小児および思春期集団におけるTENSの安全性および忍容性を支持する臨床エビデンス

執筆者 | 6月 22, 2026

小児・思春期集団におけるTENSの安全性および忍容性を支持する臨床エビデンス

本ページで紹介するエビデンスには、小児、思春期患者、および若年女性を対象としてTENS（経皮的電気神経刺激療法）を評価したランダム化比較試験（RCT）、システマティックレビュー、ならびにメタアナリシスが含まれています。

以下に掲載するエビデンスは、若年層におけるTENSの使用に関する科学的知見をより深く理解したい医療従事者、販売パートナー、保護者、および関係者の皆様に向けてまとめたものです。各研究は研究デザイン、対象疾患、患者背景などが異なりますが、全体としてのエビデンスは、TENSが適切に使用された場合に良好な忍容性を示し、多くの研究において報告された有害事象は軽度かつ一過性であることを示しています。

以下の文献は、小児および思春期集団におけるTENS技術の安全性プロファイルを支持する、近年の代表的かつ関連性の高いエビデンスをまとめたものです。

小児・思春期におけるTENSに関する注釈付きエビデンス集

  1. Meta-analysis (children with overactive bladder) — Safety & efficacy
  1. Prospective RCT in children (5–12 yrs) — Safe treatment option
  1. Feasibility & at-home use in pediatrics — Minimal AEs
  • Malhotra et al., 2023 RCT on at-home pediatric parasacral TENS reported feasible adherence and minimal adverse events.

(https://pubmed.ncbi.nlm.nih.gov/37670742/)

  1. Randomized clinical data & schedules in children
  1. Earlier pediatric trial — TENS safe & well tolerated
  1. Systematic review (general TENS) — Minimal risks/contraindications
  1. Children with neurologic conditions — Neuromodulation safety signals
  • Liu et al., 2021 (BMC Pediatrics) on TENS combined with tPCS in children with cerebral palsy reported good tolerability and minimal side effects (supports pediatric neuromodulation safety more broadly). (pdf attached)
  1. Adolescent dysmenorrhea — Pain relief & safety
  • A randomized, double-blind trial found TENS provided rapid, lasting menstrual pain relief with good safety (adolescents/young women). Pair with a 2024 Cochrane review noting reduced pain and no unwanted effects reported in included trials.

(https://www.sciencedirect.com/science/article/pii/S1166708722000288?)

  1. Recent pediatric meta-analysis (Frontiers in Pediatrics, 2025)
  1. Guidance on contraindications (for parent Q&A)

How to phrase a safety statement (for our pediatric materials)

“Rosi uses low-frequency TENS, a non-invasive, drug-free technology with a strong safety record in children and adolescents when used as directed. Multiple pediatric studies—including randomized trials and meta-analyses—report minimal side effects (typically mild, temporary skin redness/tingling) and good tolerability. Do not use if your child has an implanted pacemaker or other electronic implant, and always follow doctor/parental guidance for correct pad placement and intensity.” (https://pmc.ncbi.nlm.nih.gov/articles/PMC7136445/?)

There are about 10 recent and relevant publications focused on the use of TENS) for menstrual pain (Primary Dysmenorrhea) in adolescents or young women – each includes citation details and key take-aways for our pediatric/younger patient materials:

Key Takeaways

  • Multiple randomized trials have evaluated TENS in pediatric populations.
  • Meta-analyses support a favorable safety profile.
  • Most reported side effects are mild and temporary.
  • TENS is non-invasive and drug-free.
  • TENS has been studied in children, adolescents, and young women across multiple indications.
CitationPopulation & Key Findings
U. Manisha et al., “Effect of high frequency transcutaneous electrical nerve stimulation at root level menstrual pain in primary dysmenorrhea”, J Bodyw Mov Ther. 2021;26:108-112. (https://pubmed.ncbi.nlm.nih.gov/33992229/ )Adolescents aged 14-19: RCT showing significant pain reduction with high-frequency TENS.
Michal Elboim-Gabyzon & Leonid Kalichman, “TENS for Primary Dysmenorrhea: An Overview”, Int J Women’s Health 2020;12:1-10. (https://pmc.ncbi.nlm.nih.gov/articles/PMC6955615/? )Review covering young women with PD; supports TENS safety and efficacy.
Lin C., “Is TENS therapy to the pelvic region effective in alleviating menstrual pain in adolescent and young adult females with PD?”, PCOM Physician Assistant Studies Student Scholarship 2023. (https://digitalcommons.pcom.edu/pa_systematic_reviews/671/? )Selective EBM review focusing on adolescents & young adults with PD; demonstrates pain reduction.
“Transcutaneous electrical nerve stimulation for pain control …” Cochrane Review 2024. (https://pubmed.ncbi.nlm.nih.gov/39037764/)Systematic review including participants aged 12-49 yrs; supports that TENS may reduce menstrual pain with minimal adverse effects.
“TENS for menstrual pain in young women: Randomized, sham-controlled trial” (Chinese young women) – Effect of transcutaneous electrical nerve stimulation therapy for the … 2019-2021.
https://pmc.ncbi.nlm.nih.gov/articles/PMC6392990/?		Young adult women, compared active vs sham TENS: greater pain relief, no adverse events.
R. M. Amaral et al., “High and low frequency TENS in young people with primary dysmenorrhea: Clinical trial protocol”, Manual Therapy, Posturology & Rehabilitation Journal 2024;22. https://submission-mtprehabjournal.com/revista/article/view/1361?Protocol for randomized trial in young people (15-29 yrs) with PD; relevant for upcoming evidence.
“Effectiveness of Transcutaneous Electrical Nerve Stimulation and Interferential Current in Primary Dysmenorrhea”, Pain Med. 2007;8(4):295-300. https://pubmed.ncbi.nlm.nih.gov/17610451/Early adult study (mean age ~21 yrs) showing TENS vs interferential current; no adverse effects.
Jakhar R. et al., “Efficacy of one time transcutaneous electrical nerve stimulation … in PD”, Int J Physiother Res. 2017;5(2):1987-92. (Semantic Scholar)Study in young women—showed decreased pain and fewer analgesics after TENS use.
“The Effects of Electrode Placement on Analgesia Using iTENS in Females with PD”, Camilo FM et al., 2023. (attached pdf)Young female sample; looked at electrode placement—reports improvement in pain with TENS and minimal side-effects.
“Effectiveness of TENS on women with PD: An Evidence-Based Review”, IJRPP (2024) — 10 studies reviewed. https://ijrpp.com/ijrpp/article/view/671?Review focused on women including younger cohorts; found TENS to be safe, well-tolerated and effective in most studies.

重要: 以下に掲載する文献は、さまざまな小児・思春期集団および適応症におけるTENS（経皮的電気神経刺激療法）を評価したものです。各研究は必ずしもRosi®デバイスそのものを評価したものではなく、TENS技術全般に関するエビデンスとしてご参照ください。