- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04415281
Photobiomodulation for the Management of Temporomandibular Disorder Pain (PBM)
October 11, 2023 updated by: University of Florida
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- University of Florida
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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.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active PBM
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.
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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.
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Sham Comparator: Sham PBM
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.
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sham THOR® laser system
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Level Change With PBM Treatment Using a Numerical Rating Scale 0=no Pain and 100=the Most Intense Pain Imaginable
Time Frame: Through study completion; an average of 10 weeks
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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.
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Through study completion; an average of 10 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Margarete Ribeiro-Dasilva, DDS, MS, PhD, 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 Major Dates
Study Start (Actual)
April 28, 2021
Primary Completion (Actual)
December 16, 2022
Study Completion (Actual)
December 16, 2022
Study Registration Dates
First Submitted
April 15, 2020
First Submitted That Met QC Criteria
June 2, 2020
First Posted (Actual)
June 4, 2020
Study Record Updates
Last Update Posted (Actual)
October 12, 2023
Last Update Submitted That Met QC Criteria
October 11, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202000766
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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