Photobiomodulation for the Management of Temporomandibular Disorder Pain

  • STATUS
    Recruiting
  • End date
    Mar 1, 2028
  • participants needed
    180
  • sponsor
    University of Florida
Updated on 4 June 2021

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 TMD pain. Also, we propose to determine if PBM-induced changes in inflammation contribute to PBM's analgesic effects. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

Details
Condition Pain Related to TMD
Treatment THOR® laser system, sham THOR® laser system
Clinical Study IdentifierNCT04415281
SponsorUniversity of Florida
Last Modified on4 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 Criteria

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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