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

Crohn´s Disease Clinical Trial

— ONManCD  

Official title:

Soft Ostheopathic Techniques Improve the Quality of Life in Patients With Crohn's Disease. A Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02763293
• Other study ID #: ID013
• Status: Completed
• Phase: N/A
• First received: May 3, 2016
• Last updated: July 22, 2016
• Start date: May 2016
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: University of Valencia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn´s Disease

Intervention

Other:
• Manual Therapy
Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease

Locations

Country	Name	City	State
Spain	Faculty of Physiotherapy	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Florance BM, Frin G, Dainese R, Nébot-Vivinus MH, Marine Barjoan E, Marjoux S, Laurens JP, Payrouse JL, Hébuterne X, Piche T. Osteopathy improves the severity of irritable bowel syndrome: a pilot randomized sham-controlled study. Eur J Gastroenterol Hepat — View Citation

Piche T, Pishvaie D, Tirouvaziam D, Filippi J, Dainese R, Tonohouhan M, DeGalleani L, Nébot-Vivinus MH, Payrouse JL, Hébuterne X. Osteopathy decreases the severity of IBS-like symptoms associated with Crohn's disease in patients in remission. Eur J Gastro — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain.	by a horizontal line 10 cm in length (0 = no pain to 10 = maximum pain).	4 weeks	No
Secondary	Global Quality Of Life	Functional Assessment of Cancer Therapy- General (Versión 4- FACT-G)	4 weeks	No
Secondary	Quality Of Life in CD	Inflammatory Bowel Disease Quality Of Life-32 (IBDQ-32)	4 weeks	No
Secondary	Index of Crohn's disease activity	By the Harvey-Bradshaw Index (HBI)	4 weeks	No
Secondary	Existence of anxiety and depression	by Goldberg Anxiety and Depression Scale	4 weeks	No
Secondary	Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS)	4 weeks	No