Acs-Tens Treatment for Faecal Incontinence: a RCT With Sham-controls
Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.
研究概览
详细说明
Faecal incontinence (FI) is the involuntary loss of flatus, liquid or solid stool per rectum. Owing to the emotional stress and the psychosocial stigma surrounding this problem, it is under-reported by patients.
Conservative management of FI involves lifestyle, medical adjustments and pelvic floor sphincter training. If conservative treatment fails, surgical options such as sphincter repair, sacral nerve stimulation (SNM) and percutaneous tibial nerve stimulation (PTNS) can be reformed. SNM and PTNS involve application of nervous electrical stimulation (neuromodulation) with significant improvement of symptoms. The positions of electrical stimuli are also very similar to acupuncture sites (acupoints) used in Traditional Chinese Medicine for the treatment of faecal incontinence. However, disadvantage of these methods are; 1) they are invasive and may cause complications such as pain, infection and bleeding and; 2) the devices for each SNM device can be costly.
Transcutaneous Electrical Nerve Stimulation (TENS) is non-invasive, which is commonly used for the management of pain. It works via the application of electrical stimuli using adhesive gel pads. They are cheap to run and are widely accepted by patients. Hence application of TENS over acupoints (Acu-TENS) may provide a novel non-invasive treatment.
A randomised controlled trial will be carried out on patients with FI. Demographic data, past medical history, in particular any structural or neurological causes of FI, will be recorded. Ano-rectal manometry and endoanal ultrasound will be performed before and after treatment. Acu-TENS machine will be applied to standardised acupuncture points. Assessment of FI via Cleveland Clinic Florida Faecal Incontinence Score and Quality of life measurements via the validated questionnaires Short Form 36 (SF-36) and the Fecal Incontinence Quality of Life Scale (FIQL) (Chinese version) questionnaires will be carried out at baseline, and followup intervals.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Sha Tin、香港
- Chinese University of Hong Kong
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients aged 18 years or above
- Acupuncture naïve patients
- Faecal incontinence with solid or liquid stool causing disruption of lifestyle
- Psychological stability and suitability as determined by the investigator
- Failed conservative or surgical treatment
- Intact peripheral neurosensory nervous system as determined by clinical investigation
- Able to read and write
Exclusion Criteria:
- Major internal and/or external sphincter defect (>120 degrees of sphincter circumference)
- Faecal impaction
- Presence of full thickness rectal prolapse
- Patients who have contact allergies to adhesive pads
- Implanted pacemaker, defibrillator, cardiopathy
- Pregnancy or intention to become pregnant
- Neurogenic or congenital disorders resulting in faecal incontinence (e.g. Multiple Sclerosis, uncontrolled diabetes, Parkinson's disease, Spina Bifida)
- Inflammatory bowel disease
- Chronic diarrhoea uncontrolled by medication or diet
- Previous rectal surgery (rectopexy or rectal resection)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：AcuTENS
Patients treated with TENS over Acupuncture points for faecal incontinence
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Stimulation of acupuncture points with TENS machine
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假比较器：Sham
Sham treatment arm with no electrical stimulations over acupuncture points
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Stimulation of acupuncture points with TENS machine
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
大体时间：post treatment 8 weeks and 6 months compared with baseline
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Response to treatment is defined as 50% or greater change in Faecal incontinence Severity index score compared to sham
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post treatment 8 weeks and 6 months compared with baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in the severity of faecal incontience
大体时间：post treatment 8 weeks and 6 months compared with baseline
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Wexner score will be used the assess the severity of faecal incontinence
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post treatment 8 weeks and 6 months compared with baseline
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Episodes of faecal urgency per week
大体时间：post treatment 8 weeks and 6 months compared with baseline
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the number of episodes of faecal urgency experienced by the patient per week
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post treatment 8 weeks and 6 months compared with baseline
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Reduction in the number of incontinence episode per week
大体时间：post treatment 8 weeks and 6 months compared with baseline
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the number of episodes of faecal incontience experienced by the patient per week
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post treatment 8 weeks and 6 months compared with baseline
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Differences in Quality of Life score between two groups
大体时间：post treatment 8 weeks and 6 months compared with baseline
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using the tradition chinese version of the faecal incontinence quality of life questionnaire (FIQL)
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post treatment 8 weeks and 6 months compared with baseline
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合作者和调查者
调查人员
- 首席研究员：Tony WC Mak, MD, FRCS、Chinese University of Hong Kong
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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