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

Running, not enrolling · Not applicable

Conditions studied: Back Pain

In brief

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.

Key facts

Study ID: NCT07700433
Run by: BTL Industries Ltd.
People needed: 60
Starts: 2025-12-08
Expected to finish: 2026-12-01
Last updated by the study team: 2026-07-14

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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
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

Where it is running

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

Full record on ClinicalTrials.gov

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