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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Sha Tin、香港
- Chinese University of Hong Kong
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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偽コンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Changes in the severity of faecal incontience
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Tony WC Mak, MD, FRCS、Chinese University of Hong Kong
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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