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The Effect of Botulinum Toxin A on Headache Attributed to TMD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03346252
Recruitment Status : Unknown
Verified July 2017 by State University of New York at Buffalo.
Recruitment status was:  Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Information provided by (Responsible Party):
State University of New York at Buffalo

Brief Summary:
This study will evaluate the effect of of botulinum toxin on the treatment of Headache Attributed to TMD.

Condition or disease Intervention/treatment Phase
Secondary Headache Disorder Drug: Botulinum Toxin type A Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Botulinum Toxin A (BOTOX®) on Headache Attributed to TMD - An Open Label Trial
Actual Study Start Date : May 8, 2017
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox Headache

Arm Intervention/treatment
Experimental: Botulinum Toxin type A
Participants will be injected intramuscularly with total of 50 Units, 25 units of Botulinum A per temporalis muscle. The BTX injection will be prepared by dissolving 100 U vial in 2 ml of 0.9 % of Sodium Chloride (NaCl), yielding 25 U/ml. Each participant will receive 0.1 ml of BTX/NaCl mixture in 5 spots per temporalis muscle.
Drug: Botulinum Toxin type A

All the participants meeting the inclusion criteria will be seen for a total of 4 visits and 3 phone interviews. Participants will complete a set of self-reporting questionnaires, assessing the disability associated with Headaches Attributed to TMD, and other pain-related TMD diagnoses, the impact of headaches on the quality of life, and psychosocial distress questionnaires.

In addition, they will undergo 3 cycles of treatment, each 12 weeks apart.

Other Name: Botox

Primary Outcome Measures :
  1. Reduction in number of Headaches Attributed to TMD (HA) [ Time Frame: Every 12 weeks up to 1 year ]

  2. Reduction in Headache Impact Test-6 score (HIT-6) [ Time Frame: Every 12 weeks up to 1 year ]

  3. Pressure Pain Threshold [ Time Frame: Every 12 weeks up to 1 year ]
    Using algometer at the temporalis and masseter muscles

Secondary Outcome Measures :
  1. Graded Chronic Pain Scale (GCPS), 1 and 6 months score [ Time Frame: Every 12 weeks up to 1 year ]

    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

  2. Jaw Functional Limitation Scale [ Time Frame: Every 12 weeks up to 1 year ]
    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.

  3. Migraine Disability Assessment/ HA-TMD [ Time Frame: Every 12 weeks up to 1 year ]

    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Restricted to female due to: a) higher prevalence of the condition in this group and b) small sample size
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03346252

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Contact: Yoly M Gonzalez-Stucker, DDS, MS, MPH 716-829-3551
Contact: Thomas Holmlund, MD 716-250-2000

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United States, New York
University at Buffalo Recruiting
Buffalo, New York, United States, 14214
Contact: Yoly M Gonzalez-Stucker, DDS, MS, MPH    716-829-3551   
Sponsors and Collaborators
State University of New York at Buffalo
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Principal Investigator: Yoly M Gonzalez-Stucker, DDS, MS, MPH University at Buffalo

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Responsible Party: State University of New York at Buffalo Identifier: NCT03346252    
Other Study ID Numbers: STUDY00000054
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: July 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Headache Disorders
Headache Disorders, Secondary
Neurologic Manifestations
Signs and Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents