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NCT04415281 · ClinicalTrials.gov registry record · NA
Photobiomodulation for the Management of Temporomandibular Disorder Pain
A NA study, sponsored by University of Florida.
- Terminated
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT04415281: Clinical Trial NA study, sponsored by University of Florida.
NCT04415281 is a NA study that was terminated before completion, run by University of Florida. The registered enrollment target is 14 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04415281, a NA study, was terminated before completion, sponsored by University of Florida.
- TERMINATED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE THOR® laser system
- DEVICE sham THOR® laser system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-04-28 |
| Est. Completion | 2022-12-16 |
| Phase | NA |
Why NCT04415281 stopped before completion
NCT04415281 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which THOR® laser system is the first listed.
NCT04415281 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04415281 about?
NCT04415281 is a clinical study titled "Photobiomodulation for the Management of Temporomandibular Disorder Pain". 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 ...
What is the current status of trial NCT04415281?
This trial is currently terminated. It is a NA study. The enrollment target is 14 participants. The study started on 2021-04-28. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT04415281?
The interventions under investigation include: THOR® laser system (DEVICE), sham THOR® laser system (DEVICE).
Who is sponsoring clinical trial NCT04415281?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04415281's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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