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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03491618
Acronym
EARL
Enrollment
43
Registered
2018-04-09
Start date
2018-03-09
Completion date
2019-12-20
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Facet Joint Pain, Lumbar Medial Branch Neurotomy

Keywords

lumbar facet joint pain, Lumbar Medial Branch Neurotomy, Chronic Low Back Pain

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.

Interventions

OTHERPAIN REDUCTION ON VAS/NRS

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

Sponsors

Instituto de Investigación Hospital Universitario La Paz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Prospective comparative study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PAIN REDUCTION ON VAS/NRS1-3-6 monthsReduction in pain, at 1,3 and 6 months

Secondary

MeasureTime frameDescription
OSWESTRY DISABILITY INDEX1-3-6 monthsQuantify disability for low back pain.
ROLAND MORRIS1-3-6 monthsHealth status measure for low back pain
MEDICATION REDUCTION1-3-6 monthsPain medication reduction
WORKING STATUS1-3-6 monthsCHANGE IN WORKING STATUS

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026