NCT04387006

Osteopathic Manipulative Treatment Induces Functional Connectivity Changes

Completed NA Last updated 14 May 2020

What this trial tests

NA trial testing OMT in Osteopathic Manipulative Treatment in 30 participants. Completed in 8 January 2019.

Timeline

30 September 2017

Primary endpoint
30 July 2018

8 January 2019

Quick facts

Lead sponsor	I.R.C.C.S. Fondazione Santa Lucia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	30 September 2017
Primary completion	30 July 2018
Estimated completion	8 January 2019
Sites	1 location across Italy

Drugs / interventions tested

• OMT — full drug profile →
• MP

Conditions studied

• Osteopathic Manipulative Treatment — all drugs for Osteopathic Manipulative Treatment →

Sponsor

I.R.C.C.S. Fondazione Santa Lucia — full company profile →

Who can join

Adults 18 to 40, any sex, with Osteopathic Manipulative Treatment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Brain Connectivity Changes after Osteopathic Manipulative Treatment: A Randomized Manual Placebo-Controlled Trial.
   Tramontano M, Cerritelli F, Piras F, Spanò B, et al · · 2020 · cited 37× · PMID 33322255 · DOI 10.3390/brainsci10120969