Osteopathy Non-manipulative in Patients With Crohn's Disease.
ONManCD
Soft Ostheopathic Techniques Improve the Quality of Life in Patients With Crohn's Disease. A Randomized Controlled Trial.
1 other identifier
interventional
33
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 3, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJuly 25, 2016
July 1, 2016
1 month
May 3, 2016
July 22, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain.
by a horizontal line 10 cm in length (0 = no pain to 10 = maximum pain).
4 weeks
Secondary Outcomes (5)
Global Quality Of Life
4 weeks
Quality Of Life in CD
4 weeks
Index of Crohn's disease activity
4 weeks
Existence of anxiety and depression
4 weeks
Anxiety and Depression
4 weeks
Study Arms (2)
Manual Therapy
EXPERIMENTALCranial therapy (CT). Neuro-lymphatic reflexes treatment (NL) Viscerosomatic reflexes (VR) Induction myofascial Visceral osteopathic therapy (VOT)
Control Group
NO INTERVENTIONPatients only came to make assessments, without receiving any treatment.
Interventions
Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Physiotherapy
Valencia, 46010, Spain
Related Publications (2)
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.
PMID: 25357218RESULTFlorance 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.
PMID: 22546751RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gemma Espí
Faculty of Physiotherapy
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
May 3, 2016
First Posted
May 5, 2016
Study Start
May 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
July 25, 2016
Record last verified: 2016-07