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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy Subject Heart Rate Variability | Other: Osteopathic manipulative treatment Other: SHAM Other: CONTROL | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
OMT
Each osteopathic session is based on structural evaluation and treatment using indirect techniques.
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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.
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Other: SHAM |
CONTROL
No intervention
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Other: CONTROL |
- Change from baseline high frequency (HF) value at 1 week [ Time Frame: baseline and 1 week ]
- 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 ]

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

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
Italy | |
Accademia Italiana Osteopatia Tradizionale | |
Pescara, Italy |
Study Chair: | Francesco Cerritelli, MS, DO | Italian Academy of Traditional Osteopathy - AIOT |
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 |