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Ultrasound Guided Epidural Block in Axial SPA

Primary Purpose

Epidural Block in Axial Spondyloarthritis

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Epidural block with lidocaine and triamcinilone
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epidural Block in Axial Spondyloarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sohag university

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Epidural block

control group

Arm Description

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)

patients did not receive injection

Outcomes

Primary Outcome Measures

change in pain
visual analogue scale for pain minimum score 0 maximum score 10
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
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
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

Secondary Outcome Measures

Full Information

First Posted
October 26, 2019
Last Updated
April 3, 2020
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT04143165
Brief Title
Ultrasound Guided Epidural Block in Axial SPA
Official Title
Ultrasound Guided Epidural Block in Axial SPA Patient With Limited Spine Mobility: a Prospective Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 12, 2019 (Actual)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epidural Block in Axial Spondyloarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidural block
Arm Type
Active Comparator
Arm Description
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)
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients did not receive injection
Intervention Type
Drug
Intervention Name(s)
Epidural block with lidocaine and triamcinilone
Intervention Description
caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)
Primary Outcome Measure Information:
Title
change in pain
Description
visual analogue scale for pain minimum score 0 maximum score 10
Time Frame
Baseline, after 2 weeks and after 8 weeks
Title
Change in functional ability of the patient
Description
Bath Ankylosing Spondylitis Functional Index (BASFI) minimum score 0 maximum 100, Oswestry Disability Index (ODI) minimum 0 no disability, maximum 100 means complete disability
Time Frame
Baseline, after 2 weeks and after 8 weeks
Title
Change in spinal mobility
Description
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
Time Frame
Baseline, after 2 weeks and after 8 weeks
Title
Change in ASDAS- CRP score
Description
≥ 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
Time Frame
Baseline, after 2 weeks and after 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sohag university
City
Sohag
ZIP/Postal Code
82749
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The consent form does not include this item
Citations:
PubMed Identifier
33380574
Citation
Elsaman AM, Hamed A, Radwan AR. Ultrasound-guided epidural block in axial spondyloarthritis patients with limited spine mobility: a randomized controlled trial. Korean J Pain. 2021 Jan 1;34(1):114-123. doi: 10.3344/kjp.2021.34.1.114.
Results Reference
derived

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Ultrasound Guided Epidural Block in Axial SPA

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