Transcutaneous electrical nerve stimulation for women with primary dysmenorrhea: Study protocol for a randomized controlled clinical trial with economic evaluation

Abstract

Primary dysmenorrhea (PD) is a common gynecological disorder characterized by cramping pain in the lower abdomen during menstruation, in the absence of identifiable pathology. While Transcutaneous Electrical Nerve Stimulation (TENS) is used to promote PD pain relief, there is still a need to understand the parameters and cost-effectiveness of this intervention. As such, this study aims to disclose a study that will evaluate the effectiveness and cost-effectiveness of TENS on pain intensity in women with PD. This is a protocol for an assessor-blinded randomized controlled trial that includes 174 women with PD, >18 years old, with menstrual pain greater than or equal to four points in the Numerical Rating Scale. Participants will be randomized into three groups (active TENS, placebo TENS, and educational booklet). Participants allocated to the active TENS group will receive electrical stimulation (F = 100 Hz, pulse duration = 200 μs, for 30 min). In contrast, the placebo TENS group will receive placebo stimulation (same parameters, but for only 30 s, and then the current will be ramped off over a 15-s time frame) for three consecutive months during menstruation. Participants allocated to the educational booklet group will receive instructions about health promotion and education actions related to PD. A blinded assessor will evaluate the pain intensity (Numerical Rating Scale), presenteeism (Stanford Presenteeism Scale), Health-Related Quality of Life (Short-Form 6 dimensions and SF-36), and health costs of menstrual pain. This is the first study to propose a health economic evaluation while assessing the benefits of using TENS to treat PD symptoms. It is hypothesized that active TENS will be more effective than placebo TENS or the educational booklet in improving clinical outcomes in the short-, medium- and long-term. The study will also provide information about the cost-effectiveness of TENS, which can be used by policy makers to improve PD care in public and private health systems.

Effects of Transcutaneous Electrical Nerve Stimulation on Pain and Chemotherapy-Induced Peripheral Neuropathy in Cancer Patients: A Systematic Review

“…All SRs reported the low quality of existing RCTs included in qualitative assessment and low confidence in the effect estimate stated. An issue with the quality of the studies assessing TENS' effectiveness was described almost 10 years ago [49]. Non-optimal TENS dosing and inadequate outcome evaluation were the common flaws indicating low fidelity.…”

Multimodal non-invasive non-pharmacological therapies for chronic pain: mechanisms and progress

“…Clinical studies demonstrate the analgesic effects of acupuncture across diverse chronic pain conditions. Beyond low back pain and knee osteoarthritis, clinical trials show acupuncture analgesic effects in cancerrelated pain, dysmenorrhea, migraine, tension headaches, abdominal pain, and chemotherapy-induced peripheral neuropathy, potentially by modulating sensory, affective, and cognitive pain dimensions [230][231][232][233][234][235][236][237] (Additional file 1: Fig. S3).…”

Efektivitas TENS untuk Menurunkan Tingkat Nyeri dan Meningkatkan Fungsional pada Remaja dengan Dismenore

“…Menurut Rodrigues, Avila, & Driusso (2021), dalam studi mereka, parameter TENS yang aktif akan berupa frekuensi 100 Hz, durasi pulsa 200 s, dan amplitudo arus (tingkat sensorik) yang maksimal namun nyaman. Amplitudo arus akan ditingkatkan sampai peserta melaporkan merasakan arus sebagai sensasi kesemutan yang kuat.…”

“…Dari hasil penelitianRodrigues, Avila, & Driusso, (2021) yang memiliki nilai skala PEDro 8/10 dengan indeks biasnya rendah sehingga jurnal masuk dalam kategori jurnal yang baik, bahwa TENS dengan frekuensi tinggi pada tingkat dermatom menunjukan peningkatan yang signifikan untuk mengelola dismenore, dan metode non farmaklogis yang aman, efisien dan terbaik untuk meredakan nyeri haid pada dismenore. Sedangkan dalam Bai, Bai, & Yang (2017) yang memiliki nilai skala PEDro 8/10 dimana indeks biasnya rendah sehingga jurnal masuk dalam jurnal yang baik, pada kelompok intervensi diberikan TENS, sedangkan kelompok palsu diberikan TENS palsu.…”