Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

NCT ID: NCT01908920

Last Updated: 2013-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Subject Heart Rate Variability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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OMT

Each osteopathic session is based on structural evaluation and treatment using indirect techniques.

Group Type OTHER

Osteopathic manipulative treatment

Intervention Type 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.

Group Type OTHER

SHAM

Intervention Type OTHER

CONTROL

No intervention

Group Type OTHER

CONTROL

Intervention Type OTHER

Interventions

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Osteopathic manipulative treatment

Intervention Type OTHER

SHAM

Intervention Type OTHER

CONTROL

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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European Institute for Evidence Based Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Francesco Cerritelli

MS, DO

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Cerritelli, MS, DO

Role: STUDY_CHAIR

Italian Academy of Traditional Osteopathy - AIOT

Locations

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Accademia Italiana Osteopatia Tradizionale

Pescara, , Italy

Site Status

Countries

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Italy

References

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Ruffini N, D'Alessandro G, Mariani N, Pollastrelli A, Cardinali L, Cerritelli F. Variations of high frequency parameter of heart rate variability following osteopathic manipulative treatment in healthy subjects compared to control group and sham therapy: randomized controlled trial. Front Neurosci. 2015 Aug 4;9:272. doi: 10.3389/fnins.2015.00272. eCollection 2015.

Reference Type DERIVED
PMID: 26300719 (View on PubMed)

Other Identifiers

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HRVOST

Identifier Type: -

Identifier Source: org_study_id