Back to resultsAnalgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain (EARL)
Primary Purpose
Lumbar Facet Joint Pain, Lumbar Medial Branch Neurotomy
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PAIN REDUCTION ON VAS/NRS
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Facet Joint Pain focused on measuring lumbar facet joint pain, Lumbar Medial Branch Neurotomy, Chronic Low Back Pain
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
Sites / Locations
- Hospital Universitario La Paz
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
PARALLEL
PERPENDICULAR
Arm Description
Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy.
Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy.
Outcomes
Primary Outcome Measures
PAIN REDUCTION ON VAS/NRS
Reduction in pain, at 1,3 and 6 months
Secondary Outcome Measures
OSWESTRY DISABILITY INDEX
Quantify disability for low back pain.
ROLAND MORRIS
Health status measure for low back pain
MEDICATION REDUCTION
Pain medication reduction
WORKING STATUS
CHANGE IN WORKING STATUS
Full Information
NCT ID
NCT03491618
First Posted
April 2, 2018
Last Updated
January 14, 2020
Sponsor
Instituto de Investigación Hospital Universitario La Paz
1. Study Identification
Unique Protocol Identification Number
NCT03491618
Brief Title
Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain
Acronym
EARL
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 9, 2018 (Actual)
Primary Completion Date
December 10, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Hospital Universitario La Paz
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Facet Joint Pain, Lumbar Medial Branch Neurotomy
Keywords
lumbar facet joint pain, Lumbar Medial Branch Neurotomy, Chronic Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective comparative study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PARALLEL
Arm Type
Active Comparator
Arm Description
Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy.
Arm Title
PERPENDICULAR
Arm Type
Active Comparator
Arm Description
Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy.
Intervention Type
Other
Intervention Name(s)
PAIN REDUCTION ON VAS/NRS
Intervention Description
Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.
Primary Outcome Measure Information:
Title
PAIN REDUCTION ON VAS/NRS
Description
Reduction in pain, at 1,3 and 6 months
Time Frame
1-3-6 months
Secondary Outcome Measure Information:
Title
OSWESTRY DISABILITY INDEX
Description
Quantify disability for low back pain.
Time Frame
1-3-6 months
Title
ROLAND MORRIS
Description
Health status measure for low back pain
Time Frame
1-3-6 months
Title
MEDICATION REDUCTION
Description
Pain medication reduction
Time Frame
1-3-6 months
Title
WORKING STATUS
Description
CHANGE IN WORKING STATUS
Time Frame
1-3-6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28029
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain
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