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Laser device aims to zap away back pain without drugs

NCT ID NCT07661082

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device called BTL-043 that uses a combination of laser energy and TriHIL technology to treat back pain. Twenty-four adults with chronic back pain will receive four 30-minute treatment sessions over a few weeks. Researchers will measure changes in pain levels and disability using standard questionnaires up to three months after treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BTL-043 device (EMVITAL) using TriHIL technology with 1064 nm near-infrared laser
What this could lead to
If it works, this could offer a non-invasive, drug-free option for reducing chronic back pain and improving daily function.
What could go wrong
This is a very small, early study with only 24 participants and no comparison group, so results may not apply broadly. Pain relief may be temporary or no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

24 people

The number who actually took part.

Started

Aug 2024

Finished

Mar 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adult subjects seeking treatment for alleviating back pain, and expressing interest in treatment will be considered eligible for the study. * Enrollment of the subject will depend on meeting the following criteria: * Adults seeking alleviation of pain in the treatment area * Age 22 years and older * Voluntarily signed an informed consent form * Subject is willing to comply with study instructions, to return to the clinic for the required visits * Willingness to adhere to and continue current pain management plan * Subjects willing and able to maintain their regular (pre-procedure) diet, exercise, and therapy regimen without affecting significant change during study participation * Subject willing and able to abstain from partaking in any new treatments other than this study procedure to treat back pain * Women of child-bearing potential\* are required to use birth control measures during the whole duration of the study * Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Exclusion Criteria: * A potential subject who meets any of the following criteria will be excluded from participation in the study: * Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus * Ongoing pregnancy * Photosensitivity, medications affecting sensitivity to light * Tattoos or other highly-pigmented regions in the treated area * Corticosteroids or injections of the treated area within the last 3 months, long-term corticosteroids use * Anticoagulant therapy, bleeding disorders * Hemorrhage in the treated area * Application within 4 to 6 months after radiotherapy * Known or suspected malignancy, history of cancer or any type of malignancy * Febrile conditions, serious illness, chronic infection * Epilepsy * Sensory loss in the treatment area * Deep vein thrombosis

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Conditions

The condition(s) this trial relates to.

Back Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Aria Integrative Health

    Denver, Colorado, 80211, United States

  • River Oaks Hospital & Clinics

    Houston, Texas, 77027, United States

  • Royal Spine Surgery, Scottsdale, AZ, USA

    Scottsdale, Arizona, 85260, United States

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