Healthy Young AdultsNCT05515926
Physiological Responses to Osteopathic Manipulative Techniques in Healthy Young Adults
A study testing Cranial manipulation group, or cranial osteopathic techniques (OMM) in people with Healthy Young Adults, run by Touro University Nevada.
Trial summary
This study was designed to investigate the effect of selected osteopathic manipulative techniques (OMT) on cardiovascular functions in healthy young men and women. This work addressed questions regarding physiological responses to OMT in maintaining the cardiovascular homeostasis by (1) measuring changes in the… Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Cranial manipulation group, or cranial osteopathic techniques (OMM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- No sites listed yet
- Study dates
- 4 Oct 2013to 7 Aug 2019
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young adults
Who cannot join
- Clinical diagnosis of chronic cardiovascular diseases
- Clinical diagnosis of pulmonary diseases
- Clinical diagnosis of renal diseases
- Clinical diagnosis of diabetes mellitus
- Clinical diagnosis of endocrine disorders affecting the cardiovascular system
- Clinical diagnosis of pregnancy
- Clinical diagnosis of musculoskeletal conditions that can affect the use of the cranial OMTs
- Any acute illness that necessitates consulting a healthcare provider
About this study
This study was designed to investigate the effect of selected osteopathic manipulative techniques (OMT) on cardiovascular functions in healthy young men and women.
This work addressed questions regarding physiological responses to OMT in maintaining the cardiovascular homeostasis by (1) measuring changes in the cardiac autonomic nerves activity, (2) measuring changes in cardiovascular parameters such as blood pressure, cardiac contractility, and heart rate, and (3) investigating if changes in the cardiac autonomic nerves activity were related to changes in blood pressure, cardiac contractility, or heart rate.
Read more
This controlled not-randomized pilot study with repeated measures was conducted at the Touro University Nevada College of Osteopathic Medicine. Healthy 21-35 years old students and employees volunteered in the study. The experimental group received the three cranial osteopathic manipulative techniques, occipital-atlantal decompression, occipital-mastoid decompression, and compression of the fourth ventricle, consecutively applied. This study included two control groups; one group received sham manipulations, and the second group did not receive any manipulations and was the non-touch group.
The computerized MP150 BIOPAC System was used for data collection and analysis. The skin electrodes were used for the one-lead ECG and impedance cardiography. Digital data were recorded during the entire experimental protocol. The blood pressure was measured manually before and after the experimental procedure using blood pressure cuff and stethoscope. Cardiovascular responses to OMT were evaluated by using the heart rate variability test (HRV), calculating changes in cardiac contractility, and comparing changes in pre- and post- blood pressure readings.
An analysis of variance (ANOVA) with a Bonferroni post-hoc test was used to evaluate treatment effects. The type I error rate (alpha) was set at 0.05.
Read the detailed description
Healthy, 21-35 year old, male and female volunteers were recruited from Touro University students, faculty and staff using a brochure, poster, e-mail or personal conversation. Each participant signed an informed consent form. Participants were allowed to participate in multiple experiments (in the experimental and control groups) at least 7 days after the last experiment.
Each subject's weight and height were measured before the procedure. Anthropometric measures were used in cardiac impedance analysis, and as descriptive statistics of the studied population. All cardiovascular parameters were recorded by using a non-invasive method. The disposable skin electrodes were used for impedance cardiography and a one-lead ECG.
The subjects were lying in the supine position and were asked to relax. All surface electrodes were connected to the computerized MP150 BIOPAC System for data recording. The duration of experimental protocol was about 30 minutes, and included three intervals: 10 minutes, pre-OMT rest phase (Rest); 8 to12 minutes (about 10 minutes) of the OMT/Sham (Manipulations); and 10 minutes post-OMT recovery phase (Recovery).
OMT and sham manipulations were administered by an osteopathic physician. The participants were told to lie supine with physician seated at the side of the table facing the participant. Cranial OMT included three techniques and was administered in the following sequence: occipital-atlantal decompression, occipital-mastoid joint, and compression of the fourth ventricle. Control subjects received the sham manipulative procedure or relaxed in supine position (non-touch control). The total duration of OMT controlled by an osteopathic physician and was about 10 minutes.
OMT and sham manipulations Occipital-atlantal decompression: Patient is in the supine position. The operator places the tip of a finger against the posterior tubercle of the atlas and holds that bone anteriorly, preventing it from moving posteriorly with the condyles as the patient nods or tips the head forward. This will release tension between the occipital condyles and the first cervical vertebrae.
Occipital-mastoid joint decompression: The occipital squama is gently moved forward and upward (anteriorly and superiorly) with the pads of the long finger, and the mastoid process of the temporal bone is lifted anterolaterally with the pads of the index fingers. This technique decompresses the jugular foramen, which the vagus nerve passes through.
Compression of the fourth ventricle: Manipulation is accomplished by having the operator's hands cupped to receive the lateral angles and supra-occiput on their thenar eminences. Gentle compression medially is maintained (generally 2 to 3 minutes) until tissue changes, such as a softening or increased motion, are noted in the supraoccipital area.
Sham: The osteopathic physician placed his hands on the skull of the subject and did not influence cranial motion. The sham manipulative procedure (SMP) was administered for 10 minutes.
All manipulations were administered by the osteopathic physician; experiments were conducted at Touro University Nevada. Data were collected by a non-invasive method using BIOPAC Systems, Inc. Equipment MP150 for data acquisition and analysis. The protocol consisted of three phases: rest before manipulations (10 min), manipulations (OMT) (approximately 10 min), and recovery after manipulations (10 min).
Data analysis Most cardiovascular response variables were measured at baseline, immediately after manipulation ("immediate response"), and at the end of protocol ("after rest"). The immediate responses and at the end of protocol were calculated on a percentage basis relative to baseline to control some individual variations.
The percent response variables were each analyzed in a three-way analysis of variance (ANOVA) which included time ("Immediate response", "after rest"), treatment (cranial manipulation, sham), and sex (male, female) as fixed effects. For significant interactions in the ANOVA, a Bonferroni post-hoc test was used to compare treatment effects within time, sex, or both. The type I error rate (alpha) was set at 0.05. The relationships among dependent variables were described with Spearman correlations between percent response variables within. Analyses were done in Rv3.5.1 (R Core Team 2018).
- Conditions
- Healthy Young Adults
- Being tested
- Cranial manipulation group, or cranial osteopathic techniques (OMM), Sham manipulation
- Keywords
- Osteopathic manipulation, Autonomic, Cardiovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial manipulation group, or cranial osteopathic techniques (OMM)Procedure or surgery
Also called Cranial osteopathic manipulations, cranial osteopathic techniques, cranial OMT procedure
Cranial OMT procedure:
Subjects were relaxed and lying on the back for entire time of the research protocol (approximately 30 min). Osteopathic physician performed the osteopathic manipulations using his hands. The physician gently applied a small amount of force to the neck and head to release tissue tension until feeling a softening and warmth of tissues. Subjects experienced a sensation of slight pulling, releasing, or relaxing of the tissue.
Sham manipulationProcedure or surgery
Also called Sham
The osteopathic physician placed his hands on the skull of the subject but did not influence cranial motion.
| Study group | Role | What they receive |
|---|---|---|
| Cranial OMT | Experimental | The experimental group received the three cranial osteopathic manipulative techniques, occipital-atlantal decompression (OAD), occipital-mastoid decompression (OMD), and compression of the fourth ventricle (CV4), consecutively applied. Receives: Procedure: Cranial manipulation group, or cranial osteopathic techniques (OMM) |
| Sham manipulation | Sham comparator | The osteopathic physician placed his hands on the skull of the subject but did not influence cranial motion. Receives: Procedure: Sham manipulation |
| Non touch group | No intervention | The control group whose members did not receive any manipulations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability immediately after manipulation
The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.
Measured: Baseline and 2 minutes after manipulation
Change in heart rate variability 10 min after manipulation
The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.
Measured: Baseline and 10 minutes after manipulation
Change in cardiac impedance immediately after manipulation
Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.
Measured: Baseline and 2 minutes after manipulation
Change in cardiac impedance 10 minutes after manipulation
Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.
Measured: Baseline and 10 minutes after manipulation
Change in blood pressure 10 minutes after manipulation
Blood pressure was measured by sphygmomanometer. Changes in blood pressure would indicate the effect of manipulation on vascular sympathetic tone.
Measured: Baseline and 10 minutes after manipulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start4 Oct 2013
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Healthy Young AdultsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Touro University Nevada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Ioudina, Touro University Nevada
- Investigators
- Marina Ioudina, MD, PhD, MS, Principal investigator, Touro University Nevada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05515926
- Sponsor's protocol ID
- TUN IRB4-10-13A
- Status last verified
- Aug 2022
- First submitted
- 27 Jul 2022
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data that underlie results in a publication
Publications
Zurowska 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 29234380Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.
PubMed 26199632Cerritelli F, Carinci F, Pizzolorusso G, Turi P, Renzetti C, Pizzolorusso F, Orlando F, Cozzolino V, Barlafante G. Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications: 12-Months follow-up of intima media and blood pressure on a cohort affected by hypertension. J Bodyw Mov Ther. 2011 Jan;15(1):68-74. doi: 10.1016/j.jbmt.2010.03.005. Epub 2010 May 8.
PubMed 21147421Cutler 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 15750368Jakel 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 22182954
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological Responses to Osteopathic Manipulative Techniques in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT05515926
- Acronym / sponsor ID
- TUN IRB4-10-13A
- Conditions
- Healthy Young Adults
- Keywords
- Osteopathic manipulation, Autonomic, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Touro University NevadaUniversity, hospital or other
- Study start
- 4 Oct 2013 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 25 Aug 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.
This study was designed to investigate the effect of selected osteopathic manipulative techniques (OMT) on cardiovascular functions in healthy young men and women.
This work addressed questions regarding physiological responses to OMT in maintaining the cardiovascular homeostasis by (1) measuring changes in the cardiac autonomic nerves activity, (2) measuring changes in cardiovascular parameters such as blood pressure, cardiac contractility, and heart rate, and (3) investigating if changes in the cardiac autonomic nerves activity were related to changes in blood pressure, cardiac contractility, or heart rate.
This controlled not-randomized pilot study with repeated measures was conducted at the Touro University Nevada College of Osteopathic Medicine. Healthy 21-35 years old students and employees volunteered in the study. The experimental group received the three cranial osteopathic manipulative techniques, occipital-atlantal decompression, occipital-mastoid decompression, and compression of the fourth ventricle, consecutively applied. This study included two control groups; one group received sham manipulations, and the second group did not receive any manipulations and was the non-touch group.
The computerized MP150 BIOPAC System was used for data collection and analysis. The skin electrodes were used for the one-lead ECG and impedance cardiography. Digital data were recorded during the entire experimental protocol. The blood pressure was measured manually before and after the experimental procedure using blood pressure cuff and stethoscope. Cardiovascular responses to OMT were evaluated by using the heart rate variability test (HRV), calculating changes in cardiac contractility, and comparing changes in pre- and post- blood pressure readings.
An analysis of variance (ANOVA) with a Bonferroni post-hoc test was used to evaluate treatment effects. The type I error rate (alpha) was set at 0.05.
Detailed description
Healthy, 21-35 year old, male and female volunteers were recruited from Touro University students, faculty and staff using a brochure, poster, e-mail or personal conversation. Each participant signed an informed consent form. Participants were allowed to participate in multiple experiments (in the experimental and control groups) at least 7 days after the last experiment.
Each subject's weight and height were measured before the procedure. Anthropometric measures were used in cardiac impedance analysis, and as descriptive statistics of the studied population. All cardiovascular parameters were recorded by using a non-invasive method. The disposable skin electrodes were used for impedance cardiography and a one-lead ECG.
The subjects were lying in the supine position and were asked to relax. All surface electrodes were connected to the computerized MP150 BIOPAC System for data recording. The duration of experimental protocol was about 30 minutes, and included three intervals: 10 minutes, pre-OMT rest phase (Rest); 8 to12 minutes (about 10 minutes) of the OMT/Sham (Manipulations); and 10 minutes post-OMT recovery phase (Recovery).
OMT and sham manipulations were administered by an osteopathic physician. The participants were told to lie supine with physician seated at the side of the table facing the participant. Cranial OMT included three techniques and was administered in the following sequence: occipital-atlantal decompression, occipital-mastoid joint, and compression of the fourth ventricle. Control subjects received the sham manipulative procedure or relaxed in supine position (non-touch control). The total duration of OMT controlled by an osteopathic physician and was about 10 minutes.
OMT and sham manipulations Occipital-atlantal decompression: Patient is in the supine position. The operator places the tip of a finger against the posterior tubercle of the atlas and holds that bone anteriorly, preventing it from moving posteriorly with the condyles as the patient nods or tips the head forward. This will release tension between the occipital condyles and the first cervical vertebrae.
Occipital-mastoid joint decompression: The occipital squama is gently moved forward and upward (anteriorly and superiorly) with the pads of the long finger, and the mastoid process of the temporal bone is lifted anterolaterally with the pads of the index fingers. This technique decompresses the jugular foramen, which the vagus nerve passes through.
Compression of the fourth ventricle: Manipulation is accomplished by having the operator's hands cupped to receive the lateral angles and supra-occiput on their thenar eminences. Gentle compression medially is maintained (generally 2 to 3 minutes) until tissue changes, such as a softening or increased motion, are noted in the supraoccipital area.
Sham: The osteopathic physician placed his hands on the skull of the subject and did not influence cranial motion. The sham manipulative procedure (SMP) was administered for 10 minutes.
All manipulations were administered by the osteopathic physician; experiments were conducted at Touro University Nevada. Data were collected by a non-invasive method using BIOPAC Systems, Inc. Equipment MP150 for data acquisition and analysis. The protocol consisted of three phases: rest before manipulations (10 min), manipulations (OMT) (approximately 10 min), and recovery after manipulations (10 min).
Data analysis Most cardiovascular response variables were measured at baseline, immediately after manipulation ("immediate response"), and at the end of protocol ("after rest"). The immediate responses and at the end of protocol were calculated on a percentage basis relative to baseline to control some individual variations.
The percent response variables were each analyzed in a three-way analysis of variance (ANOVA) which included time ("Immediate response", "after rest"), treatment (cranial manipulation, sham), and sex (male, female) as fixed effects. For significant interactions in the ANOVA, a Bonferroni post-hoc test was used to compare treatment effects within time, sex, or both. The type I error rate (alpha) was set at 0.05. The relationships among dependent variables were described with Spearman correlations between percent response variables within. Analyses were done in Rv3.5.1 (R Core Team 2018).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cranial OMT | Experimental | Procedure: Cranial manipulation group, or cranial osteopathic techniques (OMM)The experimental group received the three cranial osteopathic manipulative techniques, occipital-atlantal decompression (OAD), occipital-mastoid decompression (OMD), and compression of the fourth ventricle (CV4), consecutively applied. |
| Sham manipulation | Sham comparator | Procedure: Sham manipulationThe osteopathic physician placed his hands on the skull of the subject but did not influence cranial motion. |
| Non touch group | No intervention | –The control group whose members did not receive any manipulations. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young adults
Key exclusion criteria (8 listed)
- Clinical diagnosis of chronic cardiovascular diseases
- Clinical diagnosis of pulmonary diseases
- Clinical diagnosis of renal diseases
- Clinical diagnosis of diabetes mellitus
- Clinical diagnosis of endocrine disorders affecting the cardiovascular system
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 |
|---|---|---|
| Cranial manipulation group, or cranial osteopathic techniques (OMM)Also: Cranial osteopathic manipulations, cranial osteopathic techniques, cranial OMT procedureCranial OMT procedure: Subjects were relaxed and lying on the back for entire time of the research protocol (approximately 30 min). Osteopathic physician performed the osteopathic manipulations using his hands. The physician gently applied a small amount of force to the neck and head to release tissue tension until feeling a softening and warmth of tissues. Subjects experienced a sensation of slight pulling, releasing, or relaxing of the tissue. | Procedure or surgery | Cranial OMT |
| Sham manipulationAlso: ShamThe osteopathic physician placed his hands on the skull of the subject but did not influence cranial motion. | Procedure or surgery | Sham manipulation |
Primary outcome
Change in heart rate variability immediately after manipulation
Time frame: Baseline and 2 minutes after manipulation
The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.
Change in heart rate variability 10 min after manipulation
Time frame: Baseline and 10 minutes after manipulation
The heart rate variability test was used to study the effect of OMT on heart rate and, by inference, on autonomic nervous system activity. A decrease in heart rate accompanied by an increase in vagal and decrease in sympathetic activity would indicate parasympathetic activation by OMT.
Change in cardiac impedance immediately after manipulation
Time frame: Baseline and 2 minutes after manipulation
Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.
Change in cardiac impedance 10 minutes after manipulation
Time frame: Baseline and 10 minutes after manipulation
Changes in impedance cardiography were used to evaluate the effect of OMT on myocardial contractility.
Change in blood pressure 10 minutes after manipulation
Time frame: Baseline and 10 minutes after manipulation
Blood pressure was measured by sphygmomanometer. Changes in blood pressure would indicate the effect of manipulation on vascular sympathetic tone.
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 25 Aug 2022.
- 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 26199632Cardoso-de-Mello-E-Mello-Ribeiro AP, Rodriguez-Blanco C, Riquelme-Agullo I, Heredia-Rizo AM, Ricard F, Oliva-Pascual-Vaca A. Effects of the Fourth Ventricle Compression in the Regulation of the Autonomic Nervous System: A Randomized Control Trial. Evid Based Complement Alternat Med. 2015;2015:148285. doi: 10.1155/2015/148285. Epub 2015 Jun 14.
- Background: PubMed 21147421Cerritelli F, Carinci F, Pizzolorusso G, Turi P, Renzetti C, Pizzolorusso F, Orlando F, Cozzolino V, Barlafante G. Osteopathic manipulation as a complementary treatment for the prevention of cardiac complications: 12-Months follow-up of intima media and blood pressure on a cohort affected by hypertension. J Bodyw Mov Ther. 2011 Jan;15(1):68-74. doi: 10.1016/j.jbmt.2010.03.005. Epub 2010 May 8.
- 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 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.
- Individual participant dataSharing planned: Yes. All individual patient data that underlie results in a publication
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Healthy Volunteers
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.
Marina Ioudina, MD, PhD, MS principal investigator
Touro University Nevada
Questions about this trial
What is this clinical trial studying?
A study testing Cranial manipulation group, or cranial osteopathic techniques (OMM) in people with Healthy Young Adults, run by Touro University Nevada.
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 8 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in heart rate variability immediately after manipulation (time frame: Baseline and 2 minutes after manipulation). The study lists 5 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 NCT05515926, which also lists 5 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 25 Aug 2022.