Table 4 Summary of measurable outcomes on pain, function, quality of life and compliance for SAM clinical studies in the peer-reviewed literature
Author | Pain reduction VAS/NRS | Improved function (WOMAC/ROM/dynamometry) | Improved health (GROC) | Mechanistic outcomes included | Clinical trail registration number | Safety profile | Subject receptivity and compliance to treatment |
|---|---|---|---|---|---|---|---|
Lewis et al. [53] | YES: 16–21% p < 0.05, p = 0.03 | Not measured | YES: 60% p = 0.05 | NA | NA | Excellent | YES: 100% compliance to treatment |
Lewis et al. [65] | YES: 30–52% p < 0.05 | Not measured | YES: 52% p < 0.05 | NA | NA | Excellent | NA |
Langer et al. [67] | YES: 52% p < 0.05 | YES: 20% improvement in mobility | Not measured | NA | NCT01993693 | Excellent | NA |
Taggart et al. [71] | NA | NA | NA | NA | NA | Excellent | YES: 87–95% ease of use, receptive and positive experience |
Rigby et al. [55] | NA | NA | NA | YES: Diathermic temperature increase by 3.22–4.45C | NA | Excellent | NA |
Best et al. [50] | YES: 3.94 points p = 0.002 | YES: 2.83 kg improvement in strength p = 0.04 | Not measured | NA | NCT02466308 | Good, n = 3 skin response | YES: 92% use of the device and 72% compliance with study |
Langer et al. [51] | YES: 2.5 points p < 0.03 | Not measured | Not measured | NA | NCT01993693 | Excellent | NA |
Langer et al. [68] | NA | YES: Power p = 0.024, torque p = 0.031 and work p = 0.031 improvement | NA | YES: Blood lactate reduction p = 0.002 | NA | Excellent | NA |
Langer et al. [69] | NA | NA | NA | YES: Diathermic temperature increase by 12–13C | NA | Excellent | NA |
Draper et al. [52] | YES: 1.96 point p < 0.001 | YES: 505 point function p = 0.02, 3.2 N strength p = 0.03 | Not measured | NA | NCT02083861 | Excellent, less than 0.1% reported irritation | YES: 93% study retention |
Petterson et al. [64] | YES: 2.61 points p < 0.001 | Not measured | YES: 2.84 points p < 0.01 | NA | NCT02135094 | Excellent, no reportable | YES: 100% compliance |
Draper et al. [70] | YES: 3.33 points p < 0.05 | YES: 87% improvement | Not measured | NA | NCT04177537 | Excellent | YES: 55% able to return to work |
Madzia et al. [66] | YES: 2.06–2.96 point p < 0.001 | YES: 510 point function p < 0.001 | Not measured | NA | NCT04391842 | Excellent | YES: 95% receptive and continuation of treatment |
N = 13 Studies, N = 372 subjects | N = 9 Studies significant pain reduction | N = 6 studies significant functional improvement | N = 3 studies significant health improvement | N = 3 studies mechanisms of action measured | N = 7 studies registered | N = 13 studies no adverse events | N = 7 high compliance and treatment receptivity |