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
  Purpose

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.


Condition
Migraine

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Enrollment: 60
Study Start Date: August 2006
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Sampling Method:   Non-Probability Sample
Study Population

Adult women and men with a diagnosis of episodic migraine

Criteria

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.
  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: NCT00386880

Locations
United States, Pennsylvania
Jefferson Headache Center
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
Investigators
Principal Investigator: Abraham A. Ashkenazi, M.D. Thomas Jefferson University
  More Information

No publications provided

Responsible Party: Abraham (Avi) Ashkenazi, MD- Principal Investigator
ClinicalTrials.gov Identifier: NCT00386880     History of Changes
Other Study ID Numbers: AA-Phono-CA
Study First Received: October 11, 2006
Last Updated: November 11, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014