Osteopathy Non-manipulative in Patients With Crohn's Disease.

NCT ID: NCT02763293

Last Updated: 2016-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Crohn´s Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Manual Therapy

Cranial therapy (CT). Neuro-lymphatic reflexes treatment (NL) Viscerosomatic reflexes (VR) Induction myofascial Visceral osteopathic therapy (VOT)

Group Type EXPERIMENTAL

Manual Therapy

Intervention Type OTHER

Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease

Control Group

Patients only came to make assessments, without receiving any treatment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Manual Therapy

Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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GEMMA V ESPÍ LÓPEZ, PhD

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gemma Espí

Role: PRINCIPAL_INVESTIGATOR

Faculty of Physiotherapy

Locations

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Faculty of Physiotherapy

Valencia, , Spain

Site Status

Countries

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Spain

References

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Piche T, Pishvaie D, Tirouvaziam D, Filippi J, Dainese R, Tonohouhan M, DeGalleani L, Nebot-Vivinus MH, Payrouse JL, Hebuterne X. Osteopathy decreases the severity of IBS-like symptoms associated with Crohn's disease in patients in remission. Eur J Gastroenterol Hepatol. 2014 Dec;26(12):1392-8. doi: 10.1097/MEG.0000000000000219.

Reference Type RESULT
PMID: 25357218 (View on PubMed)

Florance BM, Frin G, Dainese R, Nebot-Vivinus MH, Marine Barjoan E, Marjoux S, Laurens JP, Payrouse JL, Hebuterne X, Piche T. Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):944-9. doi: 10.1097/MEG.0b013e3283543eb7.

Reference Type RESULT
PMID: 22546751 (View on PubMed)

Other Identifiers

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ID013

Identifier Type: -

Identifier Source: org_study_id

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