Osteopathic Manipulative Treatments and Neurogenic Bowel Dysfunction in Patients With Spinal Cord Injuries.

NCT04367571 | Completed

• 1 other identifier: FSLCE/800/OMT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (1)

• Neurogenic Bowel Dysfunction (NBD)

  NBD score changes from baseline at 3 moths. self-reported questionnaire. The Neurogenic Bowel Dysfunction 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 NBD score.

  at 3 months

Secondary Outcomes (2)

• Knowles Eccersley Scott Symptom (KESS)

  at baseline, after one month, after 4 treatment sessions, one month after the last treatment

• Patient Assessment of Constipation Quality Of Life scale (PAC-QOL)

  at baseline, after one month, after 4 treatment sessions, one month after the last treatment

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

Other: Osteopathic Manipulative treatment (OMT)

Manual Placebo

PLACEBO COMPARATOR

Other: Manual Placebo (MP)

Interventions

Osteopathic Manipulative treatment (OMT) OTHER

OMT techniques were focused on correcting the dysfunctions found before each OMT session and included myofascial techniques, balanced ligamentous tension, visceral manipulations and osteopathy in the cranial field. OMT group will receive a total of 4 sessions, one time each week for 4 weeks. Each session will last 40 minutes. It will be required by the patients to modify their bowels habits. The subjects will be evaluated right at baseline (T0), after one month (T1) after four sessions (T2) and after 1 month after the treatment (T3).

Osteopathic Manipulative Treatment

Manual Placebo (MP) OTHER

The MP treatment consists of passive touch without joint mobilization in a protocolled order. The practictioners will be standing next to the bed, they'll touch lumbar and dorsal spine of the subjects in prone position for 10 minutes, and then in supine position, they'll touch for 10 minutes the shoulders, the hips, then the neck, the sternum and the chest for 5 minutes each. MP group will receive a total of 4 sessions, one time each week for 4 weeks. Each session will last 40 minutes. It will be required by the patients to modify their bowels habits. The subjects will be evaluated right at baseline (T0), after one month (T1) after four sessions (T2) and after 1 month after the treatment (T3).

Manual Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

Santa Lucia Foundation I.R.C.C.S.

Roma, Rm, 00179, Italy

Location

Related Publications (1)

• Todd CL, Johnson EE, Stewart F, Wallace SA, Bryant A, Woodward S, Norton C. Conservative, physical and surgical interventions for managing faecal incontinence and constipation in adults with central neurological diseases. Cochrane Database Syst Rev. 2024 Oct 29;10(10):CD002115. doi: 10.1002/14651858.CD002115.pub6.

  PMID: 39470206 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of rehabilitation Services

Study Record Dates

• First Submitted: April 27, 2020
• First Posted: April 29, 2020
• Study Start: April 1, 2020
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)