Effects of Osteopathic Manipulative Treatment in People With Neurogenic Bowel Dysfunction

Summary

People affected central nervous system (CNS) diseases often suffer from neurogenic bowel dysfunction (NBD) that causes a reduction in the quality of life and participation in social life. Although some conservative approaches exist to treat NBD, none has shown to be effective in managing this complex condition. Osteopathic manipulative treatment (OMT) has shown to be efficient in CNS diseases such as epilepsy and migraine.

This randomised trial aims at evaluating the efficacy of osteopathic manipulative treatment (OMT) in supporting the management of NBD. The research will be conducted at the outpatient service of Neuro-Urology / Spinal Unit of the Città della Salute e della Scienza Hospital of Torino.

A sample of 62 participants will be divided into two groups: standard (nursing intervention) and experimental (nursing intervention and OMT). A neuro-urologist will determine the eligibility for the study. The outcomes will include self-reported and instrumental measures that will be evaluated in 3 times (before, at the end of the intervention and the follow- up three months).

The protocol has been approved by the Ethics Committee of the Città della Salute e della Scienza Hospital of Torino on 15.04.2019, protocol number 0040534. The standard intervention has been scheduled for 28.10.2019.

Conditions

• Central Nervous System Injury
• Neurogenic Bowel Dysfunction

Interventions

OTHER

Osteopathic Manipulative Treatment

Osteopathic treatment Dural system: L5-S1 decompression; sacred decompression among the iliacs; occipital-sphenoid approach; decongestion of occipital condyles Fascial system: fascial techniques in the abdominal region: right hypochondrium, epigastrium, left hypochondrium, right side, mesogastrium, left side, right iliac area, hypogastrium, left iliac area; relationship with corresponding vertebral levels (eg, hypogastrium); fibro scar adhesions treatment. Biomechanical system: diaphragm rebalancing with respect to anatomical insertions; passive mobilization of dysfunctional areas. Nursing education as described in Standard Treatment

OTHER

Nursing Educational Care

Nursing education * assessment of the best personal evacuation strategy concerning the quality of life, individual resources, and level of autonomy; * assessment of the correct execution of the identified evacuation manoeuvre (digital stimulation, manual removal, reflex stimulation, transanal irrigation, use of micro-enemas or suppositories; * identification of the best postural strategies during evacuation; * nutrition and proper hydration education; * education in completing the evacuation diary; * colonic massage training; * verification of the correct hiring of any previously prescribed laxative drugs.

Sponsors & Collaborators

• SOMA Istituto Osteopatia Milano

  collaborator UNKNOWN

• A.O.U. Città della Salute e della Scienza

  collaborator OTHER

• University of Turin, Italy

  lead OTHER

Principal Investigators

• Alberto Manassero, MD · A.O.U. Città della Salute e della Scienza

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-28

Primary Completion

2020-10-30

Completion

2022-10-01

Countries

• Italy

Study Locations