Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back Pain

NCT07700433 | Active Not Recruiting FDA Device

• 1 other identifier: BTL-043_CTUS300
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

The study will evaluate the clinical efficacy and performance of the BTL-043 and BTL-899 devices for alleviating back pain. It 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. At the baseline visit, the Oswestry Disability Index (ODI), Visual Analogue Scale for pain (VAS), the Quebec Back Pain Disability Index (QBPDS), palpation of the treatment area, Fingertip-to-Floor-Flexion (FTFF) test, and Lateral FTFF test will be performed. Additionally, two-dimensional (2D) photographs of the subject's posture from the left and right profile will be taken, their Fitzpatrick skin type assessed, and the subject's weight and height will be recorded. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. During each treatment visit, subjects will receive treatments with both study devices, BTL-043 and BTL-899, consecutively, one immediately after the other. Therapy time will be set to 30 minutes for each treatment with each study device. After the last treatment, the subjects will complete the ODI, QBPDS, the Therapy Comfort Questionnaire (TCQ), and the Subject Satisfaction Questionnaire \& Quality of Life Questionnaire (SSQ \& QoL), along with the VAS, undergo palpation of the treatment area, FTFF, Lateral FTFF, weight and height measurements, and 2D photographing. During the 1-month and 3-month follow-up visits, the subjects will complete the SSQ \& QoL, the ODI, QBPDS, VAS, undergo palpation of the treatment area, FTFF, Lateral FTFF, weight and height measurements, and 2D photographing. Safety measures will include documentation of adverse events (AE), which will be assessed after each procedure and at all follow-up visits.

Conditions

Back Pain

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in the Visual Analogue Scale (VAS) Score at 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

  Baseline and 3 months

Secondary Outcomes (7)

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

  Baseline and 3 months]

• Change from Baseline in the Quebec Back Pain Disability Scale (QBPDS) Score at 3 Months

  Baseline and 3 months]

• Change from Baseline in Fingertip-to-Floor-Flexion (FTFF) at 3 Months

  3 months post treatment

• Change from Baseline in Lateral Fingertip-to-Floor-Flexion at 3 Months

  Baseline and 3 months

• Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire

  3 months post treatment

Study Arms (1)

Active treatment with BTL-043 and BTL-899

ACTIVE COMPARATOR

All subjects will receive treatment with the BTL-043 and BTL-899 devices. All of the study subjects will receive the treatment with both study devices, BTL-043 and BTL-899, per one treatment visit and will undergo the treatments consecutively, one immediately after the other, with BTL-043 applied first. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. Therapy time will be set to 30 minutes for each treatment with each study device.

Device: Treatment with BTL-043; Device: BTL-899

Interventions

Treatment with BTL-043 DEVICE

All of the study subjects will receive the treatment with BTL-043, with the treatment applied before BTL-899. Therapy time will be set to 30 minutes. 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.

Also known as: EMVITAL

Active treatment with BTL-043 and BTL-899

BTL-899 DEVICE

All of the study subjects will receive four treatments with BTL-899. The treatment administration phase will consist of four (4) treatment visits, delivered 5-10 days apart. Subjects will undergo the BTL-899 treatment, immediately after BTL-043 treatment. Therapy time will be set to 30 minutes.

Also known as: EMSCULPT NEO

Active treatment with BTL-043 and BTL-899

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• BTL Industries Ltd.: lead

Study Sites (4)

Royal Spine Surgery

Scottsdale, Arizona, 85260, United States

Location

Novaré Medical and Wellness

Fort Myers, Florida, 33908, United States

Location

Active Edge Health

Columbus, Ohio, 43215, United States

Location

Pinnacle Integrative Orthopedics

Wichita Falls, Texas, 76301, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 14, 2026
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-06

Locations

US (4)