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Completed

NCT Number: NCT05949970

The Lumbar Trident 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.

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Key information

Conditions

Facet Joint Pain

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pain Management Center, Neurocenter of Southern Switzerland

Lugano, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency denervation of the lumbar facet joint

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Global Impression of Change (PGIC)

    Time frame: 2 months after injection

    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.

  2. Use of analgesics

    Time frame: 2 months after injection

    The quantity of analgesics that the patient assumes for the pain:

    • All stopped
    • Decreased
    • Equal
    • Increased

  3. Sleep

    Time frame: 2 months after injection

    Question: "your sleep quality is:

    • Improved
    • Equal
    • Worsened"

  4. Walking ability

    Time frame: 2 months after injection

    Question: "after the treatment, you can walk:

    • More than before
    • Same as before
    • Less than before"

  5. Patient satisfaction

    Time frame: 2 months after injection

    Question: "are you satisfied with the result: YES/NO"

Sponsors and collaborators

Lead sponsor

Ospedale Regionale di Lugano

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 18, 2023
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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