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

The Effects of Osteopathic Manipulative Treatments on Neurogenic Bowel Dysfunction in Patients With Spinal Cord Injuries: a Randomized Manual Placebo Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Other: Osteopathic Manipulative treatment (OMT); Other: Manual Placebo (MP)

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marco Tramontano; Phone Number: 0039 0651501420; Email: m.tramontano@hsantalucia.it
• Study Contact Backup: Name: Federica Tamburella; Phone Number: 0039 0651501678; Email: f.tamburella@hsantalucia.it

Study Locations

• Italy
  • Rm
    • Roma, Rm, Italy, 00179
      • Santa Lucia Foundation I.R.C.C.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathic Manipulative Treatment	Other: Osteopathic Manipulative treatment (OMT); 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).
Placebo Comparator: Manual Placebo	Other: Manual Placebo (MP); 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowles Eccersley Scott Symptom (KESS)	KESS score changes from baseline at 3 months. The KESS is a validated questionnaire for diagnosis of constipation. KESS has an added advantage of differentiating between various subtypes of constipation. Total scores can range from 0 (no symptoms) to 39 (high symptom severity). A cut-off score of > 11 indicates constipation	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)	PAC-QOL score changes from baseline at 3 months. Each item of the 28-item questionnaire was scored on a 5-point Likert-type scale from 0 to 4, with (0 = none/not at all, 1 = a little bit/a little bit of the time, 2 = moderately/some of the time, 3 = quite a bit/most of the time, 4 = extremely/all the time). Scores were reported overall and for each of the four subscales (physical discomfort, psychosocial discomfort, worries and concerns, and satisfaction). An improvement (reduction) of ≥1 point in PAC-QOL score was considered clinically significant based on previous validation studies.	at baseline, after one month, after 4 treatment sessions, one month after the last treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): January 30, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: April 27, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 29, 2020

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 14, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Intestinal Diseases; Spinal Cord Injuries; Neurogenic Bowel
• Other Study ID Numbers: FSLCE/800/OMT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No