Completed

NCT Number: NCT04143165

Ultrasound Guided Epidural Block in Axial SPA

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epidural Block in Axial Spondyloarthritis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sohag university

Sohag, 82749, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidural block with lidocaine and triamcinilone

Drug

caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)

Primary outcomes

change in pain

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Oct 29, 2019
Registry last updated: Apr 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.