Effect of Transcutaneous Electrical Acupoint Stimulation on Dysmenorrhea Among Autoimmune Disease Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- 10 meter walk test
研究概览
简要总结
This study will be conducted to investigate transcutaneous electrical acupoint stimulation effect on pain and disease aggravation during menstruation among autoimmune disease women
详细描述
The monthly ovarian cycle is characterized by tightly regulated hormones predictably fluctuating throughout the reproductive years. The menstrual cycle plays a role in the exacerbation of rheumatologic conditions, such as rheumatoid arthritis and systemic lupus erythematosus, with flares occurring prior to and during menses, respectively Given these previous observations, sex hormones are hypothesized to influence the biologic properties of the immune system and skin.
Women with rheumatoid arthritis (RA) reported increased pain, fatigue, and disease activity right before their period. Furthermore, those with systemic lupus erythematosus (SLE) experienced similar symptom flares during menses.
The transcutaneous electrical acupoint stimulation (TEAS) is a combination of transcutaneous electrical nerve stimulation (TENS) and traditional Chi- nese acupoints. . Electroacupuncture blocks pain by activating a variety of bioactive chemicals through peripheral, spinal, and supraspinal mechanisms such as the prompt release of β-endorphin and met-enkephalin . Corticotrophin-releasing factor and prostaglandin E2 are also involved in electroacupuncture analgesia.
There are growing literature to support the relationship between the aggravation of autoimmune disease symptoms during menstruation time which maximizes the negative effect on the female's the daily activities at that time. There is lack of researches on the effect of TEAS on this point .TEAS has positive effect on pain during menstrual cycle . The result of this study will help to evaluate the efficacy of TEAS on Pain and disease severity during menstruation in women with autoimmune diseases.
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)
入排标准
- 年龄范围
- 25 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women will be diagnosed with Rheumatoid arthritis(RA) or Systemic lupus erythematosus (SLE).
- •All women will suffer from severe pain during menstruation
- •Age will range from 25-40 years old.
- •Body mass index: 18.5- 30 Kg/m²
- •All women participated in the study will have regular menstrual cycle
排除标准
- •Secondary dysmenorrhea
- •Any other autoimmune diseases not mention in research
- •Cardiac or respiratory diseases
- •Vaginal infection
- •Anemia diseases
研究组 & 干预措施
Medical treatment group
The participants will receive non-steroidal anti-inflammatory drugs (NSAID) for 3 consecutive menstrual cycle.
干预措施: Non-steroidal anti-inflammatory drugs (NSAID) (Drug)
Transcutaneous Electrical Acupoint Stimulation (TEAS) group
The participants will receive Transcutaneous Electrical Acupoint Stimulation (TEAS), 3 days per week for 3 consecutive menstrual cycle.
干预措施: Non-steroidal anti-inflammatory drugs (NSAID) (Drug)
Transcutaneous Electrical Acupoint Stimulation (TEAS) group
The participants will receive Transcutaneous Electrical Acupoint Stimulation (TEAS), 3 days per week for 3 consecutive menstrual cycle.
干预措施: Transcutaneous Electrical Acupoint Stimulation (TEAS) (Other)
结局指标
主要结局
10 meter walk test
时间窗: 3 months
Each woman in both groups will receive the 10 meter walk test to determine functional mobility, gait, and vestibular function. Calculating Gait Speed - total distance/time. For example: if you did a 10-meter gait speed test and it took you 7 seconds, the equation would like: 10 meters / 7 seconds = 1.4 meters per second. Normative Values, age 20-29 years : Average Walking Speed(m/s): 1.36-1.34 m/s, age: 30-39 years: Average Walking Speed(m/s):1.43-1.34 m/s.
Assessment of degree of pain
时间窗: 3 months
Each woman in both groups will have visual analogue scale (VAS) for conducting of degree of pain in joints just before and during menstruation for 3 consecutive menstruation. It is pointed from 0 to 10 , 0 means no pain and 10 is worst pain
Erythrocyte sedumntation rate (ESR)
时间窗: 3 months
It is a type of blood test that measures how quickly erythrocytes (red blood cells) settle at the bottom of a test tube that contains a blood sample. The blood samples will be collected at the beginning and after the end of treatment procedures to detect the level of inflammation for both groups. normal value ranges from 0 to 20 mm/hr.
C-reactive protein (CRP)
时间窗: 3 months
It is a substance the liver produces in response to inflammation. The blood samples will be collected at the beginning and after the end of treatment procedures to detect the level of inflammation for both groups. Normal value is less than 0.9 mg/dl.
Pain disability index (PDI)
时间窗: 3 months
The Pain Disability Index (PDI) a simple and rapid instrument for measuring the impact that pain has on the ability of a person to participate in essential life activities. I t includes the following items family and home responsibilities, recreation, social activity, occupation, self care, and life-support activity. It is scored from 0 to 10. 0 means no disability and 10 means worst disability.
次要结局
未报告次要终点
研究者
Lamiaa Mostafa Okeil
Principal investigator
Cairo University