Clinical trial NCT00829543: Unguided Sacroiliac Injection: Effect on Refractory Buttock Pain in Patients With Spondyloarthropathies
Official title: Guide-Free Sacroiliac Injection in Spondyloarthropathies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Spondylarthropathy
Keywords: Spodyloarthropathy
Guide-free sacroiliac injection
Lead sponsor: Tabriz University
Sponsor class: OTHER
First posted: 2009-01-27
Enrollment: 35
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Refractory inflammatory sacroiliac pain
timeFrame: 8 months
Secondary outcomes:
measure: ESR, CRP
timeFrame: 8 months
measure: Patient's assessment of: pain, sleep disturbance, morning stiffness
timeFrame: 8 months
measure: Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm)
timeFrame: 8 months
measure: MRI SIJ inflammatory scoring
timeFrame: 8 months
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Tabriz Medical University, Rheumatology Department
state: East Azarbayjan
Study officials:
affiliation: Tabriz medical university (Rheumatology Department)
name: Shahram Sadreddini, Rheumatology
role: STUDY_DIRECTOR
affiliation: Assistant professor of Tabriz medical university
name: Shahram Sadreddini, Rheumatology
role: STUDY_CHAIR
affiliation: Tehran medical university
name: Mahshid Molaeefard, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor of Tabriz medical university
name: Seyed-Kazem Shakouri, Physiatrist
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor of Tabriz medical university
name: Morteza Ghojazadeh, Physiologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor of Tabriz medical university
name: Hamid Noshad, Nephrologist
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant professor of Tabriz medical university
name: Mohammad-Reza Ardalan, Nephrologist
role: PRINCIPAL_INVESTIGATOR
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