The Lumbar Trident Study

Completed

• Conditions: Facet Joint Pain

• Registration Number: NCT05949970
• Lead Sponsor: Ospedale Regionale di Lugano

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Study First Submitted: 2023-07-10
• Study First Submitted QC: 2023-07-10
• Study First Posted: 2023-07-18
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain measurement by numeric rating score	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 Outcome Measures

Name	Time	Method
Patient satisfaction	2 months after injection	Question: "are you satisfied with the result: YES/NO"
Walking ability	2 months after injection	Question: "after the treatment, you can walk: * More than before; * Same as before; * Less than before"
Use of analgesics	2 months after injection	The quantity of analgesics that the patient assumes for the pain: * All stopped; * Decreased; * Equal; * Increased
Sleep	2 months after injection	Question: "your sleep quality is: * Improved; * Equal; * Worsened"
Patient Global Impression of Change (PGIC)	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.

Trial Locations

Locations (1)

Pain Management Center, Neurocenter of Southern Switzerland; 🇨🇭 Lugano, Switzerland