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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02763293
Acronym
ONManCD
Enrollment
33
Registered
2016-05-05
Start date
2016-05-31
Completion date
2016-06-30
Last updated
2016-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn´s Disease

Keywords

pain, effectiveness, manual therapy

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.

Interventions

OTHERManual Therapy

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

Sponsors

University of Valencia
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain.4 weeksby a horizontal line 10 cm in length (0 = no pain to 10 = maximum pain).

Secondary

MeasureTime frameDescription
Global Quality Of Life4 weeksFunctional Assessment of Cancer Therapy- General (Versión 4- FACT-G)
Quality Of Life in CD4 weeksInflammatory Bowel Disease Quality Of Life-32 (IBDQ-32)
Index of Crohn's disease activity4 weeksBy the Harvey-Bradshaw Index (HBI)
Existence of anxiety and depression4 weeksby Goldberg Anxiety and Depression Scale
Anxiety and Depression4 weeksHospital Anxiety and Depression Scale (HADS)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026