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.

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