Different Transcutaneous Electrical Nerve Stimulation Modes in Pudendal Neuralgia Post-prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- measurement of Serum cortisol level
研究概览
简要总结
The purpose of this study was to evaluate the therapeutic efficacy of two different Transcutaneous Electrical Nerve Stimulation modes in improving the pudendal neuralgia and its intractable perineal pain.
详细描述
The need for this study will be developed from the lack in quantitative knowledge and information in the published studies about the effects of two different transcutaneous electrical nerve stimulation modes in cases of pudendal neuralgia. The significance of this study will be raised from the persistence of this neuralgia and its intractable pain that may result in severe morbidity with repeated local injections, pain medications and numerous surgical attempts to alleviate pain as well as the increase in the period of hospitalization plus the delay in returning to normal life. So, this study will be conducted to add new information about the effect of different transcutaneous electrical nerve stimulation modes in relieving chronic pudendal neuralgia post-prostatectomy, which may help the field of physical therapy and patients suffering from pudendal neuralgia.
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 (Participant)
入排标准
- 年龄范围
- 50 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients will be chosen after a routine medical examination.
- •All patients will be approximately the same age (from 50-60 years old).
- •All patients have chronic pudendal neuralgia post-prostatectomy surgery.
- •They have not take another physical therapy electro- modality except the traditional physical therapy in the form of pelvic floor exercises.
- •All of them will be non smokers and will be under own prescribed medications described by their physicians.
- •The pain is located in the pudendal nerve distribution area.
- •Pain intensity increased in the sitting position.
- •There were no symptoms of nocturnal pain.
- •Pain with no objective sensory impairment.
- •Pain was relieved by diagnostic pudendal nerve block.
- •Another clinical standard provides extra support to the diagnosis of pudendal neuralgia.
- •Pain symptoms may be associated with sexual dysfunction.
排除标准
- •Patients have simple tailbone, gluteus muscle or lower abdominal pain, or only paroxysmal pain, or only pruritic symptoms, and/or having imaging anomalies that may explain the symptoms.
- •Patients who take anticoagulant drugs or have any coagulation disorder.
- •Patients who will be unable to complete the study.
- •Patients with pain, which is caused by malignant or autoimmune diseases.
- •Patients with life threatening disorders as renal failure, myocardial infarction or others will be excluded from the study.
- •Patients who suffering from skin diseases, diabetes, varicose veins, trauma and peripheral vascular diseases will be excluded.
- •Patients who suffering from myasthenia gravis, hyperthyroidism, hemorrhage, acute viral diseases, acute tuberculosis, mental disorders or those with pace makers will be excluded from the study
研究组 & 干预措施
conventional Transcutaneous Electrical Nerve Stimulation
was composed of 30 patients who received the conventional transcutaneous electrical nerve stimulation in addition to the traditional physical therapy and medical care for 3 months.
干预措施: conventional Transcutaneous Electrical Nerve Stimulation (Device)
conventional Transcutaneous Electrical Nerve Stimulation
was composed of 30 patients who received the conventional transcutaneous electrical nerve stimulation in addition to the traditional physical therapy and medical care for 3 months.
干预措施: Traditional physical therapy (Other)
conventional Transcutaneous Electrical Nerve Stimulation
was composed of 30 patients who received the conventional transcutaneous electrical nerve stimulation in addition to the traditional physical therapy and medical care for 3 months.
干预措施: Gabapentin (Drug)
Acupuncture-like) transcutaneous Electrical Nerve Stimulation
that was composed of 30 patients who received the SLR (Acupuncture-like) transcutaneous Electrical Nerve Stimulation in addition to the traditional physical therapy and medical care for 3 months
干预措施: Acupuncture-like) transcutaneous Electrical Nerve Stimulation (Device)
Acupuncture-like) transcutaneous Electrical Nerve Stimulation
that was composed of 30 patients who received the SLR (Acupuncture-like) transcutaneous Electrical Nerve Stimulation in addition to the traditional physical therapy and medical care for 3 months
干预措施: Traditional physical therapy (Other)
Acupuncture-like) transcutaneous Electrical Nerve Stimulation
that was composed of 30 patients who received the SLR (Acupuncture-like) transcutaneous Electrical Nerve Stimulation in addition to the traditional physical therapy and medical care for 3 months
干预措施: Gabapentin (Drug)
结局指标
主要结局
measurement of Serum cortisol level
时间窗: at baseline and 12 weeks
Normal morning serum cortisol levels range from 9 to 25 µg/dL, and patients with painful conditions tend to exhibit higher-than-normal serum cortisol levels. Estimation of serum cortisol levels will be performed before and after 3 months of the treatment program. A venous blood sample (8 cubic centimeter) will be collected in the morning, centrifuged, and stored at -20 °C until analysis.
次要结局
- assessment of pain intensity(at baseline and 12 weeks)
- assessment of the carbamazepine intake(at baseline and 12 weeks)
研究者
Mohamed Mahmoud Tawfik
Principal Investigator
Cairo University