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

Lumbar Facet Joint Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03491618
• Other study ID #: HULP5017
• Status: Completed
• Phase: N/A
• Start date: March 9, 2018
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2020
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 20, 2019
• Est. primary completion date: December 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Lumbar Facet Joint Pain
• Lumbar Medial Branch Neurotomy

Intervention

Other:
• PAIN REDUCTION ON VAS/NRS
Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.

Locations

Country	Name	City	State
Spain	Hospital Universitario La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PAIN REDUCTION ON VAS/NRS	Reduction in pain, at 1,3 and 6 months	1-3-6 months
Secondary	OSWESTRY DISABILITY INDEX	Quantify disability for low back pain.	1-3-6 months
Secondary	ROLAND MORRIS	Health status measure for low back pain	1-3-6 months
Secondary	MEDICATION REDUCTION	Pain medication reduction	1-3-6 months
Secondary	WORKING STATUS	CHANGE IN WORKING STATUS	1-3-6 months