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NCT05916235 · ClinicalTrials.gov registry record · NA
Photobiomodulation for Management of Temporomandibular Disorder Pain
A NA study of Pain Related to TMD, sponsored by University of Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT05916235: Recruiting NA study of Pain Related to TMD, sponsored by University of Florida.
NCT05916235 is a NA study of Pain Related to TMD that is actively recruiting participants, run by University of Florida. The registered enrollment target is 130 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05916235, a NA study of Pain Related to TMD, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
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. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy of PBM for pain related to TMD.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE THOR® laser system
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2024-02-08 |
| Est. Completion | 2028-10 |
| Phase | NA |
What NCT05916235 shows while recruiting
NCT05916235 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Pain Related to TMD appearing as the primary indexed condition, and to 1 intervention - of which THOR® laser system is the first listed.
NCT05916235 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05916235 about?
NCT05916235 is a clinical study titled "Photobiomodulation for 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. This study will be a double-blind, sham-controlled, randomized trial testing the efficacy...
What is the current status of trial NCT05916235?
This trial is currently recruiting. It is a NA study. The enrollment target is 130 participants. The study started on 2024-02-08. Estimated completion is 2028-10.
What conditions does trial NCT05916235 study?
This clinical trial studies the following conditions: Pain Related to TMD.
What interventions are being tested in trial NCT05916235?
The interventions under investigation include: THOR® laser system (DEVICE).
Who is sponsoring clinical trial NCT05916235?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05916235 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05916235's enrollment target sits among peer trials
130 733rd of 2000 higher than 1,257 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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