The Lumbar Trident Study

Facet Joint Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05949970
• Other study ID #: The Lumbar Trident Study
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2023
• Source: Ospedale Regionale di Lugano
• Contact: Eva Koetsier, MD PhD LLM
• Phone: 0041918117590
• Email: eva.koetsier[@]usi.ch
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: July 31, 2023
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Facet Joint Pain

Intervention

Procedure:
• Radiofrequency 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.

Locations

Country	Name	City	State
Switzerland	Pain Management Center, Neurocenter of Southern Switzerland	Lugano

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Regionale di Lugano

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 months after injection in comparison to baseline
Secondary	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.	2 months after injection
Secondary	Use of analgesics	The quantity of analgesics that the patient assumes for the pain: All stopped; Decreased; Equal; Increased	2 months after injection
Secondary	Sleep	Question: "your sleep quality is: Improved; Equal; Worsened"	2 months after injection
Secondary	Walking ability	Question: "after the treatment, you can walk: More than before; Same as before; Less than before"	2 months after injection
Secondary	Patient satisfaction	Question: "are you satisfied with the result: YES/NO"	2 months after injection