ) are recorded at baseline and every 4 weeks until the end of the study. MRI scoring of sacroiliac joint is recorded according to the Spondyloarthritis Research Consortium of Canada (SPARCC) magnetic resonance imaging (MRI) index for scoring inflammatory lesions in the sacroiliac joints, at baseline and in the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sacroiliac injection | Experimental | Procedure: guide-free sacroiliac corticosteroid injectionan open label study designed to evaluate the efficacy and safety of guide-free sacroiliac injection in refractory sacroiliac pain due to spondyloarthropathies |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients had to fulfill the European Spondylarthropathy Study Group criteria for SpA.
- The presence of inflammatory buttock pain for at least 4 months (typical night pain and morning stiffness) despite of receiving NSAIDs, corticosteroid and DMARDs (Disease Modifying Anti-Rheumatic Drugs) such as: methotrexate, sulfasalazin and azathioprine.
- Tenderness over sacroiliac joint: pain over the sacroiliac sulcus with 4-5 kg/cm2 direct pressure.
Key exclusion criteria (4 listed)
- Spinal infections (such as Brucellosis).
- Local infection in the site of injection.
- Sacroiliac ankylosis based on pelvic X-Ray (sacroilitis grade IV).
- Patients who had received anti TNF, corticosteroid pulse or an investigational drugs during 4 months before.
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 |
|---|---|---|
| guide-free sacroiliac corticosteroid injectionAlso: Unguided sacroiliac injectionguide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint | Procedure or surgery | sacroiliac injection |
Primary outcome
Refractory inflammatory sacroiliac pain
Time frame: 8 months
4 secondary outcomes
ESR, CRP
Time frame: 8 months
Patient's assessment of: pain, sleep disturbance, morning stiffness
Time frame: 8 months
Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm)
Time frame: 8 months
MRI SIJ inflammatory scoring
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2009.
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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.
Shahram Sadreddini, Rheumatology study director
Tabriz medical university (Rheumatology Department)
Shahram Sadreddini, Rheumatology study chair
Assistant professor of Tabriz medical university
Mahshid Molaeefard, MD principal investigator
Tehran medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing guide-free sacroiliac corticosteroid injection in people with Spondylarthropathy, run by Tabriz University at 1 site in Iran.
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 3 inclusion and 4 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 3 Feb 2009. 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 Iran. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
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?
Refractory inflammatory sacroiliac pain (time frame: 8 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 3 Feb 2009.