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Photobiomodulation for Management of Temporomandibular Disorder Pain (ULLTRA)

Primary Purpose

Pain Related to TMD

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
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: 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 Exclusion Criteria: 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

Sites / Locations

  • University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Experimental: 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
The primary outcome measure will be the average of daily pain ratings on the numerical rating scale (0 = no pain, 100 = worst pain imaginable) from the Daily Symptom Diary. Daily pain ratings averaged over one week prior to randomization will be treated as the baseline variable. The average daily pain for one week prior to Visit 9 will be treated as the primary endpoint. This outcome measure averaged across multiple days provides a stable measure of pain that is less subject to recall bias.

Secondary Outcome Measures

Full Information

First Posted
June 14, 2023
Last Updated
August 15, 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
NCT05916235
Brief Title
Photobiomodulation for Management of Temporomandibular Disorder Pain
Acronym
ULLTRA
Official Title
Photobiomodulation for Management of Temporomandibular Disorder Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2028 (Anticipated)
Study Completion Date
October 2028 (Anticipated)

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. 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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: 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.
Primary Outcome Measure Information:
Title
Pain Level Change with PBM treatment using a Numerical Rating Scale
Description
The primary outcome measure will be the average of daily pain ratings on the numerical rating scale (0 = no pain, 100 = worst pain imaginable) from the Daily Symptom Diary. Daily pain ratings averaged over one week prior to randomization will be treated as the baseline variable. The average daily pain for one week prior to Visit 9 will be treated as the primary endpoint. This outcome measure averaged across multiple days provides a stable measure of pain that is less subject to recall bias.
Time Frame
Through study completion; about 6 months

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: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Weber, CCRP
Phone
352-273-7802
Email
ebweber@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Siegrist, MS, BASDH
Phone
352-273-5964
Email
jsiegrist@dental.ufl.edu
Facility Information:
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Weber, CCRP
Phone
352-273-7802
Email
ebweber@ufl.edu
First Name & Middle Initial & Last Name & Degree
Julie Siegrist, MS, BASDH
Phone
352-273-5964
Email
jsiegrist@dental.ufl.edu
First Name & Middle Initial & Last Name & Degree
Margarete Ribeiro-Dasilva, DDS, MS, Ph.D

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Photobiomodulation for Management of Temporomandibular Disorder Pain

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