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
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.
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.
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