Soft Ostheopathic Techniques Improve the Quality of Life in Patients With Crohn's Disease. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Pain.
研究概览
简要总结
Crohn's disease (CD) is an inflammatory bowel disease with a high prevalence. Its etiology is unknown and is considered a multifactorial disease. It is known that the existence of a genetic factor, industrialization and development of the country and environmental factors have great influence on the appearance of intestinal pathology (the Val; Buderus; Molodecky). CD is a chronic inflammatory bowel disease localized throughout the course of the digestive tract (oral-anal). The aim of this study is to evaluate the effect of a treatment program combining technical nonmanipulative appropriate in affected patients (CD) to increase the overall quality of life and related EC, lower abdominal pain direct and indirect osteopathic soft, observe the sense of change after treatment, and psychological aspects.
详细描述
All of the participants were recruited, in a non-probabilistic way, from the Valencian Association of Enfermos de Crohn y Colitis Ulcerosa (ACCU) The participants were allocated to two different groups depending on their possibility of participation in the therapeutic sessions. The group that received the therapy was called experimental group (EG) and the group, who did not, control group (CG). The participants were allocated independently of their disease status (outbreak or remission).
An experimental study carried out during a period of four weeks in order to explore the effect of the specific treatment on the following outcomes: global quality of life, quality of life in CD and pain.
The participants, in the EG were treated in three sessions, that lasted 45 minutes, during the study duration (1 session each 9-10 days). The physiotherapist who applied the treatment had an extensive experience in manual therapy.
Both groups come to laboratory two times for the assessment, one at the beginning of the study and the other one at the end. In each session several questionnaires were administered by a physiotherapist who was blinded to the group assignment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Patients diagnosed with active CD of at least one year of evolution, aged between 18 and 65, with a presence of abdominal pain, receiving conservative or surgical treatment (after 6 months after surgery and absence of diverting ileostomy) were included. Once they expressed their interest in taking part of the study, potential participants underwent an examination by a specialist of the association to confirm the diagnosis of CD.
排除标准
- •Conversely, patients with non-specific inflammatory bowel, abdominal tenderness, infection, ischaemia, physical damage, or specific immunologic sensitivity or pregnancy be excluded of this study were discarded for the study.
结局指标
主要结局
Pain.
时间窗: 4 weeks
by a horizontal line 10 cm in length (0 = no pain to 10 = maximum pain).
次要结局
- Anxiety and Depression(4 weeks)
- Existence of anxiety and depression(4 weeks)
- Global Quality Of Life(4 weeks)
- Quality Of Life in CD(4 weeks)
- Index of Crohn's disease activity(4 weeks)
研究者
GEMMA V ESPÍ LÓPEZ, PhD
PhD
University of Valencia