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Kariolis et al., 2020)

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An institutional review board (IRB) in the USA (Pearl IRB) considered this study to be exempt according to FDA 21 CFR 56.104 and 45CFR46.104(b)(2):(2)

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Furthermore, as discussed, the potential contributions of collateral sprouting from the saphenous nerve and/or intraspinal sprouting to the reorganization of afferent terminal fields should be further assessed

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Metaanalyses of 15 randomized studies (1,200 participants) confirm a statistically significant advantage for the combined approach, with mean VAS differences of 1.8 cm and larger effect sizes for disability scores

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