NCT00829543

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Sep 2004

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2009

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 3, 2009

Status Verified

February 1, 2009

Enrollment Period

2.3 years

First QC Date

January 26, 2009

Last Update Submit

February 2, 2009

Conditions

Spondylarthropathy

Keywords

SpodyloarthropathyGuide-free sacroiliac injection

Outcome Measures

Primary Outcomes (1)

  • Refractory inflammatory sacroiliac pain

    8 months

Secondary Outcomes (4)

  • ESR, CRP

    8 months

  • Patient's assessment of: pain, sleep disturbance, morning stiffness

    8 months

  • Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm)

    8 months

  • MRI SIJ inflammatory scoring

    8 months

Study Arms (1)

sacroiliac injection

EXPERIMENTAL

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

Interventions

guide-free sacroiliac corticosteroid injectionPROCEDURE

guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint

Also known as: Unguided sacroiliac injection
sacroiliac injection

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients had to fulfill the European Spondylarthropathy Study Group criteria for SpA.
  • 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.
  • Tenderness over sacroiliac joint: pain over the sacroiliac sulcus with 4-5 kg/cm2 direct pressure.

You may not qualify if:

  • Spinal infections (such as Brucellosis).
  • Local infection in the site of injection.
  • Sacroiliac ankylosis based on pelvic X-Ray (sacroilitis grade IV).
  • Patients who had received anti TNF, corticosteroid pulse or an investigational drugs during 4 months before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tabriz Medical University, Rheumatology Department

Tabriz, East Azarbayjan, +989123355170, Iran

Location

MeSH Terms

Conditions

Spondylarthropathies

Condition Hierarchy (Ancestors)

SpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • Shahram Sadreddini, Rheumatology

    Tabriz medical university (Rheumatology Department)

    STUDY DIRECTOR

  • Shahram Sadreddini, Rheumatology

    Assistant professor of Tabriz medical university

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 27, 2009

Study Start

September 1, 2004

Primary Completion

January 1, 2007

Study Completion

February 1, 2009

Last Updated

February 3, 2009

Record last verified: 2009-02

Locations

IR(1)