Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain
NCT: NCT07661082 · COMPLETED
Brief 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.
Frequently Asked Questions
What is Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain?
Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain is a clinical trial registered under NCT07661082. Current status: COMPLETED.
What is the status of NCT07661082?
The current status of NCT07661082 (Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain) is: COMPLETED.
When did Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain start?
Safety and Efficacy of the BTL-043 Device in Alleviating Back Pain started on 2024-08-09.
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Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.