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

January 14, 2020 updated by: Instituto de Investigación Hospital Universitario La Paz

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

43

Phase

  • Not Applicable

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

  • Spain
      • Madrid, Spain, 28029
        • Hospital Universitario La Paz

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 to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PARALLEL
Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy.
Other: PAIN REDUCTION ON VAS/NRS
Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.
Active Comparator: PERPENDICULAR
Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy.
Other: PAIN REDUCTION ON VAS/NRS
Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAIN REDUCTION ON VAS/NRS
Time Frame: 1-3-6 months
Reduction in pain, at 1,3 and 6 months
1-3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OSWESTRY DISABILITY INDEX
Time Frame: 1-3-6 months
Quantify disability for low back pain.
1-3-6 months
ROLAND MORRIS
Time Frame: 1-3-6 months
Health status measure for low back pain
1-3-6 months
MEDICATION REDUCTION
Time Frame: 1-3-6 months
Pain medication reduction
1-3-6 months
WORKING STATUS
Time Frame: 1-3-6 months
CHANGE IN WORKING STATUS
1-3-6 months

Collaborators and Investigators

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

Sponsor

Instituto de Investigación Hospital Universitario La Paz

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)

March 9, 2018

Primary Completion (Actual)

December 10, 2019

Study Completion (Actual)

December 20, 2019

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 9, 2018

Study Record Updates

Last Update Posted (Actual)

January 18, 2020

Last Update Submitted That Met QC Criteria

January 14, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HULP5017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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