Transcutaneous Electric Nerve Stimulation on Acupoints (Acu-TENS) for the Treatment of Faecal Incontinence: a Prospective, Randomised, Sham-controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
研究概览
简要总结
This study assess the effectiveness on AcuTENS on the treatment of faecal incontinence
详细描述
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 (Participant, Outcomes Assessor)
盲法说明
participant will not be told on which treatment arm are in. Outcome assessors will be blinded on participants' treatment arm.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
时间窗: post treatment 8 weeks and 6 months compared with baseline
Response to treatment is defined as 50% or greater change in Faecal incontinence Severity index score compared to sham
次要结局
- Reduction in the number of incontinence episode per week(post treatment 8 weeks and 6 months compared with baseline)
- Changes in the severity of faecal incontience(post treatment 8 weeks and 6 months compared with baseline)
- Episodes of faecal urgency per week(post treatment 8 weeks and 6 months compared with baseline)
- Differences in Quality of Life score between two groups(post treatment 8 weeks and 6 months compared with baseline)
研究者
Tony Wing Chung Mak
Associate Professor
Chinese University of Hong Kong