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Completed

NCT Number: NCT02763293

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy

Valencia, 46010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual therapy

Other

Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease

Primary outcomes

  1. Pain.

    Time frame: 4 weeks

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

Secondary outcomes

  1. Global Quality Of Life

    Time frame: 4 weeks

    Functional Assessment of Cancer Therapy- General (Versión 4- FACT-G)

  2. Quality Of Life in CD

    Time frame: 4 weeks

    Inflammatory Bowel Disease Quality Of Life-32 (IBDQ-32)

  3. Index of Crohn's disease activity

    Time frame: 4 weeks

    By the Harvey-Bradshaw Index (HBI)

  4. Existence of anxiety and depression

    Time frame: 4 weeks

    by Goldberg Anxiety and Depression Scale

  5. Anxiety and Depression

    Time frame: 4 weeks

    Hospital Anxiety and Depression Scale (HADS)

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Registry information

Official study title

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

Acronym: ONManCD

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 5, 2016
Registry last updated
Jul 25, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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