Allevia Health

Alpha-Stim® Efficacy Surveys

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Alpha-Stim® Postmarketing Surveys

Several postmarking surveys of the efficacy of the Alpha-Stim technology were conducted for the FDA in 2001, 2011 and 2013 by the manufacturer of Alpha-Stim, Electromedical Products International, Inc. The surveys included self-reports from 5,917 Alpha-Stim users, including civilians, service members and veterans.

The vast majority of patients (94.4%) reported no adverse side effects of CES therapy. Side effects were generally limited and disappear once the intensity of the current is reduced.

The degree of improvement in the patient’s symptoms was recorded for multiple indications for which CES was prescribed. Similar to pharmaceutical studies, a level of improvement of at least 25% was considered clinically relevant.

Download results of Alpha-Stim 2011 surveys

Condition N Worse No Change Slight <24% Fair 25-49% Moderate 50-74% Marked 75-99% Complete 100% Clinically Significant >25%
Anxiety 349 0.00 2.29 4.01 11.17 25.50 51.86 5.16 93.70
Stress 259 0.00 2.32 4.63 14.29 27.03 47.88 3.86 93.05
Insomnia 135 0.00 11.85 8.89 12.59 25.19 33.33 8.15 79.26
Depression 184 0.00 4.35 5.98 16.85 20.65 44.57 7.61 89.67
Pain 286 0.35 1.75 6.99 16.78 26.92 37.76 9.44 90.91
Muscle Tension 259 0.77 2.32 2.32 16.22 29.34 42.86 6.18 94.59

 

Survey of Alpha-Stim Warranty Cards

Additional support for the efficacy and safety of Alpha-Stim, and validation of the post-marketing clinical results achieved with this therapy, comes from an analysis of warranty cards  received by the manufacturer.

None of the patients reported any significant side effects of the therapy even though they were explicitly asked to list them on the warranty card. A level of improvement of at least 25% was considered clinically significant.

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Psychological Conditions

Condition N Slight 24% Fair 25-49% Moderate 50-74% Marked 75-100% Clinically Significant >25%
Anxiety (with other) 370 8.92 22.97 32.97 35.14 91.08
Anxiety/Depression 58 5.17 32.76 32.76 29.31 94.83
Stress 123 4.88 24.39 31.71 39.02 95.12
Insomnia 163 6.13 28.83 28.83 36.20 93.87
Depression (alone) 53 13.21 20.75 43.40 22.64 86.79
Depression (with other) 265 10.94 23.02 35.09 30.94 89.06
Chronic Fatigue 50 6.00 60.00 20.00 14.00 94.00
Psychological (All Cases) 723 8.44 24.20 32.78 34.58 91.56

 

Pain Conditions

Condition N Slight <24% Fair 25-49% Moderate 50-74% Marked 75-100% Clinically Significant >25%
Back Pain 403 4.96 27.05 38.96 29.03 95.04
Cervical Pain 265 6.79 26.04 47.17 20.00 93.21
Hip/Leg/Foot Pain 160 3.75 26.88 33.13 36.25 96.25
Shoulder/Arm/Hand Pain 150 8.67 27.33 42.00 22.00 91.33
Carpal Tunnel 25 0.00 20.00 68.00 12.00 100.00
Arthritis Pain 188 5.85 27.13 46.81 20.21 94.15
TMJ Pain 158 10.76 37.97 37.97 13.29 89.24
Myofascial Pain 62 9.68 29.03 29.03 32.26 90.32
Reflex Sympathetic Dystrophy 55 18.18 29.09 34.55 18.18 81.82
Fibromyalgia (alone) 142 9.15 37.32 36.62 16.90 90.85
Fibromyalgia (with other) 363 9.09 36.09 41.87 12.95 90.91
Migraine 118 1.69 41.53 25.42 31.36 98.31
Headaches (all other) 112 17.86 26.79 21.43 33.93 82.14
Pain (all cases) 723 8.44 24.20 32.78 34.58 91.56