Receive treatment with a handheld device for therapy-resistant muscle pain

Back to Myofascial Pain Syndrome - Lower Back trials

Recruiting

What is this trial?

This trial is testing a device called Sonodyn, a handheld medical device that combines ultrasound, electrical stimulation, and magnetic field energy to treat chronic muscle pain. The device is designed for people whose muscle pain in the lower back, neck, or head hasn't gotten better with standard treatments. Researchers want to see if using this treatment regularly can reduce pain compared to a placebo device that looks identical but doesn't deliver any energy.

Muscle pain syndromes in the back, neck, and head affect many adults and can be difficult to treat with standard approaches. This trial exists to see whether this new combination device might offer relief for people whose pain has persisted despite other treatments.

Do you qualify?

You likely qualify if…

you are between 18 and 99 years old
you have chronic muscle pain in your lower back, neck, or have tension headaches that has lasted at least 3 months
your pain is not adequately controlled by current treatments
you experience an average pain level of 4 or higher on most days during the screening period
you are able to use the device 3 times daily for 10 minutes and complete daily pain tracking

You likely don't qualify if…

you have active medical implants or metal implants in the area where the device would be placed
you are pregnant
you have epilepsy or a seizure disorder
you are taking high-dose opioids (more than 120 mg morphine equivalent daily) or certain muscle relaxants
you have psychiatric conditions or certain pain disorders that might affect participation

What participation looks like

You would first go through a 1-week screening period to confirm you qualify. Then you would be randomly assigned to either use an active Sonodyn device or an identical-looking sham device that doesn't deliver any energy. During the 3-week treatment phase, you would activate your device 3 times a day for 10 minutes each time, placing it over the area causing pain. You would also track your pain daily. After treatment ends, you'll have 8 weeks of follow-up visits to monitor your progress, making the total study duration 12 weeks.

Testing a handheld device for stubborn muscle pain in the back, neck, and head

What is this trial?

Do you qualify?

What participation looks like

Trial locations(6 sites)