Back PainNCT07700433
Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back Pain
A study testing Treatment with BTL-043 and BTL-899 in people with Back Pain, run by BTL Industries Ltd. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Back Pain
- What is being tested?
- Treatment with BTL-043 and BTL-899
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesUnited States
- Study dates
- 8 Dec 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Active Edge Health
Columbus, Ohio, 43215
Novaré Medical and Wellness
Fort Myers, Florida, 33908
Royal Spine Surgery
Scottsdale, Arizona, 85260
Pinnacle Integrative Orthopedics
Wichita Falls, Texas, 76301
About this study
Official title: 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.
- Conditions
- Back Pain
- Being tested
- Treatment with BTL-043, BTL-899
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with BTL-043Device
Also called EMVITAL
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.
BTL-899Device
Also called EMSCULPT NEO
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Treatment with BTL-043; Device: BTL-899 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline and 3 months
Secondary outcomes (7)
Change from Baseline in the Oswestry Disability Index (ODI) Score at 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.
Measured: Baseline and 3 months]
Change from Baseline in the Quebec Back Pain Disability Scale (QBPDS) Score at 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.
Measured: Baseline and 3 months]
Change from Baseline in Fingertip-to-Floor-Flexion (FTFF) at 3 Months
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.
Measured: 3 months post treatment
Change from Baseline in Lateral Fingertip-to-Floor-Flexion at 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.
Measured: Baseline and 3 months
Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
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.
Measured: 3 months post treatment
Therapy Comfort Assessed by the Therapy Comfort Questionnaire
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.
Measured: Immediately after the final treatment
Change from Baseline in the position measurements of the left and right profile based on the 2D photographs at 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.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start8 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BTL Industries Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07700433
- Sponsor's protocol ID
- BTL-043_CTUS300
- Status last verified
- Jun 2026
- First submitted
- 9 Jul 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Safety and Efficacy of the BTL-043 and BTL-899 Devices in Alleviating Back Pain
- ClinicalTrials.gov ID
- NCT07700433
- Acronym / sponsor ID
- BTL-043_CTUS300
- Conditions
- Back Pain
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- BTL Industries Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active treatment with BTL-043 and BTL-899 | Active comparator | Device: Treatment with BTL-043, Device: BTL-899All 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. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (28 listed)
- Major systemic diseases - e.g. uncontrolled Diabetes mellitus, systemic lupus erythematosus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment with BTL-043Also: EMVITALAll 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. | Device | Active treatment with BTL-043 and BTL-899 |
| BTL-899Also: EMSCULPT NEOAll 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. | Device | Active treatment with BTL-043 and BTL-899 |
Primary outcome
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
7 secondary outcomes
Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months
Time frame: 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]
Change from Baseline in Fingertip-to-Floor-Flexion (FTFF) at 3 Months
Time frame: 3 months post treatment
Change from Baseline in Lateral Fingertip-to-Floor-Flexion at 3 Months
Time frame: Baseline and 3 months
Subject Satisfaction Assessed by the Subject Satisfaction & Quality of Life Questionnaire
Time frame: 3 months post treatment
Therapy Comfort Assessed by the Therapy Comfort Questionnaire
Time frame: Immediately after the final 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Related trials for Back Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with BTL-043 and BTL-899 in people with Back Pain, run by BTL Industries Ltd. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Visual Analogue Scale (VAS) Score at 3 Months (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.