Treatment for therapy-resistant myofascial pain using a handheld device
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
This study tests whether a handheld device that uses sound and electrical stimulation can help people with chronic myofascial pain feel better when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Sobet AG Industry-sponsored |
| Locations | 6 sites (Graz and 5 other locations) |
| Trial ID | NCT05851326 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 99 who have chronic pain from myofascial pain syndrome persisting for at least three months.
Not a fit: Patients with active implants, allergies to study medications, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate chronic pain for patients suffering from therapy-resistant myofascial pain syndrome.
How similar studies have performed: While the approach of using combined low-energy stimulation techniques is innovative, similar studies have shown promise in treating chronic pain conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Graz and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.