Frequently Asked Questions
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sam® is a bio-regenerative medical therapy that delivers Sustained Acoustic Medicine, providing 1.3 W of low-intensity (132 mW/cm2) ultrasound energy at 3MHz frequency to accelerate biological healing processes and reduce pain. Through the sustained delivery of low intensity acoustic waves, sam® stimulates the body’s natural repair process.
sam® is most commonly prescribed for acute and chronic tendinopathies; muscle strain or spasms; or pain associated with osteoarthritis. sam® can be used to treat injured sites throughout the body such as the tendons of the elbow, Achilles, patella, shoulder and bicep; and muscles including the trapezius, hamstring, and quadriceps. Please consult Contraindications and Warnings.
Yes, in a clinical study of subjects with elbow tendinosis, treatment with sam® increased the grip strength of the injured arm by 17%1. Subjects in this study also reported a 70% decrease in pain on a 0-10 scale over the six week study. Whether sam® can effectively prevent future injuries has not been studied in a clinical trial.
EXOGEN® ultrasound is for 20 minutes daily and is not a wearable device for multi hour daily treatment. Traditional therapeutic ultrasound requires active administration by a trained professional at a bench, thereby limiting treatments to only a few times per week or less.
Research conducted on ultrasound has shown that given correct dosing, which includes treatment frequency, intensity and duration, ultrasound is effective in treating soft tissue injuries2-7. Until sam®, ultrasound treatments have been limited to only 20 minutes. sam® allows the patient to self-administer the therapy anytime throughout their busy day– saving time for both the health care provider and the patient. More importantly, sam® 4 hour dose is clinically effective on accelerating recovery and reducing pain.
Transcutaneous Electrical Nerve Stimulation, otherwise known as TENS, uses electrical currents to control pain by stimulating nerves and blocking the pain signals that would otherwise be sent to the brain. While TENS and sam® have proven successful in clinical studies for relieving pain, only sam® and its ultrasonic energy aid in the recovery process by increasing circulation, and accelerating the natural healing cascades through mechanical stimulation.
If unfamiliar with using ultrasound-based treatments, it is recommended that patients begin wearing the device for one hour the first day. The next day, increase the time by one hour. Continue on this regimen until you reach four hours total per day. It is suggested to begin usage of sam® in this manner since every individual has a slightly different anatomy and physiology (e.g. such as muscle mass, skin sensitivity, and core body temperature) that can affect your treatment.
sam® should be used for four hours each day for at least five days per week to receive the recommended dose of treatment. On average, patients with an acute injury should expect to wear the device for two to six weeks. Patients with chronic injuries may require eight to 12 weeks of sam® usage to receive its full benefits. Patients may need to continue wearing the device after the recommended number of weeks, on an as needed or preventative basis.
sam® has effectively been shown to reduce pain due to osteoarthritis. As part of a randomized placebo controlled study funded by the National Institutes of Health8, subjects treated with an active device (n=28) who experienced moderate to severe pain at baseline reported a 40% decrease in pain measured on a zero to 10 numeric rating scale over a six week treatment period. While sam® has proven effective in reducing pain associated with osteoarthritis, it is clinically unknown if it actually impacts the disease progression. However, it has been shown in animal studies that long-term administration of ultrasound treatment can diminish the severity of knee osteoarthritis9.
Yes, sam® can be used in your recovery process after a surgery under the direction of your health care provider. sam® should not be used over an open wound, inflamed skin, or an implanted medical device. These factors should be considered in determining when and how to implement sam® into your recovery process.
The most common side effect is skin sensitivity resulting from two possibilities: improper coupling of the applicator to the skin, or skin irritation from prolonged use of the patch. These side effects are avoidable by ensuring that adequate sam® coupling gel is applied to the applicator before it is placed on the skin, and by avoiding placement of the applicator over a bony part of the body. If you experience skin irritation from use of the patch, it is recommended that the placement of the adhesive part of the patch be rotated (approximately 45°) each day. If you have significant body hair in the area of application it is recommended that you shave the area before using sam®.
In a human clinical evaluation and market survey of subjects who use the device, 0% of subjects reported an adverse event or skin damage from treatment. Repeated use of the patch caused discomfort or irritation of the skin in only 3% of cases10.
No, sam® should not negatively impact any physical therapy, athletic training, or massage therapies. sam® is designed as a drug-free alternative to treating pain, however, it should not interact with any current medications you may be taking.
Please reference Contraindications and Warnings, which further discuss specific cases in which the device should not be used. For example, sam® should not be used over an implanted medical device, or cardiac pacemakers. Precautions should be taken in individuals with potential acute infections, sepsis, peripheral artery disease, or deep vein thrombosis.
You do not need to do anything. sam® is designed to work with the human body and maximize the safe and effective delivery of sustained acoustic medicine. When the applicators go into sam® Sensing Mode, a red LED will replace the normal blue LED light. The device will continuously monitor the status and the blue lights will return when ideal operating conditions are sensed. However, you should check that the unit is not covered by thick insulating material such as coats, blankets or a sports wrap, as this may cause the sam® to disable and remain disabled. Do not turn the device power “off” and “on” if the unit goes into sam® Sensing Mode.