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.
Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.