Laser and electromagnetic combo targets back pain without drugs
NCT ID NCT07700433
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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22 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Active Edge Health
Columbus, Ohio, 43215, United States
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Novaré Medical and Wellness
Fort Myers, Florida, 33908, United States
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Pinnacle Integrative Orthopedics
Wichita Falls, Texas, 76301, United States
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Royal Spine Surgery
Scottsdale, Arizona, 85260, United States
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