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.
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.
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).
Parallel
Transcutaneous Tibial Nerve Stimulation (TTNS)
DeviceElectrical stimulation will be delivered through a TENS device using surface electrodes placed over the posterior tibial nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
Transcutaneous Auricular Vagus Nerve Stimulation (TaVNS)
DeviceElectrical stimulation delivered through a TENS device using surface electrodes placed on the auricular branch of the vagus nerve for 30 mins according to the study protocol for the management of primary dysmenorrhea. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
TTNS+TaVNS
DeviceElectrical stimulation delivered through a TENS device to both the posterior tibial nerve and the auricular branch of the vagus nerve sequentially according to the study protocol. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
Sham Stimulation
DeviceSham stimulation delivered using the same TENS device and electrode placement as the active intervention but without therapeutic electrical stimulation. The intervention will be applied for 5 consecutive days, including 2 days before and 3 days during the mensturation period.
Dysmenorrhea Severity - WaLIDD Score
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)
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)
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)
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.
Menstrual Symptoms - Menstrual Distress Questionnaire (MEDI-Q) Score
Menstrual-related symptoms will be assessed using the Menstrual Distress Questionnaire (MDQ). The questionnaire evaluates the severity of menstrual symptoms across multiple symptom categories. Higher scores indicate greater menstrual symptom severity.
NSAID Consumption
NSAID consumption will be assessed using a participant diary/log to record the frequency and quantity of NSAID use during each menstrual cycle.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
