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
  Purpose

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


Condition Intervention Phase
Spondylarthropathy
Procedure: guide-free sacroiliac corticosteroid injection
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Guide-Free Sacroiliac Injection in Spondyloarthropathies

Resource links provided by NLM:


Further study details as provided by Tabriz University:

Primary Outcome Measures:
  • Refractory inflammatory sacroiliac pain [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 35
Study Start Date: September 2004
Estimated Study Completion Date: February 2009
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Procedure: guide-free sacroiliac corticosteroid injection
guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint
Other Name: Unguided sacroiliac injection

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

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00829543

Locations
Iran, Islamic Republic of
Tabriz Medical University, Rheumatology Department
Tabriz, East Azarbayjan, Iran, Islamic Republic of, +989123355170
Sponsors and Collaborators
Tabriz University
Investigators
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
  More Information

No publications provided

Responsible Party: Dr Shahram Sadreddini, Assistant professor of Rheumatology, Tabriz university (medical sciences)
ClinicalTrials.gov Identifier: NCT00829543     History of Changes
Other Study ID Numbers: 8715
Study First Received: January 26, 2009
Last Updated: February 2, 2009
Health Authority: Iran: Ethics Committee

Keywords provided by Tabriz University:
Spodyloarthropathy
Guide-free sacroiliac injection

Additional relevant MeSH terms:
Spondylarthropathies
Arthritis
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthritis
Spondylitis

ClinicalTrials.gov processed this record on October 22, 2014