The Lumbar Trident Study

• Sponsor: Ospedale Regionale di Lugano (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05949970
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Anticipated Duration (Months): 17.1
• Patients Per Site Per Month: 4.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Facet Joint Pain	Procedure: Radiofrequency denervation of the lumbar facet joint

Study Design

• Study Type: Observational
• Anticipated Enrollment: 80 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Lumbar Facet Joint Denervation With a Trident Electrode, a Retrospective Observational Study
• Anticipated Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2023
• Anticipated Study Completion Date: Dec 1, 2024

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. Use of analgesics [2 months after injection]

   The quantity of analgesics that the patient assumes for the pain: All stopped Decreased Equal Increased

3. Sleep [2 months after injection]

   Question: "your sleep quality is: Improved Equal Worsened"

4. Walking ability [2 months after injection]

   Question: "after the treatment, you can walk: More than before Same as before Less than before"

5. Patient satisfaction [2 months after injection]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pain Management Center, Neurocenter of Southern Switzerland	Lugano		Switzerland

Sponsors and Collaborators

• Ospedale Regionale di Lugano

Investigators

• Principal Investigator: Eva Koetsier, MD PhD LLM, Neurocenter of Southern Switzerland, EOC, Lugano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eva Koetsier MD PhD LLM, MD PhD LLM, Ospedale Regionale di Lugano
• ClinicalTrials.gov Identifier: NCT05949970
• Other Study ID Numbers: The Lumbar Trident Study
• First Posted: Jul 18, 2023
• Last Update Posted: Jul 18, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Arthralgia

Study Results

No Results Posted as of Jul 18, 2023