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Photobiomodulation for the Management of Temporomandibular Disorder Pain (PBM)

Primary Purpose

Pain Related to TMD

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
THOR® laser system
sham THOR® laser system
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Related to TMD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active PBM

Sham PBM

Arm Description

PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.

When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 15, 2020
Last Updated
October 11, 2023
Sponsor
University of Florida
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
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1. Study Identification

Unique Protocol Identification Number
NCT04415281
Brief Title
Photobiomodulation for the Management of Temporomandibular Disorder Pain
Acronym
PBM
Official Title
Photobiomodulation for the Management of Temporomandibular Disorder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Funding not secured
Study Start Date
April 28, 2021 (Actual)
Primary Completion Date
December 16, 2022 (Actual)
Study Completion Date
December 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Related to TMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active PBM
Arm Type
Experimental
Arm Description
PBM has been used clinically in the treatment of musculoskeletal and other pain conditions for over 30 years. Despite the low quality of the existing evidence, PBM has been increasingly used in other countries for the treatment of TMD. However, in the US PBM is not widely used for the treatment of TMD pain. Due to the multifactorial nature of chronic TMD pain, we propose that a multimodal PBM protocol targeting multiple pathophysiological mechanisms will be the optimal approach for PBM implementation in patients with TMD.
Arm Title
Sham PBM
Arm Type
Sham Comparator
Arm Description
When applying PBM therapy, there are some heating elements in the treatment device, and most of the sham treatment devices available do not offer this feature, which increases the likelihood of unblinding both the patient and the interventionist. The THOR® LX2.3 PBM machine includes this new feature, such that the sham condition mimics the heating activity of the active treatment.
Intervention Type
Device
Intervention Name(s)
THOR® laser system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham THOR® laser system
Intervention Description
sham THOR® laser system
Primary Outcome Measure Information:
Title
Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable
Description
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.
Time Frame
Through study completion; an average of 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margarete Ribeiro-Dasilva, DDS, MS, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Photobiomodulation for the Management of Temporomandibular Disorder Pain

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