Ultrasound Guided Epidural Block in Axial SPA

Epidural Block in Axial Spondyloarthritis Clinical Trial

Official title:

Ultrasound Guided Epidural Block in Axial SPA Patient With Limited Spine Mobility: a Prospective Pilot Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143165
• Other study ID #: 20/10/2019
• Status: Completed
• Phase: Phase 4
• Start date: October 12, 2019
• Est. completion date: February 12, 2020

Study information

• Verified date: April 2020
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 12, 2020
• Est. primary completion date: January 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epidural Block in Axial Spondyloarthritis
• Spondylarthritis

Intervention

Drug:
• Epidural block with lidocaine and triamcinilone
caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)

Locations

Country	Name	City	State
Egypt	Sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in pain	visual analogue scale for pain minimum score 0 maximum score 10	Baseline, after 2 weeks and after 8 weeks
Primary	Change in functional ability of the patient	Bath Ankylosing Spondylitis Functional Index (BASFI) minimum score 0 maximum 100, Oswestry Disability Index (ODI) minimum 0 no disability, maximum 100 means complete disability	Baseline, after 2 weeks and after 8 weeks
Primary	Change in spinal mobility	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	Baseline, after 2 weeks and after 8 weeks
Primary	Change in ASDAS- CRP score	= 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	Baseline, after 2 weeks and after 8 weeks