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Ultrasound Guided Epidural Block in Axial SPA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04143165
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Mahrous, Sohag University

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.


Condition or disease Intervention/treatment Phase
Epidural Block in Axial Spondyloarthritis Drug: Epidural block with lidocaine and triamcinilone Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Ultrasound Guided Epidural Block in Axial SPA Patient With Limited Spine Mobility: a Prospective Pilot Randomized Controlled Trial
Actual Study Start Date : October 12, 2019
Actual Primary Completion Date : January 12, 2020
Actual Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. change in pain [ Time Frame: Baseline, after 2 weeks and after 8 weeks ]
    visual analogue scale for pain minimum score 0 maximum score 10

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04143165


Locations
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Egypt
Sohag university
Sohag, Egypt, 82749
Sponsors and Collaborators
Sohag University
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Responsible Party: Ahmed Mahrous, Associate professor, Sohag University
ClinicalTrials.gov Identifier: NCT04143165    
Other Study ID Numbers: 20/10/2019
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The consent form does not include this item

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action