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The Lumbar Trident Study

Lumbar Facet Joint Denervation with a Trident Electrode, a Retrospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05949970
Enrollment
44
Registered
2023-07-18
Start date
2023-07-01
Completion date
2023-07-31
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facet Joint Pain

Brief 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.

Interventions

PROCEDURERadiofrequency denervation of the lumbar facet joint

Radiofrequency denervation of the medial branch of the dorsal ramus of the lumbar facet joint with a three-tined expandable needle.

Sponsors

Ospedale Regionale di Lugano
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Age \> 18 years old * Patients with lumbar pain * Patient who had two diagnostic medial branch blocks with significant (\>50%) improvement on both injections

Exclusion criteria

\- No patient related outcome measures available in hospital's patient charts

Design outcomes

Primary

MeasureTime frameDescription
Pain measurement by numeric rating score2 months after injection in comparison to baselineThe 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.

Secondary

MeasureTime frameDescription
Patient Global Impression of Change (PGIC)2 months after injectionThe 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.
Use of analgesics2 months after injectionThe quantity of analgesics that the patient assumes for the pain: * All stopped * Decreased * Equal * Increased
Sleep2 months after injectionQuestion: your sleep quality is: * Improved * Equal * Worsened
Walking ability2 months after injectionQuestion: after the treatment, you can walk: * More than before * Same as before * Less than before
Patient satisfaction2 months after injectionQuestion: are you satisfied with the result: YES/NO

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026