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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Austria
Schmerzambulanz, Krankenhaus der Elisabethinen Graz
RECRUITING
Graz
Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
RECRUITING
Klagenfurt
Krankenhaus St. Vinzenz Zams
RECRUITING
Zams
Switzerland
RSB Neurochirurgie AG, Salem-Spital Bern
RECRUITING
Bern
Clinique de la Douleur, La Tour Hospital
RECRUITING
Meyrin
Schmerzklinik Zürich AG
RECRUITING
Zurich
Contact Information
Primary
Lidia Anguiano, Dr.
lidia.anguiano@alirahealth.com
+49 1511 0177825
Time Frame
Start Date: 2023-05-25
Estimated Completion Date: 2025-10
Participants
Target number of participants: 126
Treatments
Experimental: Active Sonodyn Therapy (Treatment Group)
Patients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.
Sham_comparator: Sham Therapy (Control Group)
Patients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each.
Related Therapeutic Areas
Sponsors
Collaborators: Salem-Spital Bern, Krankenhaus St. Vinzenz Zams, Klinikum Klagenfurt am Wörthersee, Schmerzklinik Zürich, La Tour Hospital, Krankenhaus der Elisabethinen Graz
Leads: Sobet AG

This content was sourced from clinicaltrials.gov