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

July 22, 2016 updated by: GEMMA V ESPÍ LÓPEZ, PhD, University of Valencia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46010
        • Faculty of Physiotherapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Manual Therapy
Cranial therapy (CT). Neuro-lymphatic reflexes treatment (NL) Viscerosomatic reflexes (VR) Induction myofascial Visceral osteopathic therapy (VOT)
Other: Manual Therapy
Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease
No Intervention: Control Group
Patients only came to make assessments, without receiving any treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain.
Time Frame: 4 weeks
by a horizontal line 10 cm in length (0 = no pain to 10 = maximum pain).
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Global Quality Of Life
Time Frame: 4 weeks
Functional Assessment of Cancer Therapy- General (Versión 4- FACT-G)
4 weeks
Quality Of Life in CD
Time Frame: 4 weeks
Inflammatory Bowel Disease Quality Of Life-32 (IBDQ-32)
4 weeks
Index of Crohn's disease activity
Time Frame: 4 weeks
By the Harvey-Bradshaw Index (HBI)
4 weeks
Existence of anxiety and depression
Time Frame: 4 weeks
by Goldberg Anxiety and Depression Scale
4 weeks
Anxiety and Depression
Time Frame: 4 weeks
Hospital Anxiety and Depression Scale (HADS)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Valencia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gemma Espí, Faculty of Physiotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ID013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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