Status:
COMPLETED
The Effect of Botulinum Toxin A on Headache Attributed to TMD
Lead Sponsor:
State University of New York at Buffalo
Conditions:
Secondary Headache Disorder
Eligibility:
FEMALE
18-74 years
Phase:
EARLY_PHASE1
Brief Summary
This study will evaluate the effect of of botulinum toxin on the treatment of Headache Attributed to TMD.
Detailed Description
Temporomandibular Disorders (TMD) is a collective term, embracing a number of clinical problems that involve the masticatory muscles, the temporomandibular joint (TMJ) and the associated structures. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 8 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03346252
Start Date
May 8 2017
End Date
March 15 2021
Last Update
October 4 2022
Active Locations (1)
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1
University at Buffalo
Buffalo, New York, United States, 14214