Focus of the Report: The use of Scrambler therapy (ST), also referred to as Calmare Pain Therapy and transcutaneous electrical modulation pain reprocessing (Calmare Therapeutics Inc.), for the management of chronic pain not related to cancer or cancer treatments.
Technology Description: ST is a noninvasive, transdermal treatment for the symptomatic relief of chronic pain. Treatment is performed by applying electrodes corresponding to the dermatome on the skin just above and below the area of pain. The system is a multiprocessor with artificial neurons that generate synthetic action potentials. The device provides electrical signals to nerves via electrodes presenting nonpain information to the painful area using continuously changing, variable, nonlinear waveforms, aiming to substitute the “pain” sensation for “nonpain.”
Controversy: Chronic pain is often difficult to treat and standard treatments such as opioids, neuroleptics, and other drugs can fail or cause adverse side effects. ST provides a nonpharmacological and noninvasive option for management of chronic pain. There are potential barriers to access and clinical implementation of ST. The therapy is administered in a clinical setting and patients are required to make daily visits for at least 2 weeks to receive treatment; this may not be tenable for patients with fragile health status or transportation limitations status. Further, ST relies on practitioner training, skill, and familiarity with the technique; and the benefits of may be operator dependent.
Key Questions:
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Is ST effective in managing chronic pain not related to cancer?
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How does ST compare with clinical alternatives?
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Is ST safe?
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Have definitive patient selection criteria been identified for ST?
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