Triple Target Treatment (3T) Combining Amplitude Modulated Middle Frequency (AM-MF) Stimulation With Electromyography (EMG)EMG-Biofeedback Versus EMG-Biofeedback in Chronic Obstipation
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.
研究概览
简要总结
Previous studies revealed only a low evidence for the various biofeedback methods and pelvic floor exercises for treatment of chronic obstipation. The number of randomized controlled trials is low with in part significant systemic deficiencies. However, the results from the previous study with 3T treatment in patients with obstructed defecation syndrome (ODS) are so promising that a further randomized controlled trial appears useful to demonstrate a higher degree of evidence. The purpose of this study is to determine whether triple target treatment (3T) or EMG-Biofeedback alone are effective in the treatment of chronic obstipation and if the duration of treatment (3, 6 or 9 months) influence the efficacy.
详细描述
Methods in this parallel-group randomized multicenter study with blinded observer we enroll 140 patients with chronic obstipation. The study is divided into two trials. After three months the first trial is completed and can be extended directly into the second trial (completed after 12 months) after an interim analysis. Primary endpoints are changes from baseline to three and twelve months in the Altomare ODS Score.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All Patients with chronic obstipation (Rom criteria II)
排除标准
- •Chronic inflammatory bowel disease, systemic peripheral neuropathy (MS, diabetes), disorders of enteric nervous system (Hirschsprung disease, chagas, IND, myopathy desmosis coli), idiopathic megacolon/megarectum, patients with mental or intellectual deficits.
研究组 & 干预措施
Triple Target Treatment
In the 3T arm, patients were stimulated with a carrier wave of 25 KHz and biphasic modulations of the pulse train of 40 Hz. Anxious patients trained at first only in the biofeedback mode. The stimulation was introduced after four weeks for these patients. Patients were instructed to carry out the training at home, with an alternating combination in the morning and with EMG-triggered stimulation in the evening, each for 20-minute periods. Apart from this, the protocol of the active treatment group was identical to that of the control group.
干预措施: Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation (Device)
EMG-biofeedback alone
In the biofeedback arm, patients were instructed to carry out EMG-biofeedback training at home, standing, mornings and evenings, for 20-minute periods. The core of the task was to pull the plug-electrode upward inside the anal channel, like a lift, and to hold it there during varying periods of tension. This can only be done successfully if the perineum rises and at the same time the puborectal muscle is activated. Just squeezing the sphincter muscles does not produce this lifting effect.
干预措施: EMG-biofeedback alone (Device)
结局指标
主要结局
Altomare ODS Score in its validated form after 3 and 12 months, compared to baseline.
时间窗: 3 months
次要结局
- Constipation severity instrument (CSI) in adapted German form after 3 and 12 months, compared to baseline.(3 and 12 months)
- Modified Wexner Incontinence Score after 3 and 12 months, compared to baseline(3 and 12 Months)
- Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QoL) after 3 and 12 months compared to baseline, as well as between the two treatment groups over the course of time as compared to baseline.(3 and 12 months)
- Hinton Test after 3 and 12 months(3 and 12 months)
- Cleveland Clinic Incontinence Score (CCS) in its validated German form after 3 and 12 months, compared to baseline(3 and 12 months)
- International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) applied to patients with urine incontinence after 3 and 12 months, compared to baseline.(3 and 12 months)
- Adapted Vaizey score after 3 and 12 months compared to baseline(3 and 12 months)
研究者
dr. schwandner
Head of Coloproctology
University of Giessen