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Pulsed Radiofrequency vs. Steroid Injections for Occipital Neuralgia

This study has been completed.
Sponsor:
Collaborators:
United States Naval Medical Center, San Diego
Landstuhl Regional Medical Center
Madigan Army Medical Center
United States Naval Medical Center, Portsmouth
Information provided by (Responsible Party):
Steven P. Cohen, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01670825
First received: August 19, 2012
Last updated: January 10, 2017
Last verified: January 2017
  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
Drug: Local anethestic injection

Study Type: Interventional
Study Design: Allocation: Randomized
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:
  • Change in Average Occipital Pain 6 Weeks After the Start of Treatment [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Worst Occipital Pain 6 Weeks After the Start of Treatment [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    The change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Average Occipital Pain 6 Months After the Start of Treatment [ Time Frame: From baseline to 6 months after the start of treatment ]
    The change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Worst Occipital Pain 6 Months After the Start of Treatment [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Average Occipital Pain 3 Months After the Start of Treatment [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Worst Occipital Pain 3 Months After the Start of Treatment [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Average Occipital Pain 2 Weeks After the Start of Treatment [ Time Frame: From baseline to 2 weeks after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Worst Occipital Pain 2 Weeks After the Start of Treatment [ Time Frame: From baseline to 2 weeks after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Average Headache Pain 2 Weeks After the Start of Treatment [ Time Frame: From baseline to 2 weeks after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Worst Headache Pain 2 Weeks After the Start of Treatment [ Time Frame: From baseline to 2 weeks after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 2 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Average Headache Pain 6 Weeks After the Start of Treatment [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Worst Overall Headache Pain 6 Weeks After the Start of Treatment [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 6 weeks after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Average Headache Pain 3 Months After the Start of Treatment [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Worst Headache Pain 3 Months After the Start of Treatment [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 3 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Average Headache Pain 6 Months After the Start of Treatment [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.

  • Change in Overall Worst Headache Pain 6 Months After the Start of Treatment [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome measures the change in the numeric pain scale score from baseline to 6 months after treatment. The scale ranges from 0-10. The minimum score is 0 which is defined as no pain and the maximum score is 10, which is defined as the worst pain imaginable. The best possible outcome would be a 0. The worst possible outcome would be a 10.


Secondary Outcome Measures:
  • Change in the Presence of Insomnia 6 Weeks After the Start of Treatment Measured Using the Athens Insomnia Scale. [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.

  • Change in the Presence of Insomnia 3 Months After the Start of Treatment Measured Using the Athens Insomnia Scale. [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.

  • Change in the Presence of Insomnia 6 Months After the Start of Treatment Measured Using the Athens Insomnia Scale. [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome will measure the participant's perceived improvement in sleep using the Athens Insomnia Scale. Scores in this scale can range from 0 to 24. 0 being the best possible outcome and 24 being the worst possible outcome. A score greater than or equal to 6 indicates a presence of insomnia.

  • Change in the Severity of Depression 6 Weeks After the Start of Treatment Measured Using the Beck's Depression Inventory [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.

  • Change in the Severity of Depression 3 Months After the Start of Treatment Measured Using the Beck's Depression Inventory [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.

  • Change in the Severity of Depression 6 Months After the Start of Treatment Measured Using the Beck's Depression Inventory [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome will measure the change in severity of depression using the Beck's Depression Inventory. Scores in this inventory can range from 0 to 63. 0 being the best possible outcome and 63 being the worst possible outcome. A score between 14 and 19 indicates mild depression and a score greater than or equal 29 indicates severe depression.

  • Severe Headache Frequency for Migraine Headaches 6 Weeks After the Start of Treatment Measured Asking the Number of Severe Headaches in the Past Week. [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.

  • 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 [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.

  • 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 [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 3 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.

  • 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 [ Time Frame: 3 months ]
    This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.

  • 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 [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome will measure the number of days the patient has severe migraine headaches in the week (7 days) prior to the 6 month follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.

  • 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 [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome will measure the number of days the patient has severe occipital neuralgia headaches in the week (7 days) prior to the 6 week follow-up visit. A severe headache is defined as a headache with a score greater than or equal to 7 on the numeric pain scale.

  • Disability Due to Headaches 6 Weeks After the Start of Treatment Measured Using the Headache Impact Scale [ Time Frame: From baseline to 6 weeks after the start of treatment ]
    This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.

  • Disability Due to Headaches 3 Months After the Start of Treatment Measured Using the Headache Impact Scale [ Time Frame: From baseline to 3 months after the start of treatment ]
    This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.

  • Disability Due to Headaches 6 Months After the Start of Treatment Measured Using the Headache Impact Scale [ Time Frame: From baseline to 6 months after the start of treatment ]
    This outcome measures what the patient feels they cannot do because headaches. This outcome is measured using the Headache Impact Test. Scores in this test range from range from 36 to 78, with higher scores indicating greater negative impact. A score of less than 50 indicates minimal impact, while a score greater than or equal to 60 indicates headaches are severely impacting one's life.


Enrollment: 81
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
Drug: Local anethestic injection
Other Name: Local anethestic injection that both arms will receive
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
Drug: Local anethestic injection
Other Name: Local anethestic injection that both arms will receive

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
United States Naval Medical Center, San Diego
Landstuhl Regional Medical Center
Madigan Army Medical Center
United States Naval Medical Center, Portsmouth
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: August 10, 2016
Last Updated: January 10, 2017

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

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

ClinicalTrials.gov processed this record on March 24, 2017