Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain

The study will evaluate the clinical efficacy and performance of the BTL-043 device for alleviating back pain. The study is a prospective, multi-center, open-label, single-arm study. Subjects will be required to complete four (4) treatment visits and two (2) follow-up visits. All of the study subjects will receive the treatment with the subject device. At the baseline visit, the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and the Quebec Back Pain Disability Index (QBPDS) will be administered. The subject's weight and height will be recorded. The treatment administration phase will consist of four (4) treatments, delivered 2-10 days apart. Therapy time is set to 30 minutes for each treatment. After the last treatment, the subjects will receive the ODI, QBPDS, and the Therapy Comfort Questionnaire to fill in along with the VAS. During the 1-month and 3-month follow-up visits, the subjects will fill in the Subject Satisfaction & Quality of Life Questionnaire, in addition to the ODI, QBPDS, and VAS. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits.

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Key information

Conditions

Back Pain Chronic Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Spine Surgery, Scottsdale, AZ, USA, Scottsdale, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Device: Treatment with BTL-043

Device

All patients received four treatment sessions with BTL-043, with treatment sessions spaced 2 to 10 days apart. The treatment was applied to the upper, middle, or lower back region based on pain location. BTL-043 uses the TriHIL technology, which combines 1064 nm near-infrared laser energy at a maximum power of 30 W delivered through a hands-free applicator.

Other names: EMVITAL

Primary outcomes

Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months

Time frame: Baseline and 3 months

Oswestry Disability Index (ODI) The ODI will be used to evaluate the presence and impact of pain on the subjects' lives. The Oswestry Disability Index is a validated questionnaire used in assessment of back related pain and its impact on daily life. It consists of ten (10) items in total. The final score (sum of all items) is then calculated as a percentage of maximum possible points (50). The higher the percentage, the greater the disability.
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months

Time frame: Baseline and 3 months

The Visual Analogue Scale (VAS) is a self-reported measure used to assess the intensity of back pain experienced by the participants in the treatment area. Participants rate their perceived pain level on a numerical scale ranging from 0 to 10. On this scale, 0 is equivalent to "no pain" and 10 indicates the "worst possible pain". The baseline score is compared to the score collected at the 3-month follow-up visit. A negative change from baseline (a decrease in the VAS score) indicates a reduction in pain intensity and an improvement in the participant's condition over time.

Sponsors and collaborators

Lead sponsor

BTL Industries Ltd.

Industry

Registry information

Official study title

Evaluating the Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Jun 22, 2026
Registry last updated: Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed