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Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome

RecruitingNAAges 18 Years - 99 YearsAllSobet AG
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female aged 18 to 99 years at screening * Patient has an understanding of the study and its procedures, agrees to its provisions, and gives written informed consent prior to any study-related procedures * Patient is suffering from one of the following chronic pain conditions originating from myofascial pain: * low back pain * tension headache * neck pain having been persisting for a minimum of 3 months and where myofascial pain syndrome is the pre-dominant cause for pain. * Patient is constant with respect to pain treatment for 1 week during the screening phase * A daily average NRS \>= 4 on 4 out of 7 days in the screening phase * Compliance with the daily status reporting requirements as demonstrated Exclusion Criteria: * Patients with active implants * Allergy against rescue medication used during the study * Pregnancy * Mental or physical impairments that represent a source of risk for handling the device * Patients with cerebral spams (epilepsy) * Patients with psychiatric diseases or somatoform pain disorders * Patients with oral morphine equivalent of more than 120mg daily dose * Patients taking centrally acting muscle relaxants like Sirdalud or benzodiacepines * Patients with a contraindication against NSAID's * Presence of artificial joints made from methylmethacrylate or polyethylene at stimulation site * Presence of ferromagnetic metal implants at stimulation site, especially aneurysm clips, dental implants, etc.
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What it tests

  • Active Sonodyn
  • Sham
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Where

6 sites
Schmerzambulanz, Krankenhaus der Elisabethinen Graz
Graz, Austria
Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria
Krankenhaus St. Vinzenz Zams
Zams, Austria
RSB Neurochirurgie AG, Salem-Spital Bern
Bern, Switzerland
Clinique de la Douleur, La Tour Hospital
Meyrin, Switzerland
Schmerzklinik Zürich AG
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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