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Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01908920
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine

Tracking Information
First Submitted Date  ICMJE July 19, 2013
First Posted Date  ICMJE July 26, 2013
Last Update Posted Date September 10, 2013
Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
Change from baseline high frequency (HF) value at 1 week [ Time Frame: baseline and 1 week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2013)
  • Change from baseline in low frequency (LF) value at 1 week [ Time Frame: baseline and 1 week ]
  • Change from baseline LF/HF ratio value at 1 week [ Time Frame: baseline and 1 week ]
  • Change from baseline very low frequency (VLF) value at 1 week [ Time Frame: baseline and 1 week ]
  • Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week [ Time Frame: 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 ]
  • 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 ]
  • Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week [ Time Frame: baseline and 1 week ]
  • Change in LF value [ Time Frame: during treatment session ]
  • Change in LF/HF ratio value [ Time Frame: during treatment session ]
  • Change in VLF value [ Time Frame: during treatment session ]
  • Change in SDNN value [ Time Frame: during treatment session ]
  • Change in RMSSD value [ Time Frame: during treatment session ]
  • Change in pNN50 value [ Time Frame: during treatment session ]
  • Change in DFAa1 value [ Time Frame: during treatment session ]
  • Change from baseline intrasubject HF value at 1 week [ Time Frame: 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 ]
  • Change from baseline 15D questionnaire at 1 week [ Time Frame: baseline and 1 week ]
  • Differences in skin conductance value between groups [ Time Frame: 1 week ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
Official Title  ICMJE Not Provided
Brief Summary 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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Condition  ICMJE
  • Healthy Subject
  • Heart Rate Variability
Intervention  ICMJE
  • Other: Osteopathic manipulative treatment
  • Other: SHAM
  • Other: CONTROL
Study Arms  ICMJE
  • OMT
    Each osteopathic session is based on structural evaluation and treatment using indirect techniques.
    Intervention: Other: Osteopathic manipulative treatment
  • 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.
    Intervention: Other: SHAM
  • CONTROL
    No intervention
    Intervention: Other: CONTROL
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2013)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01908920
Other Study ID Numbers  ICMJE HRVOST
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine
Study Sponsor  ICMJE European Institute for Evidence Based Osteopathic Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Francesco Cerritelli, MS, DO Italian Academy of Traditional Osteopathy - AIOT
PRS Account European Institute for Evidence Based Osteopathic Medicine
Verification Date September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP