N/A N=81 Randomized Quadruple-blind Treatment

Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

Occipital Neuralgia

Bottom Line

View on ClinicalTrials.gov: NCT01670825 ↗

Enrolled (actual)

Serious AEs

11.1%

Results posted

Mar 2017

Primary outcome: Primary: Change in Average Occipital Pain 6 Weeks After the Start of Treatment — 3.068; 3.738 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Pulsed radiofrequency (Procedure); Corticosteroid injection (Drug); Local anethestic injection (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Feb 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Average Occipital Pain 6 Weeks After the Start of Treatment	3.068; 3.738	—
PRIMARY Change in Worst Occipital Pain 6 Weeks After the Start of Treatment	5.354; 6.064	—
PRIMARY Change in Average Occipital Pain 6 Months After the Start of Treatment	4.312; 4.765	—
PRIMARY Change in Worst Occipital Pain 6 Months After the Start of Treatment	6.705; 7.541	—
PRIMARY Change in Average Occipital Pain 3 Months After the Start of Treatment	3.791; 4.441	—
PRIMARY Change in Worst Occipital Pain 3 Months After the Start of Treatment	5.850; 7.149	—
PRIMARY Change in Average Occipital Pain 2 Weeks After the Start of Treatment	2.495; 3.694	—
PRIMARY Change in Worst Occipital Pain 2 Weeks After the Start of Treatment	4.726; 5.846	—
PRIMARY Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment	3.392; 4.220	—
PRIMARY Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment	5.540; 6.650	—
PRIMARY Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment	3.678; 4.410	—
PRIMARY Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment	6.583; 6.825	—
PRIMARY Change in Overall Average Headache Pain 3 Months After the Start of Treatment	4.000; 4.694	—
PRIMARY Change in Overall Worst Headache Pain 3 Months After the Start of Treatment	6.522; 7.417	—
PRIMARY Change in Overall Average Headache Pain 6 Months After the Start of Treatment	6.761; 7.556	—
PRIMARY Change in Overall Worst Headache Pain 6 Months After the Start of Treatment	6.761; 7.556	—
SECONDARY Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale.	10.025; 8.132	—
SECONDARY Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.	9.539; 9.069	—
SECONDARY Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale.	9.256; 9.431	—
SECONDARY Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory	12.775; 10.842	—
SECONDARY Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory	11.333; 11.972	—
SECONDARY Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory	12.590; 12.250	—
SECONDARY Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week.	1.708; 1.810	—
SECONDARY Severe Headache Frequency for Occipital Neuralgia Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit	1.436; 1.436	—
SECONDARY Severe Headache Frequency for Migraine Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit	2.087; 2.263	—
SECONDARY Severe Headache Frequency for Occipital Neuralgia Headaches 3 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit	1.846; 1.919	—
SECONDARY Severe Headache Frequency for Migraine Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit	2.044; 2.368	—
SECONDARY Severe Headache Frequency for Occipital Neuralgia Headaches 6 Months After the Start of Treatment Measured Asking the Number of Severe Headache Days 1 Week Prior to Study Visit	2.128; 2.162	—
SECONDARY Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale	60.087; 59.553	—
SECONDARY Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale	59.718; 60.556	—
SECONDARY Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale	59.641; 61.389	—

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.

Eligibility Criteria

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.

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

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).
Serious medical or uncontrolled or severe psychiatric -

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01670825). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.