Effects of Osteopathic Manipulative Treatment in People With Neurogenic Bowel Dysfunction

Central Nervous System Injury Clinical Trial

Official title:

Neurogenic Bowel Dysfunction: Evaluation of the Effects of Osteopathic Manipulative Treatment in People With Central Nervous System Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127617
• Other study ID #: 0040534
• Status: Recruiting
• Phase: N/A
• Start date: October 28, 2019
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2019
• Source: University of Turin, Italy
• Contact: Silvia Mozzone
• Phone: 3335390895
• Email: si.mozzone[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Aim of the study The present randomised trial aims to evaluate the efficacy of osteopathic manipulative treatment in supporting the management of neurogenic bowel dysfunction in CNS diseases.

Study design Randomised controlled trial. Participants recruited will be divided into two groups. The treatment group will receive five osteopathic manipulative treatment sessions in addition to the standard treatment.

The control group will only receive standard treatment.

Sample A neuro-urologist will determine eligibility for the study during an interview. Participants will be conducted during outpatient visits to the Neuro Urology department. This study does not include any diagnostic assessment or treatment, which are different from the normal patient's evaluation and management process.

Informed consent will be obtained before any evaluation or treatment. Principal Investigator will explain in detail the study purpose and procedures, risks and potential benefits. Participants will be provided with contact information and have adequate time to consider their participation in the study and encouraged to ask questions, both during the initial interview and throughout the study.

Staff involved in the study Operative Unit Staff (1 urologist specialist, 1 nursing coordinator, 2 nurses); Osteopaths of the School of Osteopathy of Milan (SOMA) who administer osteopathic manipulative treatment; Researcher performing randomisation and data analysis.

Interventions

Eligible participants will be randomised in two different treatment groups:

Conventional therapy (control group)

The conventional treatment consists of education provided by qualified nurses through an individual interview of 45-60 minutes structured as follows:

assessment of the best personal evacuation strategy concerning the quality of life, resources, and level of autonomy; evaluation 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 an evacuation; nutrition and proper hydration education; education in completing the evacuation diary; bowel massage training; verification of the correct hiring of any previously prescribed laxative drugs. Approximately two months later, patients will be contacted by telephone to assess the effectiveness of the strategies used to carry out any telephone nursing counselling.

Osteopathic manipulative treatment (experimental group)

In addition to the conventional treatment described above, the experimental group will receive osteopathic manipulative treatment (OMT).

The treatment will last 45 - 60 minutes with the following frequency: the subjects will receive three OMT every week, the two following twice weekly. The osteopathic treatment protocol will, therefore, last seven weeks. Each patient will be taken in charge by two operators during the entire duration of the study.

OMT procedures will be provided by a team of osteopaths, who will practice through specific training to improve palpation reliability before enrollment. The diagnostic and treatment procedures will follow a specific protocol, developed from clinical experience and evidence to improve treatment specificity, safety and reproducibility.

Osteopathic assessment General assessment: the presence of asymmetries, scars. The observation can provide a lot of information on the fascial structure; Assessment of the dural system: cranial and sacral grip, evaluating its intrinsic motility;

Assessment of the fascial system:

lower extremity intrarotation tests and upper limb flexion tests, assesses their quality and amount of movement and any restrictions; abdominal palpation, fascial entrainment in the abdominal-pelvic region; thoracic palpation, fascial entrainment in thoraco-abdominal area.

Assessment of the biomechanical system:

Diaphragms: pelvic, respiratory, upper thoracic, cranial; Structural palpation, spring test:

iliac crests, hip mobility, ribs, glenohumeral / clavicles, supine vertebral test.

Each level of assessment (fascial, dural or biomechanical) in which dysfunction is highlighted will be correlated with all other systems and with autonomous nervous system. In relation to the dysfunctions found in the various systems, using parameters such as alterations of tissue density, asymmetry, rigidity (or reduction of range of motion) and tenderness (TART), treatment procedures will be implemented in the specific subject areas at somatic dysfunction.

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 (e.g. hypogastrium); fibro scar adhesions treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: October 1, 2022
• Est. primary completion date: October 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Central Nervous System Injury
• Gastrointestinal Diseases
• Intestinal Diseases
• Neurogenic Bowel
• Neurogenic Bowel Dysfunction
• Trauma, Nervous System

Intervention

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
• 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.

Locations

Country	Name	City	State
Italy	Silvia Mozzone	Vezza d'Alba	CN

Sponsors (3)

Lead Sponsor	Collaborator
University of Turin, Italy	Azienda Ospedaliera Città della Salute e della Scienza di Torino, SOMA Istituto Osteopatia Milano

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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Faaborg 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. — View Citation

Gstaltner K, Rosen H, Hufgard J, Märk 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. — View Citation

Licciardone 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. Erratum in: J Am Osteopath Assoc. 2017 Jun 1;117(6):350. — View Citation

Lombardi 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. — View Citation

Ruffini 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. — View Citation

Schleip R, Müller 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. Review. — View Citation

Tesarz J, Hoheisel U, Wiedenhöfer 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life Short Form-36 (SF-36) Questionnaire	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.	- Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment
Secondary	Bowel transit time	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.	- Pre-treatment - Follow-up at three months after the end of the treatment

External Links

•   American Association of Colleges of Osteopathic Medicine, (2017). Glossary of Osteopathic Terminology
•   International Classification of Disease 10, (2016). Segmental and somatic dysfunction.
•   World Health Organization. (2010). Benchmarks for training in Osteopathy. 1st ed.