The Cervical Trident Study

July 6, 2023 updated by: Eva Koetsier MD PhD LLM, Ospedale Regionale di Lugano

Cervicale Facet Joint Denervation With a Trident Electrode, a Retrospective Observational 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 cervical facet joint pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lugano, Switzerland
        • Pain Management Center, Neurocenter of Southern Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

All adult patients that are treated with radiofrequency (RF) ablation of the facet joints in patients selected by symptom improvement with dual medial branch blocks.

Description

Inclusion Criteria:

  • Age > 18 years old
  • Patients with neck 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months after injection in comparison to baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2 months after injection
Sleep
Time Frame: 2 months after injection

Question: 'your sleep quality is:

  • Improved
  • Equal
  • Worsened'
2 months after injection
Walking ability
Time Frame: 2 months after injection

Question: 'after the treatment, you can walk:

  • More than before
  • Same as before
  • Less than before'
2 months after injection
Patient satisfaction
Time Frame: 2 months after injection
Question: are you satisfied with the result: YES/NO
2 months after injection
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.

  • very much improved
  • much improved
  • minimally improved
  • no change
  • minimally worse
  • much worse
  • very much worse
2 months after injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Regionale di Lugano

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2022

Primary Completion (Actual)

June 3, 2022

Study Completion (Actual)

July 3, 2022

Study Registration Dates

First Submitted

April 23, 2022

First Submitted That Met QC Criteria

April 23, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 10, 2023

Last Update Submitted That Met QC Criteria

July 6, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • The Cervical Trident Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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