Lumbar Facet Joint PainEARLNCT03491618
Analgesic Effect of Different Positions and Canulae on Medial Branch Radiofrequency Denervation for Lumbar Zygapophyseal Joint Pain
A study testing PAIN REDUCTION ON VAS/NRS in people with Lumbar Facet Joint Pain and Lumbar Medial Branch Neurotomy, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
Trial summary
Prospective study to analyse pain reduction with two types of canulae and two types of placements for lumbar medial branch radiofrequency denervation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lumbar Facet Joint Pain, Lumbar Medial Branch Neurotomy
- What is being tested?
- PAIN REDUCTION ON VAS/NRS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSpain
- Study dates
- 9 Mar 2018to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low back pain of > 3 months
- 18-80 years
- VAS or NRS>6
- Positive controlled block
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Being tested
- PAIN REDUCTION ON VAS/NRS
- Keywords
- lumbar facet joint pain, Lumbar Medial Branch Neurotomy, Chronic Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PAIN REDUCTION ON VAS/NRSOther
Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.
| Study group | Role | What they receive |
|---|---|---|
| PARALLEL | Active comparator | Thick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy. Receives: Other: PAIN REDUCTION ON VAS/NRS |
| PERPENDICULAR | Active comparator | Thin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy. Receives: Other: PAIN REDUCTION ON VAS/NRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN REDUCTION ON VAS/NRS
Reduction in pain, at 1,3 and 6 months
Measured: 1-3-6 months
Secondary outcomes (4)
OSWESTRY DISABILITY INDEX
Quantify disability for low back pain.
Measured: 1-3-6 months
ROLAND MORRIS
Health status measure for low back pain
Measured: 1-3-6 months
MEDICATION REDUCTION
Pain medication reduction
Measured: 1-3-6 months
WORKING STATUS
CHANGE IN WORKING STATUS
Measured: 1-3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start9 Mar 2018
- Primary completion10 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Facet Joint PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective comparative study.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491618
- Sponsor's protocol ID
- HULP5017
- Acronym
- EARL
- Status last verified
- Jan 2020
- First submitted
- 2 Apr 2018
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03491618
- Acronym / sponsor ID
- EARL / HULP5017
- Keywords
- lumbar facet joint pain, Lumbar Medial Branch Neurotomy, Chronic Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Study start
- 9 Mar 2018 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective comparative study.
| Arm | Type | Receives |
|---|---|---|
| PARALLEL | Active comparator | Other: PAIN REDUCTION ON VAS/NRSThick canulae (18 gauge) placed parallel to Medial Branch under fluoroscopy. |
| PERPENDICULAR | Active comparator | Other: PAIN REDUCTION ON VAS/NRSThin canulae (22 gauge) placed perpendicular to Medial Branch under fluoroscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Low back pain of > 3 months
- 18-80 years
- VAS or NRS>6
- Positive controlled block
Key exclusion criteria (7 listed)
- Pregnancy
- Psichiatric disorders
- Not being able to fulfil questionnaires
- Body Mass Index>35
- Labor Litigation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PAIN REDUCTION ON VAS/NRSPain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance. | Other | PARALLEL, PERPENDICULAR |
Primary outcome
PAIN REDUCTION ON VAS/NRS
Time frame: 1-3-6 months
Reduction in pain, at 1,3 and 6 months
4 secondary outcomes
OSWESTRY DISABILITY INDEX
Time frame: 1-3-6 months
ROLAND MORRIS
Time frame: 1-3-6 months
MEDICATION REDUCTION
Time frame: 1-3-6 months
WORKING STATUS
Time frame: 1-3-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PAIN REDUCTION ON VAS/NRS in people with Lumbar Facet Joint Pain and Lumbar Medial Branch Neurotomy, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN REDUCTION ON VAS/NRS (time frame: 1-3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2020.