Ultrasound Guided Epidural Block in Axial SPA

NCT ID: NCT04143165

Last Updated: 2020-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-12

Study Completion Date

2020-02-12

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.

Detailed Description

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Conditions

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Epidural Block in Axial Spondyloarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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)

Group Type ACTIVE_COMPARATOR

Epidural block with lidocaine and triamcinilone

Intervention Type DRUG

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

control group

patients did not receive injection

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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)

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mahrous

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag university

Sohag, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 33380574 (View on PubMed)

Other Identifiers

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20/10/2019

Identifier Type: -

Identifier Source: org_study_id

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