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

Primary Purpose

Crohn´s Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Manual Therapy
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn´s Disease focused on measuring pain, effectiveness, manual therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physiotherapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Manual Therapy

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pain.
by a horizontal line 10 cm in length (0 = no pain to 10 = maximum pain).

Secondary Outcome Measures

Global Quality Of Life
Functional Assessment of Cancer Therapy- General (Versión 4- FACT-G)
Quality Of Life in CD
Inflammatory Bowel Disease Quality Of Life-32 (IBDQ-32)
Index of Crohn's disease activity
By the Harvey-Bradshaw Index (HBI)
Existence of anxiety and depression
by Goldberg Anxiety and Depression Scale
Anxiety and Depression
Hospital Anxiety and Depression Scale (HADS)

Full Information

First Posted
May 3, 2016
Last Updated
July 22, 2016
Sponsor
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT02763293
Brief Title
Osteopathy Non-manipulative in Patients With Crohn's Disease.
Acronym
ONManCD
Official Title
Soft Ostheopathic Techniques Improve the Quality of Life in Patients With Crohn's Disease. A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn´s Disease
Keywords
pain, effectiveness, manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manual Therapy
Arm Type
Experimental
Arm Description
Cranial therapy (CT). Neuro-lymphatic reflexes treatment (NL) Viscerosomatic reflexes (VR) Induction myofascial Visceral osteopathic therapy (VOT)
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients only came to make assessments, without receiving any treatment.
Intervention Type
Other
Intervention Name(s)
Manual Therapy
Intervention Description
Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease
Primary Outcome Measure Information:
Title
Pain.
Description
by a horizontal line 10 cm in length (0 = no pain to 10 = maximum pain).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Global Quality Of Life
Description
Functional Assessment of Cancer Therapy- General (Versión 4- FACT-G)
Time Frame
4 weeks
Title
Quality Of Life in CD
Description
Inflammatory Bowel Disease Quality Of Life-32 (IBDQ-32)
Time Frame
4 weeks
Title
Index of Crohn's disease activity
Description
By the Harvey-Bradshaw Index (HBI)
Time Frame
4 weeks
Title
Existence of anxiety and depression
Description
by Goldberg Anxiety and Depression Scale
Time Frame
4 weeks
Title
Anxiety and Depression
Description
Hospital Anxiety and Depression Scale (HADS)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gemma Espí
Organizational Affiliation
Faculty of Physiotherapy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physiotherapy
City
Valencia
ZIP/Postal Code
46010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
25357218
Citation
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.
Results Reference
result
PubMed Identifier
22546751
Citation
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.
Results Reference
result

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

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