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临床试验/NCT02594774
NCT02594774Unknown不适用

Efficacy of Osteopathic Treatment in Function Abdominal Pain in Children and Adolescents

Parc de Salut Mar2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Change in pain (visual analog scale)

研究概览

简要总结

The objective is to evaluate the efficacy of osteopathic treatment as an adjunct to standard medical treatment in reducing child functional abdominal pain.

A convenience sample that includes no more than 30 patients per study group (n = 60) are being recruited. As an exploratory study the investigators did not proceed to make any sample size calculation.

This is a comparative study of two quasi-experimental interventions (standard treatment vs. standard treatment + Osteopathy).

This will be a single-blind trial where only the evaluator will be blinded. The principal outcome will be pain measured by a visual analog scale. A version with more appropriate pictograms for pediatric patients is used. Measurements will be taken at baseline (baseline measurements) at 4, 8 weeks (the duration of interventions) and 6 months post-study.

详细描述

Although the functional or structural disease can be identified by physicians and sometimes cured by medical technology, non-structural or functional symptoms, those without an identified organic cause and associated with a high rate of response to placebo are yet enigmatic and less susceptible to explanation or effective treatment.

Often considered as non-pathological, there are physiological and sociocultural factors, nociceptive, psychic that expand the perception of these symptoms which are experienced as serious, problematic and threatening with the consequent impact on daily activities. Although it represents the most frequent cause of consultation in the specialty of Pediatric Gastroenterology there is currently no drug therapy that has demonstrated its effectiveness.

In these cases, unnecessary diagnostic studies can be performed to find an organic cause, resulting in increased health care costs and possibly in an inappropriate patient care. These types of beliefs and behaviors can delegitimize the DFG and the suffering of these patients.

There are studies that say that 35% of patients suffering from irritable bowel syndrome (no organic cause but if organic effect) use complementary therapies, but in the absence of clinical trials, it is emphasized the need for more controlled studies to advise and / or direct the patient from the medical community to which of these therapies could be more adequate.

According to the General Osteopathic Council (UK) and the Osteopathic International Alliance (OIA), Osteopathy is a health profession that is dedicated to the diagnosis, treatment and prevention of problems of the musculoskeletal and its effects on the nervous system and global health. It is based on the theory that well-being depends on a good relationship between the skeleton, muscles, ligaments and connective tissue. The lack of this good relationship can lead to symptoms and musculoskeletal problems but also visceral. Health is seen as a complex process involving all parts and systems of the body. Palpatory techniques are used to diagnose dysfunction and physical manipulation is used to improve the functioning of joints, relax muscle tension, promote the innervation and blood supply to tissues and help the healing mechanisms of the body.

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
6 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients of school age (6-16 years old)
  • Diagnosed with functional abdominal pain (Functional Abdominal Pain-Related Disorders) according to the diagnostic criteria for functional gastrointestinal disorders ROME guide III
  • Signed informed consent

排除标准

  • Patients diagnosed with digestive disease
  • Patients who have or are receiving medical aids
  • Patients who are not studying physical treatments
  • Refusal to participate

研究组 & 干预措施

Osteopathic treatment

Experimental

Manipulative osteopathy (and standard medical treatment)

干预措施: Manipulative osteopathy (Other)

Standard medical treatment

No Intervention

Standard medical treatment

结局指标

主要结局

Change in pain (visual analog scale)

时间窗: Baseline, 4 weeks, 8 weeks, 6 months

Pain measurement through visual analog scale

次要结局

未报告次要终点

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Oscar Garcia Algar

PhD

Parc de Salut Mar

研究点 (2)

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