Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

Chronic Migraine, Headache Clinical Trial

Official title:

Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device: Overview and Results of a Placebo-Controlled Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04871581
• Other study ID #: NTI v Placebo
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: April 2021
• Source: ChairsideSplint.com
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic -

Exclusion Criteria: none

-

Related Conditions & MeSH terms

• Chronic Migraine, Headache
• Headache
• Migraine Disorders

Intervention

Device:
• NTI-tss
FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
• Placebo
Similar to Device, but having no influence on clenching intensity

Locations

Country	Name	City	State
United States	Boyd James	Solana Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
ChairsideSplint.com

Country where clinical trial is conducted

United States, 

References & Publications (14)

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. — View Citation

Castillo J, Muñoz P, Guitera V, Pascual J. Kaplan Award 1998. Epidemiology of chronic daily headache in the general population. Headache. 1999 Mar;39(3):190-6. — View Citation

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. — View Citation

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. — View Citation

Goadsby PJ. Migraine pathophysiology. Headache. 2005 Apr;45 Suppl 1:S14-24. Review. — View Citation

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. Review. — View Citation

Graff-Radford SB. Oromandibular disorders and headache. A critical appraisal. Neurol Clin. 1990 Nov;8(4):929-45. Review. — View Citation

Lamey PJ, Barclay SC. Clinical effectiveness of occlusal splint therapy in patients with classical migraine. Scott Med J. 1987 Feb;32(1):11-2. — View Citation

Nishigawa K, Bando E, Nakano M. Quantitative study of bite force during sleep associated bruxism. J Oral Rehabil. 2001 May;28(5):485-91. — View Citation

Pascual J, Colás R, Castillo J. Epidemiology of chronic daily headache. Curr Pain Headache Rep. 2001 Dec;5(6):529-36. Review. — View Citation

Rozen TD. Migraine prevention: what patients want from medication and their physicians (a headache specialty clinic perspective). Headache. 2006 May;46(5):750-3. — View Citation

Silberstein SD, Lipton RB. Chronic daily headache. Curr Opin Neurol. 2000 Jun;13(3):277-83. Review. — View Citation

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. — View Citation

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. Review. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of negative impact on life	At least a one-category improvement in subject's HIT-6 score	one month