NCT05353465

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 cervical facet joint pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2022

Completed
21 days until next milestone

Study Start

First participant enrolled

May 20, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

14 days

First QC Date

April 23, 2022

Last Update Submit

November 7, 2023

Conditions

Facet Joint Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Patient Global Impression of Change (PGIC)

    2 months after injection

  • Use of analgesics

    2 months after injection

  • Sleep

    2 months after injection

  • Walking ability

    2 months after injection

  • Patient satisfaction

    2 months after injection

Interventions

Radiofrequency denervation of the cervical facet jointPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age \> 18 years old
  • Patients with neck pain
  • Patient who had two diagnostic medial branch blocks with significant (\>50%) improvement on both injections.

You may not qualify if:

  • \- No patient related outcome measures available in hospital's patient charts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pain Management Center, Neurocenter of Southern Switzerland

Lugano, Switzerland

Location

Study Officials

  • Eva Koetsier, MD PhD LLM

    Neurocenter of Southern Switzerland, EOC, Lugano

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pain Management Center, Neurocenter of Southern Switzerland, EOC

Study Record Dates

First Submitted

April 23, 2022

First Posted

April 29, 2022

Study Start

May 20, 2022

Primary Completion

June 3, 2022

Study Completion

July 3, 2022

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)