Status:
TERMINATED
Photobiomodulation for the Management of Temporomandibular Disorder Pain
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Pain Related to TMD
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Photobiomodulation (PBM), is FDA-approved for temporary relief of muscle and joint pain, but there is no indication for TMD. Our goal in this study is to conduct a clinical trial of multimodal PBM for...
Eligibility Criteria
Inclusion
- Provides a signed and dated informed consent form
- Is at least 18 years of age (male or female and any race or ethnicity)
- Meets diagnostic criteria for TMD, ( Masticatory Muscle Disorders, 1A: Myalgia)
- Has experienced facial pain for at least 3 months
- At Screening and Baseline Visit (Visit 0), reports an average pain intensity rating over the past week of ≥ 30 on a numerical rating scale (0-100)
Exclusion
- Starting a new daily prescription medication for the management of pain within 30 days prior to treatment session;
- Use of any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 2 weeks prior to the CATI;
- Starting occlusal appliance therapy within 30 days prior to CATI; d) history of facial trauma or orofacial surgery within 6 weeks prior to CATI;
- Active orthodontic treatment;
- Psychiatric hospitalization within one year prior to screening.
- Has known hypersensitivity to laser therapy.
- Currently being treated with chemotherapy or radiation therapy
- Has been treated with another investigational drug or treatment within 30 days prior to the Screening and Baseline Visit
- Is pregnant or nursing
- Anything that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04415281
Start Date
April 28 2021
End Date
December 16 2022
Last Update
October 12 2023
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32610