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 arm patients that cannot convey any energy signals to the device output. The devices will look fully identical.
Randomization will be stratified by study site, pain diagnosis and sex of the patient.
For each subject, after a screening phase of 1 week, patients will be treated for 3 weeks with a follow-up of additional 8 weeks, adding up to 12 weeks. During treatment patients will activate their device 3 times a day for 10 minutes each.
During screening, treatment and follow-up period, all patients will twice per day report the average and maximum intensity of their pain Numeric Rating Scale (NRS). Patients will also enter the date, amount, and time of intake of rescue medication, if applicable.
The primary objective of this study is to assess the impact on pain. Secondary objectives are to compare the performance between active therapy and sham, as well as to correlate changes in pain intensity with other pain related scales.
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
low back pain
tension headache
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
Parallel
Active Sonodyn
DeviceSonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.
Sham
DeviceNon-functional Sonodyn device that cannot convey any energy signals to the device output, however, looks and behaves fully identical as the active Sonodyn device.
Average Numeric Rating Scale (NRS)
Change in Treatment group from Baseline to EoT in average Numeric Rating Scale (NRS, 0-10, with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced) per day
Difference in average NRS between groups - Baseline to EoT
Difference between groups in change of average NRS from Baseline to EoT
Maximum NRS - Baseline to EoT
Change from Baseline to EoT in maximum NRS in both groups
Average and maximum NRS - Baseline to end of follow-up
Change from Baseline to end of follow-up in average and maximum NRS in both groups
AUC of average and maximum NRS - Baseline to EoT
Baseline-adjusted area under the curve (AUC) of average and maximum NRS from Baseline to EoT in both groups
Safety Outcome #1
Adverse Events (AEs), Adverse Device Effects (ADEs), and Device Deficiencies (DDs) observed until EoT
Safety Outcome #2
Serious Adverse Events (SAEs), Serious Adverse Device Effects (SADEs), and related AEs observed until end of follow-up
Click on the lead sponsor to view all of their trials.
Sobet AG
Lead sponsor
Klinikum Klagenfurt am Wörthersee
Collaborator
Krankenhaus der Elisabethinen Graz
Collaborator
Krankenhaus St. Vinzenz Zams
Collaborator
La Tour Hospital
Collaborator
Schmerzklinik Zürich
Collaborator
Salem-Spital Bern
Collaborator
