Combined Effect of Therapeutic Ultrasound and Trans Cutaneous Electrical Nerve Stimulation on Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 主要终点
- The Endometriosis Health profile (EHP30) questionnaire
研究概览
简要总结
This study will be conducted to investigate the combined effect of therapeutic ultrasound and transcutaneous electrical nerve stimulation (TENS) on relieving adhesions and pain related to endometriosis.
详细描述
Endometriosis affects 10-15% of reproductive-age women, causing pelvic pain and infertility. While laparoscopy is the primary treatment, it has risks. Medications are also used but often have side effects. Complementary therapies like acupuncture, yoga, and physical therapy modalities show promise. Therapeutic ultrasound has demonstrated effectiveness in managing chronic pain and adhesions associated with endometriosis. Transcutaneous electrical nerve stimulation (TENS) has shown positive results in pain relief and potentially improving uterine conditions for implantation. This study aims to investigate the combined effect of therapeutic ultrasound and TENS on endometriosis-related adhesion and pain, providing valuable information for physical therapists in treating this condition.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Forty-five women clinically diagnosed by the gynecologist with endometriosis will be included in the study.
- •Abdominal wall endometriosis will be diagnosed via Color Doppler ultrasonography.
- •Their ages will range from 25 to 35 years old.
- •Their body mass index (BMI) will be ranged from 25 to 35 Kg/m
- •All patients have reported mild to moderate endometriosis symptoms such as (chronic pelvic pain (CPP), dysmenorrhea, dyspareunia, pain with bowel movements and urination and excessive bleeding) as recorded by Endometriosis Health profile questionnaire (EHP30).
- •All patients use continuous hormonal treatment for at least 3 months.
排除标准
- •Severe endometriosis which is diagnosed by the gynecologist.
- •Pregnancy, peacemaker, epilepsy, cardiac arrhythmia, cancer, acute inflammatory pelvic disease.
- •Use of injectable hormonal therapy within the previous 6 weeks.
- •Patients with contraindication of ultrasound (Patients with reduced sensation to pain and/or heat, local malignancy, local acute infection and over areas of thrombosis or other vascular abnormalities).
- •Cognitive deficiency and difficulty to understand instructions or use the instruments.
研究组 & 干预措施
Therapeutic ultrasound (US) Group
It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, Therapeutic US, 3 sessions, per week for eight weeks.
干预措施: Medical treatment (Drug)
Therapeutic ultrasound (US) Group
It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, Therapeutic US, 3 sessions, per week for eight weeks.
干预措施: Therapeutic ultrasound (US) (Device)
Transcutaneous Electrical Nerve Stimulation (TENS) Group
It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, TENS therapy, 3 sessions, per week for eight weeks.
干预措施: Medical treatment (Drug)
Transcutaneous Electrical Nerve Stimulation (TENS) Group
It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, TENS therapy, 3 sessions, per week for eight weeks.
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
US + TENS Group
It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, both Therapeutic US and TENS therapy, 3 sessions, per week for eight weeks.
干预措施: Medical treatment (Drug)
US + TENS Group
It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, both Therapeutic US and TENS therapy, 3 sessions, per week for eight weeks.
干预措施: Therapeutic ultrasound (US) (Device)
US + TENS Group
It will include 15 women, who will receive their hormonal treatment as prescribed by the gynecologist in addition to, both Therapeutic US and TENS therapy, 3 sessions, per week for eight weeks.
干预措施: Transcutaneous electrical nerve stimulation (TENS) (Device)
结局指标
主要结局
The Endometriosis Health profile (EHP30) questionnaire
时间窗: 8 weeks
The Endometriosis Health profile (EHP30) questionnaire will be used to assess symptoms of endometriosis in all groups (A, B \& C) before and after the end of treatment program. It is self-reporting instrument that contains a core questionnaire consisting of 30 items assessing five dimensions. The five dimensions included pain, control and impotence, emotional well-being, social support, and self -image. Each scale is converted into a score from 0 to 100, with a lower score representing a better quality of life.
The McGill pain questionnaire (MPQ)
时间窗: 8 weeks
The pain intensity for all groups (A, B, \& C) will be assessed using the McGill Pain Questionnaire (MPQ) before and after the treatment program. The MPQ is a comprehensive tool that evaluates various dimensions of a patient's pain experience through three parts. The first part includes an anatomical drawing where the patient marks the location of their pain. The second part is a Verbal Descriptor Scale (VDS) for the patient to indicate the intensity of their current pain. The third part is an inventory of 72 descriptive adjectives to detail the pain further. The MPQ measures three key aspects: (1) the pain rating index, which assigns numerical values to each word descriptor, (2) the number of words chosen, and (3) the present pain intensity on a 1-5 scale (1 for mild, 2 for discomforting, 3 for distressing, 4 for horrible, and 5 for excruciating).
Assessment of adhesion size
时间窗: 8 weeks
New Color Doppler Ultrasound scanner will be used in the study to assess adhesion size for all women with endometriosis in all groups (A, B, \& C) before and after the study, and this procedure will be applied by the gynecologist.
次要结局
- The Health-related quality of life (HRQOL-36) questionnaire(8 weeks)
研究者
Rania Mohammed Ibrahim Mohammed Derwa
Principal Investigator
Cairo University