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

A Combination of Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Patients With Therapy-Resistant Myofascial Pain Syndrome: A Randomized, Controlled, Double-Blind Multi-Center Study

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.

Study Overview

• Status: Recruiting
• Conditions: Myofascial Pain Syndrome - Lower Back; Myofascial Pain Syndrome - Neck; Myofascial Pain Syndrome - Tension Headache
• Intervention / Treatment: Device: Active Sonodyn; Device: Sham

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lidia Anguiano, Dr.; Phone Number: +49 1511 0177825; Email: lidia.anguiano@alirahealth.com

Study Locations

• Austria
  • Graz, Austria, 8020
    • Recruiting
    • Schmerzambulanz, Krankenhaus der Elisabethinen Graz
    • Contact: Michael Kern, Dr.
    • Principal Investigator: Michael Kern, Dr.
    • Sub-Investigator: Julia Kolb, Dr.
  • Klagenfurt, Austria, 9020
    • Recruiting
    • Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
    • Contact: Rudolf Likar, Prof. Dr.
    • Principal Investigator: Rudolf Likar, Prof. Dr.
    • Sub-Investigator: Stefan Neuwersch-Sommeregger, Dr.
    • Sub-Investigator: Markus Köstenberger, Dr.
  • Zams, Austria, 6511
    • Recruiting
    • Krankenhaus St. Vinzenz Zams
    • Contact: Andreas Wolf, Dr.
    • Principal Investigator: Andreas Wolf, Dr.
    • Sub-Investigator: Christian Wolf, Dr.
• Switzerland
  • Bern, Switzerland, 3013
    • Recruiting
    • RSB Neurochirurgie AG, Salem-Spital Bern
    • Contact: Ralph Binggeli, Dr.
    • Principal Investigator: Ralph Binggeli, Dr.
    • Sub-Investigator: Bernhard Voller, Prof. Dr.
  • Meyrin, Switzerland, 1217
    • Recruiting
    • Clinique de la Douleur, La Tour Hospital
    • Contact: Christophe Perruchoud, PD Dr.
    • Principal Investigator: Christophe Perruchoud, PD Dr.
    • Sub-Investigator: Blaise Rutschmann, Dr.
  • Zurich, Switzerland, 8050
    • Recruiting
    • Schmerzklinik Zürich AG
    • Contact: Michael Hartmann, Dr.
    • Principal Investigator: Michael Hartmann, Dr.
    • Sub-Investigator: Tomislav Kovacevic, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Sonodyn Therapy (Treatment Group); Patients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.	Device: Active Sonodyn; Sonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.
Sham Comparator: Sham Therapy (Control Group); Patients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.	Device: Sham; Non-functional Sonodyn device that cannot convey any energy signals to the device output, however, looks and behaves fully identical as the active Sonodyn device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in average NRS between groups - Baseline to EoT	Difference between groups in change of average NRS from Baseline to EoT	3 weeks
Maximum NRS - Baseline to EoT	Change from Baseline to EoT in maximum NRS in both groups	3 weeks
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	11 weeks
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	3 weeks
Average and maximum NRS - Follow-up	Average and maximum NRS during follow-up in both groups	8 weeks
Medication consumption	Pain and rescue medication consumption during treatment and follow-up phase in both groups	11 weeks
EQ-5D-5L	EQ-5D-5L questionnaire from Baseline to EoT and end of follow-up	11 weeks
Quality of sleep	Quality of sleep questionnaire from Baseline to EoT and end of follow-up	11 weeks
Socioeconomic data	Change in socioeconomic data from Screening to EoT	4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Outcome #1	Adverse Events (AEs), Adverse Device Effects (ADEs), and Device Deficiencies (DDs) observed until EoT	3 weeks
Safety Outcome #2	Serious Adverse Events (SAEs), Serious Adverse Device Effects (SADEs), and related AEs observed until end of follow-up	11 weeks

Collaborators and Investigators

• Sponsor: Sobet AG
• Collaborators: La Tour Hospital; Klinikum Klagenfurt am Wörthersee; Krankenhaus der Elisabethinen Graz; Krankenhaus St. Vinzenz Zams; Schmerzklinik Zürich; Salem-Spital Bern
• Investigators: Principal Investigator: Rudolf Likar, Prof. Dr., Klinikum Klagenfurt am Worthersee

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Chronic Pain; Myofascial Pain Syndrome; Low-Energy Stimulation; Ultrasound, Electrical and Magnetic Field Stimulation; Transcutaneous Pain Therapy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Myofascial Pain Syndromes; Chronic Pain
• Other Study ID Numbers: Sonodyn

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No