Meta description: This regulatory update summarizes a clinical trial on ClinicalTrials.gov that tests the acute effects of low level laser therapy on pain threshold and pain tolerance using a sham control. The record uses the acronym LLLT for low level laser therapy. Published February 19, 2026.
What is the trial investigating?
The study aims to determine if a device that provides low level laser therapy can affect pain threshold and pain tolerance in an acute pain setting. The design compares active therapy with a sham procedure to assess effects beyond placebo. The sponsor named in the record is the European University of Lefke, and recruitment is listed as ongoing.
What is the role of the sham control?
The sham arm serves to distinguish true therapeutic effects from placebo. The available text does not provide details on sham methods, but the presence of a sham arm indicates a blinded comparison.
Who is conducting and sponsoring?
The sponsor listed is the European University of Lefke. The record does not reveal additional sponsoring or collaborating organizations within the provided excerpt. Regulatory oversight may be applied by the sponsor and by local authorities as the study progresses.
What does sponsorship imply for oversight?
Sponsorship generally entails study oversight and compliance responsibilities. The trial on this topic will be evaluated under applicable medical device and clinical trial regulations. The wording here reflects the nature of a sponsor led study rather than claims about device performance.
What interventions are used?
The intervention involves a device delivering low level laser therapy. The comparator is a sham low level laser therapy procedure. The description in the source text specifies both arms but does not include device parameters or procedural details. No efficacy claims are made in this report.
What is a low level laser therapy device in this context?
In this context the term refers to a device used to deliver laser light at therapeutic levels. The text does not specify wavelength or dosage parameters. The inclusion of a sham arm is a standard technique in device trials to establish a blinded comparison.
What outcomes are measured?
The outcomes explicitly listed are pain threshold and pain tolerance. The focus is on acute pain, and the trial compares active therapy with a sham to determine if observed changes exceed placebo for these measures.
Are these outcomes patient centered?
Pain related measures are commonly used in clinical research and have direct relevance to patient experience. The source provides these two endpoints without expanding into additional effects.
What is the current status?
According to the record the study is recruiting. The sponsor remains the European University of Lefke. The ClinicalTrials.gov entry provides an overview of the trial arms and outcomes, and the status may change as recruitment continues.
What should readers do next?
Professionals should review the official record for complete details including inclusion criteria, locations, and contact information. Updates may occur as the study progresses.
FAQ
- What is the purpose of the trial? The trial aims to assess whether low level laser therapy can influence pain threshold and pain tolerance in acute pain conditions, using a sham control for comparison.
- What interventions are compared? The trial compares a device delivering low level laser therapy against a sham procedure.
- Who sponsors the study? The sponsor listed is the European University of Lefke.
- Where can official information be found? Official information is on the ClinicalTrials.gov page for NCT07422272.
Conclusion and implications for readers
This study represents an early stage in evaluating a therapeutic modality for acute pain. For device developers and clinicians, the trial signals regulatory attention to design and control in studies of low level laser therapy. Readers should monitor the official registry for updates on recruitment status, protocol details, and reported results if any become available.
Disclaimer
The information in this article is intended for professionals and is not legal advice. It summarizes publicly available trial data and does not provide regulatory opinions. Always consult official regulatory sources for binding guidance.
Announcement line
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07422272?term=medical+device