Ultrasound Guided Epidural Block in Axial SPA

Study Overview
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Brief Summary
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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.

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

Conditions
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Epidural Block in Axial Spondyloarthritis

Intervention / Treatment
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* Drug: Epidural block with lidocaine and triamcinilone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epidural block<br>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) | Drug: Epidural block with lidocaine and triamcinilone<br>* caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)<br>|
| No Intervention: control group<br>patients did not receive injection | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in pain | visual analogue scale for pain minimum score 0 maximum score 10 | Baseline, after 2 weeks and after 8 weeks | 
| 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 | 
| 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 | 
| 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 |