NCT05949970

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

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

Study Start

First participant enrolled

July 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

1 month

First QC Date

July 10, 2023

Last Update Submit

March 23, 2025

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 lumbar facet jointPROCEDURE

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

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
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 lumbar 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
MD PhD LLM, Scientific Director of the Center for Pain Therapy

Study Record Dates

First Submitted

July 10, 2023

First Posted

July 18, 2023

Study Start

July 1, 2023

Primary Completion

July 31, 2023

Study Completion

July 31, 2023

Last Updated

March 26, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)