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Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device | Active Comparator | Subjects receiving the FDA-cleared device |
|
| Placebo | Placebo Comparator | Subjects receiving the sham device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTI-tss | Device | FDA cleared device for prophylactic treatment of medically diagnosed migraine pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of negative impact on life | At least a one-category improvement in subject's HIT-6 score | one month |
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Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -
Exclusion Criteria: none
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boyd James | Solana Beach | California | 92075 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10871251 | Background | Silberstein SD, Lipton RB. Chronic daily headache. Curr Opin Neurol. 2000 Jun;13(3):277-83. doi: 10.1097/00019052-200006000-00008. | |
| 11676887 | Background | Pascual J, Colas R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001 Dec;5(6):529-36. doi: 10.1007/s11916-001-0070-6. |
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| ID | Term |
|---|---|
| D006261 | Headache |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Single blinded cross-over study
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Participants were advised that two different designs of device were being compared to each other.
| Placebo | Device | Similar to Device, but having no influence on clenching intensity |
|
| 16643577 | Background | Rozen TD. Migraine prevention: what patients want from medication and their physicians (a headache specialty clinic perspective). Headache. 2006 May;46(5):750-3. doi: 10.1111/j.1526-4610.2006.00429.x. |
| 15833086 | Background | Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. doi: 10.1111/j.1526-4610.2005.4501003.x. |
| 12207852 | Background | Graff-Radford SB, Newman AC. The role of temporomandibular disorders and cervical dysfunction in tension-type headache. Curr Pain Headache Rep. 2002 Oct;6(5):387-91. doi: 10.1007/s11916-002-0081-y. |
| 1800695 | Background | Steele JG, Lamey PJ, Sharkey SW, Smith GM. Occlusal abnormalities, pericranial muscle and joint tenderness and tooth wear in a group of migraine patients. J Oral Rehabil. 1991 Sep;18(5):453-8. doi: 10.1111/j.1365-2842.1991.tb01690.x. |
| 3563468 | Background | Lamey PJ, Barclay SC. Clinical effectiveness of occlusal splint therapy in patients with classical migraine. Scott Med J. 1987 Feb;32(1):11-2. doi: 10.1177/003693308703200105. |
| 9656905 | Background | Clark GT, Sakai S, Merrill R, Flack VF, McArthur D, McCreary C. Waking and sleeping temporalis EMG levels in tension-type headache patients. J Orofac Pain. 1997 Fall;11(4):298-306. |
| 2259320 | Background | Graff-Radford SB. Oromandibular disorders and headache. A critical appraisal. Neurol Clin. 1990 Nov;8(4):929-45. |
| 27656052 | Background | Yap AU, Chua AP. Sleep bruxism: Current knowledge and contemporary management. J Conserv Dent. 2016 Sep-Oct;19(5):383-9. doi: 10.4103/0972-0707.190007. |
| 11135025 | Background | Burnett CA, Fartash L, Murray B, Lamey PJ. Masseter and temporalis muscle EMG levels and bite force in migraineurs. Headache. 2000 Nov-Dec;40(10):813-7. doi: 10.1046/j.1526-4610.2000.00147.x. |
| 15189309 | Background | Chandu A, Suvinen TI, Reade PC, Borromeo GL. The effect of an interocclusal appliance on bite force and masseter electromyography in asymptomatic subjects and patients with temporomandibular pain and dysfunction. J Oral Rehabil. 2004 Jun;31(6):530-7. doi: 10.1111/j.1365-2842.2004.01377.x. |
| 11380790 | Background | Nishigawa K, Bando E, Nakano M. Quantitative study of bite force during sleep associated bruxism. J Oral Rehabil. 2001 May;28(5):485-91. doi: 10.1046/j.1365-2842.2001.00692.x. |
| 15613213 | Result | Castillo J, Munoz P, Guitera V, Pascual J. Kaplan Award 1998. Epidemiology of chronic daily headache in the general population. Headache. 1999 Mar;39(3):190-6. doi: 10.1046/j.1526-4610.1999.3903190.x. |
| 35246048 | Derived | Blumenfeld AM, Boyd JP. Adjunctive treatment of chronic migraine using an oral dental device: overview and results of a randomized placebo-controlled crossover study. BMC Neurol. 2022 Mar 4;22(1):72. doi: 10.1186/s12883-022-02591-8. |