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Clinical Trials/NCT03491618
NCT03491618
Completed
Not Applicable

Evaluación de la Analgesia a Corto y Medio Plazo de Las Diferentes Posiciones y Tipos de Las cánulas de Radiofrecuencia, en la denervación Del Ramo Medial Del Nervio Dorsal Lumbar

Instituto de Investigación Hospital Universitario La Paz1 site in 1 country43 target enrollmentMarch 9, 2018
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ConditionsLumbar Facet Joint PainLumbar Medial Branch Neurotomy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lumbar Facet Joint Pain
Sponsor
Instituto de Investigación Hospital Universitario La Paz
Enrollment
43
Locations
1
Primary Endpoint
PAIN REDUCTION ON VAS/NRS
Status
Completed
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation.

Detailed Description

Patients who suffer from lumbar zygapophyseal joint pain often receive radiofrequency medial branch denervation as treatment. Many types if canulae exist, and many types of placing them in relation to the Medial Branch nerves (MB). The EARL study tries to compare the analgesic effect of thin canulae (22 gauge) placed perpendicular to MB to thicker canulae (18 gauge) placed parallel to MB.

Registry
clinicaltrials.gov
Start Date
March 9, 2018
End Date
December 20, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •Low back pain of \> 3 months
  • •18-80 years
  • •VAS or NRS\>6
  • •Positive controlled block

Exclusion Criteria

  • •Pregnancy
  • •Psichiatric disorders
  • •Not being able to fulfil questionnaires
  • •Body Mass Index\>35
  • •Labor Litigation
  • •Negative or non conclusive controlled block
  • •Failed Back Surgery Syndrome

Outcomes

Primary Outcomes

PAIN REDUCTION ON VAS/NRS

Time Frame: 1-3-6 months

Reduction in pain, at 1,3 and 6 months

Secondary Outcomes

  • MEDICATION REDUCTION(1-3-6 months)
  • OSWESTRY DISABILITY INDEX(1-3-6 months)
  • ROLAND MORRIS(1-3-6 months)
  • WORKING STATUS(1-3-6 months)

Study Sites (1)

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