N/A
N=28
Research Study to Determine Sensitivity to Gentle Touch and Pressure During an Active Migraine Attack.
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT00329771 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Proportion of Subjects With Allodynia During a Migraine Attack — 15 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- No intervention: We are testing for the presence of allodynia (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects With Allodynia During a Migraine Attack |
15 | — |
Summary
Cutaneous allodynia (pronounced q-tane-ee-us all-o-din-ee-a) is common in migraine. It is a heightened skin sensitivity during an active migraine attack. Migraine attacks in patients who experience allodynia are more difficult to treat. This study intends to collect and evaluate data on the phenomenon of allodynia in patients with episodic migraine during an actual attack. The results of this study may help clinicians better understand allodynia, thereby helping them diagnose and more effectively manage patients with migraine and allodynia.
Eligibility Criteria
Inclusion Criteria
- Male and female patients aged 18-65, inclusive
- Diagnosis of episodic migraine with or without aura.
- Ability to read and understand an informed consent form and study procedures
Exclusion Criteria
- Patients with abnormal sensory findings on examination, or any known neurological disease that may affect skin sensation (peripheral neuropathy, multiple sclerosis, stroke, etc).
- Patients who suffer from headache (of any type) 15 or more days per month
- Patients who are cognitively impaired, as determined by investigator
- Patients with significant psychiatric disorder that may affect their understanding of the study protocol and/or their cooperation with the investigators.
- Patients who had taken any acute pain medication (e.g. triptans, ergots, NSAIDs, opioids, butalbital, acetaminophen) for any indication within 12 hours prior to allodynia testing.
- Patients with skin diseases that may cause abnormal skin sensation.
- Patients who had been treated with a nerve block in the 4 week period prior to allodynia testing Patients who had been treated with Botulinum neurotoxin within the 4 month period prior to allodynia testing
Data sourced from ClinicalTrials.gov (NCT00329771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.