HealthyNCT04492917
The Effect of CV4 and Sacral Technique on the Alpha Bands Power
A study testing CV4 and ST in people with Healthy and Osteopathic Manipulation, run by Istituto Superiore di Osteopatia di Milano at 1 site in Italy.
Trial summary
Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on nervous system functions, however, the supporting evidence for CV4 clinical benefits is promising but still poor. Read more about this study
- Who is it for?
- Ages 20 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Osteopathic Manipulation
- What is being tested?
- CV4 and ST
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2018to 25 Oct 2018
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age
- Subjects had to sleep for at least 6 hours the night before the experiment
Who cannot join
- Use of Psychoactive or Psychotropic Substances
- Cerebrovascular diseases
- Recent headaches
- Use of nicotine in the 24 hours prior to the quantitative EEG registration
- Use of alcohol in the previous 12 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of CV4 and Sacral Technique on the Alpha Bands Power: A Randomized Controlled Trial
Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on nervous system functions, however, the supporting evidence for CV4 clinical benefits is promising but still poor. The osteopathic tradition considers the sacrum linked to the cranium through anatomical and functional connections. To our knowledge, no studies explored the potential effect of a sacral technique on brain activity as an indicator of a neurophysiological connection between the occiput and sacrum. This study aims to explore this effect by measuring the alpha-band activity during the application of a sacral technique (ST) compared to the CV4 application.
Read the detailed description
Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral technique (ST) and sacral sham technique (sST).
Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting state), followed by two randomized interventions. Alpha EEG will be continuously recorded during each intervention and 10 min after, for a total of approximately 50-60 min per session.
- Conditions
- Healthy, Osteopathic Manipulation
- Being tested
- CV4, ST, Sham CV4, Sham ST
- Keywords
- EEG, Alpha Rhythm, CV4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV4Other
The osteopath was sitting at the head of the examination table, with the subject lying supine. The osteopath approximated with the hands the lateral angles of the occipital squama, taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.
STOther
The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point
Sham CV4Other
the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
Sham STOther
The sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch
| Study group | Role | What they receive |
|---|---|---|
| Cranial Technique CV4 | Experimental | All subjects received a combination of the active technique (CV4) and the corresponding sham technique (shamCV4).
CV4: the lateral angles of the occipital squama are manually approximated slightly exaggerating the posterior convexity of the occiput and taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.
ShamCV4: sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch Receives: Other: CV4; Other: Sham CV4 |
| Sacral Technique ST | Active comparator | All subjects received a combination of the active technique (ST) and the corresponding sham technique (sST).
ST: The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point.
ShamST: sham intervention was performed by placing the hands in the same position of the corresponding active technique, applying a light touch Receives: Other: ST; Other: Sham ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alpha EEG
Quantitative EEG recording of alpha wave (8-12Hz)
Measured: 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start10 Sep 2018
- Primary completion25 Oct 2018
- Study completion25 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Superiore di Osteopatia di Milano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Viviana Pisa, Istituto Superiore di Osteopatia di Milano
- Investigators
- Pisa, Principal investigator, Istituto Superiore di Osteopatia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04492917
- Sponsor's protocol ID
- CV4 Alpha Band
- Status last verified
- Mar 2022
- First submitted
- 27 Jul 2020
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CV4 and Sacral Technique on the Alpha Bands Power: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04492917
- Acronym / sponsor ID
- CV4 Alpha Band
- Conditions
- Healthy, Osteopathic Manipulation
- Keywords
- EEG, Alpha Rhythm, CV4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Istituto Superiore di Osteopatia di MilanoUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 25 Oct 2018 (actual)
- Study completion
- 25 Oct 2018 (actual)
- First posted
- 30 Jul 2020 (actual)
- 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.
Compression of the fourth ventricle (CV4), is the most studied cranial technique, commonly used by Osteopathy in Cranial Field practitioners. Evidence attributed to CV4 some effects on nervous system functions, however, the supporting evidence for CV4 clinical benefits is promising but still poor. The osteopathic tradition considers the sacrum linked to the cranium through anatomical and functional connections. To our knowledge, no studies explored the potential effect of a sacral technique on brain activity as an indicator of a neurophysiological connection between the occiput and sacrum. This study aims to explore this effect by measuring the alpha-band activity during the application of a sacral technique (ST) compared to the CV4 application.
Detailed description
Forty healthy volunteers will receive a combination of CV4 technique, CV4 sham, sacral technique (ST) and sacral sham technique (sST).
Each session, split by a 4-hour washout, will start with 10 min of no treatment (resting state), followed by two randomized interventions. Alpha EEG will be continuously recorded during each intervention and 10 min after, for a total of approximately 50-60 min per session.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial Technique CV4 | Experimental | Other: CV4, Other: Sham CV4All subjects received a combination of the active technique (CV4) and the corresponding sham technique (shamCV4). CV4: the lateral angles of the occipital squama are manually approximated slightly exaggerating the posterior convexity of the occiput and taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved. ShamCV4: sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch |
| Sacral Technique ST | Active comparator | Other: ST, Other: Sham STAll subjects received a combination of the active technique (ST) and the corresponding sham technique (sST). ST: The subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point. ShamST: sham intervention was performed by placing the hands in the same position of the corresponding active technique, applying a light touch |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age
- Subjects had to sleep for at least 6 hours the night before the experiment
Key exclusion criteria (5 listed)
- Use of Psychoactive or Psychotropic Substances
- Cerebrovascular diseases
- Recent headaches
- Use of nicotine in the 24 hours prior to the quantitative EEG registration
- Use of alcohol in the previous 12 hours.
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 |
|---|---|---|
| CV4The osteopath was sitting at the head of the examination table, with the subject lying supine. The osteopath approximated with the hands the lateral angles of the occipital squama, taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved. | Other | Cranial Technique CV4 |
| STThe subject was lying in the supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point | Other | Sacral Technique ST |
| Sham CV4the sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch | Other | Cranial Technique CV4 |
| Sham STThe sham intervention was performed by placing the hands in the same position as the corresponding active technique, applying a light touch | Other | Sacral Technique ST |
Primary outcome
Alpha EEG
Time frame: 50 minutes
Quantitative EEG recording of alpha wave (8-12Hz)
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 8 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Pisa principal investigator
Istituto Superiore di Osteopatia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CV4 and ST in people with Healthy and Osteopathic Manipulation, run by Istituto Superiore di Osteopatia di Milano 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 2 inclusion and 5 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 8 Apr 2022. 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?
Alpha EEG (time frame: 50 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2022.