Healthy SubjectNCT01908920
Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
A study testing Osteopathic manipulative treatment in people with Healthy Subject and Heart Rate Variability, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subject, Heart Rate Variability
- What is being tested?
- Osteopathic manipulative treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- May 2013to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 45;
- No chronic symptomatology;
- No acute symptomatology during the last 72 hours before intervention;
- No pathologies
Who cannot join
- 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;
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Subject, Heart Rate Variability
- Being tested
- Osteopathic manipulative treatment, SHAM, CONTROL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic manipulative treatmentOther
SHAMOther
CONTROLOther
| Study group | Role | What they receive |
|---|---|---|
| OMT | Other | Each osteopathic session is based on structural evaluation and treatment using indirect techniques. Receives: Other: Osteopathic manipulative treatment |
| SHAM | Other | 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. Receives: Other: SHAM |
| CONTROL | Other | No intervention Receives: Other: CONTROL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline high frequency (HF) value at 1 week
Measured: baseline and 1 week
Secondary outcomes (18)
Change from baseline in low frequency (LF) value at 1 week
Measured: baseline and 1 week
Change from baseline LF/HF ratio value at 1 week
Measured: baseline and 1 week
Change from baseline very low frequency (VLF) value at 1 week
Measured: baseline and 1 week
Change from baseline standard deviation beat-to-beat (SDNN) value at 1 week
Measured: baseline and 1 week
Changes from baseline square root of the mean squared difference of successive beat-to-beat (RMSSD) at 1 week
Measured: 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
Measured: baseline and 1 week
Change from baseline detrended fluctuation scaling exponent (DFAa1) value at 1 week
Measured: baseline and 1 week
Change in LF value
Measured: during treatment session
Change in LF/HF ratio value
Measured: during treatment session
Change in VLF value
Measured: during treatment session
Change in SDNN value
Measured: during treatment session
Change in RMSSD value
Measured: during treatment session
Change in pNN50 value
Measured: during treatment session
Change in DFAa1 value
Measured: during treatment session
Change from baseline intrasubject HF value at 1 week
Measured: baseline and 1 week
Change from baseline heart rate variability parameters between smokers and no-smokers at 1 week
Measured: baseline and 1 week
Change from baseline 15D questionnaire at 1 week
Measured: baseline and 1 week
Differences in skin conductance value between groups
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy SubjectStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Institute for Evidence Based Osteopathic Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Cerritelli, European Institute for Evidence Based Osteopathic Medicine
- Investigators
- Francesco Cerritelli, MS, DO, Study chair, Italian Academy of Traditional Osteopathy - AIOT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908920
- Sponsor's protocol ID
- HRVOST
- Status last verified
- Sep 2013
- First submitted
- 19 Jul 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26300719
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment Effects on High Frequency Parameters in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01908920
- Acronym / sponsor ID
- HRVOST
- Conditions
- Healthy Subject, Heart Rate Variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- European Institute for Evidence Based Osteopathic MedicineUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OMT | Other | Other: Osteopathic manipulative treatmentEach osteopathic session is based on structural evaluation and treatment using indirect techniques. |
| SHAM | Other | Other: SHAMSham 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. |
| CONTROL | Other | Other: CONTROLNo intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 45;
- No chronic symptomatology;
- No acute symptomatology during the last 72 hours before intervention;
- No pathologies
Key exclusion criteria (11 listed)
- Age below 18 or over 45;
- Pregnancy;
- Menopause;
- Abuse of alcool during the last 48 hours;
- Chronic pain;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Osteopathic manipulative treatment | Other | OMT |
| SHAM | Other | SHAM |
| CONTROL | Other | CONTROL |
Primary outcome
Change from baseline high frequency (HF) value at 1 week
Time frame: baseline and 1 week
18 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
- Derived from this study: PubMed 26300719Ruffini 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.
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Healthy Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Cerritelli, MS, DO study chair
Italian Academy of Traditional Osteopathy - AIOT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Osteopathic manipulative treatment in people with Healthy Subject and Heart Rate Variability, run by European Institute for Evidence Based Osteopathic Medicine at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline high frequency (HF) value at 1 week (time frame: baseline and 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01908920, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.