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

February 2, 2009 updated by: Tabriz University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

35

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • East Azarbayjan
      • Tabriz, East Azarbayjan, Iran, Islamic Republic of, +989123355170
        • Tabriz Medical University, Rheumatology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Unguided sacroiliac injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Refractory inflammatory sacroiliac pain
Time Frame: 8 months
8 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

January 26, 2009

First Submitted That Met QC Criteria

January 26, 2009

First Posted (Estimate)

January 27, 2009

Study Record Updates

Last Update Posted (Estimate)

February 3, 2009

Last Update Submitted That Met QC Criteria

February 2, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8715

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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