Chronic Migraine, Headache
Conditions
Keywords
single blinded study
Brief summary
Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.
Detailed description
In order to determine if nocturnal jaw clenching can be an influence on chronic migraine pain, the FDA cleared NTI (Nociceptive Trigeminal Inhibition) device with the Indications for Use of for prophylactic treatment of medically diagnosed migraine pain was compared to a similar device that had no influence on jaw clenching.The HIT-6 (Headache Impact Test) score was selected as the outcome measure, as the goal was to focus on improving disability in sufferer's lives, as in chronic migraine, changes in headache days may not be as helpful as improving disability.
Interventions
DEVICENTI-tss
FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
DEVICEPlacebo
Similar to Device, but having no influence on clenching intensity
Sponsors
ChairsideSplint.com
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Participants were advised that two different designs of device were being compared to each other.
Intervention model description
Single blinded cross-over study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Diagnosed with chronic migraine at a neurology clinic -
Exclusion criteria
none \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of negative impact on life | one month | At least a one-category improvement in subject's HIT-6 score |
Countries
United States
Outcome results
None listed