Ultrasound Guided Epidural Block in Axial SPA

April 3, 2020 updated by: Ahmed Mahrous, Sohag University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82749
        • Sohag University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in pain
Time Frame: Baseline, after 2 weeks and after 8 weeks
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
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
Baseline, after 2 weeks and after 8 weeks
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
Baseline, after 2 weeks and after 8 weeks
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
Baseline, after 2 weeks and after 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2019

Primary Completion (Actual)

January 12, 2020

Study Completion (Actual)

February 12, 2020

Study Registration Dates

First Submitted

October 26, 2019

First Submitted That Met QC Criteria

October 28, 2019

First Posted (Actual)

October 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 7, 2020

Last Update Submitted That Met QC Criteria

April 3, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20/10/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The consent form does not include this item

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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