Clinical Trial: Efficacy of Osteopathic Treatment in Function Abdominal Pain in Children and Adolescents

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Efficacy of Osteopathic Treatment in Function Abdominal Pain in Children and Adolescents

Brief Summary:

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.

Detailed Summary:

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-
Sponsor: Parc de Salut Mar

Current Primary Outcome: Change in pain (visual analog scale) [ Time Frame: Baseline, 4 weeks, 8 weeks, 6 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Parc de Salut Mar

Dates:
Date Received: October 30, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: November 2, 2015
Last Verified: October 2015