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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02763293
Other study ID # ID013
Secondary ID
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


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 (VersiĆ³n 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
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