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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2009 by Tabriz University.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00829543
First Posted: January 27, 2009
Last Update Posted: February 3, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tabriz University
  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 Early Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • ESR, CRP [ Time Frame: 8 months ]
  • Patient's assessment of: pain, sleep disturbance, morning stiffness [ Time Frame: 8 months ]
  • Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm) [ Time Frame: 8 months ]
  • MRI SIJ inflammatory scoring [ Time Frame: 8 months ]

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

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 26, 2009
First Posted: January 27, 2009
Last Update Posted: February 3, 2009
Last Verified: February 2009

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

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