Osteopathic Manipulative Treatment Induces Functional Connectivity Changes

Not Applicable

Completed

• Conditions: Osteopathic Manipulative Treatment
• Interventions: Other: MP; Other: OMT

• Registration Number: NCT04387006
• Lead Sponsor: I.R.C.C.S. Fondazione Santa Lucia

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-30
• Primary Completion: 2018-07-30
• Study Completion: 2019-01-08
• Status Verified: 2020-05
• Study First Submitted: 2020-05-09
• Study First Submitted QC: 2020-05-09
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-13
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manual Placebo (MP)	MP	-
Osteopatic Manipulative Treatment (OMT)	OMT	-

Primary Outcome Measures

Name	Time	Method
functional Magnetic Resonance Imaging (fMRI) changes	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 Outcome Measures

Name	Time	Method
De-Blinding questionnaire	immediately after the intervention	The questionnaire consists of three consecutive questions about subjects' perception of the treatment received. After being questioned on whether according to their perception, they thought they have received OMT or MP treatment, subjects were asked on a 0-10 numeric rating scale (NRS), where 0 represented absolutely uncertainty and 10 represented absolutely certainty, how certain they were regarding group allocation. Finally, they were asked to rate the perceived usefulness of the treatment received, based on a 0-10 NRS, where 0 represented absolutely useless and 10 represented absolutely useful

Trial Locations

Locations (1)

Santa Lucia Foundation I.R.C.C.S.; 🇮🇹 Roma, Rm, Italy