Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
NCT ID: NCT05851326
Last Updated: 2024-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2023-05-25
2025-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Active Sonodyn
Sonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.
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.
Sham
Non-functional Sonodyn device that cannot convey any energy signals to the device output, however, looks and behaves fully identical as the active Sonodyn device.
Interventions
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Active Sonodyn
Sonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.
Sham
Non-functional Sonodyn device that cannot convey any energy signals to the device output, however, looks and behaves fully identical as the active Sonodyn device.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
99 Years
ALL
No
Sponsors
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Klinikum Klagenfurt am Wörthersee
OTHER
Krankenhaus der Elisabethinen Graz
UNKNOWN
Krankenhaus St. Vinzenz Zams
UNKNOWN
La Tour Hospital
OTHER
Schmerzklinik Zürich
UNKNOWN
Salem-Spital Bern
UNKNOWN
Sobet AG
INDUSTRY
Responsible Party
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Principal Investigators
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Rudolf Likar, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Klinikum Klagenfurt am Wörthersee
Locations
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Schmerzambulanz, Krankenhaus der Elisabethinen Graz
Graz, , Austria
Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
Klagenfurt, , Austria
Krankenhaus St. Vinzenz Zams
Zams, , Austria
RSB Neurochirurgie AG, Salem-Spital Bern
Bern, , Switzerland
Clinique de la Douleur, La Tour Hospital
Meyrin, , Switzerland
Schmerzklinik Zürich AG
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Michael Kern, Dr.
Role: primary
Rudolf Likar, Prof. Dr.
Role: primary
Andreas Wolf, Dr.
Role: primary
Ralph Binggeli, Dr.
Role: primary
Christophe Perruchoud, PD Dr.
Role: primary
Michael Hartmann, Dr.
Role: primary
Other Identifiers
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Sonodyn
Identifier Type: -
Identifier Source: org_study_id