Efficacy of Electro-Acupuncture at Dai Mai Meridian among Individuals with Primary Dysmenorrhea - A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The Wong-Baker FACES Pain Rating Scale (WBFS): Wong-Baker FACES Pain Rating Scale was developed by Donna Wong and Connie Baker in 1983 as a pain assessment tool. It features a series of faces ranging from a happy face at 0, indicating no hurt, to a crying face at 10, representing hurts like the worst pain imaginable. Participants select the face that best corresponds to their pain level, which is associated with a numerical score.
研究概览
简要总结
Dysmenorrhea refers to painful menstruation and is classified into primary PD and secondary forms. Primary dysmenorrhea occurs without underlying pelvic pathology and is common in adolescents, manifesting as lower abdominal pain and associated symptoms like nausea, fatigue, and leg pain. It significantly affects daily activities, and its prevalence in India ranges from 50 to 87.8 percent. Secondary dysmenorrhea is linked to pelvic conditions like fibroids or endometriosis and often affects married women.
PD involves hormonal imbalances estradiol and progesterone, leading to elevated prostaglandin levels, which cause uterine muscle contraction, ischemia, and pain. Treatment options include pharmacological methods, like NSAIDs, but these have side effects, prompting interest in non-pharmacological treatments, such as acupuncture.
Acupuncture, particularly Electro-Acupuncture EA, is an effective side-effect-free alternative that can manage chronic pelvic pain and is endorsed by the National Institute of Health. EA involves stimulating acupuncture needles with electrical current to enhance autonomic nervous system activity and reduce pain. The Dai Mai meridian, a key acupuncture point associated with the liver, kidney, and spleen, plays a significant role in regulating pelvic pain, especially in PD cases.
The aim of the study is to assess the impact of Electro-Acupuncture at Dai Mai Meridian on pain severity in primary dysmenorrhea. The primary objective is to evaluate the role of EA on pain, using the Wong-Baker FACES pain scale, and the secondary objective is to assess its effect on heart rate variability HRV in women with PD.
Research Questions
Can Electro-Acupuncture at Dai Mai Meridian influence pain in Primary Dysmenorrhea
Hypothesis
Null Hypothesis: EA at Dai Mai Meridian may not significantly affect pain in PD. Alternate Hypothesis: EA at Dai Mai Meridian may impact pain in PD.
Materials and Methods
Study Design A randomized controlled trial with two groups: intervention n=30 and control n=30. The intervention group will receive electro-acupuncture on Dai Mai meridian points LIV13, GB26, GB27, GB28 using four needles 1-1.5 cun, depth 16-30 mm and electrical stimulation SDZ-V model with a 100 Hz frequency for 20 minutes. Intensity will be adjusted based on patient feedback. Sessions will be conducted twice weekly except during menstruation, totaling 18 sessions over 3 months. The control group will receive no intervention. Baseline and post-assessments will occur on Day 1 and Day 90, respectively.
Participants
Sample Size: 60 Study group: 30 Control group: 30 Sampling Technique: Convenience sampling Source: OPD and IPD of International Institute of Yoga and Naturopathy Medical Sciences College and Hospital, Chengalpattu Inclusion Criteria
Females aged 18-30 years History of primary dysmenorrhea for at least 6 consecutive cycles Moderate to severe dysmenorrhea impacting daily activities Willingness for electrical acupuncture intervention Exclusion Criteria
Conditions like immunodeficiency, malignancy, neurological diseases, or irregular cycles Pregnant lactating women, or those on contraceptives medications for dysmenorrhea in the last 6 months Other medical conditions e.g., cardiovascular diseases, diabetes Fear or unwillingness toward acupuncture Ethical Considerations IEC approval will be obtained. Participants will provide informed written consent.
Randomization and Blinding Participants will be randomized 1:1 ratio using a lottery method with allocation concealment via SNOSE. Subjects will not be blinded to interventions.
Screening Procedures Eligible participants will be screened based on inclusion exclusion criteria. After providing consent, the study will be conducted over 3 months with outcomes assessed using the Wong-Baker FACES Pain Rating Scale WBFS and Heart Rate Variability HRV.
Intervention Electro-acupuncture on the Dai-Mai Meridian LIV13, GB26, GB27, GB28 for 18 sessions over 3 months. Needles inserted unilaterally, stimulated for 20 minutes per session in supine position.
Control Group No intervention.
Primary Outcome
Wong-Baker FACES Pain Rating Scale WBFS: Assesses pain intensity using facial expressions and numerical scores 0-10. Secondary Outcome
Heart Rate Variability HRV: Evaluates autonomic nervous system balance and its impact on pain-related stress. Data Analysis Statistical analysis will be performed using SPSS v16.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 30.00 Year(s)（—）
入选标准
- •Age range from 18 to 30 years Gender: Female History of Primary Dysmenorrhea for at least 6 consecutive menstrual cycles.
- •Moderate to severe Primary Dysmenorrhea (Pain that significantly impacts daily activities or registers high on a validated pain scale) Readiness to electrical acupuncture intervention.
排除标准
- •Females with conditions such as immunodeficiency, bleeding disorders, allergies, and neurological diseases, History of malignancy, current malignancy, or findings of malignancy.
- •Females experiencing irregular menstrual cycles.
- •Lactating mothers and pregnant women.
- •Women currently using oral contraceptive pills, intrauterine devices, or medications for primary dysmenorrhea in the past 6 months.
- •Should not have conditions causing abdominal pain such as pelvic inflammatory disease and inflammatory bowel disease.
- •Lack of willingness or fear regarding electrical acupuncture intervention.
- •Should not have any medical conditions such as cardiovascular diseases, diabetes mellitus, or hypertension.
- •Skin lesions from needles, scars, cardiac pacemaker, or other implants.
结局指标
主要结局
The Wong-Baker FACES Pain Rating Scale (WBFS): Wong-Baker FACES Pain Rating Scale was developed by Donna Wong and Connie Baker in 1983 as a pain assessment tool. It features a series of faces ranging from a happy face at 0, indicating no hurt, to a crying face at 10, representing hurts like the worst pain imaginable. Participants select the face that best corresponds to their pain level, which is associated with a numerical score.
时间窗: Baseline, and 90 days after Intervention
次要结局
- Heart Rate Variability(Baseline, & After 90 days)
研究者
Dr K Anniesheryl
International Institute of Yoga and Naturopathy Medical Sciences