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

Primary Purpose

Spinal Cord Injuries

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Osteopathic Manipulative treatment (OMT)
Manual Placebo (MP)
Sponsored by
I.R.C.C.S. Fondazione Santa Lucia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Santa Lucia Foundation I.R.C.C.S.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Osteopathic Manipulative Treatment

Manual Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
April 27, 2020
Last Updated
April 14, 2023
Sponsor
I.R.C.C.S. Fondazione Santa Lucia
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1. Study Identification

Unique Protocol Identification Number
NCT04367571
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
January 30, 2022 (Actual)
Study Completion Date
January 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
I.R.C.C.S. Fondazione Santa Lucia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Osteopathic Manipulative Treatment
Arm Type
Experimental
Arm Title
Manual Placebo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative treatment (OMT)
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Manual Placebo (MP)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Neurogenic Bowel Dysfunction (NBD)
Description
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.
Time Frame
at 3 months
Secondary Outcome Measure Information:
Title
Knowles Eccersley Scott Symptom (KESS)
Description
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
Time Frame
at baseline, after one month, after 4 treatment sessions, one month after the last treatment
Title
Patient Assessment of Constipation Quality Of Life scale (PAC-QOL)
Description
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.
Time Frame
at baseline, after one month, after 4 treatment sessions, one month after the last treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Santa Lucia Foundation I.R.C.C.S.
City
Roma
State/Province
Rm
ZIP/Postal Code
00179
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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