Osteopathic Manipulative TreatmentNCT04387006
Osteopathic Manipulative Treatment Induces Functional Connectivity Changes
A study testing OMT and MP in people with Osteopathic Manipulative Treatment, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopathic Manipulative Treatment
- What is being tested?
- OMT and MP
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 30 Sep 2017to 8 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age between 18 and 40 years
- suitability for MRI scanning
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Osteopathic Manipulative Treatment
- Being tested
- OMT, MP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMTOther
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
MPOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Osteopatic Manipulative Treatment (OMT) | Experimental | Not described Receives: Other: OMT |
| Manual Placebo (MP) | Placebo comparator | Not described Receives: Other: MP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at baseline, immediately after the intervention and after 3 days
Secondary outcomes (1)
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
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2020
- Study start30 Sep 2017
- Primary completion30 Jul 2018
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteopathic Manipulative TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S. Fondazione Santa Lucia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Tramontano, I.R.C.C.S. Fondazione Santa Lucia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04387006
- Sponsor's protocol ID
- CE/PROG625
- Status last verified
- May 2020
- First submitted
- 9 May 2020
- Last updated
- 14 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment Induces Functional Connectivity Changes: a Randomized Manual Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT04387006
- Acronym / sponsor ID
- CE/PROG625
- Conditions
- Osteopathic Manipulative Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- I.R.C.C.S. Fondazione Santa LuciaUniversity, hospital or other
- Study start
- 30 Sep 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 13 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopatic Manipulative Treatment (OMT) | Experimental | Other: OMT |
| Manual Placebo (MP) | Placebo comparator | Other: MP |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- age between 18 and 40 years
- suitability for MRI scanning
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMTOMT 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 | Other | Osteopatic Manipulative Treatment (OMT) |
| MPMP 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. | Other | Manual Placebo (MP) |
Primary outcome
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).
1 secondary outcome
De-Blinding questionnaire
Time frame: immediately after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Osteopathic Manipulative Treatment
Not yet recruiting
Osteopathic Manipulative Treatment for Children With Chronic or Recurrent Otitis Media
Otitis Media, Otitis Media Effusion
Not yet recruiting
Exploring How Osteopathic Manipulative Treatment May Affect Spinal Fluid Flow: An MRI Study
Osteopathic Manipulative Treatment (OMT) Effects on Cerebrospinal Fluid (CSF) Dynamics
Not yet recruiting
Efficacy of Osteopathic Manipulative Techniques With Progressive Pulmonary Fibrosis Patients
Osteopathic Manipulative Treatment
Not yet recruiting
Visceral Osteopathic Manual Therapy Methods in Women With Stress Urinary Incontinence
Osteopathic Manipulative Treatment (OMT)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMT and MP in people with Osteopathic Manipulative Treatment, run by I.R.C.C.S. Fondazione Santa Lucia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
functional Magnetic Resonance Imaging (fMRI) changes (time frame: at baseline, immediately after the intervention and after 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2020; AzTrials last refreshed its copy on 29 Oct 2026.