ClinicalTrials.gg
CompletedNCT03491618EARLUpdated Jan 18, 2020

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

An interventional study of PAIN REDUCTION ON VAS/NRS in Lumbar Facet Joint Pain and Lumbar Medial Branch Neurotomy, sponsored by Instituto de Investigación Hospital Universitario La Paz. Completed at 1 site in Spain. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-18.

Sponsored by Instituto de Investigación Hospital Universitario La Paz · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 31 studies in Arthralgia with a site in Spain — 7 open to participants now, 8 under way, 1 of them phase 3. Arthralgia · Spain.

Enrollment
15th of 24
43 · median 78
Started
2018
with 3 others
No phase
13 of 31
5 open now
Registered
8th of 31
by date
Lead sponsor
1 of 31
Instituto de Investigación Hospital Universitario La Paz

Among the 31 studies in Arthralgia with a site in Spain, this one is the 15th largest by enrollment of the 24 interventional ones that give a count, is one of 4 that started in 2018, is one of 13 with no phase, and was the 8th registered.

Arthralgia

277 studies on the registry are indexed under Arthralgia; 54 are open to participants now.

Browse Arthralgia studies →

Open to participants now

7 of the 31 studies in Arthralgia with a site in Spain are open now. Recruiting first, the newest first:

2 more — sign in →

All 7 open studies →

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 35 Arthralgia studies recruiting now, 18 (51%) set no upper age limit and 16 (46%) stop at 75 or younger; 1 takes children under 18; 9 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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02

Study summary

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

Read the 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.

03

Conditions studied

  • Lumbar Facet Joint Pain
  • Lumbar Medial Branch Neurotomy

Browse trials for

Keywords

  • lumbar facet joint pain
  • Lumbar Medial Branch Neurotomy
  • Chronic Low Back Pain
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Low back pain of > 3 months
  • 18-80 years
  • VAS or NRS>6
  • Positive controlled block

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Psichiatric disorders
  • Not being able to fulfil questionnaires
  • >35
  • Labor Litigation
  • Negative or non conclusive controlled block
  • Failed Back Surgery Syndrome
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Active comparator
    PARALLEL

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

    Other: PAIN REDUCTION ON VAS/NRS

  • Active comparator
    PERPENDICULAR

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

    Other: PAIN REDUCTION ON VAS/NRS

Interventions

  • OtherPAIN REDUCTION ON VAS/NRS

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

06

What researchers measure

Primary outcomes

  1. PAIN REDUCTION ON VAS/NRS

    Reduction in pain, at 1,3 and 6 months

    Time frame: 1-3-6 months

Secondary outcomes

  1. OSWESTRY DISABILITY INDEX

    Quantify disability for low back pain.

    Time frame: 1-3-6 months

  2. ROLAND MORRIS

    Health status measure for low back pain

    Time frame: 1-3-6 months

  3. MEDICATION REDUCTION

    Pain medication reduction

    Time frame: 1-3-6 months

  4. WORKING STATUS

    CHANGE IN WORKING STATUS

    Time frame: 1-3-6 months

07

Study locations

1 site
  • Hospital Universitario La Paz
    Madrid, 28029, Spain
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Dec 2019, 21 months.

Of 64 non-industry interventional studies with no phase under Arthralgia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 31. This study's 21 months is above that.

Counting every sponsor, half of 82 studies reached it within 14 months; a quarter within 4 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 2, 2018
First posted
Apr 9, 2018
StartActual
Mar 9, 2018
Primary completionActual
Dec 10, 2019
CompletionActual
Dec 20, 2019
Last update
Jan 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03491618
Responsible party
Sponsor
First posted
Apr 9, 2018
Start date
Mar 9, 2018
Primary completion
Dec 10, 2019
Completion
Dec 20, 2019
Last update
Jan 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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