Effects of Osteopathic Manipulative Treatment in People With Neurogenic Bowel Dysfunction
Neurogenic Bowel Dysfunction: Evaluation of the Effects of Osteopathic Manipulative Treatment in People With Central Nervous System Injury
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2019
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
October 4, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedStudy Start
First participant enrolled
October 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 17, 2019
October 1, 2019
1 year
October 4, 2019
October 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurogenic bowel dysfunction score (NBDS)
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.
- Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment
Secondary Outcomes (2)
Quality of Life Short Form-36 (SF-36) Questionnaire
- Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment
Bowel transit time
- Pre-treatment - Follow-up at three months after the end of the treatment
Study Arms (2)
Osteopathic Manipulative Treatment
EXPERIMENTALthe 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.
Nursing Care
ACTIVE COMPARATORThe conventional treatment consists in educational nursing care.
Interventions
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
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.
Eligibility Criteria
You may qualify if:
- neurogenic bowel dysfunction secondary to acquired disease of the central nervous system
- Neurogenic Bowel Dysfunction Score (NBDS) between 6 and 30
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Turin, Italylead
- SOMA Istituto Osteopatia Milanocollaborator
- A.O.U. Città della Salute e della Scienzacollaborator
Study Sites (1)
Silvia Mozzone
Vezza d'Alba, CN, 12040, Italy
Related Publications (10)
Coggrave M, Norton C, Cody JD. Management of faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2014 Jan 13;2014(1):CD002115. doi: 10.1002/14651858.CD002115.pub5.
PMID: 24420006BACKGROUNDFaaborg PM, Christensen P, Buntzen S, Laurberg S, Krogh K. Anorectal function after long-term transanal colonic irrigation. Colorectal Dis. 2010 Oct;12(10 Online):e314-9. doi: 10.1111/j.1463-1318.2010.02198.x.
PMID: 20070334BACKGROUNDGstaltner K, Rosen H, Hufgard J, Mark R, Schrei K. Sacral nerve stimulation as an option for the treatment of faecal incontinence in patients suffering from cauda equina syndrome. Spinal Cord. 2008 Sep;46(9):644-7. doi: 10.1038/sc.2008.6. Epub 2008 Mar 4.
PMID: 18317481BACKGROUNDLombardi G, Del Popolo G, Cecconi F, Surrenti E, Macchiarella A. Clinical outcome of sacral neuromodulation in incomplete spinal cord-injured patients suffering from neurogenic bowel dysfunctions. Spinal Cord. 2010 Feb;48(2):154-9. doi: 10.1038/sc.2009.101. Epub 2009 Aug 11.
PMID: 19668257BACKGROUNDSchleip R, Muller DG. Training principles for fascial connective tissues: scientific foundation and suggested practical applications. J Bodyw Mov Ther. 2013 Jan;17(1):103-15. doi: 10.1016/j.jbmt.2012.06.007. Epub 2012 Jul 21.
PMID: 23294691BACKGROUNDBranchini M, Lopopolo F, Andreoli E, Loreti I, Marchand AM, Stecco A. Fascial Manipulation(R) for chronic aspecific low back pain: a single blinded randomized controlled trial. F1000Res. 2015 Nov 3;4:1208. doi: 10.12688/f1000research.6890.2. eCollection 2015.
PMID: 26834998BACKGROUNDRuffini N, D'Alessandro G, Mariani N, Pollastrelli A, Cardinali L, Cerritelli F. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial. Front Neurosci. 2015 Aug 4;9:272. doi: 10.3389/fnins.2015.00272. eCollection 2015.
PMID: 26300719BACKGROUNDTesarz J, Hoheisel U, Wiedenhofer B, Mense S. Sensory innervation of the thoracolumbar fascia in rats and humans. Neuroscience. 2011 Oct 27;194:302-8. doi: 10.1016/j.neuroscience.2011.07.066. Epub 2011 Aug 2.
PMID: 21839150BACKGROUNDLicciardone JC, Kearns CM, Hodge LM, Bergamini MV. Associations of cytokine concentrations with key osteopathic lesions and clinical outcomes in patients with nonspecific chronic low back pain: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Sep;112(9):596-605. doi: 10.7556/jaoa.2012.112.9.596.
PMID: 22984233BACKGROUNDBramati-Castellarin I, Patel VB, Drysdale IP. Repeat-measures longitudinal study evaluating behavioural and gastrointestinal symptoms in children with autism before, during and after visceral osteopathic technique (VOT). J Bodyw Mov Ther. 2016 Jul;20(3):461-70. doi: 10.1016/j.jbmt.2016.01.001. Epub 2016 Jan 14.
PMID: 27634066BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Manassero, MD
A.O.U. Città della Salute e della Scienza
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN, PhD - Postoctoral Fellow in Nursing
Study Record Dates
First Submitted
October 4, 2019
First Posted
October 15, 2019
Study Start
October 28, 2019
Primary Completion
October 30, 2020
Study Completion
October 1, 2022
Last Updated
October 17, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share