Cluster Headache
Conditions
Brief summary
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.
Interventions
OTHERThere are no interventions in the observational study. The symptom of allodynia was measured.
No intervention. Description of allodynia testing appears elsewhere in this document
Sponsors
Thomas Jefferson University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Allodynia in Subjects With Cluster Headache | Allodynia was assessed at the screening visit | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects with cluster headache recruited from Jefferson Headache Center office practice or community. First subject enrolled 7/5/05. Last subject enrolled 6/9/06.
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Cluster Headache Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled. | 41 |
| Total | 41 |
Baseline characteristics
| Characteristic | Subjects With Cluster Headache |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants |
| Age, Continuous | 44.9 years STANDARD_DEVIATION 10.5 |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 41 |
| serious Total, serious adverse events | 0 / 41 |
Outcome results
Primary
Prevalence of Allodynia in Subjects With Cluster Headache
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.
Time frame: Allodynia was assessed at the screening visit
Population: All enrolled subjects were analyzed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Subjects With Cluster Headache | Prevalence of Allodynia in Subjects With Cluster Headache | 20 participants |