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This study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| guide-free sacroiliac corticosteroid injection | Procedure | guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint |
|
| Measure | Description | Time Frame |
|---|---|---|
| Refractory inflammatory sacroiliac pain | 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| ESR, CRP | 8 months | |
| Patient's assessment of: pain, sleep disturbance, morning stiffness | 8 months | |
| Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm) |
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Inclusion Criteria:
Patients had to fulfill the European Spondylarthropathy Study Group criteria for SpA.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shahram Sadreddini, Rheumatology | Tabriz medical university (Rheumatology Department) | Study Director |
| Shahram Sadreddini, Rheumatology | Assistant professor of Tabriz medical university | Study Chair |
| Mahshid Molaeefard, MD | Tehran medical university | Principal Investigator |
| Seyed-Kazem Shakouri, Physiatrist | Assistant professor of Tabriz medical university | Principal Investigator |
| Morteza Ghojazadeh, Physiologist | Assistant professor of Tabriz medical university | Principal Investigator |
| Hamid Noshad, Nephrologist | Assistant professor of Tabriz medical university | Principal Investigator |
| Mohammad-Reza Ardalan, Nephrologist | Assistant professor of Tabriz medical university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tabriz Medical University, Rheumatology Department | Tabriz | East Azarbayjan | +989123355170 | Iran |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 5, 2009 | |
| Unrelease | Yes | |
| Release | Feb 13, 2009 | |
| Reset | Mar 10, 2009 | |
| Release | Mar 12, 2009 | |
| Reset | Apr 14, 2009 | |
| Release | May 4, 2009 | |
| Reset | Jun 22, 2009 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 5, 2009 | Yes | |||
| Feb 13, 2009 |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| ID | Term |
|---|---|
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
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|
| 8 months |
| MRI SIJ inflammatory scoring | 8 months |
| Mar 10, 2009 |
| Mar 12, 2009 | Apr 14, 2009 |
| May 4, 2009 | Jun 22, 2009 |
| D009140 |
| Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |