Secondary Headache Disorder Clinical Trial
Official title:
The Effect of Botulinum Toxin A (BOTOX®) on Headache Attributed to TMD - An Open Label Trial
Verified date | September 2022 |
Source | State University of New York at Buffalo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the effect of of botulinum toxin on the treatment of Headache Attributed to TMD.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 15, 2021 |
Est. primary completion date | March 15, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 74 Years |
Eligibility | Inclusion Criteria: - Adults age 18 to 74 years old. - Participants with Headaches Attributed to TMD based on Diagnostic Criteria for TMD (DC-TMD) criteria. - A minimum of 15 headaches/events per month, for the last 3 months. - Average pain intensity in the last month of =5 (0 to 10 scale) where 0 is no pain and 10 is the worst pain ever. Exclusion Criteria: - Pregnancy - Participants with a history of neurological/neuromuscular disorders and bleeding disorders. - Participants taking prescribed analgesics, muscle relaxants, amino glycosides, or anticholinesterases. - Participants currently under BTX treatment. - Participants currently under active treatment for TMD during the last month, which includes physical therapy and pharmacological management. |
Country | Name | City | State |
---|---|---|---|
United States | University at Buffalo | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
State University of New York at Buffalo |
United States,
Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Group†. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in number of Headaches Attributed to TMD (HA) | Self-report | Every 12 weeks up to 1 year | |
Primary | Reduction in Headache Impact Test-6 score (HIT-6) | Self-report. | Every 12 weeks up to 1 year | |
Primary | Pressure Pain Threshold | Using algometer at the temporalis and masseter muscles | Every 12 weeks up to 1 year | |
Secondary | Graded Chronic Pain Scale (GCPS), 1 and 6 months score | This scale provides the characterization of chronic pain as well as disability associated to the chronic pain. This scale includes 3 items for pain intensity and 4 items for function, one item for number of days of pain.
Characteristic Pain Intensity (CPI): compute mean of items 2-4(pain right now, worst pain, average pain), and multiply by 10. Interference Score: compute mean of items 6-8 (daily activities, social activities, work activities), and multiply by 10. Interpretation Determination of Chronic Pain Grade Grade 0: (no pain, no disability) I Low intensity pain, without disability: (Less than 50 points in CPI and less than 3 point in disability) II: High Intensity pain, without disability: (Greater than or equal to 50 points in CPI and less than 3 point in disability III: Moderately limiting: N/A in CPI and 3-4 points in disability IV: Severely limiting: N/A in CPI and 5-6 points in disability |
Every 12 weeks up to 1 year | |
Secondary | Jaw Functional Limitation Scale | Comprised within a 20-item instrument. a single global score of "jaw functional limitation" can be computed as the mean of the available items. Sub-scale scores for each type of functional limitation are computed, as follows: Mastication: mean of items 1-6. Mobility: mean of items 7-10. Verbal and non-verbal communication: mean of items 13-20. Norms have not yet been established for this instrument. | Every 12 weeks up to 1 year | |
Secondary | Migraine Disability Assessment/ HA-TMD | This self reported instruments comprise 6 items and based on the number of days of disability a MIDAS level is calculated as follows:
0 to 5- MIDAS Grade I, Little or no disability 6 to 10- MIDAS Grade II, Mild disability 11 to 20- MIDAS Grade III, Moderate disability 21+ MIDAS Grade IV, Severe disability |
Every 12 weeks up to 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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