Photobiomodulation for the Management of Temporomandibular Disorder Pain

Pain Related to TMD Clinical Trial

— PBM  

Official title:

Photobiomodulation for the Management of Temporomandibular Disorder Pain

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04415281
• Other study ID #: IRB202000766
• Status: Terminated
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: December 16, 2022

Study information

• Verified date: October 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 16, 2022
• Est. primary completion date: December 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain Related to TMD
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• THOR® laser system
We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.
• sham THOR® laser system
sham THOR® laser system

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable	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.	Through study completion; an average of 10 weeks