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| Sponsored by: |
Department of Veterans Affairs |
|---|---|
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00018811 |
Purpose
Subjects with chronic migraine or tension headaches will receive 12 sessions of biofeedback or relaxation training after fulfilling screening, intake interviews, & psychological testing requirements. They will chart headache pain, anger level, & medication usage throughout baseline, treatment, and 3 month follow-up periods.
Migraine sufferers will receive a combination of progressive muscle relaxation training and thermal biofeedback (learning to warm hands). Subjects are randomly assigned to receive treatment either in the office with the therapist or from another room (where communication will be over a computer). The research is designed to compare the effectiveness of treatment based on location.
Tension headache sufferers will receive training in how to reduce their muscle tension levels. They will be randomly assigned to have equipment monitor muscle tension levels either in the forehead or shoulder regions.
The research is designed to compare the effectiveness of feedback to the forehead versus the shoulder muscles.
| Condition | Intervention |
|---|---|
|
Headache Migraine Tension Headache Stress Headache Vascular Headache |
Behavioral: Relaxation training & thermal biofeedback Behavioral: Surface EMG biofeedback |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Psychological Assessment and Treatment of Chronic Benign Headache |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Subjects must be at least 18 years old and have chronic headaches of any of the following types: migraine, coexisting migraine/tension, or tension. Participants must be intellectually intact and have no significant physical, neurological, or psychological problems. They must have seen a physician for their headaches within the past year. They must successfully complete screening/interview/testing process prior to admission to treatment.
All vascular headache subjects must meet the criteria for chronic migraine or coexisting migraine and tension type headache as set forth by the Headache Classification Committee of the International Headache Society.
All tension headache subjects must meet the criteria for either episodic or chronic tension headache set forth by the Headache Classification Committee, as well as the Ad Hoc Committee's criteria for tension headache.
Contacts and Locations More Information
| Study ID Numbers: | MHBS-001-99S2 |
| Study First Received: | July 3, 2001 |
| Last Updated: | January 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00018811 History of Changes |
| Health Authority: | United States: Federal Government |
|
Relaxation Techniques Behavior Therapy Feedback Psychophysiology |
|
Tension-Type Headache Vascular Headaches Vascular Diseases Stress Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases |
Cerebrovascular Disorders Headache Disorders Signs and Symptoms Headache Disorders, Secondary Migraine Disorders Headache Neoplasm Metastasis Neurologic Manifestations |
|
Tension-Type Headache Vascular Headaches Nervous System Diseases Vascular Diseases Central Nervous System Diseases Pain Headache Disorders, Primary Brain Diseases |
Cerebrovascular Disorders Headache Disorders Signs and Symptoms Headache Disorders, Secondary Migraine Disorders Headache Neurologic Manifestations Cardiovascular Diseases |
