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Radiofrequency Neurotomy for Chronic Facet Joint Related Neck Pain

NCT03066960 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-12-11

No results posted yet for this study

Summary

This is a single-center, double blind, sham-controlled randomized trial (N: 34) to assess the long term efficacy of RF neurotomy of cervical medial branches. Patients with chronic unilateral neck pain who are found eligible and achieve ≥50% pain relief of two predictive and comparative test blocks will be included in the trial in a primary analysis. We will further test whether a strict selection of ≥80% pain relief better predicts efficacious RF neurotomy compared with a less strict selection of ≥50% to \<80%. After 6 months sham-treated patients may also be offered active unblinded RF treatment. Demographic and clinical data will be recorded at baseline while primary and secondary outcome measurements are recollected after 1, 3, 6, 9 and 12 months. Primary outcome measurements include self-reported neck function (NDI) and pain relief after 6 months.

Conditions

  • Neck Pain

Interventions

PROCEDURE

Radiofrequency neurotomy

RF neurotomy represents a nerve destructive, coagulating technique affecting the conduction through all nerve fibers.

PROCEDURE

Sham treatment

Sham treatment represents no coagulation of the nerve and will not affect the nerve conduction.

Sponsors & Collaborators

  • St. Olavs Hospital

    collaborator OTHER

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Gunnvald Kvarstein, Dr. Med · Oslo University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2024-12-14
Completion
2025-12-14

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03066960 on ClinicalTrials.gov