Effects of OMT on Interoception

Chronic Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02464475
• Other study ID #: InterOST
• Status: Completed
• Phase: N/A
• Start date: June 2015
• Est. completion date: December 2017

Study information

• Verified date: March 2019
• Source: Come Collaboration
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Other:
• osteopathic manipulative treatment

• sham osteopathic treatment

Locations

Country	Name	City	State
Italy	University of Chieti-Pescara	Chieti

Sponsors (2)

Lead Sponsor	Collaborator
Come Collaboration	University of Chieti

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional connectivity on right anterior insula cortex	before-after change in fMRI values	4 weeks
Secondary	differences on salience network activities	report any change between study and control group on pattern activation of salience network	4 weeks
Secondary	acute changes on salience network	voxel differences	2 hours
Secondary	resting state network differences between groups	voxel differences	4 weeks
Secondary	DTI changes between groups	differences in DTI parameters and indexes	4 weeks
Secondary	changes in GABA concentration	amount of GABA in the given voxel	4 weeks
Secondary	changes in quality of life	SF-36v2 self-reported questionnaire	4 weeks
Secondary	changes in perception of pain	McGill self-reported questionnaire	4 weeks
Secondary	changes in disability	Oswestry disability questionnaire	4 weeks
Secondary	changes in depression symptoms	Beck Depression Inventory questionnaire	4 weeks
Secondary	changes in anxiety symptoms	Hospital Anxiety and Depression Scale questionnaire	4 weeks