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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Tabriz University
ClinicalTrials.gov Identifier:
NCT00829543
First received: January 26, 2009
Last updated: February 2, 2009
Last verified: February 2009
History of Changes

January 26, 2009
February 2, 2009
September 2004
January 2007   (final data collection date for primary outcome measure)
Refractory inflammatory sacroiliac pain [ Time Frame: 8 months ] [ Designated as safety issue: No ]
refractory inflammatory buttock pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00829543 on ClinicalTrials.gov Archive Site
  • ESR, CRP [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Patient's assessment of: pain, sleep disturbance, morning stiffness [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm) [ Time Frame: 8 months ] [ Designated as safety issue: No ]
  • MRI SIJ inflammatory scoring [ Time Frame: 8 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Unguided Sacroiliac Injection: Effect on Refractory Buttock Pain in Patients With Spondyloarthropathies
Guide-Free Sacroiliac Injection in Spondyloarthropathies

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

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.
Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Spondylarthropathy
Procedure: guide-free sacroiliac corticosteroid injection
guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint
Other Name: Unguided sacroiliac injection
Experimental: sacroiliac injection
an open label study designed to evaluate the efficacy and safety of guide-free sacroiliac injection in refractory sacroiliac pain due to spondyloarthropathies
Intervention: Procedure: guide-free sacroiliac corticosteroid injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
35
February 2009
January 2007   (final data collection date for primary outcome measure)

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.
Both
16 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00829543
8715
Yes
Dr Shahram Sadreddini, Assistant professor of Rheumatology, Tabriz university (medical sciences)
Tabriz University
Not Provided
Study Director: Shahram Sadreddini, Rheumatology Tabriz medical university (Rheumatology Department)
Study Chair: Shahram Sadreddini, Rheumatology Assistant professor of Tabriz medical university
Principal Investigator: Mahshid Molaeefard, MD Tehran medical university
Principal Investigator: Seyed-Kazem Shakouri, Physiatrist Assistant professor of Tabriz medical university
Principal Investigator: Morteza Ghojazadeh, Physiologist Assistant professor of Tabriz medical university
Principal Investigator: Hamid Noshad, Nephrologist Assistant professor of Tabriz medical university
Principal Investigator: Mohammad-Reza Ardalan, Nephrologist Assistant professor of Tabriz medical university
Tabriz University
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP