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

Tabriz University

Status and phase: Unknown; Early Phase 1

Conditions: Spondylarthropathy

Treatments: Procedure: guide-free sacroiliac corticosteroid injection

Study type: Interventional

Funder types: Other

Identifiers

NCT00829543

8715

Details and patient eligibility

About

This study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint (SIJ) injection in refractory sacroiliac pain due to spondyloarthropathies.

Full 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.

Enrollment: 35 estimated patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

sacroiliac injection

Experimental group

Description:

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

Treatment:

Procedure: guide-free sacroiliac corticosteroid injection