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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Subject Heart Rate Variability Other: Osteopathic manipulative treatment Other: SHAM Other: CONTROL Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Study Start Date : May 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013
Arms and Interventions
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Arm Intervention/treatment
OMT
Each osteopathic session is based on structural evaluation and treatment using indirect techniques.
 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.
 Other: SHAM
CONTROL
No intervention
 Other: CONTROL


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline high frequency (HF) value at 1 week [ Time Frame: baseline and 1 week ]

Secondary Outcome Measures :
  1. Change from baseline in low frequency (LF) value at 1 week [ Time Frame: baseline and 1 week ]
  2. Change from baseline LF/HF ratio value at 1 week [ Time Frame: baseline and 1 week ]
  3. Change from baseline very low frequency (VLF) value at 1 week [ Time Frame: baseline and 1 week ]
  4. Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week [ Time Frame: baseline and 1 week ]
  5. 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 ]
  6. 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 ]
  7. Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week [ Time Frame: baseline and 1 week ]
  8. Change in LF value [ Time Frame: during treatment session ]
  9. Change in LF/HF ratio value [ Time Frame: during treatment session ]
  10. Change in VLF value [ Time Frame: during treatment session ]
  11. Change in SDNN value [ Time Frame: during treatment session ]
  12. Change in RMSSD value [ Time Frame: during treatment session ]
  13. Change in pNN50 value [ Time Frame: during treatment session ]
  14. Change in DFAa1 value [ Time Frame: during treatment session ]
  15. Change from baseline intrasubject HF value at 1 week [ Time Frame: baseline and 1 week ]
  16. Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week [ Time Frame: baseline and 1 week ]
  17. Change from baseline 15D questionnaire at 1 week [ Time Frame: baseline and 1 week ]
  18. Differences in skin conductance value between groups [ Time Frame: 1 week ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01908920


Locations
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Italy
Accademia Italiana Osteopatia Tradizionale
Pescara, Italy
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
Investigators
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Study Chair: Francesco Cerritelli, MS, DO Italian Academy of Traditional Osteopathy - AIOT
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Francesco Cerritelli, MS, DO, European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01908920    
Other Study ID Numbers: HRVOST
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013