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

Evaluating the 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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Chronic Back Pain
• Intervention / Treatment: Device: Device: Treatment with BTL-043

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85260
      • Royal Spine Surgery, Scottsdale, AZ, USA
  • Colorado
    • Denver, Colorado, United States, 80211
      • Aria Integrative Health
  • Texas
    • Houston, Texas, United States, 77027
      • River Oaks Hospital & Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Active Comparator: Active treatment with 043_CTUS100

Device: Device: Treatment with BTL-043; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in the Oswestry Disability Index (ODI) Score at 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.	Baseline and 3 months
Change from Baseline in the Visual Analogue Scale (VAS) Pain 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

Collaborators and Investigators

• Sponsor: BTL Industries Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Actual): March 5, 2025
• Study Completion (Actual): March 5, 2025

Study Registration Dates

• First Submitted: June 16, 2026
• First Submitted That Met QC Criteria: June 16, 2026
• First Posted (Actual): June 22, 2026

Study Record Updates

• Last Update Posted (Actual): June 22, 2026
• Last Update Submitted That Met QC Criteria: June 16, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Back Pain
• Other Study ID Numbers: BTL-043_CTUS100

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