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New handheld device aims to soothe stubborn muscle pain

NCT ID NCT05851326

Symptom relief Sponsor: Sobet AG Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a handheld device called Sonodyn for people with chronic back, neck, or tension headache pain that hasn't improved with other treatments. The device uses a mix of low-energy ultrasound, electrical, and magnetic pulses to target painful trigger points. About 126 adults will either receive active therapy or a sham (inactive) device for 3 weeks, and researchers will track pain levels for 12 weeks total.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 126 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

Chronic Pain myofascial pain syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myofascial pain syndrome - lower back Myofascial pain syndrome - neck Myofascial pain syndrome - tension headache

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee

    RECRUITING

    Klagenfurt, 9020, Austria

  • Clinique de la Douleur, La Tour Hospital

    RECRUITING

    Meyrin, 1217, Switzerland

  • Krankenhaus St. Vinzenz Zams

    RECRUITING

    Zams, 6511, Austria

  • RSB Neurochirurgie AG, Salem-Spital Bern

    RECRUITING

    Bern, 3013, Switzerland

  • Schmerzambulanz, Krankenhaus der Elisabethinen Graz

    RECRUITING

    Graz, 8020, Austria

  • Schmerzklinik Zürich AG

    RECRUITING

    Zurich, 8050, Switzerland

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