Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

Completed · Not applicable · Has a placebo group

Conditions studied: Occipital Neuralgia

In brief

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.

Key facts

Study ID

NCT01670825

Run by

Johns Hopkins University

People needed

81

Starts

2012-08-01

Expected to finish

2015-02-01

Last updated by the study team

2017-03-01

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater or equal to 18 years
• Occipital neuralgia diagnosed based on history \& physical exam and diagnostic local anesthetic blocks, or migraine with occipital nerve(s) tenderness that responds to diagnostic blocks.
• a. Greater or equal to 50% relief based on diagnostic local anesthetic block of the greater and/ or lesser occipital nerves that lasts for at least 90 minutes with lidocaine or 3 hours with bupivacaine or ropivacaine 20
• Baseline Numerical Rating Scale average pain score > 4/10
• Frequency of greater or equal to 4/10 pain for at least 10 days per month

You may not qualify if…

• Untreated coagulopathy
• Automatic implantable cardiac defibrillator or pacemaker that cannot be temporarily disabled for medical reasons
• Previous pulsed radiofrequency
• Other sources of headache, such as tension-type headache, cervicogenic headache, migraine headache without occipital neuralgia, and other causes (e.g. tumors, congenital abnormalities etc.). Those that can be confused with ON must be excluded based on history and exam (e.g. cervicogenic headaches), symptoms (tension-type headache), response to blocks (all of the above); and lab work (temporal arteritis, which would be confirmed by biopsy after an elevated erythrocyte sedimentation rate).
• Serious medical or uncontrolled or severe psychiatric -

Where it is running

• Johns Hopkins — Baltimore, Maryland, United States
• Walter Reed National Military Medical Center — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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