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Effects of Osteopathic Manipulative Treatment in People With Neurogenic Bowel Dysfunction

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ClinicalTrials.gov Identifier: NCT04127617
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 17, 2019
Sponsor:
Collaborators:
SOMA Istituto Osteopatia Milano
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Information provided by (Responsible Party):
Alessio Conti, University of Turin, Italy

Brief 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.


Condition or disease Intervention/treatment Phase
Central Nervous System Injury Neurogenic Bowel Dysfunction Other: Osteopathic Manipulative Treatment Other: Nursing Educational Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial. Participants in the study will be divided into two groups: the treatment group will receive five osteopathic manipulative treatment sessions in addition to the standard treatment, and the control group will only receive standard treatment.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurogenic Bowel Dysfunction: Evaluation of the Effects of Osteopathic Manipulative Treatment in People With Central Nervous System Injury
Estimated Study Start Date : October 28, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 1, 2022

Arm Intervention/treatment
Experimental: Osteopathic Manipulative Treatment
the treatment group will receive 5 osteopathic manipulative treatment. The treatment will last 45 - 60 minutes with the following frequency: the subjects will receive 3 OMT on a weekly basis, the two following twice weekly. The osteopathic treatment protocol will therefore last 7 weeks. Each individual patient will be taken in charge by two operators during the entire duration of the study.
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 Name: Experimental treatment combining osteopathic manipulative treatment with nursing education

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.
Other Name: Standard Treatment

Active Comparator: Nursing Care
The conventional treatment consists in educational nursing care.
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.
Other Name: Standard Treatment




Primary Outcome Measures :
  1. Neurogenic bowel dysfunction score (NBDS) [ Time Frame: - Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment ]

    self-reported questionnaire. The Neurogenic Bowel Dysfunction Score is a 10-item questionnaire covering frequency of bowel movements, headache, perspiration or discomfort during defaecation; medication for constipation or faecal incontinence; time spent on defaecation; frequency of digital stimulation or evacuation; frequency of faecal incontinence; flatus; and perianal skin problems. It ranges between 0 and 47; lower scores indicate a better bowel function, while a score over 14 is considered to be an index of severe bowel dysfunction.

    Score 0-6 Very low 7-9 Low 10-13 Moderate 14 or more Severe The hypothesis of treatment efficacy is supported by the observation of a difference between the groups in the NBDS score.



Secondary Outcome Measures :
  1. Quality of Life Short Form-36 (SF-36) Questionnaire [ Time Frame: - Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment ]
    self-reported questionnaire. This questionnaire was developed in 1992 to be applied in all health conditions and detect fundamental human values that describe health concepts significant to a person's functional status and wellbeing. It consists of 36 self-administered questions covering eight main domains (vitality, physical functioning, bodily pain, general health, physical role functioning, emotional role functioning, social role functioning, and mental health) represented on a 0-100 scale; a lower score indicates lower quality of life with significant impairments in the specific domain. Higher scores indicate better quality of life in the different domains.

  2. Bowel transit time [ Time Frame: - Pre-treatment - Follow-up at three months after the end of the treatment ]
    Bowel transit time is a non - invasive diagnostic rx. The exam involves the assumption of radiopaque markers of about two or three millimeters each for six consecutive days and the execution of a single radiograph of the abdomen on the seventh day.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • neurogenic bowel dysfunction secondary to acquired disease of the central nervous system
  • Neurogenic Bowel Dysfunction Score (NBDS) between 6 and 30

Exclusion Criteria:

  • previous dysfunctional conditions or organic diseases affecting the bowel tract that are pre-existing at neurological diagnosis
  • patients with an NBDS score lower than 6 (very mild bowel dysfunction) and above 30 (very severe neurogenic bowel dysfunction)
  • ostomy condition (ileus and colon)
  • psychiatric patients
  • presence of cognitive disorders
  • female patients with proven, or even doubtful, pregnancy status.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127617


Contacts
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Contact: Silvia Mozzone 3335390895 si.mozzone@gmail.com
Contact: Alessio Conti, PhD 3397855171 alessio.conti@unito.it

Locations
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Italy
Silvia Mozzone Recruiting
Vezza d'Alba, CN, Italy, 12040
Contact: Silvia Mozzone    3335390895    si.mozzone@gmail.com   
Sponsors and Collaborators
University of Turin, Italy
SOMA Istituto Osteopatia Milano
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Investigators
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Principal Investigator: Alberto Manassero, MD AOU Città della Salute e della Scienza di Torino
Additional Information:
Publications:

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Responsible Party: Alessio Conti, RN, PhD - Postoctoral Fellow in Nursing, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT04127617    
Other Study ID Numbers: 0040534
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alessio Conti, University of Turin, Italy:
Manipulation, Osteopathic
Neurogenic Bowel
Nervous System Diseases
Nursing
Additional relevant MeSH terms:
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Intestinal Diseases
Gastrointestinal Diseases
Neurogenic Bowel
Trauma, Nervous System
Wounds and Injuries
Digestive System Diseases
Colonic Diseases, Functional
Colonic Diseases
Nervous System Diseases