Central Nervous System InjuryNCT04127617
Effects of Osteopathic Manipulative Treatment in People With Neurogenic Bowel Dysfunction
A study testing Osteopathic Manipulative Treatment and Nursing Educational Care in people with Central Nervous System Injury and Neurogenic Bowel Dysfunction, run by University of Turin, Italy at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Injury, Neurogenic Bowel Dysfunction
- What is being tested?
- Osteopathic Manipulative Treatment and Nursing Educational Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteItaly
- Study dates
- 28 Oct 2019to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurogenic bowel dysfunction secondary to acquired disease of the central nervous system
- Neurogenic Bowel Dysfunction Score (NBDS) between 6 and 30
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Silvia Mozzone
Vezza d'Alba, CN, 12040
Silvia Mozzone, 3335390895, si.mozzone@gmail.com
About this study
Official title: Neurogenic Bowel Dysfunction: Evaluation of the Effects of Osteopathic Manipulative Treatment in People With Central Nervous System Injury
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.
Read more
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.
Read the detailed 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.
- Being tested
- Osteopathic Manipulative Treatment, Nursing Educational Care
- Keywords
- Manipulation, Osteopathic, Neurogenic Bowel, Nervous System Diseases, Nursing
- Medical subject headings
- Neurogenic Bowel, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentOther
Also called Experimental treatment combining osteopathic manipulative treatment with nursing education
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 CareOther
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | 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. Receives: Other: Osteopathic Manipulative Treatment; Other: Nursing Educational Care |
| Nursing Care | Active comparator | The conventional treatment consists in educational nursing care. Receives: Other: Nursing Educational Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: - 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
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.
Measured: - Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment
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.
Measured: - Pre-treatment - Follow-up at three months after the end of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start28 Oct 2019 (estimated)
- Primary completion30 Oct 2020 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Central Nervous System InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Turin, Italy
- Sponsor type
- University, hospital or other
- Collaborators
- SOMA Istituto Osteopatia Milano, A.O.U. Città della Salute e della Scienza
- Responsible party
- Principal investigator, Alessio Conti, University of Turin, Italy
- Investigators
- Alberto Manassero, MD, Principal investigator, A.O.U. Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127617
- Sponsor's protocol ID
- 0040534
- Status last verified
- Oct 2019
- First submitted
- 4 Oct 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24420006Faaborg 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.
PubMed 20070334Gstaltner 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.
PubMed 18317481Lombardi 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.
PubMed 19668257Schleip 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.
PubMed 23294691Branchini 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.
PubMed 26834998Ruffini 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.
PubMed 26300719Tesarz 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.
PubMed 21839150Licciardone 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.
PubMed 22984233Bramati-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.
PubMed 27634066
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurogenic Bowel Dysfunction: Evaluation of the Effects of Osteopathic Manipulative Treatment in People With Central Nervous System Injury
- ClinicalTrials.gov ID
- NCT04127617
- Acronym / sponsor ID
- 0040534
- Keywords
- Manipulation, Osteopathic, Neurogenic Bowel, Nervous System Diseases, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Turin, ItalyUniversity, hospital or other
- Collaborators
- SOMA Istituto Osteopatia Milano, A.O.U. Città della Salute e della Scienza
- Study start
- 28 Oct 2019 (estimated)
- Primary completion
- 30 Oct 2020 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Other: Osteopathic Manipulative Treatment, Other: Nursing Educational Carethe 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 comparator | Other: Nursing Educational CareThe conventional treatment consists in educational nursing care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- neurogenic bowel dysfunction secondary to acquired disease of the central nervous system
- Neurogenic Bowel Dysfunction Score (NBDS) between 6 and 30
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic Manipulative TreatmentAlso: Experimental treatment combining osteopathic manipulative treatment with nursing educationOsteopathic 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 | Osteopathic Manipulative Treatment |
| Nursing Educational CareAlso: Standard TreatmentNursing 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 | Nursing Care, Osteopathic Manipulative Treatment |
Primary outcome
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.
2 secondary outcomes
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
Bowel transit time
Time frame: - Pre-treatment - Follow-up at three months after the end of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 24420006Coggrave 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.
- Background: PubMed 20070334Faaborg 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.
- Background: PubMed 18317481Gstaltner 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.
- Background: PubMed 19668257Lombardi 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.
- Background: PubMed 23294691Schleip 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.
- Background: PubMed 26834998Branchini 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.
- Background: PubMed 26300719Ruffini 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.
- Background: PubMed 21839150Tesarz 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.
- Background: PubMed 22984233Licciardone 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.
- Background: PubMed 27634066Bramati-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.
- International Classification of Disease 10, (2016). Segmental and somatic dysfunction.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Spinal Cord Injuries
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Manassero, MD principal investigator
A.O.U. Città della Salute e della Scienza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic Manipulative Treatment and Nursing Educational Care in people with Central Nervous System Injury and Neurogenic Bowel Dysfunction, run by University of Turin, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Silvia Mozzone (3335390895, si.mozzone@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurogenic bowel dysfunction score (NBDS) (time frame: - Pre-treatment - Immediately after the treatment - Follow-up at three months after the end of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127617, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2019.