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Photobiomodulation for Temporomandibular Disorder Pain (ULLTRA Trial)
N/A
Recruiting
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; about 6 months
Awards & highlights
ULLTRA Trial Summary
This trial aims to test if light therapy can help relieve pain from TMD, a gum and jaw disorder. Double-blind, sham-controlled, randomized study used.
Who is the study for?
This trial is for adults over 18 with facial pain from Temporomandibular Disorder (TMD) lasting at least 3 months, and a weekly average pain score of ≥30 out of 100. Participants must meet specific diagnostic criteria for TMD, agree to the study's procedures, and be available throughout the study.Check my eligibility
What is being tested?
The trial tests Photobiomodulation (PBM) using the THOR® laser system for TMD-related pain. It's a double-blind study where participants are randomly assigned to receive either PBM or a sham treatment without knowing which one they're getting.See study design
What are the potential side effects?
While PBM is FDA-approved for temporary muscle and joint pain relief, potential side effects specific to this treatment in the context of TMD have not been detailed but may include discomfort or changes in sensation at the application site.
ULLTRA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; about 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; about 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain Level Change with PBM treatment using a Numerical Rating Scale
ULLTRA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Active PBMExperimental Treatment1 Intervention
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.
Group II: Sham PBMPlacebo Group1 Intervention
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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Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,516 Total Patients Enrolled
National Institute of Dental and Craniofacial Research (NIDCR)NIH
300 Previous Clinical Trials
848,214 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had facial pain for at least 3 months with a pain intensity of 30 or more.I started treatments like acupuncture or biofeedback within the last 30 days.I have an active rheumatic disease.I do not have any health conditions like severe kidney failure or uncontrolled diabetes that would stop me from joining.I started a new pain management medication within the last 30 days.I haven't had any injection for pain management in the last 14 days.I had facial surgery or injury within the last 6 weeks.I am 18 years old or older.I have been diagnosed with a jaw muscle disorder causing pain.I am currently undergoing chemotherapy or radiation therapy.I am willing and able to follow the study rules and attend all appointments.I started using a dental device for my jaw within the last 30 days.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Active PBM
- Group 2: Sham PBM
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this clinical experiment confined to those over a certain age?
"As the inclusion criteria states, this medical trial is only available to those aged 18-65. However, there are 7 trials for minors and 22 additional studies accessible for individuals above 65 years old."
Answered by AI
Has the FDA concluded its evaluation of Experimental: Active PBM?
"Our analysis identified Experimental: Active PBM as having an approximate safety rating of 2, given that there is currently only supportive evidence for its protective qualities but no data yet regarding efficacy."
Answered by AI
Is eligibility for this research trial open to me?
"This medical trial requires that participants have temporomandibular disorder and are between the ages of 18 to 65. At this time, 130 patients need to be sourced for enrollment."
Answered by AI
Are participants being recruited at this juncture for the experiment?
"Clinicaltrials.gov data reveals that this research project, posted October 1st 2023 and last modified on June 14th 2023 is not currently seeking participants. Nevertheless, there are 40 other clinical trials actively recruiting candidates at the present time."
Answered by AI
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