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

Spondylarthropathy Clinical Trial

Official title:

Guide-Free Sacroiliac Injection in Spondyloarthropathies

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00829543
• Other study ID #: 8715
• Status: Unknown status
• Phase: Early Phase 1
• First received: January 26, 2009
• Last updated: February 2, 2009
• Start date: September 2004
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Tabriz University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 35
• Est. completion date: February 2009
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Spondylarthritis
• Spondylarthropathies
• Spondylarthropathy

Intervention

Procedure:
• guide-free sacroiliac corticosteroid injection
guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each sacroiliac joint

Locations

Country	Name	City	State
Iran, Islamic Republic of	Tabriz Medical University, Rheumatology Department	Tabriz	East Azarbayjan

Sponsors (1)

Lead Sponsor	Collaborator
Tabriz University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Refractory inflammatory sacroiliac pain		8 months
Secondary	ESR, CRP		8 months
Secondary	Patient's assessment of: pain, sleep disturbance, morning stiffness		8 months
Secondary	Clinician assessment of: SIJ pain, change of finger to floor (cm) and Schober tests (mm)		8 months
Secondary	MRI SIJ inflammatory scoring		8 months