Effectiveness of Osteopathic Manipulative Therapy for Managing Symptoms of Irritable Bowel Syndrome. A Prospective Randomized Study -IBSOMT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Changes from baseline of IBSSS at V4.
研究概览
简要总结
The Irritable Bowel Syndrome (IBS) is defined by a combination of abdominal pain, bowel dysfunction during recurrent periods of shorter or longer duration. The absence of well-defined pathophysiological marker requires a clinical definition. The most used are the Rome criteria III whose version was published in 2006 and version IV under development.
An epidemiological study conducted in 2003 in Europe in 8 countries with over 42 000 people, found on the basis of questionnaires a prevalence of 11.5% with a diagnosis of IBS of 4.8%.in the total population; the results of this study were comparable to data obtained in the USA. A French work of our team at 35 447 healthy adults found a 6.2% frequency. In all these studies, there is a very large predominance of women (sex ratio near 2), with a preponderance of subjects of the age group 40-50 years.
IBS economic weight is high, partly due to costs directly incurred by the IBS and the costs generated by associated diseases: number of visits to the general practitioner, to the specialist, the prescription and realization of complementary examinations, hospitalization, purchase drugs and work stoppage.
From a pathophysiologic perspective, IBS is now considered as a multifactorial disease involving varying degrees, depending on the individual variables, visceral hypersensitivity, disturbances of digestive motility, impaired sensorimotor way communications between the gastrointestinal tract and the central nervous system, intestinal micro-inflammation.
Hypothesis of this search is that the osteopathic manipulative treatment (OMT) will improve the symptomatology of IBS in patients with functional gastrointestinal disorders.
详细描述
The Irritable Bowel Syndrome (IBS) is defined by the association between abdominal pain, bowel dysfunction for longer or shorter periods of time, but in any case, recurring. The absence of well-defined pathophysiological marker, requires a clinical definition. The most used are the Rome criteria III whose version was published in 2006, Version IV is under development.
coordinator's team demonstrated in a randomized, placebo-controlled, 31 patients with refractory IBS, visceral osteopathy that is associated with a significant improvement in diarrhea, abdominal distension and abdominal pain without change constipation. This improvement was associated with a decrease in rectal sensitivity without changes of depression, time of total or segmental colonic transit. This effect persisted one year after the end of this essay.
Primary objective To evaluate the efficacy of osteopathic manipulative treatment on IBS symptoms in IBS adult patients over a 3-sessions period according to our preliminary study (73).
Secondary objectives To evaluate and to compare the results of two therapeutic modalities : osteopathic manipulative treatment and placebo manipulative treatment on
- Subjective clinical criteria: Constipation, Diarrhea, abdominal pain, bloating, topology of abdominal pain.
- Improvement of quality of life
- Decrease of depression and anxiety
- Changes in the medication after treatment
- Search for a possible practitioner effect.
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)
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
- •Patients of both sexes ≥18 years.
- •Patient suffering from IBS according to the Rome III criteria:
- •IBS SSS must be ≥ 175 at inclusion. Patients who received over the past 5 years a colonoscopy.
- •Physical examination without clinically relevant abnormalities during the Screening period.
- •Patient is willing to be compliant with study procedures.
- •Patient who signed the informed consent before carrying out any procedure related to the study.
- •Mentally competent, able to give written informed consent prior to any study-related procedure and compliant to undergo all visits and procedures scheduled in the study
- •Medical Insurance
排除标准
- •Patient has had surgery that meets any of the following criteria:
- •Patient has any elective major surgery planned or expected at any time during the study.
- •Use of new drugs indicated in treatment the IBS
- •Patient has a history of inflammatory bowel diseases, complicated diverticulosis (i.e. diverticulitis), ischaemic colitis, microscopic colitis.
- •Patient has a history of organic abnormalities of the GI tract, intestinal: obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, adhesions or impaired intestinal circulation (e.g., aorto-iliac disease).
- •Patient has a history of pancreatitis of any etiology, cholecystitis or of symptomatic gallbladder stone disease in the previous 6 months.
- •Patient has an active biliary duct disease or a history of Sphincter of Oddi dysfunction.
- •Patient has a history of gluten enteropathy.
- •Patient has a history of lactose intolerance as assessed by response to diet.
- •Patient has a small intestinal bacterial overgrowth.
- •Patient has a current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission ≥5 years, squamous and basal cell carcinomas and cervical carcinoma in situ).
- •Patient has a history of ectopic endometriosis.
- •Patient has a history of positive tests for ova or parasites, or clostridium difficile toxin or occult blood in the stool in the previous 6 months.
- •Patient has a history of human immunodeficiency virus infection.
- •Patient has insulin-dependent diabetes mellitus.
- •Patient has a major psychiatric or neurological disorder.
- •Patient has an unstable medical condition, which may compromise the efficacy and safety assessments as required in the study and/or require change in concomitant medication.
- •Patient has a history of abnormal thyroid function. Patient is candidate for the study if thyroid hormone replacement therapy is stable from at least 2 months.
- •Patient has evidence of anemia as confirmed by hemoglobin <9 g/dl during the Screening period.
- •Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. (dietary habits, lifestyle and exercise regimen should be maintained for the duration of the study).
- •Use of prohibited concurrent medication within the previous month
- •Pregnancy.
- •Patient is not able to understand or collaborate throughout the study.
- •Patient has any condition that, in the opinion of the Investigator, would compromise the well-being of the patient or the requirements of the study.
- •Concomitant participation in a biomedical research trial.
结局指标
主要结局
Changes from baseline of IBSSS at V4.
时间窗: 8 weeks after the first osteopathic manipulative treatment
It measured by the IBS severity score (IBSSS) after osteopathic manipulative treatment. The IBS Severity Scoring System is a validated measure to assess the severity of IBS symptoms, and can help monitor response to treatment.
次要结局
- Depression and anxiety quantified using the STAI questionnaires.(2, 3 and 6 months after the first osteopathic manipulative treatment)
- Clinical improvement (IBSSS)(3 and 6 months after the first osteopathic manipulative treatment)
- Percentage of patients with improvement at V4, V5 and V6.(2, 3 and 6 months after the first osteopathic manipulative treatment)
- Changes of the severity of IBS(2, 3 and 6 months after the first osteopathic manipulative treatment)
- Depression and anxiety quantified using the Beck Depression Inventory II(BDI-II) questionnaires.(2, 3 and 6 months after the first osteopathic manipulative treatment)
- Cardinal signs of IBS measured by visual analogic scales(2, 3 and 6 months after the first osteopathic manipulative treatment)
- Shape of the stool(2, 3 and 6 months after the first osteopathic manipulative treatment)
- Quality of life defined by IBS-QOL.(2, 3 and 6 months after the first osteopathic manipulative treatment)