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Completed

NCT Number: NCT03491618

Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain

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

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Key information

Conditions

Lumbar Facet Joint Pain Lumbar Medial Branch Neurotomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario La Paz

Madrid, 28029, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAIN REDUCTION ON VAS/NRS

Other

Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.

Primary outcomes

  1. PAIN REDUCTION ON VAS/NRS

    Time frame: 1-3-6 months

    Reduction in pain, at 1,3 and 6 months

Secondary outcomes

  1. OSWESTRY DISABILITY INDEX

    Time frame: 1-3-6 months

    Quantify disability for low back pain.

  2. ROLAND MORRIS

    Time frame: 1-3-6 months

    Health status measure for low back pain

  3. MEDICATION REDUCTION

    Time frame: 1-3-6 months

    Pain medication reduction

  4. WORKING STATUS

    Time frame: 1-3-6 months

    CHANGE IN WORKING STATUS

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Hospital Universitario La Paz

Other

Registry information

Official study title

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

Acronym: EARL

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 9, 2018
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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