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

NCT ID: NCT03491618

Last Updated: 2020-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-09

Study Completion Date

2019-12-20

Brief Summary

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

Detailed Description

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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.

Conditions

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Lumbar Facet Joint Pain Lumbar Medial Branch Neurotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective comparative study.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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PARALLEL

Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy.

Group Type ACTIVE_COMPARATOR

PAIN REDUCTION ON VAS/NRS

Intervention Type OTHER

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

PERPENDICULAR

Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy.

Group Type ACTIVE_COMPARATOR

PAIN REDUCTION ON VAS/NRS

Intervention Type OTHER

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

Interventions

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PAIN REDUCTION ON VAS/NRS

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Investigación Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Universitario La Paz

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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HULP5017

Identifier Type: -

Identifier Source: org_study_id

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