Effects of OMT on Interoception

March 21, 2019 updated by: Francesco Cerritelli, Come Collaboration

Effects of Osteopathic Manual Treatment on Interoception: 2- Armed RCT on cLBP Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Chieti, Italy, 66100
        • University of Chieti-Pescara

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Other: sham osteopathic treatment
Experimental: OMT
Other: osteopathic manipulative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
functional connectivity on right anterior insula cortex
Time Frame: 4 weeks
before-after change in fMRI values
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
differences on salience network activities
Time Frame: 4 weeks
report any change between study and control group on pattern activation of salience network
4 weeks
acute changes on salience network
Time Frame: 2 hours
voxel differences
2 hours
resting state network differences between groups
Time Frame: 4 weeks
voxel differences
4 weeks
DTI changes between groups
Time Frame: 4 weeks
differences in DTI parameters and indexes
4 weeks
changes in GABA concentration
Time Frame: 4 weeks
amount of GABA in the given voxel
4 weeks
changes in quality of life
Time Frame: 4 weeks
SF-36v2 self-reported questionnaire
4 weeks
changes in perception of pain
Time Frame: 4 weeks
McGill self-reported questionnaire
4 weeks
changes in disability
Time Frame: 4 weeks
Oswestry disability questionnaire
4 weeks
changes in depression symptoms
Time Frame: 4 weeks
Beck Depression Inventory questionnaire
4 weeks
changes in anxiety symptoms
Time Frame: 4 weeks
Hospital Anxiety and Depression Scale questionnaire
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Come Collaboration

Collaborators

University of Chieti

Investigators

  • Principal Investigator: Francesco Cerritelli, MS, DO, University of Chieti-Pescara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

May 28, 2015

First Submitted That Met QC Criteria

June 3, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

March 25, 2019

Last Update Submitted That Met QC Criteria

March 21, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • InterOST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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