RECRUITING

Photobiomodulation for Management of Temporomandibular Disorder Pain

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.

Official Title

Photobiomodulation for Management of Temporomandibular Disorder Pain

Quick Facts

Study Start:2024-02-08

Study Completion:2028-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05916235

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female, aged 18 years and older * Meets the CATI pre-screening criteria during pre-screening visit \[participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)\]. * Willing to provide signed and dated informed consent * Willing to to comply with all study procedures and to be available for the duration of the study * Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0 * Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100	* Active rheumatologic disease * Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, hyperthyroidism, fibromyalgia, or uncontrolled seizures) that precludes participation as determined by the investigator * Initiated occlusal appliance therapy within 30 days prior to CATI * Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI * Is in active orthodontic treatment * Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI * Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI * Has a history of psychiatric hospitalization within one year prior to CATI * Currently pregnant or lactating * Has a known hypersensitivity to laser therapy * Currently being treated with chemotherapy or radiation therapy * Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit * Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit. * Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator

Inclusion Criteria

Exclusion Criteria

* Male or female, aged 18 years and older
* Meets the CATI pre-screening criteria during pre-screening visit \[participant-reported facial pain for at least 3 months and an average pain intensity rating for the week preceding CATI of ≥30 on a numerical rating scale (NRS, 0-100)\].
* Willing to provide signed and dated informed consent
* Willing to to comply with all study procedures and to be available for the duration of the study
* Meets diagnostic criteria for TMD (Masticatory Muscle disorder, 1 A: Myalgia) during Visit 0
* Completes a minimum of 4 of 7 daily symptom diary (DSD) entries prior to Visit 1 (Randomization visit), and the weekly average pain score on this DSD is ≥30 of 100

* Active rheumatologic disease
* Has a medical condition, laboratory finding, or physical exam finding (e.g., renal failure or dialysis, uncontrolled diabetes mellitus, hyperthyroidism, fibromyalgia, or uncontrolled seizures) that precludes participation as determined by the investigator
* Initiated occlusal appliance therapy within 30 days prior to CATI
* Initiated non-pharmacologic therapy, such as acupuncture, biofeedback, and/or TENS within 30 days prior to CATI
* Is in active orthodontic treatment
* Received any injection therapy (e.g., tender or trigger point injections, steroid injections) for the management of pain within 14 days prior to the CATI
* Has a history of facial trauma or orofacial surgery within 6 weeks prior to CATI
* Has a history of psychiatric hospitalization within one year prior to CATI
* Currently pregnant or lactating
* Has a known hypersensitivity to laser therapy
* Currently being treated with chemotherapy or radiation therapy
* Is undergoing treatment with another investigational drug or treatment initiated within 30 days prior to the Screening and Baseline Visit
* Initiated a new daily prescribed or over-the counter medication for the management of pain within 30 days prior to Screening and Baseline Visit.
* Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study as determined by the investigator

Contacts and Locations

Study Contact

Selenia Rubio, MD

CONTACT

352-273-5590

srubio7@ufl.edu

Eric Weber, CCRP

CONTACT

352-273-7802

ebweber@ufl.edu

Study Locations (Sites)

University of Florida

Gainesville, Florida, 32610

United States

Collaborators and Investigators

Sponsor: University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-08

Study Completion Date2028-10

Study Record Updates

Study Start Date2024-02-08

Study Completion Date2028-10

Terms related to this study

Additional Relevant MeSH Terms

Pain Related to TMD