Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs
This study has been completed.
Sponsor:
Thomas Jefferson University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00386880
First received: October 11, 2006
Last updated: August 4, 2014
Last verified: August 2014
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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 | Intervention |
|---|---|
| Migraine | Other: Sounds |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Prevalence of Phonophobia and Cutaneous Allodynia in Episodic Migraineurs |
Resource links provided by NLM:
Further study details as provided by Thomas Jefferson University:
Primary Outcome Measures:
- Correlation Between Phonophobia (Sound Sensitivity) and Allodynia (Skin Sensitivity) in Subjects With Episodic Migraine [ Time Frame: Subjects with or without allodynia return during a migraine attack and are tested for Phonophobia. ]Measurement of phonophobia: determine sound aversion threshold (SAT), measured in dB during a migraine attack in subjects with and in subjects without allodynia.
| Enrollment: | 38 |
| Study Start Date: | August 2006 |
| Study Completion Date: | September 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Subjects with episodic migraine with allodynia
These are subjects with episodic migraine with allodynia
|
Other: Sounds |
|
Subjects with episodic migraine without allodynia
Subjects with episodic migraine without allodynia
|
Other: Sounds |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00386880
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
Publications:
| Responsible Party: | Thomas Jefferson University |
| ClinicalTrials.gov Identifier: | NCT00386880 History of Changes |
| Other Study ID Numbers: |
AA-Phono-CA |
| Study First Received: | October 11, 2006 |
| Results First Received: | August 5, 2012 |
| Last Updated: | August 4, 2014 |
Additional relevant MeSH terms:
|
Hyperalgesia Hyperacusis Somatosensory Disorders Sensation Disorders Neurologic Manifestations |
Nervous System Diseases Signs and Symptoms Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on July 18, 2017


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