CompletedNot Applicable

Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

United States81 participantsStarted 2012-08

Plain-language 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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

Exclusion criteria

✕. 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).

What they're measuring

Change in Average Occipital Pain 6 Weeks After the Start of Treatment

Timeframe: From baseline to 6 weeks after the start of treatment

Change in Worst Occipital Pain 6 Weeks After the Start of Treatment

Timeframe: From baseline to 6 weeks after the start of treatment

Change in Average Occipital Pain 6 Months After the Start of Treatment

Timeframe: From baseline to 6 months after the start of treatment

Change in Worst Occipital Pain 6 Months After the Start of Treatment

Timeframe: From baseline to 6 months after the start of treatment

Change in Average Occipital Pain 3 Months After the Start of Treatment

Timeframe: From baseline to 3 months after the start of treatment

Change in Worst Occipital Pain 3 Months After the Start of Treatment

Timeframe: From baseline to 3 months after the start of treatment

Change in Average Occipital Pain 2 Weeks After the Start of Treatment

Timeframe: From baseline to 2 weeks after the start of treatment

Trial details

NCT IDNCT01670825

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-02

Results submitted2016-08-10

View on ClinicalTrials.gov More Occipital Neuralgia trials