Treatment for therapy-resistant myofascial pain using a handheld device

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical investigation evaluates the effectiveness of the Sonodyn device, which combines low-energy ultrasound, electrical, and magnetic field stimulation, in treating chronic myofascial pain syndrome. The device is designed for non-invasive application over specific trigger points associated with pain in the lower back, neck, and tension headaches. Patients will receive either the active treatment or a sham treatment to assess the device's efficacy. The study aims to provide relief for individuals suffering from persistent pain that has not responded to conventional therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Schmerzambulanz, Krankenhaus der Elisabethinen Graz
  Graz, Austria Recruiting
• Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
  Klagenfurt, Austria Recruiting
• Krankenhaus St. Vinzenz Zams
  Zams, Austria Recruiting
• RSB Neurochirurgie AG, Salem-Spital Bern
  Bern, Switzerland Recruiting
• Clinique de la Douleur, La Tour Hospital
  Meyrin, Switzerland Recruiting
• Schmerzklinik Zürich AG
  Zurich, Switzerland Recruiting

Study contacts

• Principal investigator: Rudolf Likar, Prof. Dr. — Klinikum Klagenfurt am Wörthersee
• Study coordinator: Lidia Anguiano, Dr.
• Email: lidia.anguiano@alirahealth.com
• Phone: +49 1511 0177825

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effects of Different Myofascial Release Techniques on Function in Chronic Neck Pain

  This trial tests whether manual or self-applied myofascial release, in addition to standard therapy and exercise, can improve function and reduce pain in adults with chronic non-specific neck pain.

  Recruiting Eastern Mediterranean University · Famagusta, Hatay · NCT07694882

• Using MR elastography to track how manual therapy changes painful lower-back tissues

  This trial will see if a special MRI method (MR elastography) can show tissue changes in adults with chronic lower‑back myofascial pain after Tuina manual therapy compared with usual care.

  Recruiting Mayo Clinic · Rochester, Minnesota and 1 other locations · NCT07278570

• Comparing physical therapy methods to improve head‑neck alignment in neck myofascial pain

  This will test whether different physical therapy treatments—dry needling, trigger‑point therapy, Maitland mobilizations, TENS, and ultrasound—can improve head‑neck alignment and reduce symptoms in adults 20–40 with cervical myofascial pain.

  Recruiting National Orthopedic and General Hospital · Bahawalpur, Punjab Province · NCT07098754

• Trigger point injections for low back pain relief

  This study is testing whether trigger point injections can help people with lower back pain feel better and improve their ability to move after visiting the Emergency Department.

  Recruiting Phase 4 Madigan Army Medical Center · Tacoma, Washington · NCT04704297

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.