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

July 9, 2026 updated by: BTL Industries Ltd.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Royal Spine Surgery
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Novaré Medical and Wellness
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Active Edge Health
    • Texas
      • Wichita Falls, Texas, United States, 76301
        • Pinnacle Integrative Orthopedics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active treatment with BTL-043 and BTL-899
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
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.
Other Names:
  • EMVITAL
Device: BTL-899
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.
Other Names:
  • EMSCULPT NEO

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Visual Analogue Scale (VAS) 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
Baseline and 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Therapy Comfort Assessed by the Therapy Comfort Questionnaire
Time Frame: Immediately after the final treatment
Therapy comfort is assessed using a self-reported questionnaire. Participants indicate their overall comfort on a 5-point Likert scale (where 1 is "strongly disagree" and 5 is "strongly agree" with the statement "I found the treatment comfortable"). Additionally, any pain experienced during treatment is rated on a Numerical Analogue Scale ranging from 0 ("no pain") to 10 ("worst possible pain"). Lower pain scores and higher agreement scores indicate greater therapy comfort.
Immediately after the final treatment
Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months
Time Frame: Baseline and 3 months]
The ODI is a self-reported, patient-administered questionnaire used to evaluate how low back pain affects everyday activities. 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.
Baseline and 3 months]
Change from Baseline in the Quebec Back Pain Disability Scale (QBPDS) Score at 3 Months
Time Frame: Baseline and 3 months]
The QBPDS is a self-administered questionnaire consisting of 20 items designed to assess the level of functional disability in individuals with back pain. Each item is scored on a scale from 0 to 5, with higher total scores indicating greater disability. The questionnaire will be administered at the baseline, after the last therapy visit, and at both follow up visits.
Baseline and 3 months]
Change from Baseline in Fingertip-to-Floor-Flexion (FTFF) at 3 Months
Time Frame: 3 months post treatment
The FTFF is a composite test measuring multiple motions and muscles that will be used to evaluate improvement of subject's movement flexibility. The subject will be asked to bend forward, and the distance between the tip of the middle finger and the floor will be measured with a tape measure.
3 months post treatment
Change from Baseline in Lateral Fingertip-to-Floor-Flexion at 3 Months
Time Frame: Baseline and 3 months
The Lateral FTFF is a test measuring lateral flexion that will be used to evaluate improvement of subject's movement flexibility. First the subject will be standing erect, and then the subject will be asked to bend laterally flexing the spine. The distance between the middle finger to the floor will be measured with a tape. The change in distance from erect standing to lateral flexion will be considered the range of lateral flexion.
Baseline and 3 months
Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
Time Frame: 3 months post treatment
Subject satisfaction with the treatment outcomes and its impact on quality of life is assessed using a 16-item self-reported questionnaire. Each item is rated on a 5-point Likert scale, where 1 indicates "strongly disagree" and 5 indicates "strongly agree". Higher scores represent greater treatment satisfaction and improvement in the subject's quality of life.
3 months post treatment
Change from Baseline in the position measurements of the left and right profile based on the 2D photographs at 3 months
Time Frame: Baseline and 3 months
Full-body 2D photographs will be taken from the left and right profiles to evaluate improvement in the subject's posture. Subjects will be asked to stand barefoot, feet shoulder-width apart, positioned adjacent to a wall.
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BTL Industries Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 8, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BTL-043_CTUS300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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