NCT03491618

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2019

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.8 years

First QC Date

April 2, 2018

Last Update Submit

January 14, 2020

Conditions

Lumbar Facet Joint PainLumbar Medial Branch Neurotomy

Keywords

lumbar facet joint painLumbar Medial Branch NeurotomyChronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • PAIN REDUCTION ON VAS/NRS

    Reduction in pain, at 1,3 and 6 months

    1-3-6 months

Secondary Outcomes (4)

  • OSWESTRY DISABILITY INDEX

    1-3-6 months

  • ROLAND MORRIS

    1-3-6 months

  • MEDICATION REDUCTION

    1-3-6 months

  • WORKING STATUS

    1-3-6 months

Study Arms (2)

PARALLEL

ACTIVE COMPARATOR

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

Other: PAIN REDUCTION ON VAS/NRS

PERPENDICULAR

ACTIVE COMPARATOR

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

Other: PAIN REDUCTION ON VAS/NRS

Interventions

PAIN REDUCTION ON VAS/NRSOTHER

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

PARALLELPERPENDICULAR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Low back pain of \> 3 months
  • years
  • VAS or NRS\>6
  • Positive controlled block

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, 28029, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective comparative study.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 9, 2018

Study Start

March 9, 2018

Primary Completion

December 10, 2019

Study Completion

December 20, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

ES(1)