Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00386880
First received: October 11, 2006
Last updated: November 11, 2010
Last verified: November 2010

October 11, 2006
November 11, 2010
August 2006
August 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00386880 on ClinicalTrials.gov Archive Site
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Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
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Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about the occurrence of phonophobia (increased sensitivity to sound) and allodynia may help us understand how the pain system works in migraine. It is hoped that the knowledge gained from this trial may enable us to more effectively treat patients with migraine headache.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Adult women and men with a diagnosis of episodic migraine

Migraine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

Inclusion criteria for migraine subjects:

  • Age: 18 - 65 years, inclusive.
  • Gender: male or female
  • Diagnosis: Episodic migraine with or without aura, as defined by the International Headache Society (IHS), for at least 6 months prior to enrollment.
  • An average of ≥1 migraine attack per month over the 6-month period prior to enrollment.
  • An average of <15 headache (of any type) days per month for the 6 months prior to enrollment.
  • Normal audiogram. (A hearing threshold of 20 dB or less at the frequency range of 200-8000Hz.).

Inclusion criteria for control subjects:

  • Age: 18 - 65 years, inclusive.
  • Gender: male or female
  • Non-headache sufferers with the exception of infrequent ETTH according to IHS criteria (lifetime occurrence of at least 10 episodes occurring on <1 day per month on average and <12 days per year)
  • Normal audiogram, (A hearing threshold of 20 dB or less at the frequency range of 200-8000Hz.).

Exclusion criteria for migraine subjects:

  • Any other headache diagnosis (e.g. cluster headache, hemicrania continua, post traumatic headache, etc.) except for episodic tension type headache (ETTH) with an average of no more than 10 ETTH headache days per month for the 6 months prior to enrollment (note: average <15 total HA days is specified in inclusion)
  • Use of any headache preventive drug (determined by investigator) in the 90 days prior to screening.
  • Treatment with botulinum toxin (for any indication) within the 90 day period prior to enrollment.
  • Treatment with occipital nerve block or block, or block of any other nerve in the head or neck area, within the 30 day period prior to enrollment.
  • Any dermatological disease that may affect skin sensation.
  • Any neurological disease that may affect sensory functions (e.g stroke, multiple sclerosis, peripheral neuropathy).
  • Cognitive disturbance that may affect the subject's ability to understand the study procedure.
  • Significant psychiatric disturbance that may impair the subject from co-operating with the study procedures.
  • Use of acute pain medications on a daily or frequent pattern (for any indication) as defined by the IHS.

Exclusion criteria for control subjects:

  • Any other headache diagnosis except for IHS-defined infrequent ETTH.
  • Use of any headache preventive drug (determined by investigator) in the 90 days prior to screening.
  • Treatment with botulinum toxin (for any indication) within the 90 day period prior to enrollment.
  • Treatment with occipital nerve block or block, or block of any other nerve in the head or neck area, within the 30 day period prior to enrollment.
  • Any dermatological disease that may affect skin sensation.
  • Any neurological disease that may affect sensory functions (e.g stroke, multiple sclerosis, peripheral neuropathy).
  • Cognitive disturbance that may affect the subject's ability to understand the study procedure.
  • Significant psychiatric disturbance that may impair the subject from co-operating with the study procedures.
  • Use of acute pain medications on a daily or frequent pattern (for any indication) as defined by the IHS.
Both
18 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00386880
AA-Phono-CA
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Abraham (Avi) Ashkenazi, MD- Principal Investigator
Thomas Jefferson University
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Principal Investigator: Abraham A. Ashkenazi, M.D. Thomas Jefferson University
Thomas Jefferson University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP