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OpenTrials
Completed

NCT Number: NCT03142373

Effect of CV4 and Rib Raising Techniques on Autonomic Balance

Background. Heart rate variability (HRV) and skin conductance (SC) highlight autonomic activity and the balance of autonomic nervous system (ANS) which regulates involuntary physiological functions. The modulation of ANS tonic activity is a target of osteopathic manipulative treatment (OMT). The main aim of the present study was to verify whether CV4 and RR osteopathic techniques influence ANS activity.

Trial design. A randomized-controlled clinical trial was performed from June 2010 to January 2011.

Methods. 32 healthy adults were selected. At enrollment, all healthy subjects were randomized in three groups: CV4 group (CV4 technique), Rib Raising group (RR technique), and Placebo group (PL technique). HRV and SC was recorded during the session respectively with heart rate monitor Polar S810i and with Onda Scanner Domiana (OSD-Microsale model). All data analysis was performed using SPSS statistical software and the significance level set at p≤0.05.

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Key information

Conditions

Autonomic Nervous System Disease Osteopathy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • healthy subjects
  • between 18-65 years old
  • both gender

Exclusion criteria

  • BMI ≥ 30
  • pregnancy
  • menstrual flow during the session
  • chronic pain
  • chronic drug treatment
  • presence of skin, cardiovascular, psychiatric and neurological diseases
  • medical history of surgical interventions
  • OMT in the previous 3 months

Treatment and study plan

CV4 technique

Other

RR technique

Other

Placebo treatment

Other

Primary outcomes

  1. Heart Rate Variability

    Time frame: 1200 seconds

    HRV was measured using a heart rate monitor Polar S810i frequency meter

Secondary outcomes

  1. Skin Conductance

    Time frame: 1200 seconds

    SC was measured using a Onda Scanner Domiana (OSD-Microsale model).

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

Variations of Heart Rate Variability and Skin Conductance Reveal the Influence of CV4 and Rib Raising Osteopathic Techniques on the Autonomic Nervous System: a Randomized Controlled Trial

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
May 5, 2017
Registry last updated
Mar 13, 2019

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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