NCT02763293

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 25, 2016

Status Verified

July 1, 2016

Enrollment Period

1 month

First QC Date

May 3, 2016

Last Update Submit

July 22, 2016

Conditions

Keywords

paineffectivenessmanual therapy

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

EXPERIMENTAL

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

Other: Manual Therapy

Control Group

NO INTERVENTION

Patients 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

Manual Therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

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.

  • 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.

MeSH Terms

Conditions

Crohn DiseasePain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Gemma Espí

    Faculty of Physiotherapy

    PRINCIPAL INVESTIGATOR

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

Locations