Spondylarthropathy
Conditions
Keywords
Spodyloarthropathy, Guide-free sacroiliac injection
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.
Interventions
PROCEDUREguide-free sacroiliac corticosteroid injection
guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint
Sponsors
Tabriz University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refractory inflammatory sacroiliac pain | 8 months |
Secondary
| Measure | 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 |
Countries
Iran
Outcome results
None listed