Osteopathic Manipulative Treatment Induces Functional Connectivity Changes: a Randomized Manual Placebo-controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Osteopathic Manipulative Treatment
- Sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- functional Magnetic Resonance Imaging (fMRI) changes
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
Osteopathic Manipulative Treatment (OMT) is a whole-body intervention mainly focused on correcting the somatic dysfunctions present in different regions of the body. Osteopathic research to date has mostly been concerned with various clinical conditions such as musculoskeletal disorders and primary headache. The neurophysiological effects underlying clinical improvements are still under debate. Although models explaining the therapeutic effects of OMT include the potential for higher brain mechanism, OMT effects on functional brain connectivity is not fully understood and still lacking in healthy adults. Magnetic resonance imaging (MRI) research includes several different approaches to estimate cortical functions. Several of these approaches have demonstrated functional brain changes associated with OMT. Using Arterial Spin Labeling MRI, recently was demonstrated that the treatment of somatic dysfunctions induces cerebral perfusion changes in asymptomatic young participant. Thus, the aim of this study is to explore the neural correlates associated with OMT effect in terms of cerebral functional connectivity, as derived by complex network analysis of resting state fMRI data recorded in asymptomatic young volunteers with somatic dysfunctions
Investigators
Marco Tramontano
Head of Rehabilitation Services
I.R.C.C.S. Fondazione Santa Lucia
Eligibility Criteria
Inclusion Criteria
- •age between 18 and 40 years
- •suitability for MRI scanning
Exclusion Criteria
- •cognitive impairment, based on Mini Mental State Examination (MMSE) score ≤ 24 according to norms for the Italian population, and confirmed by a deeper clinical neuropsychological evaluation using the Mental Deterioration Battery and NINCDS-ADRDA criteria for dementia
- •subjective complaints of memory difficulties or of any other cognitive deficit, interfering or not, with daily living activities;
- •major medical illnesses, e.g., diabetes (not stabilized), obstructive pulmonary disease, or asthma; hematologic and oncologic disorders; pernicious anemia; clinically significant and unstable active gastrointestinal, renal, hepatic, endocrine, or cardiovascular system diseases; newly treated hypothyroidism;
- •current or reported psychiatric (assessed by the SCID-II or neurological (assessed by a clinical neurological evaluation) disorders (e.g., schizophrenia, mood disorders, anxiety disorders, stroke, Parkinson's disease, seizure disorder, head injury with loss of consciousness, and any other significant mental or neurological disorder);
- •known or suspected history of alcoholism or drug dependence and abuse during lifetime
Outcomes
Primary Outcomes
functional Magnetic Resonance Imaging (fMRI) changes
Time Frame: at baseline, immediately after the intervention and after 3 days
Changes in correlation of brain activity in different regions of brain as assessed by Blood Oxygenation Level Dependent (BOLD) signal. fMRI data are collected using gradient-echo echo-planar imaging at 3T (Philips Achieva) using a (T2\*)-weighted imaging sequence sensitive to BOLD (TR = 3 s, TE = 30 ms, matrix = 80 x 80, FOV=224x224, slice thickness = 3 mm, flip angle = 90°, 50 slices, 240 vol).
Secondary Outcomes
- De-Blinding questionnaire(immediately after the intervention)