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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03346252|
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Secondary Headache Disorder||Drug: Botulinum Toxin type A||Early Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open Label.|
|Masking:||None (Open Label)|
|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|
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
- Reduction in number of Headaches Attributed to TMD (HA) [ Time Frame: Every 12 weeks up to 1 year ]Self-report
- Reduction in Headache Impact Test-6 score (HIT-6) [ Time Frame: Every 12 weeks up to 1 year ]Self-report.
- Pressure Pain Threshold [ Time Frame: Every 12 weeks up to 1 year ]Using algometer at the temporalis and masseter muscles
- 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
- 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.
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT03346252
|Contact: Yoly M Gonzalez-Stucker, DDS, MS, MPHfirstname.lastname@example.org|
|Contact: Thomas Holmlund, MDemail@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Yoly M Gonzalez-Stucker, DDS, MS, MPH||University at Buffalo|