Autonomic ImbalanceNCT05190731
Alterations in Bioelectric Activity at Acupuncture Points Following CV4 Cranial Manipulation
A study testing Osteopathic cranial manipulative medicine in people with Autonomic Imbalance, run by Jan T Hendryx at 1 site in United States.
Trial summary
By measuring specific electrical parameters at acupuncture points that have been shown to correlate with ANS activity, the objectives of this study were to: 1) determine if CV4 has any influence on the bioelectric properties of the acupuncture meridian system, and 2) determine if CV4 affects the ANS. Read more about this study
- Who is it for?
- Ages 18 to 78 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomic Imbalance
- What is being tested?
- Osteopathic cranial manipulative medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2017to 7 Nov 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 18 to 78 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females from the Erie, PA, area aged 18-78 years
- Recruited by local flyers and word of mouth marketing
- Able to lay supine for about 30 minutes
Who cannot join
- Persons under the age of 18 years and persons unable to attend the in-person research sessions in Erie, PA.
- Identifiable acute illness of any kind
- Past medical history of stroke or transient ischemic attack within past 6 months
- Past medical history of intracranial hemorrhage, increased intracranial pressure, or seizure disorder
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Alterations in Bioelectric Activity at Acupuncture Jing-Well (Ting) Points Following CV4 Cranial Manipulation
By measuring specific electrical parameters at acupuncture points that have been shown to correlate with ANS activity, the objectives of this study were to: 1) determine if CV4 has any influence on the bioelectric properties of the acupuncture meridian system, and 2) determine if CV4 affects the ANS.
Read the detailed description
This study is designed to measure bioelectrical activity at acupuncture Ting (Jing-Well) points immediately before and after employing a specific Osteopathic Cranial Manipulative Medicine (OCMM) technique called CV4 (Compression of the 4th Ventricle) vs. a Sham treatment.
Ting (Jing-Well) points are acupuncture points located at the proximal edges of the finger- and toenails that represent the beginning and end of 14 acupuncture meridians as described in Traditional Chinese Medicine and Japanese systems. Measurement of electrical activity at Ting points is performed by a physicist who has extensive experience using a device known as the Apparatus for Meridian Identification (AMI). Data collected and analyzed by the AMI for both CV4 and Sham groups is compared statistically for significant differences in before vs. after electrical activity and specific acupuncture meridians affected. One particular analysis of After Polarization (AP) potentials correlates with changes in autonomic nervous system activity.
- Conditions
- Autonomic Imbalance
- Being tested
- Osteopathic cranial manipulative medicine, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic cranial manipulative medicineOther
Osteopathic cranial manipulative medicine technique using compression of 4th ventricle technique
ShamOther
Touch only, no osteopathic cranial manipulation
| Study group | Role | What they receive |
|---|---|---|
| Contact touch at occipital region, but no actual cranial manipulation | Sham comparator | Each subject was treated with Sham by CSPOMM and NMM board-certified osteopathic physicians. The physician's finger pads of both hands were placed underneath the supine subject's head in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. The subject's head rested passively on the finger pads for 3 minutes. No cranial manipulative forces were applied. Receives: Other: Sham |
| Osteopathic cranial manipulative medicine | Active comparator | Each subject was treated with CV4 technique by CSPOMM and NMM board-certified osteopathic physicians. All CV4 treatments were performed by one individual according to standardized protocol. The physician's hands were placed underneath the occiput with the thenar eminences in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. Inherent cranial rhythmic motion was identified and thenar eminences followed occipital motion anteriorly during the extension phase until a still point was attained. This position was held until the still point released (usually about 3 minutes) and normal cranial motion ensued. Receives: Other: Osteopathic cranial manipulative medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic Nervous System Activity at Acupuncture Ting Points
Bioelectric skin conductance at acupuncture points
Measured: Within 15 minutes of sham or intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start10 Nov 2017
- Primary completion24 Jun 2018
- Study completion7 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Autonomic ImbalanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants randomized to sham group or osteopathic cranial manipulative medicine treatment group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan T Hendryx
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jan T Hendryx, Lake Erie College of Osteopathic Medicine
- Investigators
- Jan Hendryx, DO, Principal investigator, Lake Erie College of Osteopathic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190731
- Sponsor's protocol ID
- 24-177
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2021
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data underlying the results appearing in a scientific publication after de-identification including text, table, figures and appendices.
Publications
Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
PubMed 22182954Zurowska A, Malak R, Kolcz-Trzesicka A, Samborski W, Paprocka-Borowicz M. Compression of the Fourth Ventricle Using a Craniosacral Osteopathic Technique: A Systematic Review of the Clinical Evidence. Evid Based Complement Alternat Med. 2017;2017:2974962. doi: 10.1155/2017/2974962. Epub 2017 Oct 18.
PubMed 29234380Curi ACC, Maior Alves AS, Silva JG. Cardiac autonomic response after cranial technique of the fourth ventricle (cv4) compression in systemic hypertensive subjects. J Bodyw Mov Ther. 2018 Jul;22(3):666-672. doi: 10.1016/j.jbmt.2017.11.013. Epub 2017 Dec 9.
PubMed 30100295Abenavoli A, Badi F, Barbieri M, Bianchi M, Biglione G, Dealessi C, Grandini M, Lavazza C, Mapelli L, Milano V, Monti L, Seppia S, Tresoldi M, Maggiani A. Cranial osteopathic treatment and stress-related effects on autonomic nervous system measured by salivary markers: A pilot study. J Bodyw Mov Ther. 2020 Oct;24(4):215-221. doi: 10.1016/j.jbmt.2020.07.017. Epub 2020 Aug 4.
PubMed 33218514Arienti C, Farinola F, Ratti S, Dacco S, Fasulo L. Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):395-401. doi: 10.1016/j.jbmt.2020.07.002. Epub 2020 Jul 31.
PubMed 33218540Rechberger V, Biberschick M, Porthun J. Effectiveness of an osteopathic treatment on the autonomic nervous system: a systematic review of the literature. Eur J Med Res. 2019 Oct 25;24(1):36. doi: 10.1186/s40001-019-0394-5.
PubMed 31653268Cutler 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 15750368Miana L, Bastos VH, Machado S, Arias-Carrion O, Nardi AE, Almeida L, Ribeiro P, Machado D, King H, Silva JG. Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: a qEEG pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):291-6. doi: 10.1016/j.jbmt.2012.10.002. Epub 2012 Nov 16.
PubMed 23768271Li QQ, Shi GX, Xu Q, Wang J, Liu CZ, Wang LP. Acupuncture effect and central autonomic regulation. Evid Based Complement Alternat Med. 2013;2013:267959. doi: 10.1155/2013/267959. Epub 2013 May 26.
PubMed 23762116Ahn AC, Colbert AP, Anderson BJ, Martinsen OG, Hammerschlag R, Cina S, Wayne PM, Langevin HM. Electrical properties of acupuncture points and meridians: a systematic review. Bioelectromagnetics. 2008 May;29(4):245-56. doi: 10.1002/bem.20403.
PubMed 18240287Muehsam D, Chevalier G, Barsotti T, Gurfein BT. An Overview of Biofield Devices. Glob Adv Health Med. 2015 Nov;4(Suppl):42-51. doi: 10.7453/gahmj.2015.022.suppl. Epub 2015 Nov 1.
PubMed 26665041Comunetti A, Laage S, Schiessl N, Kistler A. Characterisation of human skin conductance at acupuncture points. Experientia. 1995 Apr 15;51(4):328-31. doi: 10.1007/BF01928888.
PubMed 7729497Ahn AC, Wu J, Badger GJ, Hammerschlag R, Langevin HM. Electrical impedance along connective tissue planes associated with acupuncture meridians. BMC Complement Altern Med. 2005 May 9;5:10. doi: 10.1186/1472-6882-5-10.
PubMed 15882468Kramer S, Winterhalter K, Schober G, Becker U, Wiegele B, Kutz DF, Kolb FP, Zaps D, Lang PM, Irnich D. Characteristics of electrical skin resistance at acupuncture points in healthy humans. J Altern Complement Med. 2009 May;15(5):495-500. doi: 10.1089/acm.2008.0331.
PubMed 19422323Colbert AP, Hammerschlag R, Aickin M, McNames J. Reliability of the Prognos electrodermal device for measurements of electrical skin resistance at acupuncture points. J Altern Complement Med. 2004 Aug;10(4):610-6. doi: 10.1089/acm.2004.10.610.
PubMed 15353016
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations in Bioelectric Activity at Acupuncture Jing-Well (Ting) Points Following CV4 Cranial Manipulation
- ClinicalTrials.gov ID
- NCT05190731
- Acronym / sponsor ID
- 24-177
- Conditions
- Autonomic Imbalance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Jan T HendryxUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 24 Jun 2018 (actual)
- Study completion
- 7 Nov 2018 (actual)
- First posted
- 13 Jan 2022 (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.
By measuring specific electrical parameters at acupuncture points that have been shown to correlate with ANS activity, the objectives of this study were to: 1) determine if CV4 has any influence on the bioelectric properties of the acupuncture meridian system, and 2) determine if CV4 affects the ANS.
Detailed description
This study is designed to measure bioelectrical activity at acupuncture Ting (Jing-Well) points immediately before and after employing a specific Osteopathic Cranial Manipulative Medicine (OCMM) technique called CV4 (Compression of the 4th Ventricle) vs. a Sham treatment.
Ting (Jing-Well) points are acupuncture points located at the proximal edges of the finger- and toenails that represent the beginning and end of 14 acupuncture meridians as described in Traditional Chinese Medicine and Japanese systems. Measurement of electrical activity at Ting points is performed by a physicist who has extensive experience using a device known as the Apparatus for Meridian Identification (AMI). Data collected and analyzed by the AMI for both CV4 and Sham groups is compared statistically for significant differences in before vs. after electrical activity and specific acupuncture meridians affected. One particular analysis of After Polarization (AP) potentials correlates with changes in autonomic nervous system activity.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants randomized to sham group or osteopathic cranial manipulative medicine treatment group
| Arm | Type | Receives |
|---|---|---|
| Contact touch at occipital region, but no actual cranial manipulation | Sham comparator | Other: ShamEach subject was treated with Sham by CSPOMM and NMM board-certified osteopathic physicians. The physician's finger pads of both hands were placed underneath the supine subject's head in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. The subject's head rested passively on the finger pads for 3 minutes. No cranial manipulative forces were applied. |
| Osteopathic cranial manipulative medicine | Active comparator | Other: Osteopathic cranial manipulative medicineEach subject was treated with CV4 technique by CSPOMM and NMM board-certified osteopathic physicians. All CV4 treatments were performed by one individual according to standardized protocol. The physician's hands were placed underneath the occiput with the thenar eminences in contact on the occipital squama medial to the lambdoidal and occipitomastoid sutures. Inherent cranial rhythmic motion was identified and thenar eminences followed occipital motion anteriorly during the extension phase until a still point was attained. This position was held until the still point released (usually about 3 minutes) and normal cranial motion ensued. |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females from the Erie, PA, area aged 18-78 years
- Recruited by local flyers and word of mouth marketing
- Able to lay supine for about 30 minutes
Key exclusion criteria (5 listed)
- Persons under the age of 18 years and persons unable to attend the in-person research sessions in Erie, PA.
- Identifiable acute illness of any kind
- Past medical history of stroke or transient ischemic attack within past 6 months
- Past medical history of intracranial hemorrhage, increased intracranial pressure, or seizure disorder
- Pregnant females
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 cranial manipulative medicineOsteopathic cranial manipulative medicine technique using compression of 4th ventricle technique | Other | Osteopathic cranial manipulative medicine |
| ShamTouch only, no osteopathic cranial manipulation | Other | Contact touch at occipital region, but no actual cranial manipulation |
Primary outcome
Autonomic Nervous System Activity at Acupuncture Ting Points
Time frame: Within 15 minutes of sham or intervention
Bioelectric skin conductance at acupuncture points
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 22 Apr 2022.
- Background: PubMed 22182954Jakel A, von Hauenschild P. Therapeutic effects of cranial osteopathic manipulative medicine: a systematic review. J Am Osteopath Assoc. 2011 Dec;111(12):685-93.
- Background: PubMed 29234380Zurowska A, Malak R, Kolcz-Trzesicka A, Samborski W, Paprocka-Borowicz M. Compression of the Fourth Ventricle Using a Craniosacral Osteopathic Technique: A Systematic Review of the Clinical Evidence. Evid Based Complement Alternat Med. 2017;2017:2974962. doi: 10.1155/2017/2974962. Epub 2017 Oct 18.
- Background: PubMed 30100295Curi ACC, Maior Alves AS, Silva JG. Cardiac autonomic response after cranial technique of the fourth ventricle (cv4) compression in systemic hypertensive subjects. J Bodyw Mov Ther. 2018 Jul;22(3):666-672. doi: 10.1016/j.jbmt.2017.11.013. Epub 2017 Dec 9.
- Background: PubMed 33218514Abenavoli A, Badi F, Barbieri M, Bianchi M, Biglione G, Dealessi C, Grandini M, Lavazza C, Mapelli L, Milano V, Monti L, Seppia S, Tresoldi M, Maggiani A. Cranial osteopathic treatment and stress-related effects on autonomic nervous system measured by salivary markers: A pilot study. J Bodyw Mov Ther. 2020 Oct;24(4):215-221. doi: 10.1016/j.jbmt.2020.07.017. Epub 2020 Aug 4.
- Background: PubMed 33218540Arienti C, Farinola F, Ratti S, Dacco S, Fasulo L. Variations of HRV and skin conductance reveal the influence of CV4 and Rib Raising techniques on autonomic balance: A randomized controlled clinical trial. J Bodyw Mov Ther. 2020 Oct;24(4):395-401. doi: 10.1016/j.jbmt.2020.07.002. Epub 2020 Jul 31.
- Background: PubMed 31653268Rechberger V, Biberschick M, Porthun J. Effectiveness of an osteopathic treatment on the autonomic nervous system: a systematic review of the literature. Eur J Med Res. 2019 Oct 25;24(1):36. doi: 10.1186/s40001-019-0394-5.
- 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 23768271Miana L, Bastos VH, Machado S, Arias-Carrion O, Nardi AE, Almeida L, Ribeiro P, Machado D, King H, Silva JG. Changes in alpha band activity associated with application of the compression of fourth ventricular (CV-4) osteopathic procedure: a qEEG pilot study. J Bodyw Mov Ther. 2013 Jul;17(3):291-6. doi: 10.1016/j.jbmt.2012.10.002. Epub 2012 Nov 16.
- Background: PubMed 23762116Li QQ, Shi GX, Xu Q, Wang J, Liu CZ, Wang LP. Acupuncture effect and central autonomic regulation. Evid Based Complement Alternat Med. 2013;2013:267959. doi: 10.1155/2013/267959. Epub 2013 May 26.
- Background: PubMed 18240287Ahn AC, Colbert AP, Anderson BJ, Martinsen OG, Hammerschlag R, Cina S, Wayne PM, Langevin HM. Electrical properties of acupuncture points and meridians: a systematic review. Bioelectromagnetics. 2008 May;29(4):245-56. doi: 10.1002/bem.20403.
- Background: PubMed 26665041Muehsam D, Chevalier G, Barsotti T, Gurfein BT. An Overview of Biofield Devices. Glob Adv Health Med. 2015 Nov;4(Suppl):42-51. doi: 10.7453/gahmj.2015.022.suppl. Epub 2015 Nov 1.
- Background: PubMed 7729497Comunetti A, Laage S, Schiessl N, Kistler A. Characterisation of human skin conductance at acupuncture points. Experientia. 1995 Apr 15;51(4):328-31. doi: 10.1007/BF01928888.
- Individual participant dataSharing planned: Yes. Individual participant data underlying the results appearing in a scientific publication after de-identification including text, table, figures and appendices.
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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.
Jan Hendryx, DO principal investigator
Lake Erie College of Osteopathic Medicine
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 cranial manipulative medicine in people with Autonomic Imbalance, run by Jan T Hendryx at 1 site in United States.
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 3 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 22 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 United States. 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?
Autonomic Nervous System Activity at Acupuncture Ting Points (time frame: Within 15 minutes of sham or intervention). 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 NCT05190731, which also lists 15 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 22 Apr 2022.