Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myofascial Pain Syndrome - Lower Back, Myofascial Pain Syndrome - Neck, Myofascial Pain Syndrome - Tension Headache

Intervention / Treatment
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* Device: Active Sonodyn
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Sonodyn Therapy (Treatment Group)<br>Patients will remain on treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each. | Device: Active Sonodyn<br>* Sonodyn emits ultrasound, electrical and magnetic stimulation signals with a pre-defined, fixed set of parameters for each of the independently operated power sources.<br>|
| Sham Comparator: Sham Therapy (Control Group)<br>Patients will remain on sham treatment for 3 weeks and will activate their device 3 times a day for 10 minutes each. | Device: Sham<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in average NRS between groups - Baseline to EoT | Difference between groups in change of average NRS from Baseline to EoT | 3 weeks | 
| Maximum NRS - Baseline to EoT | Change from Baseline to EoT in maximum NRS in both groups | 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 | 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 | 3 weeks | 
| Average and maximum NRS - Follow-up | Average and maximum NRS during follow-up in both groups | 8 weeks | 
| Medication consumption | Pain and rescue medication consumption during treatment and follow-up phase in both groups | 11 weeks | 
| EQ-5D-5L | EQ-5D-5L questionnaire from Baseline to EoT and end of follow-up | 11 weeks | 
| Quality of sleep | Quality of sleep questionnaire from Baseline to EoT and end of follow-up | 11 weeks | 
| Socioeconomic data | Change in socioeconomic data from Screening to EoT | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial Pain Syndrome, Low-Energy Stimulation, Ultrasound, Electrical and Magnetic Field Stimulation, Transcutaneous Pain Therapy, Chronic Pain