Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain (NCT07661082) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain
United States24 participantsStarted 2024-08-09
Plain-language summary
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.
Who can participate
Age range
22 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sens…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in the Oswestry Disability Index (ODI) Score at 3 Months
Timeframe: Baseline and 3 months
2
Change from Baseline in the Visual Analogue Scale (VAS) Pain Score at 3 Months