Ultrasound Guided Epidural Block in Axial SPA

Phase 4

Completed

• Conditions: Epidural Block in Axial Spondyloarthritis
• Interventions: Drug: Epidural block with lidocaine and triamcinilone

• Registration Number: NCT04143165
• Lead Sponsor: Sohag University

Brief Summary

Study Design: A randomized, prospective, pilot, controlled trial. Setting: Rheumatology and rehabilitation department Minia University and Sohag University Objectives: To evaluate the effectiveness of caudal epidural injections with triamcinolone and lidocaine in managing limited spine mobility in axial SPA.

Methods: Patients were randomly assigned to one of 2 groups, Group I patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip), whereas Group II patients did not receive. Both groups were age and sex matched and both were under treatment with anti TNF and NSAIDs with or without sDMARDs.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-12
• Study First Submitted: 2019-10-26
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-29
• Primary Completion: 2020-01-12
• Study Completion: 2020-02-12
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-03
• Last Update Posted: 2020-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

• all participants fulfilled the ASAS criteria for axial SPA
• all participants under treatment including bDMARDS and sDMARDs beside NSAIDs

Exclusion Criteria

• Naive patients not under treatment
• limitation of spine flexion due to non inflammatory causes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epidural block	Epidural block with lidocaine and triamcinilone	Group I patients received caudal epidural injections with 1% lidocaine hydrochloride (xylocaine Astra Zeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)

Primary Outcome Measures

Name	Time	Method
change in pain	Baseline, after 2 weeks and after 8 weeks	visual analogue scale for pain minimum score 0 maximum score 10
Change in functional ability of the patient	Baseline, after 2 weeks and after 8 weeks	Bath Ankylosing Spondylitis Functional Index (BASFI) minimum score 0 maximum 100, Oswestry Disability Index (ODI) minimum 0 no disability, maximum 100 means complete disability
Change in spinal mobility	Baseline, after 2 weeks and after 8 weeks	Bath AS Metrology Index (BASMI) minimum score 0 maximum 50, modified Schober test less than 5 cm yield means limited mobility, Lateral lumbar flexion more than 55 cm yield means limited lateral flexion
Change in ASDAS- CRP score	Baseline, after 2 weeks and after 8 weeks	≥ 1.1 reduction in the initial score, less than 1.3 inactive disease, between 1.3 and 2.1 moderate, between 2.1-3.5 high disease activity, \> 3.5 very high disease activty

Trial Locations

Locations (1)

Sohag university; 🇪🇬 Sohag, Egypt