Effects of OMT on Interoception

Not Applicable

Completed

• Conditions: Chronic Low Back Pain
• Interventions: Other: sham osteopathic treatment; Other: osteopathic manipulative treatment

• Registration Number: NCT02464475
• Lead Sponsor: Come Collaboration

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 available

Study Timeline

• Study First Submitted: 2015-05-28
• Study Start: 2015-06
• Study First Submitted QC: 2015-06-03
• Study First Posted: 2015-06-08
• Primary Completion: 2017-07
• Study Completion: 2017-12
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-21
• Last Update Posted: 2019-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham	sham osteopathic treatment	-
OMT	osteopathic manipulative treatment	-

Primary Outcome Measures

Name	Time	Method
functional connectivity on right anterior insula cortex	4 weeks	before-after change in fMRI values

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Chieti-Pescara; 🇮🇹 Chieti, Italy