Facet Joint PainNCT05949970
The Lumbar Trident Study
An observational study of Facet Joint Pain, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
Trial summary
This observational retrospective study evaluates the efficacy of RF with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic lumbar facet joint pain. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Facet Joint Pain
- What is being tested?
- Radiofrequency denervation of the lumbar facet joint
- Type of treatment
- Surgery or procedure
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2023to 31 Jul 2023
- Phase
- Observational
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients that are treated with radiofrequency (RF) ablation of the facet joints in patients selected by symptom improvement with dual medial branch blocks.
Who may be able to join
- Age > 18 years old
- Patients with lumbar pain
- Patient who had two diagnostic medial branch blocks with significant (>50%) improvement on both injections
Who cannot join
- No patient related outcome measures available in hospital's patient charts
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Pain Management Center, Neurocenter of Southern Switzerland
Lugano
About this study
Official title: Lumbar Facet Joint Denervation with a Trident Electrode, a Retrospective Observational Study
This observational retrospective study evaluates the efficacy of RF with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic lumbar facet joint pain.
- Conditions
- Facet Joint Pain
- Being tested
- Radiofrequency denervation of the lumbar facet joint
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency denervation of the lumbar facet jointProcedure or surgery
Radiofrequency denervation of the medial branch of the dorsal ramus of the lumbar facet joint with a three-tined expandable needle.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measurement by numeric rating score
The primary outcome of this study is pain measured with the numeric rating score (NRS): 11-point NRS ranging from 0 (no pain at all) to 10 (the worst imaginable pain). A score of zero (0) will indicate that the patient is pain free, while a score of ten (10) will indicate that they are experiencing the worst pain imaginable.
Measured: 2 months after injection in comparison to baseline
Secondary outcomes (5)
Patient Global Impression of Change (PGIC)
The PGIC rating is increasingly being used for determining clinically important change in measures such as ratings of pain. This scale is designed to quantify patient's improvement or deterioration over time, usually either to determine the effect of an intervention or to chart the clinical course of a condition. The scales ask that a person assess his or her current pain, recall that status at a previous time-point, and then calculate the difference between the two.
Measured: 2 months after injection
Use of analgesics
The quantity of analgesics that the patient assumes for the pain:
- All stopped
- Decreased
- Equal
- Increased
Measured: 2 months after injection
Sleep
Question: "your sleep quality is:
- Improved
- Equal
- Worsened"
Measured: 2 months after injection
Walking ability
Question: "after the treatment, you can walk:
- More than before
- Same as before
- Less than before"
Measured: 2 months after injection
Patient satisfaction
Question: "are you satisfied with the result: YES/NO"
Measured: 2 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jul 2023
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Regionale di Lugano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano
- Investigators
- Eva Koetsier, MD PhD LLM, Principal investigator, Neurocenter of Southern Switzerland, EOC, Lugano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949970
- Sponsor's protocol ID
- The Lumbar Trident Study
- Status last verified
- Mar 2025
- First submitted
- 10 Jul 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumbar Facet Joint Denervation with a Trident Electrode, a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05949970
- Acronym / sponsor ID
- The Lumbar Trident Study
- Conditions
- Facet Joint Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Ospedale Regionale di LuganoUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Jul 2023 (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.
This observational retrospective study evaluates the efficacy of RF with the three-tined expandable electrode needle compared to before treatment in the treatment of chronic lumbar facet joint pain.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients that are treated with radiofrequency (RF) ablation of the facet joints in patients selected by symptom improvement with dual medial branch blocks.
Key inclusion criteria (3 listed)
- Age > 18 years old
- Patients with lumbar pain
- Patient who had two diagnostic medial branch blocks with significant (>50%) improvement on both injections
Key exclusion criteria (1 listed)
- No patient related outcome measures available in hospital's patient charts
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 |
|---|---|---|
| Radiofrequency denervation of the lumbar facet jointRadiofrequency denervation of the medial branch of the dorsal ramus of the lumbar facet joint with a three-tined expandable needle. | Procedure or surgery | – |
Primary outcome
Pain measurement by numeric rating score
Time frame: 2 months after injection in comparison to baseline
The primary outcome of this study is pain measured with the numeric rating score (NRS): 11-point NRS ranging from 0 (no pain at all) to 10 (the worst imaginable pain). A score of zero (0) will indicate that the patient is pain free, while a score of ten (10) will indicate that they are experiencing the worst pain imaginable.
5 secondary outcomes
Patient Global Impression of Change (PGIC)
Time frame: 2 months after injection
Use of analgesics
Time frame: 2 months after injection
Sleep
Time frame: 2 months after injection
Walking ability
Time frame: 2 months after injection
Patient satisfaction
Time frame: 2 months after injection
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 26 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Eva Koetsier, MD PhD LLM principal investigator
Neurocenter of Southern Switzerland, EOC, Lugano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Facet Joint Pain, run by Ospedale Regionale di Lugano at 1 site in Switzerland.
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 3 inclusion and 1 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 26 Mar 2025. 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 Switzerland. 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 measurement by numeric rating score (time frame: 2 months after injection in comparison to baseline). 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 26 Mar 2025.