Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

This study has been completed.
Sponsor:
Collaborators:
Naval Hospital San Diego
Landstuhl Regional Medical Center
Madigan Army Medical Center
Portsmouth Naval Hospital
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01670825
First received: August 19, 2012
Last updated: March 30, 2015
Last verified: March 2015
  Purpose

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.


Condition Intervention
Occipital Neuralgia
Procedure: Pulsed radiofrequency
Drug: Corticosteroid injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized, Double-blind, Comparative-effectiveness Study Comparing Corticosteroid Injections to Pulsed Radiofrequency for Occipital Neuralgia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Average occipital pain score [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score at 6 weeks after treatment


Secondary Outcome Measures:
  • Number of headache days with severe headache [ Time Frame: 6-weeks after treatment ] [ Designated as safety issue: No ]
    Number of days with headache greater or equal to 7/10 in past week

  • Depression [ Time Frame: 6-weeks after treatment ] [ Designated as safety issue: No ]
    Measurement of depression 6-weeks after treatment

  • Disability [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    Measurement of headache-related disability 6 weeks after treatment

  • Sleep [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    Measurement of sleep quality (insomnia) 6 weeks after treatment

  • Average occipital pain score [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 3 months after treatment

  • Number of days with severe headache [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    Number of days per week with headache greater or equal to 7/10 3 months post-treatment

  • Depression [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    Measurement of depression 3 months after treatment

  • Disability [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    Measurement of headache-related disability 3 months after treatment

  • Sleep [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    Measurement of sleep quality 3 months after treatment

  • Average occipital pain score [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 months after treatment

  • Average occipital pain score [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 months after treatment

  • Number of days with severe headache [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    Number of days per week with headache greater or equal to 7/10 6 months post-treatment

  • Depression [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    Measurement of depression 6 months after treatment

  • Disability [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    Measurement of headache-related disability 6 months after treatment

  • Sleep [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    Measurement of sleep quality 6 months after treatment

  • Worst occipital headache score [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 weeks after treatment

  • Worst occipital headache score [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 3 months after treatment

  • Worst occipital headache score [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 months after treatment

  • Worst occipital headache score [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 2 weeks after treatment

  • Worst occipital headache score [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 weeks after treatment

  • Worst overall headache score [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 2 weeks after treatment

  • Average overall headache score [ Time Frame: 2 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 2 weeks after treatment

  • Worst overall headache score [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 weeks after treatment

  • Average overall headache score [ Time Frame: 6 weeks after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 weeks after treatment

  • Worst overall headache score [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 3 months after treatment

  • Average overall headache score [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 3 months after treatment

  • Worst overall headache score [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 months after treatment

  • Average overall headache score [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]
    0-10 pain score 6 months after treatment


Enrollment: 80
Study Start Date: August 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pulsed radiofrequency + local anesthetic injection
Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve
Procedure: Pulsed radiofrequency
Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve
Active Comparator: Corticosteroid injection + sham pulsed radiofrequency
Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus "sham" pulsed radiofrequency
Drug: Corticosteroid injection
Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater or equal to 18 years
  2. 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

  3. Baseline Numerical Rating Scale average pain score > 4/10
  4. Frequency of greater or equal to 4/10 pain for at least 10 days per month

Exclusion Criteria:

  1. Untreated coagulopathy
  2. Automatic implantable cardiac defibrillator or pacemaker that cannot be temporarily disabled for medical reasons
  3. Previous pulsed radiofrequency
  4. 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).
  5. Serious medical or uncontrolled or severe psychiatric -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01670825

Locations
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21205
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Johns Hopkins University
Naval Hospital San Diego
Landstuhl Regional Medical Center
Madigan Army Medical Center
Portsmouth Naval Hospital
  More Information

Publications:
Responsible Party: Steven P. Cohen, Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01670825     History of Changes
Other Study ID Numbers: 373481-3
Study First Received: August 19, 2012
Last Updated: March 30, 2015
Health Authority: United States: Institional Review Board

Keywords provided by Johns Hopkins University:
Occipital neuralgia
corticosteroid injection
pulsed radiofrequency

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 26, 2015