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

Primary Purpose

Spondylarthropathy

Status

Unknown status

Phase

Early Phase 1

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

guide-free sacroiliac corticosteroid injection

About this trial

This is an interventional treatment trial for Spondylarthropathy focused on measuring Spodyloarthropathy, Guide-free sacroiliac injection

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Tabriz Medical University, Rheumatology Department

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sacroiliac injection

Arm Description

an open label study designed to evaluate the efficacy and safety of guide-free sacroiliac injection in refractory sacroiliac pain due to spondyloarthropathies

Outcomes

Primary Outcome Measures

Refractory inflammatory sacroiliac pain

Secondary Outcome Measures

ESR, CRP

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

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

MRI SIJ inflammatory scoring

Full Information

NCT ID

NCT00829543

First Posted

January 26, 2009

Last Updated

February 2, 2009

Sponsor

Tabriz University

1. Study Identification

Unique Protocol Identification Number

NCT00829543

Brief Title

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

Official Title

Guide-Free Sacroiliac Injection in Spondyloarthropathies

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

September 2004 (undefined)

Primary Completion Date

January 2007 (Actual)

Study Completion Date

February 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Tabriz University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spondylarthropathy

Keywords

Spodyloarthropathy, Guide-free sacroiliac injection

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

sacroiliac injection

Arm Type

Experimental

Arm Description

an open label study designed to evaluate the efficacy and safety of guide-free sacroiliac injection in refractory sacroiliac pain due to spondyloarthropathies

Intervention Type

Procedure

Intervention Name(s)

guide-free sacroiliac corticosteroid injection

Other Intervention Name(s)

Unguided sacroiliac injection

Intervention Description

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

Primary Outcome Measure Information:

Title

Refractory inflammatory sacroiliac pain

Time Frame

8 months

Secondary Outcome Measure Information:

Title

ESR, CRP

Time Frame

8 months

Title

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

Time Frame

8 months

Title

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

Time Frame

8 months

Title

MRI SIJ inflammatory scoring

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials: