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
Verified date | April 2021 |
Source | ChairsideSplint.com |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.
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 - |
Country | Name | City | State |
---|---|---|---|
United States | Boyd James | Solana Beach | California |
Lead Sponsor | Collaborator |
---|---|
ChairsideSplint.com |
United States,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT04520425 -
Osteopathic Manipulative Techniques for the Treatment of Chronic Migraine Headaches
|
N/A | |
Recruiting |
NCT06247592 -
Pulse Radiofrequency and Occipital Nerve Block for Chronic Migraine Patients
|
N/A | |
Recruiting |
NCT06133491 -
Open Label, 6-month Study for High Frequency and Chronic Migraine,
|
||
Recruiting |
NCT04989413 -
Cannabidiol 133mg + Cannabigerol 66mg + Tetrahydrocannabinol 4mg vs Placebo as Adjuvant Treatment in Chronic Migraine -
|
Phase 4 | |
Recruiting |
NCT06138171 -
Personality, Defences, Central Sensitization, and Trauma in Women With Chronic Migraine, Fibromyalgia, and Vulvodynia
|
||
Active, not recruiting |
NCT06109389 -
The Efficacy Of Lidocaine Infusion IN Chronic Unilateral Migraine Headache
|
Phase 2 | |
Withdrawn |
NCT01749423 -
A Retrospective Study to Evaluate the Effectiveness of onabotulinumtoxinA in Preventing Headaches in Patients With Chronic Migraines
|
N/A | |
Terminated |
NCT04349176 -
Onabotulinum Dose Comparison in Chronic Migraine Superior to 100 Units?
|
Phase 3 | |
Completed |
NCT05381129 -
The Effect of Accompanying Temporomandibular Joint Dysfunction in Patients With Chronic Migraine
|
N/A | |
Completed |
NCT05381012 -
Fibromyalgia Syndrome on Patients With Chronic Migraine
|
N/A | |
Withdrawn |
NCT03465826 -
Developing a Mobile Health Pain-Coping Skills Training Program for the Treatment of Chronic Migraine: AIM 4
|
N/A | |
Completed |
NCT03767062 -
Peripheral Nerve Block and Topiramate in the Treatment of Medication Overuse Headaches
|
N/A | |
Completed |
NCT05748535 -
Effect of Auricular Vagus Nerve Stimulation in Women With Migraine Disease
|
N/A | |
Recruiting |
NCT05724771 -
COACT Study: CGRPmAbs + OnabotulinumtoxinA Assessment of Chronic Migraine Treatments Study
|
Phase 4 | |
Recruiting |
NCT05313503 -
KETOMIGRAINE: Ketogenic Diet in Drug-resistant Chronic Migraineurs
|
N/A | |
Recruiting |
NCT05079659 -
Rate , Predictors and Outcome of Chronic Migraine
|
||
Completed |
NCT03698409 -
Onabotulinumtoxin Type A Reconstitution With Preserved Versus Preservative-free Saline in Chronic Migraine.
|
Phase 4 | |
Completed |
NCT06118190 -
Mesotherapy in the Treatment of Chronic Migraine
|
N/A | |
Completed |
NCT04017741 -
A Study Investigating the Efficacy of GON Blocks.
|
Phase 4 | |
Completed |
NCT05679908 -
A Study to Evaluate the Efficacy and Safety of TNX-1900 in Patients With Chronic Migraine
|
Phase 2 |