Alpha AmylaseNCT02785796
Effect of Cranial Manipulation on ANS Activity
A study testing CV4 in people with Alpha Amylase and Manipulation, Osteopathic, run by Accademia Italiana Medicina Osteopatica at 1 site in Italy.
Trial summary
In osteopathy is generally believed that the cranial bones are equipped with an inherent mobility, which like any other joint may face restrictions on movement and then somatic dysfunction. For this reason, different techniques are used with the aim of increasing the mobility of the cranial bones. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alpha Amylase, Manipulation, Osteopathic
- What is being tested?
- CV4
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteItaly
- Study dates
- May 2016to Oct 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- consensus signed
Who cannot join
- oral contraceptive
- drugs assumption
- pathology of oral cavity
- failure to comply the directives
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Cranial Manipulation in Healthy Patients Revealed by Salivary Alpha Amylase Activity
In osteopathy is generally believed that the cranial bones are equipped with an inherent mobility, which like any other joint may face restrictions on movement and then somatic dysfunction. For this reason, different techniques are used with the aim of increasing the mobility of the cranial bones. Some of these have been effective in modifying physiological parameters related to the activity of the autonomic nervous system, such as cardiac function or sleep latency. This study aims to test the effectiveness of a specific craniosacral technique, compression of the fourth ventricle CV4, using the salivary marker alpha amylase, which is sensitive to changes in the activity of the autonomic nervous system. To patients recruited from students of AIMO, we will ask to provide saliva samples before and after CV4 treatment. In particular, saliva will be collected four times per patient: at the initial time, after administration of a stressful event (hand immersion in ice water), immediately after application of the CV4 technique and thirty minutes after the application of the CV4 technique. For each sample of saliva detected, we will proceed to measure the activity of alpha amylase and flow rate, variables sensitive to the activation of the autonomic nervous system.
Read the detailed description
A minimum of 90 healthy subjects ranging from 20 to 25 years will be selected from students in Accademia Itliana di Medicina Osteopatica, Saronno, Italy (AIMO) and randomly assigned to the placebo, control or the CV4 arm. Randomization will account for sex and score in the STAI- 2 (form Y) questionnaire, assessing trait anxiety for each subject.
Every sampling session will be taken from 10.00 AM to 1.00 PM to minimize the effect of diurnal variation in salivary alpha-amylase activity. Subjects will be instructed to abstain from eating, smoking, drinking any beverages and exercising 2h before the experiment because these activities has been shown to have an influence on sAA activity.
The day of treatment each subject will completed the STAI-1 (form Y) questionnaire to evaluate the anxiety of the moment. Saliva collection will be made by passive drooling continuously for 5 minutes in a 15 ml falcon tube. Saliva will be collected before, immediately after and 30 minutes after application of a true CV4 technique or application of a sham technique performed by different osteopaths. Saliva samples will be immediately frozen at -20°C for subsequent analysis.
Operators will be osteopaths trained in cranial field. The application of the CV4 and sham protocols will occur in an examination room setting. The subject will lie in supine position with the operator at the head of the treatment table with forearms resting on table either for CV4 either for the sham procedure.
For the CV4 technique the practitioner will contact the participant's occiput (lateral to the external occipital protuberances, but medial to the occipital-mastoid suture) with his or her thenar eminences. When no cranial mobility will be found, operators will be free to use any kind of technique to enhance the cranial movement before CV4 procedure. Once the practitioner will detect the CRI, the practitioner will resist the flexion phase of the CRI and exaggerate the extension phase. This compressive pressure will be maintained until the CRI stopped, and the still-point is reached. The still-point will be held until the CRI return, at which point the compressive pressure will be slowly release. For the sham CV-4, The operator will overlap the hands so that the thumbs formed a "V". The operator's thenar eminences will contact the occiput very lightly well below the positioning used in the CV4 procedure but with no pressure on the occiput between the occipitomastoid sutures. Once placement will be achieved, the operator's hands will remain motionless for 10 min. Finally, the practitioner's hands will be gently removed and the participant's head will be placed on the table for both procedures.
Flow rate will be measured for samples thawed by 5 ml graduated capillary. Samples will be then centrifuged (for ten minutes at 3000 rpm) and the supernatant collect in clean Eppendorf tubes. Salivary alpha-amylase activity will be then measured by a commercial kit (IBL) and a spectrophotometer for the optical reading.
- Conditions
- Alpha Amylase, Manipulation, Osteopathic
- Being tested
- CV4, SHAM TECHNIQUE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CV4Other
SHAM TECHNIQUEOther
| Study group | Role | What they receive |
|---|---|---|
| CV4 | Experimental | The practitioner will contact the participant's occiput (lateral to the external occipital protuberances, but medial to the occipital-mastoid suture) with his or her thenar eminences. When no cranial mobility will be found, operators will be free to use any kind of technique to enhance the cranial movement before CV4 procedure. Once the practitioner will detect the CRI, the practitioner will resist the flexion phase of the CRI and exaggerate the extension phase. This compressive pressure will be maintained until the CRI stopped, and the still-point is reached. The still-point will be held until the CRI return, at which point the compressive pressure will be slowly release Receives: Other: CV4 |
| sham technique | Placebo comparator | The operator will overlap the hands so that the thumbs formed a "V". The operator's thenar eminences will contact the occiput very lightly well below the positioning used in the CV4 procedure but with no pressure on the occiput between the occipitomastoid sutures. Once placement will be achieved, the operator's hands will remain motionless for 10 min. Finally, the practitioner's hands will be gently removed and the participant's head will be placed on the table for both procedures Receives: Other: SHAM TECHNIQUE |
| Control | No intervention | The control group will not receive ant type of treatment: subject just stay quietly in supine position in ambulatory room for ten minutes |
What is being measured
The primary outcome is the main question the study is designed to answer.
alpha amylase activity measured by enzymatic assay
Measured: measurement before the technique application
salivary flow rate
Measured: measurement before the technique application
alpha amylase activity measured by enzymatic assay
Measured: measurement immediately after the technique application
alpha amylase activity measured by enzymatic assay
Measured: measurement 30 minutes after the technique application
salivary flow rate
Measured: measurement immediately after the technique application
salivary flow rate
Measured: measurement 30 minutes after the technique application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alpha AmylaseStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accademia Italiana Medicina Osteopatica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785796
- Sponsor's protocol ID
- 001
- Status last verified
- Jan 2017
- First submitted
- 19 May 2016
- Last updated
- 26 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.
PubMed 15750368Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009 May;34(4):486-96. doi: 10.1016/j.psyneuen.2009.01.014. Epub 2009 Feb 26.
PubMed 19249160
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cranial Manipulation in Healthy Patients Revealed by Salivary Alpha Amylase Activity
- ClinicalTrials.gov ID
- NCT02785796
- Acronym / sponsor ID
- 001
- Conditions
- Alpha Amylase, Manipulation, Osteopathic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Accademia Italiana Medicina OsteopaticaUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- May 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 30 May 2016 (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.
In osteopathy is generally believed that the cranial bones are equipped with an inherent mobility, which like any other joint may face restrictions on movement and then somatic dysfunction. For this reason, different techniques are used with the aim of increasing the mobility of the cranial bones. Some of these have been effective in modifying physiological parameters related to the activity of the autonomic nervous system, such as cardiac function or sleep latency. This study aims to test the effectiveness of a specific craniosacral technique, compression of the fourth ventricle CV4, using the salivary marker alpha amylase, which is sensitive to changes in the activity of the autonomic nervous system. To patients recruited from students of AIMO, we will ask to provide saliva samples before and after CV4 treatment. In particular, saliva will be collected four times per patient: at the initial time, after administration of a stressful event (hand immersion in ice water), immediately after application of the CV4 technique and thirty minutes after the application of the CV4 technique. For each sample of saliva detected, we will proceed to measure the activity of alpha amylase and flow rate, variables sensitive to the activation of the autonomic nervous system.
Detailed description
A minimum of 90 healthy subjects ranging from 20 to 25 years will be selected from students in Accademia Itliana di Medicina Osteopatica, Saronno, Italy (AIMO) and randomly assigned to the placebo, control or the CV4 arm. Randomization will account for sex and score in the STAI- 2 (form Y) questionnaire, assessing trait anxiety for each subject.
Every sampling session will be taken from 10.00 AM to 1.00 PM to minimize the effect of diurnal variation in salivary alpha-amylase activity. Subjects will be instructed to abstain from eating, smoking, drinking any beverages and exercising 2h before the experiment because these activities has been shown to have an influence on sAA activity.
The day of treatment each subject will completed the STAI-1 (form Y) questionnaire to evaluate the anxiety of the moment. Saliva collection will be made by passive drooling continuously for 5 minutes in a 15 ml falcon tube. Saliva will be collected before, immediately after and 30 minutes after application of a true CV4 technique or application of a sham technique performed by different osteopaths. Saliva samples will be immediately frozen at -20°C for subsequent analysis.
Operators will be osteopaths trained in cranial field. The application of the CV4 and sham protocols will occur in an examination room setting. The subject will lie in supine position with the operator at the head of the treatment table with forearms resting on table either for CV4 either for the sham procedure.
For the CV4 technique the practitioner will contact the participant's occiput (lateral to the external occipital protuberances, but medial to the occipital-mastoid suture) with his or her thenar eminences. When no cranial mobility will be found, operators will be free to use any kind of technique to enhance the cranial movement before CV4 procedure. Once the practitioner will detect the CRI, the practitioner will resist the flexion phase of the CRI and exaggerate the extension phase. This compressive pressure will be maintained until the CRI stopped, and the still-point is reached. The still-point will be held until the CRI return, at which point the compressive pressure will be slowly release. For the sham CV-4, The operator will overlap the hands so that the thumbs formed a "V". The operator's thenar eminences will contact the occiput very lightly well below the positioning used in the CV4 procedure but with no pressure on the occiput between the occipitomastoid sutures. Once placement will be achieved, the operator's hands will remain motionless for 10 min. Finally, the practitioner's hands will be gently removed and the participant's head will be placed on the table for both procedures.
Flow rate will be measured for samples thawed by 5 ml graduated capillary. Samples will be then centrifuged (for ten minutes at 3000 rpm) and the supernatant collect in clean Eppendorf tubes. Salivary alpha-amylase activity will be then measured by a commercial kit (IBL) and a spectrophotometer for the optical reading.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CV4 | Experimental | Other: CV4The practitioner will contact the participant's occiput (lateral to the external occipital protuberances, but medial to the occipital-mastoid suture) with his or her thenar eminences. When no cranial mobility will be found, operators will be free to use any kind of technique to enhance the cranial movement before CV4 procedure. Once the practitioner will detect the CRI, the practitioner will resist the flexion phase of the CRI and exaggerate the extension phase. This compressive pressure will be maintained until the CRI stopped, and the still-point is reached. The still-point will be held until the CRI return, at which point the compressive pressure will be slowly release |
| sham technique | Placebo comparator | Other: SHAM TECHNIQUEThe operator will overlap the hands so that the thumbs formed a "V". The operator's thenar eminences will contact the occiput very lightly well below the positioning used in the CV4 procedure but with no pressure on the occiput between the occipitomastoid sutures. Once placement will be achieved, the operator's hands will remain motionless for 10 min. Finally, the practitioner's hands will be gently removed and the participant's head will be placed on the table for both procedures |
| Control | No intervention | –The control group will not receive ant type of treatment: subject just stay quietly in supine position in ambulatory room for ten minutes |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- consensus signed
Key exclusion criteria (4 listed)
- oral contraceptive
- drugs assumption
- pathology of oral cavity
- failure to comply the directives
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 |
|---|---|---|
| CV4 | Other | CV4 |
| SHAM TECHNIQUE | Other | sham technique |
Primary outcome
alpha amylase activity measured by enzymatic assay
Time frame: measurement before the technique application
salivary flow rate
Time frame: measurement before the technique application
alpha amylase activity measured by enzymatic assay
Time frame: measurement immediately after the technique application
alpha amylase activity measured by enzymatic assay
Time frame: measurement 30 minutes after the technique application
salivary flow rate
Time frame: measurement immediately after the technique application
salivary flow rate
Time frame: measurement 30 minutes after the technique application
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 26 Jan 2017.
- Background: PubMed 15750368Cutler MJ, Holland BS, Stupski BA, Gamber RG, Smith ML. Cranial manipulation can alter sleep latency and sympathetic nerve activity in humans: a pilot study. J Altern Complement Med. 2005 Feb;11(1):103-8. doi: 10.1089/acm.2005.11.103.
- Background: PubMed 19249160Nater UM, Rohleder N. Salivary alpha-amylase as a non-invasive biomarker for the sympathetic nervous system: current state of research. Psychoneuroendocrinology. 2009 May;34(4):486-96. doi: 10.1016/j.psyneuen.2009.01.014. Epub 2009 Feb 26.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Alpha Amylase and Manipulation, Osteopathic, run by Accademia Italiana Medicina Osteopatica 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 1 inclusion and 4 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 26 Jan 2017. 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. Some participants in this study may receive a placebo. 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 amylase activity measured by enzymatic assay (time frame: measurement before the technique application). The study lists 6 primary outcomes in all. 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 NCT02785796, which also lists 2 linked publications.
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 26 Jan 2017.