Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03491618
Recruitment Status : Completed
First Posted : April 9, 2018
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Instituto de Investigación Hospital Universitario La Paz

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

Condition or disease Intervention/treatment Phase
Lumbar Facet Joint Pain Lumbar Medial Branch Neurotomy Other: PAIN REDUCTION ON VAS/NRS Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective comparative study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 9, 2018
Actual Primary Completion Date : December 10, 2019
Actual Study Completion Date : December 20, 2019

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.




Primary Outcome Measures :
  1. PAIN REDUCTION ON VAS/NRS [ Time Frame: 1-3-6 months ]
    Reduction in pain, at 1,3 and 6 months


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03491618


Locations
Layout table for location information
Spain
Hospital Universitario La Paz
Madrid, Spain, 28029
Sponsors and Collaborators
Instituto de Investigación Hospital Universitario La Paz

Layout table for additonal information
Responsible Party: Instituto de Investigación Hospital Universitario La Paz
ClinicalTrials.gov Identifier: NCT03491618    
Other Study ID Numbers: HULP5017
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Hospital Universitario La Paz:
lumbar facet joint pain
Lumbar Medial Branch Neurotomy
Chronic Low Back Pain
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms