Effects of OMT on Interoception

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Other: osteopathic manipulative treatment
* Other: sham osteopathic treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OMT<br> | Other: osteopathic manipulative treatment<br> <br> |
| Sham Comparator: Sham<br> | Other: sham osteopathic treatment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | 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 | 2 hours | 
| resting state network differences between groups | voxel differences | 4 weeks | 
| DTI changes between groups | differences in DTI parameters and indexes | 4 weeks | 
| changes in GABA concentration | amount of GABA in the given voxel | 4 weeks | 
| changes in quality of life | SF-36v2 self-reported questionnaire | 4 weeks | 
| changes in perception of pain | McGill self-reported questionnaire | 4 weeks | 
| changes in disability | Oswestry disability questionnaire | 4 weeks | 
| changes in depression symptoms | Beck Depression Inventory questionnaire | 4 weeks | 
| changes in anxiety symptoms | Hospital Anxiety and Depression Scale questionnaire | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteopathic manipulative treatment, interoception