Effects of OMT on Interoception | NCT02464475

Studies
Effects of OMT on Interoception

NCT02464475

Sponsor

Come Collaboration

Status

Completed

Last Update Posted

Mar 25, 2019Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Chronic Low Back Pain

Interventions

osteopathic manipulative treatment
sham osteopathic treatment

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Jul 2017Actual

Completion Date

Dec 2017Actual

First Submitted Date

May 28, 2015

First Submission Date that Met QC Criteria

Jun 3, 2015

First Posted Date

Jun 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2019

Last Update Posted Date

Mar 25, 2019Actual

Name	Class
University of Chieti	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OMT	Experimental		Other: osteopathic manipulative treatment
Sham	Sham Comparator		Other: sham osteopathic treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
osteopathic manipulative treatment	Other		OMT
sham osteopathic treatment

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
differences on salience network activities	report any change between study and control group on pattern activation of salience network	4 weeks
acute changes on salience network	voxel differences

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francesco Cerritelli, MS, DO	University of Chieti-Pescara	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Chieti-Pescara		Chieti		66100	Italy

Intervention Browse Module

MeSH Terms

ID	Term
D026301	Manipulation, Osteopathic

Ancestor Terms

ID	Term
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities

Browse Leaves

Not provided

Browse Branches

Not provided