Osteopathic Approach in Inflammatory Bowel Diseases

NCT ID: NCT04805749

Last Updated: 2021-03-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-15
• Study Completion Date: 2021-09-01

Brief Summary

Crohn's disease (CD) and ulcerative colitis are bowel disease (IBS) with an autoimmune component believed to affect approximately 1 in 140 Canadians. Despite this high prevalence, more than 30% patients with IBD have to live with recurrent gastrointestinal symptoms that is poorly relieved by allopathic medicine. Numerous studies have shown that the quality of life of individuals with IBS is lower than that of the general population. Since visceral manipulations have been shown to be effective in reducing the main discomforts associated with IBS during clinical interventions, it seems likely that it may provide similar relief to patients with IBD. To our best knowledge, no study has evaluated the impact of osteopathic manual therapy on neuro-immuno-vascular modulation of intestine to reduce IBS symptoms.

The aim of this study is to assess the relevance of an osteopathic approach addressing the brain-intestine axis in order to improve symptomatology in subject suffering from IBD by modulating inflammation and vagal tone.

Detailed Description

For this study, 10 to 12 participant (18 to 65 years) with Inflammatory Bowel Disease (in remission state) will be recruited to receiving visceral osteopathic therapy. Participant will received four standardized osteopathic session of 45 minutes (1 session every 7 days: week 0, 1, 2 and 3) and a follow up visit at week 4. The osteopathic protocol will specifically address the gut-to-brain neuro-immuno-vascular axis.

Global quality of life and severity of IBS-like symptoms will be a assess at week 0, 2 and 4 using three standardized questionnaires. Gut permeability and intestinal inflammation will be assessed at week 0 and 4 by measuring Zonulin (pre-Haptoglobin 2), Histamine and Diamine Oxidase (DO) levels respectively. Vagal tone at the beginning and at the end of each osteopathic session will be evaluate using heart rate variability (HRV) measurements.

Conditions

Inflammatory Bowel Diseases (IBD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Osteopathic manipulation

Spinal Mobilisation / Cranial Osteopathy therapy / Circulatory Techniques / Visceral osteopathic therapy

Group Type: EXPERIMENTAL

Manual Therapy: osteopathy

Intervention Type: OTHER

Osteopathic protocol applied at week 0, 1, 2 and 3:

1. Spinal mobilisation of L1, L2 and L3 vertebrae to stimulate the arterial supply of mesenteric attachments of the colon and small intestine.

2. Visceral osteopathic therapy to address adhesions/ fixations in the presacral fascia, Toldt fascia, posterior peritoneum and caudal peritoneum.

3. Circulatory techniques to stimulate the celiac plexus, the superior and inferior ganglia.

4. Cranial osteopathy techniques to address the vagus parasympathetic nerves.

Interventions

Manual Therapy: osteopathy

Osteopathic protocol applied at week 0, 1, 2 and 3:

1. Spinal mobilisation of L1, L2 and L3 vertebrae to stimulate the arterial supply of mesenteric attachments of the colon and small intestine.

2. Visceral osteopathic therapy to address adhesions/ fixations in the presacral fascia, Toldt fascia, posterior peritoneum and caudal peritoneum.

3. Circulatory techniques to stimulate the celiac plexus, the superior and inferior ganglia.

4. Cranial osteopathy techniques to address the vagus parasympathetic nerves.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects diagnosed with inflammatory bowel disease (IBD) in remission state;
• Subjects must suffer form recurrent digestive symptoms fulfilling the Rome III criteria;
• Subjects' eating habits should be stable prior to the study.

Exclusion Criteria

• Concomitant diagnosis of celiac disease or multiple food intolerance;
• Concomitant diagnosis of rheumatologic disease;
• Obesity (BMI ≥ 30);
• Concomitant diagnosis of severe depression or severe anxiety;
• Unstable thyroid or kidney condition;
• Subjects on antidepressant, anti-inflammatory (steroids) or analgesic (paracetamol, aspirin) will be excluded from the study;
• Smokers, patients with problematic alcohol consumption or consuming drugs will be excluded from the study;
• High performance athletes will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ecole Professionnelle des Osteopathes du Quebec

OTHER

Sponsor Role: lead

Responsible Party

Valérie Conway

Osteopath and Naturopath at Clinique Expertise Santé, PhD in food sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Valérie Conway, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinique Expertise Santé

Central Contacts

Valérie Conway, PhD

Role: CONTACT

info@valerieconway.com

1-418-658-2341

Reyhan El Kares, PhD

Role: CONTACT

relkares@epoqosteopathie.com

1-514-647-8465

Other Identifiers

OSTEO in subjects with IBD

Identifier Type: -

Identifier Source: org_study_id