Photobiomodulation for the Management of Temporomandibular Disorder Pain

Not Applicable

Terminated

• Conditions: Pain Related to TMD

• Registration Number: NCT04415281
• Lead Sponsor: University of Florida

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-06-02
• Study First Posted: 2020-06-04
• Study Start: 2021-04-28
• Primary Completion: 2022-12-16
• Study Completion: 2022-12-16
• Results First Submitted: 2023-08-03
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-11
• Last Update Submitted: 2023-10-11
• Results First Posted: 2023-10-12
• Last Update Posted: 2023-10-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable	Through study completion; an average of 10 weeks	Using a numerical rating scale (NRS) requires the patient to rate their pain on a defined scale 0=no pain and 100=the most intense pain imaginable to rate the average daily pain from Daily Pain \& Symptom Dairy over one week prior to V1 will be compared to the average daily pain one week prior to V8.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States