Laser and electromagnetic combo targets back pain without drugs

NCT ID NCT07700433

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study tests whether two devices used together can reduce back pain. The BTL-043 device delivers near-infrared laser energy, and the BTL-899 device uses electromagnetic energy. Sixty adults with back pain will receive four treatment sessions and be followed for three months to measure changes in pain and daily function.

What this could mean

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

Active substance
a combination of two devices: BTL-043 (EMVITAL), which delivers near-infrared laser energy, and BTL-899 (EMSCULPT NEO), which delivers electromagnetic energy
What this could lead to
If successful, this could offer a non-invasive, drug-free option for reducing back pain and improving daily function.
What could go wrong
This is a small, early-stage study with no control group, so results may not be conclusive. The devices are already used for other purposes, but their effectiveness for back pain is not yet proven.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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: * Age 22 years and older * Voluntarily signed an informed consent form * Subject is willing to comply with study instructions and to return to the clinic for the required visits * Willingness to adhere to and continue pre-enrollment pain management plan * Subjects willing and able to maintain their regular (pre-procedure) diet, exercise, and therapy regimen without causing significant changes 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: * Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus * Ongoing pregnancy, postpartum and nursing period * 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 * Hemorrhagic conditions 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 and tendency to seizures * Sensory loss in the treatment area * Deep vein thrombosis * Electronic implants (such as cardiac pacemakers, defibrillators and neurostimulators) * Metal implants, bone fixation hardware, external metallic objects or electrical devices in the vicinity of the treated area * Drug pumps * Pulmonary insufficiency * Renal insufficiency * Cardiovascular diseases * Disturbance of temperature or pain perception * Septic conditions and empyema * Acute inflammations * Systemic or local infection such as osteomyelitis and tuberculosis * Contagious skin disease * Elevated body temperature * Graves' disease * Women using birth control in the form of a metal-containing intrauterine device (IUD) * Swollen or neoplastic tissues, space occupying lesions or skin eruptions in the treated area

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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

  • Active Edge Health

    Columbus, Ohio, 43215, United States

  • Novaré Medical and Wellness

    Fort Myers, Florida, 33908, United States

  • Pinnacle Integrative Orthopedics

    Wichita Falls, Texas, 76301, United States

  • Royal Spine Surgery

    Scottsdale, Arizona, 85260, United States

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