Myofascial Pain Syndrome - Lower BackNCT05851326
Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome
A study testing Active Sonodyn in people with Myofascial Pain Syndrome - Lower Back and Myofascial Pain Syndrome - Neck, run by Sobet AG at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck, Myofascial Pain Syndrome - Tension Headache
- What is being tested?
- Active Sonodyn
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 25 May 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Austria3 sites, 3 recruiting
- Recruiting
Schmerzambulanz, Krankenhaus der Elisabethinen Graz
Graz, 8020
Michael Kern, Dr.
Michael Kern, Dr.
- Recruiting
Abteilung für Anästhesiologie und Intensivmedizin, Klinikum Klagenfurt am Wörthersee
Klagenfurt, 9020
Rudolf Likar, Prof. Dr.
Rudolf Likar, Prof. Dr.
- Recruiting
Krankenhaus St. Vinzenz Zams
Zams, 6511
Andreas Wolf, Dr.
Andreas Wolf, Dr.
Switzerland3 sites, 3 recruiting
- Recruiting
RSB Neurochirurgie AG, Salem-Spital Bern
Bern, 3013
Ralph Binggeli, Dr.
Ralph Binggeli, Dr.
- Recruiting
Clinique de la Douleur, La Tour Hospital
Meyrin, 1217
Christophe Perruchoud, PD Dr.
Christophe Perruchoud, PD Dr.
- Recruiting
Schmerzklinik Zürich AG
Zurich, 8050
Michael Hartmann, Dr.
Michael Hartmann, Dr.
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck, Myofascial Pain Syndrome - Tension Headache
- Being tested
- Active Sonodyn, Sham
- Keywords
- Myofascial Pain Syndrome, Low-Energy Stimulation, Ultrasound, Electrical and Magnetic Field Stimulation, Transcutaneous Pain Therapy, Chronic Pain
- Medical subject headings
- Myofascial Pain Syndromes, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active SonodynDevice
Sonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.
ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Sonodyn Therapy (Treatment Group) | Experimental | Patients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each. Receives: Device: Active Sonodyn |
| Sham Therapy (Control Group) | Sham comparator | Patients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Numeric Rating Scale (NRS)
Change in Treatment group from Baseline to EoT in average Numeric Rating Scale (NRS, 0-10, with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced) per day
Measured: 3 weeks
Secondary outcomes (9)
Difference in average NRS between groups - Baseline to EoT
Difference between groups in change of average NRS from Baseline to EoT
Measured: 3 weeks
Maximum NRS - Baseline to EoT
Change from Baseline to EoT in maximum NRS in both groups
Measured: 3 weeks
Average and maximum NRS - Baseline to end of follow-up
Change from Baseline to end of follow-up in average and maximum NRS in both groups
Measured: 11 weeks
AUC of average and maximum NRS - Baseline to EoT
Baseline-adjusted area under the curve (AUC) of average and maximum NRS from Baseline to EoT in both groups
Measured: 3 weeks
Average and maximum NRS - Follow-up
Average and maximum NRS during follow-up in both groups
Measured: 8 weeks
Medication consumption
Pain and rescue medication consumption during treatment and follow-up phase in both groups
Measured: 11 weeks
EQ-5D-5L
EQ-5D-5L questionnaire from Baseline to EoT and end of follow-up
Measured: 11 weeks
Quality of sleep
Quality of sleep questionnaire from Baseline to EoT and end of follow-up
Measured: 11 weeks
Socioeconomic data
Change in socioeconomic data from Screening to EoT
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start25 May 2023
- Primary completionMar 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Pain Syndrome - Lower BackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sobet AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Klinikum Klagenfurt am Wörthersee, Krankenhaus der Elisabethinen Graz, Krankenhaus St. Vinzenz Zams, La Tour Hospital, Schmerzklinik Zürich, Salem-Spital Bern
- Responsible party
- Sponsor
- Investigators
- Rudolf Likar, Prof. Dr., Principal investigator, Klinikum Klagenfurt am Wörthersee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851326
- Sponsor's protocol ID
- Sonodyn
- Status last verified
- Nov 2025
- First submitted
- 1 May 2023
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05851326
- Acronym / sponsor ID
- Sonodyn
- Conditions
- Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck, Myofascial Pain Syndrome - Tension Headache
- Keywords
- Myofascial Pain Syndrome, Low-Energy Stimulation, Ultrasound, Electrical and Magnetic Field Stimulation, Transcutaneous Pain Therapy, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Sobet AGIndustry (pharma, biotech, devices)
- Collaborators
- Klinikum Klagenfurt am Wörthersee, Krankenhaus der Elisabethinen Graz, Krankenhaus St. Vinzenz Zams, La Tour Hospital, Schmerzklinik Zürich, Salem-Spital Bern
- Study start
- 25 May 2023 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Sonodyn Therapy (Treatment Group) | Experimental | Device: Active SonodynPatients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each. |
| Sham Therapy (Control Group) | Sham comparator | Device: ShamPatients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active SonodynSonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources. | Device | Active Sonodyn Therapy (Treatment Group) |
| ShamNon-functional Sonodyn device that cannot convey any energy signals to the device output, however, looks and behaves fully identical as the active Sonodyn device. | Device | Sham Therapy (Control Group) |
Primary outcome
Average Numeric Rating Scale (NRS)
Time frame: 3 weeks
Change in Treatment group from Baseline to EoT in average Numeric Rating Scale (NRS, 0-10, with 0 indicating no pain and 10 indicating the worst pain that the patient had ever experienced) per day
9 secondary outcomes
Difference in average NRS between groups - Baseline to EoT
Time frame: 3 weeks
Maximum NRS - Baseline to EoT
Time frame: 3 weeks
Average and maximum NRS - Baseline to end of follow-up
Time frame: 11 weeks
AUC of average and maximum NRS - Baseline to EoT
Time frame: 3 weeks
Average and maximum NRS - Follow-up
Time frame: 8 weeks
Medication consumption
Time frame: 11 weeks
EQ-5D-5L
Time frame: 11 weeks
Quality of sleep
Time frame: 11 weeks
Socioeconomic data
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rudolf Likar, Prof. Dr. principal investigator
Klinikum Klagenfurt am Wörthersee
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Sonodyn in people with Myofascial Pain Syndrome - Lower Back and Myofascial Pain Syndrome - Neck, run by Sobet AG at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Austria, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lidia Anguiano, Dr. (+49 1511 0177825, lidia.anguiano@alirahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Numeric Rating Scale (NRS) (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.