Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation on Pain and Autonomic Function in Females With Primary Dysmenorrhea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 主要终点
- Dysmenorrhea Severity - WaLIDD Score
研究概览
简要总结
Primary dysmenorrhea is a common gynecological condition characterized by painful menstrual cramps that can negatively affect daily activities and quality of life. Non-invasive neuromodulation techniques, including Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS), have shown potential for pain management and modulation of autonomic nervous system function. However, limited evidence exists regarding the comparative and combined effects of these interventions.
This randomized controlled trial aims to evaluate the comparative and combined effects of TTNS and taVNS on pain, autonomic function, menstrual symptoms, and NSAID consumption in females with primary dysmenorrhea. Eligible participants will be randomly assigned to one of four groups: TTNS, taVNS, combined TTNS + taVNS, or sham stimulation. Outcome measures will be assessed before and after the intervention period by a blinded assessor.
详细描述
Primary dysmenorrhea is one of the most prevalent menstrual disorders among young females and is associated with significant pain, functional limitations, absenteeism, and increased use of analgesic medications. Current management primarily relies on non-steroidal anti-inflammatory drugs (NSAIDs), which may not provide adequate relief for all individuals and can produce adverse effects with repeated use. Therefore, effective non-pharmacological interventions are needed.
Transcutaneous Tibial Nerve Stimulation (TTNS) and Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) are non-invasive neuromodulation techniques that have demonstrated promising effects in reducing pain and regulating autonomic nervous system activity. While each intervention has been investigated separately for various pain conditions, evidence regarding their comparative effectiveness and the potential benefit of combining both interventions in females with primary dysmenorrhea remains limited.
This study is a randomized, parallel-group, assessor-blinded controlled trial. Approximately 66 participants with primary dysmenorrhea will be recruited using consecutive sampling and randomly allocated using computer-generated block randomization into one of four groups:
TTNS group, taVNS group, Combined TTNS + taVNS group Sham stimulation group
Participants will receive their allocated intervention according to standardized treatment protocols. The assessor responsible for outcome measurements will remain blinded to group allocation.
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
- Single (Outcomes Assessor)
盲法说明
This is a single-blinded randomized controlled trial. Outcome assessors will be blinded to treatment allocation throughout the study. Randomization and allocation concealment will be performed by an independent researcher. Due to the nature of the interventions, participants and intervention providers cannot be blinded.
入排标准
- 年龄范围
- 14 Years 至 30 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Nulliparous females aged 14-30 years.
- •Regular menstrual cycles.
- •Diagnosed with primary dysmenorrhea.
- •Pain located in the suprapubic area, abdomen, lower lumbar region, perineum, and/or medial aspect of the thighs during at least half of the annual menstrual cycles or the last three menstrual cycles.
- •Pain intensity greater than 4 on the Numeric Pain Rating Scale (NPRS).
排除标准
- •Females diagnosed with secondary dysmenorrhea (e.g., endometriosis, ovarian cysts).
- •Intrauterine device (IUD) users.
- •Presence of skin lesions, scars, or erosions on the inner aspect of the ankle.
- •Severe mental disorders (e.g., schizophrenia, bipolar disorder).
- •Pacemaker or other implanted electrical devices, if applicable to the stimulation
研究组 & 干预措施
TTNS
Participants will receive Transcutaneous Tibial Nerve Stimulation (TTNS) using TENS by standard stimulation parameters for the treatment of primary dysmenorrhea.
干预措施: Transcutaneous Tibial Nerve Stimulation (TTNS) (Device)
TaVNS
Participants will receive Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) using standardized stimulation parameters.
干预措施: Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS) (Device)
TTNS+TaVNS
Participants will receive both TTNS and taVNS during the same treatment session according to the study protocol
干预措施: TTNS+TaVNS (Device)
Sham Stimulation
Participants will receive sham stimulation that mimics the active interventions without providing therapeutic stimulation.
干预措施: Sham Stimulation (Device)
结局指标
主要结局
Dysmenorrhea Severity - WaLIDD Score
时间窗: Baseline, 4th Week, 8th Week , and 12th Week
Dysmenorrhea severity will be assessed using the WaLIDD score. The WaLIDD score is a multidimensional assessment of dysmenorrhea severity based on the number of pain days, pain intensity, work/activities affected, and history of dysmenorrhea. The total score ranges from 0 to 12, with higher scores indicating greater dysmenorrhea severity.
Pain Intensity - Numeric Pain Rating Scale (NPRS)
时间窗: Baseline, 4th Week, 8th Week , and 12th Week
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), ranging from 0 (no pain) to 10 (worst possible pain). NPRS will be recorded immediately before and immediately after each treatment session during the 5-day intervention period of each menstrual cycle.
Autonomic Function - Heart Rate Variability (RMSSD)
时间窗: Baseline, 4th Week, 8th Week , and 12th Week
Autonomic function will be assessed using the root mean square of successive differences (RMSSD) derived from heart rate variability. RMSSD will be reported in milliseconds (ms), with changes from pre-treatment to post-treatment used to evaluate autonomic response.
Autonomic Function - Heart Rate Variability (LF/HF Ratio)
时间窗: Baseline, 4th Week, 8th Week , and 12th Week
Autonomic function will be assessed using the low-frequency to high-frequency (LF/HF) ratio derived from heart rate variability. The LF/HF ratio will be used to evaluate changes in cardiac autonomic activity in response to the intervention.
次要结局
- Menstrual Symptoms - Menstrual Distress Questionnaire (MEDI-Q) Score(Baseline, Week 4, Week 8 and Week 12)
- NSAID Consumption(Baseline, Week 4, Week 8 and Week 12.)