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

Last updated: November 26, 2024
Sponsor: Sobet AG
Overall Status: Active - Recruiting

Phase

N/A

Condition

Somatoform And Dissociative Disorders

Pain (Pediatric)

Chronic Pain

Treatment

Active Sonodyn

Sham

Clinical Study ID

NCT05851326
Sonodyn
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female aged 18 to 99 years at screening

  • Patient has an understanding of the study and its procedures, agrees to itsprovisions, and gives written informed consent prior to any study-related procedures

  • Patient is suffering from one of the following chronic pain conditions originatingfrom 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 screeningphase

  • 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

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 thedevice

  • 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 atstimulation site

  • Presence of ferromagnetic metal implants at stimulation site, especially aneurysmclips, dental implants, etc.

Study Design

Total Participants: 126
Treatment Group(s): 2
Primary Treatment: Active Sonodyn
Phase:
Study Start date:
May 25, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Schmerzambulanz, Krankenhaus der Elisabethinen Graz

    Graz, 8020
    Austria

    Active - Recruiting

  • Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee

    Klagenfurt, 9020
    Austria

    Active - Recruiting

  • Krankenhaus St. Vinzenz Zams

    Zams, 6511
    Austria

    Active - Recruiting

  • RSB Neurochirurgie AG, Salem-Spital Bern

    Bern, 3013
    Switzerland

    Active - Recruiting

  • Clinique de la Douleur, La Tour Hospital

    Meyrin, 1217
    Switzerland

    Active - Recruiting

  • Schmerzklinik Zürich AG

    Zürich, 8050
    Switzerland

    Active - Recruiting

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