Clinical Evidence Supporting the Safety and Tolerability of TENS in Pediatric and Adolescent Populations
Reviewed evidence includes randomized controlled trials, systematic reviews, and meta-analyses evaluating TENS use in children, adolescents, and young women.
The evidence presented below is intended to support healthcare professionals, distributors, parents, and partners seeking a deeper understanding of the scientific literature surrounding TENS use in younger populations. While individual studies differ in design, indication, and patient population, the overall body of evidence suggests that TENS is generally well tolerated when used as directed, with most studies reporting minimal and transient adverse effects. The following publications represent a selection of recent and relevant evidence supporting the safety profile of TENS technology in pediatric and adolescent populations.
Pediatric & Adolescent TENS — Annotated Evidence
- Meta-analysis (children with overactive bladder) — Safety & efficacy
- Cui et al., 2020 pooled RCTs of pediatric parasacral TENS and found significant symptom improvements with no increase in discomfort/pain—supporting good tolerability in children.
(https://pmc.ncbi.nlm.nih.gov/articles/PMC7136445/)
- Prospective RCT in children (5–12 yrs) — Safe treatment option
- Gomaa et al., 2024 randomized trial concluded parasacral TENS is effective and safe for children with OAB, including those who failed meds. (https://link.springer.com/article/10.1007/s11255-024-04006-8?)
- 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/)
- Randomized clinical data & schedules in children
- Veiga et al., 2021 (IBJU) and related pediatric parasacral TENS literature show high response rates and practical weekly dosing—again without major safety concerns. (https://pmc.ncbi.nlm.nih.gov/articles/PMC8321474/?)
- Earlier pediatric trial — TENS safe & well tolerated
- Malm-Buatsi et al., 2007 reported that TENS for pediatric incontinence wassafe and well tolerated, encouraging further use.
(https://www.sciencedirect.com/science/article/abs/pii/S0090429507017888?)
- Systematic review (general TENS) — Minimal risks/contraindications
- Elboim-Gabyzon & Andrawis, 2020 review emphasizes TENS is non-invasive with minimal risks and few contraindications—useful background for parent-facing safety notes.
(https://pmc.ncbi.nlm.nih.gov/articles/PMC6955615/)
- 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)
- 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?)
- Recent pediatric meta-analysis (Frontiers in Pediatrics, 2025)
- Meta-analysis of parasacral TENS in children showed improved complete response rates vs comparators; safety acceptable (adds recency to the evidence base). (https://www.frontiersin.org/journals/pediatrics/articles/10.3389/fped.2025.1450634/full)
- Guidance on contraindications (for parent Q&A)
- Clinical references consistently list implanted pacemaker/CIEDs as a contraindication for TENS; use this to anchor your “Who should not use” section. (See expert consensus/guideline-style sources.) (https://www.heartrhythmjournal.com/article/S1547-5271%2821%2901930-5/fulltext? )
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.
| Citation | Population & 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. |
Important: The publications below evaluate TENS technology across various pediatric and adolescent populations and indications. Individual studies did not necessarily evaluate the Rosi device specifically.