MedTrace Logo

Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

NCT01670825 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2017-03-01

Study results available
· View outcomes & findings →

Summary

The aim of this study is to determine whether pulsed radiofrequency or steroids are better for occipital neuralgia. Seventy-six patients with ON or migraine with tenderness over the occipital nerve who respond to occipital nerve blocks (hereafter included under the broad category "ON") will be randomized in a 1:1 ratio to receive either corticosteroid and local anesthetic injections (n=38) or local anesthetic and PRF of the occipital nerve(s) (n=38) for occipital neuralgia. Both patients and the treating \& evaluating physicians will be blinded. The first follow-up visit will be at 6 weeks. Patients who obtain significant pain relief will remain in the study. Those patients who fail to obtain any benefit will exit the study and be allowed to crossover to the other treatments or receive alternative care. The second follow-up will be at 3 months and the final follow-up will be at 6-months post-procedure.

Conditions

  • Occipital Neuralgia

Interventions

PROCEDURE

Pulsed radiofrequency

Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve

DRUG

Corticosteroid injection

Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve

DRUG

Local anethestic injection

Sponsors & Collaborators

  • United States Naval Medical Center, San Diego

    collaborator FED

  • Landstuhl Regional Medical Center

    collaborator FED

  • Madigan Army Medical Center

    collaborator FED

  • United States Naval Medical Center, Portsmouth

    collaborator FED

  • Johns Hopkins University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT01670825 on ClinicalTrials.gov