Unguided Sacroiliac Injection: Effect on Refractory Buttock Pain in Patients With Spondyloarthropathies

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Guide-Free Sacroiliac Injection in Spondyloarthropathies

Conditions
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Spondylarthropathy

Intervention / Treatment
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* Procedure: guide-free sacroiliac corticosteroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sacroiliac injection<br>an open label study designed to evaluate the efficacy and safety of guide-free sacroiliac injection in refractory sacroiliac pain due to spondyloarthropathies | Procedure: guide-free sacroiliac corticosteroid injection<br>* guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint<br>* Other names: Unguided sacroiliac injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractory inflammatory sacroiliac pain |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 8 months | 
| MRI SIJ inflammatory scoring |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spodyloarthropathy, Guide-free sacroiliac injection