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

Early Phase 1

• Conditions: Spondylarthropathy
• Interventions: Procedure: guide-free sacroiliac corticosteroid injection

• Registration Number: NCT00829543
• Lead Sponsor: Tabriz University

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 (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 Timeline

• Study Start: 2004-09
• Primary Completion: 2007-01
• Study First Submitted: 2009-01-26
• Study First Submitted QC: 2009-01-26
• Study First Posted: 2009-01-27
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-02
• Last Update Posted: 2009-02-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Patients had to fulfill the European Spondylarthropathy Study Group criteria for SpA.

1. 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.
2. Tenderness over sacroiliac joint: pain over the sacroiliac sulcus with 4-5 kg/cm2 direct pressure.

Exclusion Criteria

1. Spinal infections (such as Brucellosis).
2. Local infection in the site of injection.
3. Sacroiliac ankylosis based on pelvic X-Ray (sacroilitis grade IV).
4. Patients who had received anti TNF, corticosteroid pulse or an investigational drugs during 4 months before.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sacroiliac injection	guide-free sacroiliac corticosteroid injection	an open label study designed to evaluate the efficacy and safety of guide-free sacroiliac injection in refractory sacroiliac pain due to spondyloarthropathies

Primary Outcome Measures

Name	Time	Method
Refractory inflammatory sacroiliac pain	8 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tabriz Medical University, Rheumatology Department; 🇮🇷 Tabriz, East Azarbayjan, Iran, Islamic Republic of