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Completed

NCT Number: NCT01908920

Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Accademia Italiana Osteopatia Tradizionale

Pescara, Italy

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Osteopathic manipulative treatment

Other

SHAM

Other

Control

Other

Primary outcomes

  1. Change from baseline high frequency (HF) value at 1 week

    Time frame: baseline and 1 week

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

European Institute for Evidence Based Osteopathic Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jul 26, 2013
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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