The Effects of Abdominal Massage on Functional (Primary) Chronic Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Severity of constipation
研究概览
简要总结
The aim of the present study is to investigate the efficacy of abdominal massage in patients with functional (primary) chronic constipation. The present study is designed as a randomized placebo controlled. Since the placebo group is included in the research design, if there is a greater improvement of symptoms of constipation and quality of life in the massage group when compared to the control group, it will be determined that this effect is not related to a placebo effect. If the efficacy of Abdominal Massage is revealed with a placebo controlled design, the therapist effect will be eliminated and further evidence on a well-known massage technique in functional (primary) chronic constipation, a common gastrointestinal problem, will be provided. The results of the present placebo controlled randomized trial will indicate that the need for pharmacological agents and the side effects associated with these agents will be reduced. According to the literature, there are studies that investigate the effects of abdominal massage on symptoms of constipation and quality of life. However, it has generally been used for secondary constipation or two applications have been compared. In addition, there is no randomized placebo-controlled study investigating the effect of abdominal massage on severity of chronic constipation and quality of life.
详细描述
Constipation is a subjective symptom that defines as inadequate defecation including several symptoms as follows: the sensation of incomplete bowel evacuation, hard stool, straining, and difficulty in defecation. The general prevalence of constipation in adults is 16%. The pre-defined risk factors are women gender, advanced age, non-white ethnicity, low socio-economic level, decreased physical activity underlying diseases, and medications. Chronic constipation affects quality of life and causes problems such as anxiety, depression, somatization, sleep disorders, sexual dysfunctions, school/work absenteeism. In the following periods, it causes serious comorbidities including dyspnea, gastro-esophageal reflux, hypertension, thyroid diseases, vaginitis, dyspareunia, diabetes, and fibromyalgia.
In the treatment of chronic constipation, conservative approaches (lifestyle change and physiotherapy applications) are used at the first phase. If conservative approaches are not helpful for patients pharmacological and surgical treatment can be performed based on the characteristics of patients, respectively. Pharmacological treatments aim to increase the frequency of spontaneous bowel movements, to reduce abdominal pain and swelling, and to improve stool consistency. However, side effects such as abdominal bloating, abdominal cramping, abdominal pain, stomach gas, nausea, diarrhea, headache and dyspnea are reported by patients in the following period. Furthermore, medications for constipation management are not cost-effective. Therefore, the level of evidence on conservative approaches with low cost, non-invasive and no-side effects in constipation treatment should be increased.
Physiotherapy approaches to alleviate chronic constipation symptoms include such as defecation training, abdominal massage, connective tissue massage, electrical stimulation, Kinesio-taping, anorectal biofeedback, and exercise training. Abdominal massage application in constipation is used in constipation management since the early 1870s and it is popular in recent years. The benefits of abdominal massage are known as follows: reduction in the abdominal muscle tension, improvement of local circulation, and stimulation of peristaltic movements. The technique of abdominal massage consists of 5 stages as follows: abdominal muscle stroking, colon stroking, colon kneading, colon stroking, and abdominal muscle stroking.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years.
- •Diagnosed with chronic constipation according to Rome IV criteria
排除标准
- •A recent history of abdominal surgery
- •Intestinal obstruction, ileus, colon cancer
- •Enteric neuropathic patients: Diabetic intestinal neuropathy, Hirschsprung's disease, Megacolon, Megarectum
- •Umbilical hernia
- •Metabolic diseases: Cancer, Chronic renal failure, Severe cardiovascular disease, Hepatic failure, Hepatosplenomegaly, Abdominal aortic aneurysm
- •Neurological diseases: Parkinson, Spinal cord injury, Multiple sclerosis, Cerebro-vascular event,
- •Paraplegia Mental problem to prevent co-operative treatment
- •Pregnancy and lactation
研究组 & 干预措施
Placebo Ultrasound
干预措施: Standard bowel management (Other)
Placebo Ultrasound
干预措施: Placebo Ultrasound (Other)
Abdominal Massage
干预措施: Standard bowel management (Other)
Abdominal Massage
干预措施: Abdominal massage (Other)
结局指标
主要结局
Severity of constipation
时间窗: Change in severity of constipation from baseline at 4 weeks
Constipation Severity Instrument (CSI) will be used to evaluate the severity of the constipation. CSI was designed to evaluate defecation frequency and consistency as well as the level of straining experienced by individuals during bowel movement. There are three subscales of CSI, obstructive defecation (OT), colonic inertia (CI), and pain. Higher scores of CSI indicate more severe constipation.
次要结局
- Abdominal pain, abdominal bloating severity and the effect of life(Change from baseline symptoms of constipation at 4 weeks)
- Patient global change scale(Change from baseline patient global change at 4 weeks)
- Patient Assessment of Constipation Quality of life(Change in quality of life from baseline at 4 weeks)
- Stool consistency(Change from baseline stool consistency at 4 weeks)
- Physical activity levels(Change from baseline symptoms of constipation at 4 weeks)
- Symptoms of constipation(Change from baseline symptoms of constipation at 4 weeks)
研究者
SERAP ÖZGÜL
Doc. Dr.
Hacettepe University