Chronic Low Back Pain
Conditions
Keywords
osteopathic manipulative treatment, interoception
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.
Interventions
OTHERosteopathic manipulative treatment
Sponsors
University of Chieti
Come Collaboration
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| functional connectivity on right anterior insula cortex | 4 weeks | before-after change in fMRI values |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| acute changes on salience network | 2 hours | voxel differences |
| resting state network differences between groups | 4 weeks | voxel differences |
| DTI changes between groups | 4 weeks | differences in DTI parameters and indexes |
| changes in GABA concentration | 4 weeks | amount of GABA in the given voxel |
| differences on salience network activities | 4 weeks | report any change between study and control group on pattern activation of salience network |
| changes in perception of pain | 4 weeks | McGill self-reported questionnaire |
| changes in disability | 4 weeks | Oswestry disability questionnaire |
| changes in depression symptoms | 4 weeks | Beck Depression Inventory questionnaire |
| changes in anxiety symptoms | 4 weeks | Hospital Anxiety and Depression Scale questionnaire |
| changes in quality of life | 4 weeks | SF-36v2 self-reported questionnaire |
Countries
Italy
Outcome results
None listed