Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

September 8, 2013 updated by: Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine
The aim of the present study is to determine the extend to which osteopathic manipulative treatment (OMT) is effective on a sample of healthy subjects in changing high frequency (HF) parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pescara, Italy
        • Accademia Italiana Osteopatia Tradizionale

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 18 and 45;
  • No chronic symptomatology;
  • No acute symptomatology during the last 72 hours before intervention;
  • No pathologies

Exclusion Criteria:

  • Age below 18 or over 45;
  • Pregnancy;
  • Menopause;
  • Abuse of alcool during the last 48 hours;
  • Chronic pain;
  • Acute pain during the last 72 hours;
  • Conclamate pathologies;
  • Use of drugs during the last 72 hours ;
  • Use of ortothic devices during the last 3 months;
  • Any type of surgery;
  • Osteopathic treatment during the last 3 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: OMT
Each osteopathic session is based on structural evaluation and treatment using indirect techniques.
Other: Osteopathic manipulative treatment
Other: SHAM
Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to "treat" the subject. A pre-determined protocol has been used. The practitioner's attention was distracted by subtracting calculation in silence.
Other: SHAM
Other: CONTROL
No intervention
Other: CONTROL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from baseline high frequency (HF) value at 1 week
Time Frame: baseline and 1 week
baseline and 1 week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in low frequency (LF) value at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change from baseline LF/HF ratio value at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change from baseline very low frequency (VLF) value at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change from baseline proportion of beat-to-beat50 divided by total number of beat-to-beats in (pNN50) at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change in LF value
Time Frame: during treatment session
during treatment session
Change in LF/HF ratio value
Time Frame: during treatment session
during treatment session
Change in VLF value
Time Frame: during treatment session
during treatment session
Change in SDNN value
Time Frame: during treatment session
during treatment session
Change in RMSSD value
Time Frame: during treatment session
during treatment session
Change in pNN50 value
Time Frame: during treatment session
during treatment session
Change in DFAa1 value
Time Frame: during treatment session
during treatment session
Change from baseline intrasubject HF value at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Change from baseline 15D questionnaire at 1 week
Time Frame: baseline and 1 week
baseline and 1 week
Differences in skin conductance value between groups
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
European Institute for Evidence Based Osteopathic Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Francesco Cerritelli, MS, DO, Italian Academy of Traditional Osteopathy - AIOT

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HRVOST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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