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

NCT05851326 | Recruiting DMC

• 1 other identifier: Sonodyn
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Myofascial Pain Syndrome - Lower Back; Myofascial Pain Syndrome - Neck; Myofascial Pain Syndrome - Tension Headache

Keywords

Myofascial Pain Syndrome; Low-Energy Stimulation; Ultrasound, Electrical and Magnetic Field Stimulation; Transcutaneous Pain Therapy; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Difference in average NRS between groups - Baseline to EoT

  3 weeks

• Maximum NRS - Baseline to EoT

  3 weeks

• Average and maximum NRS - Baseline to end of follow-up

  11 weeks

• AUC of average and maximum NRS - Baseline to EoT

  3 weeks

• Average and maximum NRS - Follow-up

  8 weeks

Other Outcomes (2)

• Safety Outcome #1

  3 weeks

• Safety Outcome #2

  11 weeks

Study Arms (2)

Active Sonodyn Therapy (Treatment Group)

EXPERIMENTAL

Patients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.

Device: Active Sonodyn

Sham Therapy (Control Group)

SHAM COMPARATOR

Patients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.

Device: Sham

Interventions

Active Sonodyn DEVICE

Sonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.

Active Sonodyn Therapy (Treatment Group)

Sham DEVICE

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.

Sham Therapy (Control Group)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sobet AG: lead
• 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

Study Sites (6)

Schmerzambulanz, Krankenhaus der Elisabethinen Graz

Graz, 8020, Austria

RECRUITING

Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee

Klagenfurt, 9020, Austria

RECRUITING

Krankenhaus St. Vinzenz Zams

Zams, 6511, Austria

RECRUITING

RSB Neurochirurgie AG, Salem-Spital Bern

Bern, 3013, Switzerland

RECRUITING

Clinique de la Douleur, La Tour Hospital

Meyrin, 1217, Switzerland

RECRUITING

Schmerzklinik Zürich AG

Zurich, 8050, Switzerland

RECRUITING

MeSH Terms

Conditions

Myofascial Pain Syndromes; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Rudolf Likar, Prof. Dr.

  Klinikum Klagenfurt am Wörthersee

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lidia Anguiano, Dr.

CONTACT

+49 1511 0177825; lidia.anguiano@alirahealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 9, 2023
• Study Start: May 25, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AU (3); CH (3)