Osteopathic Manipulative Treatment Induces Functional Connectivity Changes

Osteopathic Manipulative Treatment Induces Functional Connectivity Changes: a Randomized Manual Placebo-controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Osteopathic Manipulative Treatment
• Intervention / Treatment: Other: OMT; Other: MP

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Rm
    • Roma, Rm, Italy, 00179
      • Santa Lucia Foundation I.R.C.C.S.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopatic Manipulative Treatment (OMT)	Other: OMT; OMT techniques were focused on correcting the dysfunctions found during the initial physical examination and included articular and myofascial techniques, balanced ligamentous tension, visceral manipulations and osteopathy in the cranial field
Placebo Comparator: Manual Placebo (MP)	Other: MP; MP treatment was performed by the same osteopaths who performed OMT and was carried out in the same hospital setting. P treatment consisted of a passive touch without joint mobilization in a protocolled order. The osteopaths were standing next to the bed, they touched lumbar and dorsal spine of the subjects in prone position for 10 minutes, and then in supine position, they touched for 10 minutes the shoulders, the hips, then the neck, the sternum and the chest were touched for 5 minutes each. Another researcher on the placebo protocol specifically trained the osteopaths.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
functional Magnetic Resonance Imaging (fMRI) changes	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).	at baseline, immediately after the intervention and after 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
De-Blinding questionnaire	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	immediately after the intervention

Collaborators and Investigators

• Sponsor: I.R.C.C.S. Fondazione Santa Lucia

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): January 8, 2019

Study Registration Dates

• First Submitted: May 9, 2020
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CE/PROG625

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No