Status:
UNKNOWN
Unguided Sacroiliac Injection: Effect on Refractory Buttock Pain in Patients With Spondyloarthropathies
Lead Sponsor:
Tabriz University
Conditions:
Spondylarthropathy
Eligibility:
All Genders
16-50 years
Phase:
EARLY_PHASE1
Brief 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.
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 (f...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00829543
Start Date
September 1 2004
End Date
February 1 2009
Last Update
February 3 2009
Active Locations (1)
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1
Tabriz Medical University, Rheumatology Department
Tabriz, East Azarbayjan, Iran, +989123355170