Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs

NCT ID: NCT00386880

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-09-30

Brief Summary

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.

Conditions

Migraine

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Subjects with episodic migraine with allodynia

These are subjects with episodic migraine with allodynia

Sounds

Intervention Type: OTHER

Subjects with episodic migraine without allodynia

Subjects with episodic migraine without allodynia

Sounds

Intervention Type: OTHER

Interventions

Sounds

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.).

• 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

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Abraham A. Ashkenazi, M.D.

Role: PRINCIPAL_INVESTIGATOR

Thomas Jefferson University

Locations

Jefferson Headache Center

Philadelphia, Pennsylvania, United States

Countries

United States

References

Ashkenazi A, Yang I, Mushtaq A, Oshinsky ML. Is phonophobia associated with cutaneous allodynia in migraine? J Neurol Neurosurg Psychiatry. 2010 Nov;81(11):1256-60. doi: 10.1136/jnnp.2009.198481. Epub 2010 Jun 20.

Reference Type: RESULT

PMID: 20562466 (View on PubMed)

Other Identifiers

AA-Phono-CA

Identifier Type: -

Identifier Source: org_study_id