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Effects of OMT on Interoception

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
osteopathic manipulative treatment
sham osteopathic treatment
Sponsored by
Come Collaboration
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring osteopathic manipulative treatment, interoception

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic low back pain
  • written informed consent signed

Exclusion Criteria:

  • congenital disease
  • acute pain
  • subject below 30 and above 50
  • co-morbidities associated with low back pain
  • surgical patients
  • cardio-vascular, respiratory, gastro-enteric disease
  • obese subjects
  • diabetics
  • dizziness
  • subjects into pharmacological prophylaxis
  • drug addicted subjects
  • subjects undergoing physiotherapy
  • subjects with experience in osteopathic treatment

Sites / Locations

  • University of Chieti-Pescara

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

OMT

Sham

Arm Description

Outcomes

Primary Outcome Measures

functional connectivity on right anterior insula cortex
before-after change in fMRI values

Secondary Outcome Measures

differences on salience network activities
report any change between study and control group on pattern activation of salience network
acute changes on salience network
voxel differences
resting state network differences between groups
voxel differences
DTI changes between groups
differences in DTI parameters and indexes
changes in GABA concentration
amount of GABA in the given voxel
changes in quality of life
SF-36v2 self-reported questionnaire
changes in perception of pain
McGill self-reported questionnaire
changes in disability
Oswestry disability questionnaire
changes in depression symptoms
Beck Depression Inventory questionnaire
changes in anxiety symptoms
Hospital Anxiety and Depression Scale questionnaire

Full Information

First Posted
May 28, 2015
Last Updated
March 21, 2019
Sponsor
Come Collaboration
Collaborators
University of Chieti
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1. Study Identification

Unique Protocol Identification Number
NCT02464475
Brief Title
Effects of OMT on Interoception
Official Title
Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Come Collaboration
Collaborators
University of Chieti

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Recent evidence suggested that the anterior insula cortex seems to be the main site of interoception. Several studies showed an association between change in insula function and interoception, bodily perception and consciousness in subjects with chronic pain. Although osteopathic research has been demonstrated to be effective in reducing pain, studies exploring the effect of osteopathy on interoception are lacking. Therefore, the aim of the present study is to explore the extent to which osteopathic treatment could modify interoception parameters both measuring brain functional connectivity and clinical questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
osteopathic manipulative treatment, interoception

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
OMT
Arm Type
Experimental
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
osteopathic manipulative treatment
Intervention Type
Other
Intervention Name(s)
sham osteopathic treatment
Primary Outcome Measure Information:
Title
functional connectivity on right anterior insula cortex
Description
before-after change in fMRI values
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
differences on salience network activities
Description
report any change between study and control group on pattern activation of salience network
Time Frame
4 weeks
Title
acute changes on salience network
Description
voxel differences
Time Frame
2 hours
Title
resting state network differences between groups
Description
voxel differences
Time Frame
4 weeks
Title
DTI changes between groups
Description
differences in DTI parameters and indexes
Time Frame
4 weeks
Title
changes in GABA concentration
Description
amount of GABA in the given voxel
Time Frame
4 weeks
Title
changes in quality of life
Description
SF-36v2 self-reported questionnaire
Time Frame
4 weeks
Title
changes in perception of pain
Description
McGill self-reported questionnaire
Time Frame
4 weeks
Title
changes in disability
Description
Oswestry disability questionnaire
Time Frame
4 weeks
Title
changes in depression symptoms
Description
Beck Depression Inventory questionnaire
Time Frame
4 weeks
Title
changes in anxiety symptoms
Description
Hospital Anxiety and Depression Scale questionnaire
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic low back pain written informed consent signed Exclusion Criteria: congenital disease acute pain subject below 30 and above 50 co-morbidities associated with low back pain surgical patients cardio-vascular, respiratory, gastro-enteric disease obese subjects diabetics dizziness subjects into pharmacological prophylaxis drug addicted subjects subjects undergoing physiotherapy subjects with experience in osteopathic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli, MS, DO
Organizational Affiliation
University of Chieti-Pescara
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chieti-Pescara
City
Chieti
ZIP/Postal Code
66100
Country
Italy

12. IPD Sharing Statement

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Effects of OMT on Interoception

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