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

Not Applicable

Completed

• Conditions: Lumbar Medial Branch Neurotomy; Lumbar Facet Joint Pain
• Interventions: Other: PAIN REDUCTION ON VAS/NRS

• Registration Number: NCT03491618
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2018-03-09
• Study First Submitted: 2018-04-02
• Study First Submitted QC: 2018-04-06
• Study First Posted: 2018-04-09
• Primary Completion: 2019-12-10
• Study Completion: 2019-12-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PARALLEL	PAIN REDUCTION ON VAS/NRS	Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy.
PERPENDICULAR	PAIN REDUCTION ON VAS/NRS	Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy.

Primary Outcome Measures

Name	Time	Method
PAIN REDUCTION ON VAS/NRS	1-3-6 months	Reduction in pain, at 1,3 and 6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain