Effect of Portable Transcutaneous Electrical Nerve Stimulation on Pain Intensity in Women With Primary Dysmenorrhea: A Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain intensity measured using the Visual Analogue Scale (VAS)
研究概览
简要总结
Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of pelvic pathology. It affects a large proportion of women of reproductive age and may significantly interfere with daily activities, academic performance, and quality of life. Although pharmacological treatments such as nonsteroidal anti-inflammatory drugs are frequently used to manage menstrual pain, some women experience insufficient relief or prefer non-pharmacological treatment options.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy technique widely used in pain management. TENS is thought to reduce pain through mechanisms including modulation of nociceptive transmission at the spinal cord level and activation of endogenous analgesic pathways. Portable TENS devices may provide a convenient and accessible option for self-management of menstrual pain.
The aim of this randomized controlled pilot study was to evaluate the effectiveness of a portable TENS device in reducing pain intensity in women with primary dysmenorrhea. Participants diagnosed with primary dysmenorrhea were randomly assigned to either an intervention group receiving treatment with a portable TENS device or a control group receiving usual care.
The intervention consisted of the application of a portable TENS patch to the lower abdominal region during menstrual pain episodes. The device delivered alternating stimulation cycles combining high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each treatment session lasted approximately 20 minutes and was applied during menstrual pain episodes.
Participants were followed for up to three menstrual cycles. Pain intensity was assessed using a visual analogue scale (VAS). Additional outcomes included quality of life assessed using the Short Form-12 Health Survey (SF-12), anxiety and depression measured with the Hospital Anxiety and Depression Scale (HADS), female sexual function evaluated with the Female Sexual Function questionnaire (FSM), and analgesic medication use recorded in a pain diary.
The results of this study aim to contribute to the evidence on non-pharmacological interventions for menstrual pain and to evaluate the potential role of portable TENS devices as a safe and accessible option for women with primary dysmenorrhea.
详细描述
Primary dysmenorrhea is a common gynecological condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects a substantial proportion of women of reproductive age and is frequently associated with symptoms such as abdominal cramps, low back pain, nausea, fatigue, and headache. The condition may negatively affect daily functioning, academic performance, and quality of life. Despite its high prevalence, many women continue to experience inadequate pain control or adverse effects from pharmacological treatments.
Menstrual pain in primary dysmenorrhea is primarily associated with increased production of prostaglandins in the endometrium during menstruation. Elevated prostaglandin levels increase uterine contractility and vasoconstriction, which can result in uterine ischemia and activation of nociceptive pathways. These mechanisms contribute to the characteristic cramping pain experienced during menstruation.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used as first-line pharmacological treatment because they inhibit prostaglandin synthesis. However, some women experience insufficient pain relief, contraindications, or adverse effects associated with pharmacological therapies. For this reason, there is growing interest in non-pharmacological approaches to the management of primary dysmenorrhea.
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electrotherapy modality widely used for pain management in various clinical conditions. TENS delivers low-voltage electrical currents through electrodes placed on the skin, stimulating peripheral nerves. The analgesic effect of TENS is thought to be mediated by several physiological mechanisms, including activation of large-diameter afferent fibers that inhibit nociceptive transmission at the spinal cord level (gate control mechanism), as well as activation of descending inhibitory pathways and endogenous opioid release.
Several studies have suggested that TENS may reduce pain intensity in women with primary dysmenorrhea. In addition, portable TENS devices allow self-administration of therapy and may represent a convenient and accessible strategy for managing menstrual pain outside of clinical settings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This study was conducted as an open-label trial. No participants, care providers, investigators, or outcome assessors were blinded to group allocation due to the nature of the intervention (TENS vs usual care).
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women diagnosed with primary dysmenorrhea
- •History of recurrent menstrual pain without identifiable pelvic pathology
- •Regular menstrual cycles
- •Age between 18 and 45 years old
- •Pain intensity of at least 4 on a 10-cm Visual Analogue Scale (VAS)
- •Willingness to participate in the study and to comply with study procedures
- •Provision of written informed consent
排除标准
- •Secondary dysmenorrhea associated with identifiable pelvic pathology
- •Irregular menstrual cycles
- •Use of hormonal contraceptives initiated or modified during the study period
- •Presence of gynecological or systemic conditions that could influence menstrual pain
- •Contraindications to transcutaneous electrical nerve stimulation (TENS), such as pacemaker implantation or skin lesions at the electrode placement site
- •Inability to understand study procedures or complete study questionnaires
研究组 & 干预措施
TENS Intervention Group
Portable transcutaneous electrical nerve stimulation (TENS) device applied to the lower abdominal region during menstrual pain episodes. The device delivered alternating cycles of high-frequency stimulation (85 Hz) and burst stimulation (2 Hz). Each session lasted approximately 20 minutes, with intensity adjusted to a strong but comfortable sensory level.
干预措施: Transcutaneous Electrical Nerve Stimulation (TENS) (Device)
Usual care control group
Participants continued their usual care during menstrual pain episodes, including the use of analgesic medication if needed.
结局指标
主要结局
Pain intensity measured using the Visual Analogue Scale (VAS)
时间窗: Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles
Pain intensity associated with primary dysmenorrhea measured using a 10-cm Visual Analogue Scale (VAS), where 0 represents no pain and 10 represents the worst pain imaginable.
次要结局
- Health-related quality of life measured using the Short Form-12 Health Survey (SF-12)(Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles)
- Anxiety and depression assessed using the Hospital Anxiety and Depression Scale (HADS)(Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles)
- Female sexual function assessed using the Female Sexual Function questionnaire (FSM)(Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles)
- Analgesic medication use recorded during menstrual pain episodes(Measured at the end of each menstrual cycle (each cycle is approximately 28 days), up to 3 cycles)
研究者
Jose Vicente Leon Hernandez
Professor of Physiotherapy, Centro Superior de Estudios Universitarios La Salle (UAM)
Centro Universitario La Salle