SCRAMBLER THERAPY TRIAL
Evaluation in a larger, randomized controlled trial with standardized treatment is warranted. Scrambler Therapy (ST) is indicated in the advanced setting, acting through the neuromodulation by electrocutaneous stimulation in a non-invasive way. Similar findings from the initial randomization and crossover phases of this study support further evaluation of the efficacy of Scrambler therapy in alleviating CIPN symptoms. Similarly, Scrambler therapy appeared better than TENS when assessed by Global Impression of Change for neuropathy, pain, and overall quality of life. Unlike pain medications, our treatment does not involve side-effects or dependency. By day 4 of treatment, the two arms diverged with respect to mean change in primary symptom score this effect was largely carried through to the end of the two-week treatment period. Calmare Scrambler Therapy is a non-invasive and pain-free approach to the treatment of acute, chronic, and post-operative pain. Symptoms were assessed daily during the treatment period and weekly during an 8-week observation period.Ī 50% or greater reduction in primary symptom (pain or tingling) score on the last day of treatment was achieved by 6 of 10 Scrambler-treated patients (60%) and 3 of 12 TENS-treated patients (25%) after crossover (P = 0.11). Scrambler Therapy Used At The Scrambler Therapy device has been in active use at MD Anderson Cancer Center, Mayo clinic, John Hopkins, MUSC (Medical University of South Carolina), and Walter Reed. For more information, or to make an appointment, click the button and fill out the form, or give us a call. Aim: We evaluated Scrambler Therapy(®) (ST) in terms of efficacy, safety, and durability of treatment effect in patients suffering from CRPS. Currently 51 WC Insurance Companies and TPA’s and over 73 total carriers have approved and reimburse Calmar patients for Scrambler Therapy treatment. FDA 510(k)-cleared ( K142666) and European CE mark-certified (CE 0470) pain therapy medical device. Therapy of CRPS remains controversial the pain often can be very difficult to control, and treatment includes medications, physical therapy, regional anesthesia, and neuromodulation.
The primary means of assessment was patient-reported outcomes, including symptom severity scales and Global Impression of Change questionnaires. Scrambler Therapy Technology MC-5A is a U.S.
Referring clinicians and their patients can call 31 or email for more information. Twenty-two patients proceeded to the crossover phase. Scrambler therapy is being provided on a consultation basis in the UCLA Semel Institute Neuromodulation Division TMS Clinic. transcutaneous electrical nerve stimulation (TENS) in treating CIPN.įifty patients were accrued for the first half of this two-part, crossover trial consisting of a 2-week treatment period with either Scrambler or TENS, followed by an 8-week observation period, and then crossover treatment. The objective of this phase II, randomized controlled trial was to evaluate the efficacy of Scrambler therapy vs. Preliminary trials report that Scrambler Therapy, a form of electroanalgesia, may improve discomfort from chemotherapy-induced peripheral neuropathy (CIPN).
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