Evaluating the Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •Sensory loss in the treatment area
- •Deep vein thrombosis
研究组 & 干预措施
Active treatment with 043_CTUS100
干预措施: Device: Treatment with BTL-043 (Device)
结局指标
主要结局
Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months
时间窗: Baseline and 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.
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months
时间窗: 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.
次要结局
未报告次要终点