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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Sha Tin, 홍콩
- Chinese University of Hong Kong
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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가짜 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Effectiveness of AcuTENS as treatment for faecal incontinence compared with sham intervention
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in the severity of faecal incontience
기간: 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
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Tony WC Mak, MD, FRCS, Chinese University of Hong Kong
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HMRF13140421
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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