Clinical trial NCT04367571: Osteopathic Manipulative Treatments and Neurogenic Bowel Dysfunction in Patients With Spinal Cord Injuries.
Official title: The Effects of Osteopathic Manipulative Treatments on Neurogenic Bowel Dysfunction in Patients With Spinal Cord Injuries: a Randomized Manual Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: I.R.C.C.S. Fondazione Santa Lucia
Sponsor class: OTHER
First posted: 2020-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Studies based on the relationship between Osteopathic Manipulative Treatment (OMT) and the gastrointestinal system have been conducted in patients with constipation with Irritable Bowel Syndrome (IBS), and in children with infantile cerebral palsy. For IBS patients, OMT can facilitate visceral vascularization and restore the physiological elasticity and motility of the viscera, and of the peritoneal structures around the viscera. The study also focused on the effects of OMT on women and constipated children, indicating an improvement in the stool consistency, reduction in the symptoms of constipation, the severity of the constipation, and in the use of laxative drugs.

In patients with Spinal Cord Injury (SCI), the secondary health disorders include the alteration of gastric acid secretion, abnormal colonic myenteric activity, and neurogenic bowel dysfunction (NBD). Patients with NBD present loss or absence of normal bowel function. About 80% of SCI is accompanied by NBD resulting in a lower quality of life caused by loss of independence, sense of embarrassment, mental disorder, social isolation.

Conservative treatments for NBD after SCI include oral laxatives, enemas, retroanal trans-grade irrigation and digital anorectal stimulation. These treatments are mainly focused on promoting intestinal faecal evacuation and on strengthening the anal sphincter to improve bowel function. There are no studies that investigate the effects of OMT on patients with SCI, however, several studies have already showed the effects of OMT on the nervous system, on the hemodynamic system, and on visceral motility. Therefore, the starting hypothesis of this study is to use OMT in order to improve the symptoms of NBD in subjects with SCI, through a global OMT


Eligibility criteria: Inclusion Criteria:

* age between 18 and 70 years old,
* chronic spinal cord injury (more than six months between the spinal injury and the enrollment in the research),
* injury classified per the ASIA impairment scale AIS A, B, C or D localized at a cervical-dorsal level up to D10.

Exclusion Criteria:

* Use of bowel emptying techniques such as retrograde trans-anal irrigation
* presence of previous inflammatory intestinal diseases
* metabolic or endocrinological dysfunctions,
* pregnancy state
* cognitive disorders.

Primary outcomes:
measure: Neurogenic Bowel Dysfunction (NBD)
timeFrame: at 3 months
Secondary outcomes:
measure: Knowles Eccersley Scott Symptom (KESS)
timeFrame: at baseline, after one month, after 4 treatment sessions, one month after the last treatment
measure: Patient Assessment of Constipation Quality Of Life scale (PAC-QOL)
timeFrame: at baseline, after one month, after 4 treatment sessions, one month after the last treatment
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Santa Lucia Foundation I.R.C.C.S.
state: Rm
Study officials:
References: