A Research Study to Examine Cutaneous Allodynia and Cluster Headache

This study has been completed.
Sponsor:
Information provided by:
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00329836
First received: May 24, 2006
Last updated: July 21, 2011
Last verified: July 2011

May 24, 2006
July 21, 2011
August 2006
February 2008   (final data collection date for primary outcome measure)
Prevalence of Allodynia in Subjects With Cluster Headache [ Time Frame: Allodynia was assessed at the screening visit ] [ Designated as safety issue: No ]
Allodynia (discomfort to normal sensation) was assessed by brushing at constant rate of 2 brushes/sec and pressure allodynia with Von Frei hairs. Outcome (discomfort) was measured on a 100 mm visual analogue scale.
Not Provided
Complete list of historical versions of study NCT00329836 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Research Study to Examine Cutaneous Allodynia and Cluster Headache
Not Provided

This is a research study examining cutaneous allodynia and cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation when normally non-painful stimuli (e.g. light touch) are applied to the skin. Many studies have been performed looking at the presence of cutaneous allodynia in patients with migraines; however, few studies have examined it in cluster headache patients. There is still much to be learned about the brain and how it functions if the investigators are to understand the underlying causes of cluster headache. It is important to explore cutaneous allodynia in cluster headache as it may help guide physicians with the care of these individuals. Sixty patients will be screened for this study. Thomas Jefferson University is the only center enrolling patients in this research study.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Subjects with cluster headache

Cluster Headache
Other: There are no interventions in the observational study. The symptom of allodynia was measured.
No intervention. Description of allodynia testing appears elsewhere in this document
Subjects with cluster headache
Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
Intervention: Other: There are no interventions in the observational study. The symptom of allodynia was measured.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
41
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male and female patients aged 18-75, inclusive
  • Diagnosis of cluster headache, episodic or chronic.
  • Patients with episodic CH can be either in active cluster period or not.
  • Ability to read and understand an informed consent form, where the study protocol is described.

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 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 an acute pain medication within 24 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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00329836
CA/CH/01
No
Abraham A. Ashkenazi, MD, Doylestown Hospital
Thomas Jefferson University
Not Provided
Principal Investigator: Abraham A. Ashkenazi, M.D. Jefferson Headache Center/ thomas Jefferson University
Thomas Jefferson University
July 2011

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