Clinical Research Directory

Transcutaneous Cervical Vagus Nerve Stimulation for Primary Dysmenorrhea

This randomized, sham-controlled, parallel-group clinical trial will investigate the effects of bilateral transcutaneous cervical vagus nerve stimulation (tcVNS) on menstrual pain and related clinical outcomes in women with primary dysmenorrhea. Seventy women aged 18-30 years will be randomly allocated in a 1:1 ratio to either active tcVNS or sham stimulation. The intervention will be administered once daily for 8 minutes during the first three days of menstruation. Outcomes will include menstrual pain intensity, multidimensional pain characteristics, dysmenorrhea-related functional and emotional symptoms, anxiety and depression, menstrual symptoms, analgesic use, and heart rate variability. Participants will be followed for five days during one menstrual cycle.

A Preliminary Study on the Efficacy of Danggui Shaoyao San and Cuscuta Chinensis in Patients With Primary Dysmenorrhea

This study aims to evaluate the efficacy of two traditional Chinese medicine (TCM) formulas, Danggui Shaoyao San (DSS) and Cuscuta Chinensis (Tu Si Zi), in treating primary dysmenorrhea (PD). Primary dysmenorrhea, a common condition characterized by painful menstrual cramps, affects many women of reproductive age and significantly impacts their quality of life. Conventional treatments, such as NSAIDs and oral contraceptives, often have limited efficacy or side effects, underscoring the need for alternative therapeutic options. In this randomized, double-blind study, participants will be divided into four groups: DSS, Tu Si Zi, a combination of DSS and Tu Si Zi, and a placebo group. The study will measure treatment outcomes using the Visual Analogue Scale (VAS) for pain and the Menstrual Symptom Questionnaire (MSQ), which captures physical and emotional symptoms. Additionally, TCM-based tools like pulse diagnosis and constitution questionnaires will be employed to explore personalized treatment strategies. This research seeks to determine whether these TCM formulas can alleviate pain and improve other menstrual symptoms, potentially providing broader benefits than conventional painkillers. The findings aim to support evidence-based integration of TCM in managing dysmenorrhea and inform clinicians and patients about effective therapeutic choices.

Efficacy of Thread - Embedding Acupuncture for the Treatment of Primary Dysmenorrhea

The goal of this clinical trial is to learn whether thread-embedding acupuncture can help lower menstrual pain in women aged 18 to 29 years with primary dysmenorrhea. Thread-embedding acupuncture is a type of acupuncture in which a small absorbable thread is placed into selected acupuncture points to provide longer-lasting stimulation. The main questions this study aims to answer are: * Does thread-embedding acupuncture combined with standard treatment lower menstrual pain more than standard treatment alone? * Does it improve other menstrual symptoms and lower the need for ibuprofen? What unwanted effects occur during the study? Researchers will compare participants who receive thread-embedding acupuncture plus standard treatment with participants who receive standard treatment alone. Participants will: * Use heat therapy when menstrual pain begins. * Take ibuprofen as rescue medicine when pain is severe, according to the study instructions. * If assigned to the thread-embedding acupuncture group, receive thread-embedding acupuncture before menstruation during two menstrual cycles. * Record menstrual pain, related symptoms, and ibuprofen use during the study. * Be assessed at the start of the study, during two treatment cycles, and during one menstrual cycle after treatment ends.

Effects of Transcutaneous Tibial and Auricular Vagus Nerve Stimulation in Females With Primary Dysmenorrhea

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.

Individualized Acupoint Therapy for Dysmenorrhea: An Exploratory Research Design Based on Meridian Measurement

Primary dysmenorrhea is a common condition that significantly affects young women's quality of life. Traditional Chinese Medicine (TCM) acupoint interventions are widely used for symptom relief; however, standardized fixed-acupoint approaches often overlook individual meridian status variations. This pilot study aims to evaluate the feasibility, preliminary efficacy, and physiological responses of an individualized meridian-guided intervention for primary dysmenorrhea in females aged 18-30. Utilizing non-invasive skin electrical resistance measurements (AETOSCAN) to assess baseline meridian energy status, eligible dysmenorrhea participants will be randomized into two parallel arms: an individualized meridian-guided intervention group and a standardized fixed-acupoint group. Interventions will be administered twice weekly over a 4-week cycle. The primary outcomes focus on changes in pain severity (VAS), menstrual distress scores (MDQ), and objective meridian electrical characteristics.

Effectiveness of an Acupressure Band for Primary Dysmenorrhea in College Students

This study aims to investigate the effectiveness of an acupressure band in improving primary dysmenorrhea among college students. Primary dysmenorrhea is characterized by cramping lower abdominal pain during menstruation and is often accompanied by symptoms such as nausea, fatigue, and headache. It is also one of the leading causes of academic and work absenteeism among women of reproductive age. Previous studies have shown that acupressure applied to the Sanyinjiao (SP6) acupoint can alleviate menstrual pain. In addition, current clinical research has mainly focused on auricular acupressure using Vaccaria seeds, while relatively few studies have explored their application on body acupoints. Therefore, this study focuses on the application of Vaccaria seeds on the Sanyinjiao (SP6) acupoint to evaluate their effects on primary dysmenorrhea. To provide continuous and stable acupoint stimulation, this study utilizes an intervention device combining Vaccaria seeds with a compression band, together with acupressure stimulation. This study adopts a single-blind randomized controlled trial design. A total of 30 participants will be randomly assigned to either the experimental group or the control group (compression band only group). The study consists of four menstrual cycles, including one baseline menstrual cycle followed by three consecutive menstrual cycles of home-based intervention. Outcome measures include the Visual Analog Scale (VAS) for pain intensity, the Menstrual Distress Questionnaire (MEDI-Q) for menstrual-related symptoms and distress, and heart rate variability (HRV), monitored using the ANS Watch as an indicator of autonomic nervous system activity. Statistical analyses will be conducted to compare differences between the experimental and control groups, as well as between pre- and post-intervention measurements, in order to evaluate the clinical potential of the acupressure band for primary dysmenorrhea management.

Prevalence, Severity of Dysmenorrhea and Effectiveness of Structured Physiotherapy Interventions Among Doctor of Physical Therapy Students

\*\*Trial Summary\*\* Primary dysmenorrhea is a common condition among young women that can significantly impair daily functioning and health-related quality of life. This single-center randomized controlled trial evaluated the effectiveness of a 12-week structured physiotherapy program in 360 female Doctor of Physical Therapy (DPT) students with primary dysmenorrhea. Participants were randomly allocated to either a structured physiotherapy intervention (n=180) or a control group receiving conventional treatment (n=180). The intervention consisted of supervised sessions three times per week, including general stretching, pelvic stretching, aerobic jogging, Kegel exercises, and progressive muscle relaxation. The primary outcome was the change in dysmenorrhea symptoms over three consecutive menstrual cycles, while secondary outcomes included health-related quality of life assessed using the SF-36 questionnaire. Compared with the control group, participants receiving structured physiotherapy demonstrated significant reductions in all assessed dysmenorrhea symptoms and significant improvements in physical functioning, bodily pain, general health perception, and vitality. Greater dysmenorrhea severity was associated with poorer quality-of-life scores, and structured physiotherapy independently predicted clinical improvement. The findings indicate that a structured multimodal physiotherapy program is an effective non-pharmacological intervention for reducing the severity of primary dysmenorrhea and improving selected domains of health-related quality of life in female DPT students.

Breathing Exercises Combined With Core Stabilization Exercises in Women With Primary Dysmenorrhea

Primary dysmenorrhea is a common gynecological condition among women of reproductive age and is associated with pelvic pain, psychological distress, and reduced health-related quality of life. Although core stabilization exercises and breathing exercises have individually demonstrated beneficial effects, evidence regarding their combined effectiveness remains limited. This randomized controlled trial aims to compare the effects of core stabilization exercises alone with breathing exercises combined with core stabilization exercises in women with primary dysmenorrhea. Forty-eight women aged 18-25 years will be randomly allocated to either the control group (core stabilization exercises) or the experimental group (breathing exercises combined with core stabilization exercises). Both groups will participate in supervised exercise sessions three times per week for eight weeks. Outcome measures will include menstrual pain intensity, psychological status, and health-related quality of life, assessed using the Visual Analog Scale (VAS), Depression Anxiety Stress Scales-21 (DASS-21), and 12-Item Short Form Health Survey (SF-12) at baseline and Week 8. The study will determine whether adding breathing exercises to core stabilization exercises provides greater clinical benefits than core stabilization exercises alone.

Effect of Auricular Vagus Nerve Stimulation on Pain and Symptoms in Primary Dysmenorrhea

This study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on menstrual pain, pain threshold, depression, anxiety, menstrual symptoms, premenstrual syndrome, and functional and emotional impact of dysmenorrhea in young adult women with primary dysmenorrhea.

The Relationship Between Ophiocephalus Striatus Extract and Serum TNF-α, IL-6, and CRP Levels in Primary Dysmenorrhea

Primary dysmenorrhea is menstrual pain without any underlying pelvic disease. It affects many adolescent girls and can disrupt daily activities, school attendance, and quality of life. The pain is related to inflammation and the production of substances such as prostaglandins and inflammatory proteins like tumor necrosis factor-alpha (TNF-α), interleukin-6 (IL-6), and C-reactive protein (CRP). Ophiocephalus striatus (also known as snakehead fish) is a freshwater fish traditionally used in Southeast Asia to help wound healing and reduce inflammation. It contains high levels of albumin, which has anti-inflammatory and antioxidant properties. This study was a double-blind, randomized, placebo-controlled trial conducted in Palembang, Indonesia. A total of 40 adolescent girls aged 13-19 years with moderate to severe primary dysmenorrhea were enrolled. They were randomly assigned to receive either Ophiocephalus striatus extract (500 mg capsules) or a matching placebo twice daily for 14 days before their expected next menstruation. Pain intensity was measured using a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain). Blood samples were taken at the beginning and end of the study to measure serum levels of TNF-α, IL-6, and CRP using ELISA. The study found that after 14 days, girls who received the extract had a significant reduction in pain (average VAS decreased from 7.3 to 4.2). Their levels of TNF-α, IL-6, and CRP also decreased significantly. In the placebo group, pain also decreased but the inflammatory markers did not change significantly. No serious side effects were reported. This suggests that Ophiocephalus striatus extract may help reduce menstrual pain by lowering inflammation. Further research with larger groups and longer treatment periods is needed to confirm these findings.

Effect of Pilates Exercises Versus Gym Exercises On Primary Dysmenorrhea

This study will be conducted to assess the effect of Pilates Exercises Versus Gym Exercises On Primary Dysmenorrhea.

Effect of Semiconductor Embedded Wearable Sleeve on Treatment of Primary Dysmenorrhea Symptoms

This study is looking to test a non-compressive semiconductor embedded body sleeve for treatment of primary dysmenorrhea symptoms. Dysmenorrhea is the lower abdominal pain (sometimes referred to as "cramping") experienced during menstruation (monthly "period"), affecting up to 94% of people aged from 10-20 years old. The semiconductor embedded fabric increases blood circulation through activation of the embedded elements with body heat while worn and releases energy waves as well as negative ions. This energy has an effect inside the body that increases oxygen and nutrient flow to tissues, and can help to decrease pain and inflammation. This study is testing this technology to see if it can be used as a non-pharmacological treatment for menstrual cramping.

Graded Motor Imagery for Primary Dysmenorrhea

The goal of this clinical trial is to learn if graded motor imagery can reduce pain sensitivity and period pain in women with primary dysmenorrhea (painful periods with no medical cause). The main questions it aims to answer are: 1. Is there a decrease in pressure pain threshold (increased pain sensitivity) with graded motor imagery? 2. Is the intensity of menstrual pain reduced by graded motor imagery? 3. Is GMI helpful to reduce menstrual symptoms and pain catastrophizing (negative thinking about pain)? Researchers will compare full GMI (active intervention), a sham GMI(inactive intervention), and a wait-list (no intervention) to see if GMI works better than the alternatives. Participants will: 1. Take part in a 6-week graded motor imagery program, sham program, or no intervention control. 2. Do laterality recognition, motor imagery, and mirror therapy exercises in the graded motor imagery group. 3. Complete pain and symptom assessments before and after the program, and again at follow-up.

Pelvic Nerve Mobilization for Primary Dysmenorrhea

Primary dysmenorrhea is a highly prevalent condition among young women and is associated with significant pain, reduced quality of life, and academic absenteeism. Although non-steroidal anti-inflammatory drugs are commonly used, many women seek non-pharmacological alternatives due to limited effectiveness or adverse effects. Emerging evidence suggests that altered pelvic neurodynamics may contribute to dysmenorrheic pain. This randomized controlled trial aims to evaluate the effectiveness of external pelvic nerve mobilization in reducing menstrual pain and associated symptoms among university women with primary dysmenorrhea. Participants aged 18-30 years will be randomly allocated to receive either external pelvic nerve mobilization or a sham manual therapy intervention across three consecutive menstrual cycles. Outcomes will include pain intensity, menstrual distress, quality of life, pelvic tenderness, analgesic consumption, and academic absenteeism.

Online Pain Neuroscience Education for Women With Primary Dysmenorrhea

Primary dysmenorrhea is a highly prevalent condition characterized by recurrent menstrual pain in the absence of identifiable pelvic pathology. It affects up to 95% of menstruating women and often interferes with quality of life. Pain neuroscience education (PNE) has shown positive effects in musculoskeletal conditions but has not yet been studied in women with primary dysmenorrhea. This study aims to evaluate the effect of an online PNE intervention combined with lifestyle recommendations, compared to lifestyle recommendations alone

Pelvic Floor and Diaphragmatic Breathing Exercises for Primary Dysmenorrhea

This study investigates whether combining pelvic floor muscle exercises with diaphragmatic breathing exercises can reduce menstrual pain in women with primary dysmenorrhea. Forty participants will be randomly assigned to two groups: one performing both exercises, and the other performing only diaphragmatic breathing. The study will measure pain, menstrual symptoms, quality of life, and psychological well-being before and after the intervention.

Effect of Yoga Training on Nausea and Pain

This study was planned to determine the effect of yoga training on reducing nausea and pain symptoms in young women with primary dysmenorrhea. As a result of this study, evaluating the extent to which women with dysmenorrhea experience pain and nausea and the extent to which yoga has a positive effect on these symptoms may shed light on women experiencing these symptoms and developments in the literature, and may increase the use of non-pharmacological approaches. The results of the study will contribute to the literature on dysmenorrhea, one of the important gynecological problems in women. In addition, although there are many results in the literature on the effectiveness of yoga in the management of nausea symptoms with cancer patients, there are not many studies on nausea on dysmenorrhea. In this respect, it will provide important evidence to the literature.