Condition: Myofascial Pain Syndrome - Lower Back · Myofascial Pain Syndrome - Neck · Myofascial Pain Syndrome - Tension Headache · Sponsor: Sobet AG
Sonodyn is an investigational device that within this clinical investigation is intended for use in patients suffering from low back pain, tension headache or neck pain, originating from therapy-resistant myofascial pain syndrome. Myofascial pain syndrome is a prevalent pain condition in the adult population and a common cause of pain and dysfunction in the musculoskeletal system. It is a trigger point-induced regional musculoskeletal pain disorder affecting one or more muscles or groups of muscles. Sonodyn is a handheld medical device that combines low-energy ultrasound, electrical and magnetic field stimulation for non-invasive transcutaneous treatment of chronic myofascial pain syndrome. Sonodyn is a battery-operated, rechargeable stimulation device to be placed over specific trigger points for associated pain patterns in the human body. It emits ultrasound, electrical and magnetic stimulation signals with a pre-defined set of parameters for each of the independently operated power sources. The study will follow a prospective, randomized, sham-controlled, double-blind parallel group design. It will be conducted as a multi-center investigation at 6 sites in Austria and Switzerland. Patients are randomized in a 2:1 ratio into Treatment and Control. * Active Sonodyn therapy (Treatment) * No therapy (Sham Control) Two types of Sonodyn devices will be used: a fully functional one for Therapy arm patients that can deliver stimulation, and a non-functional one for Control ar…
This description comes directly from the study's public registry record.
Lidia Anguiano, Dr. · +49 1511 0177825 · lidia.anguiano@alirahealth.com
Always discuss trial participation with your own doctor first.
| Schmerzambulanz, Krankenhaus der Elisabethinen Graz | Graz, Austria | Recruiting |
| Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee | Klagenfurt, Austria | Recruiting |
| Krankenhaus St. Vinzenz Zams | Zams, Austria | Recruiting |
| RSB Neurochirurgie AG, Salem-Spital Bern | Bern, Switzerland | Recruiting |
| Clinique de la Douleur, La Tour Hospital | Meyrin, Switzerland | Recruiting |
| Schmerzklinik Zürich AG | Zurich, Switzerland | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05851326