OsteopathiaNCT03852212
Ninth Dorsal Osteopathic Visceral Manipulation D9
A study testing Manipulation in people with Osteopathia and Manipulation, run by Universidad Católica San Antonio de Murcia.
Trial summary
The aims of this study is to verify that the vertebral manipulation of dorsal level D9 influences the pancreas biochemical and endocrinology blood values. Read more about this study
- Who is it for?
- Ages 18 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteopathia, Manipulation
- What is being tested?
- Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to May 2017
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- students between 18-27 years old
- healthy persons
- Acceptance of informed consent
Who cannot join
- pancreatitis
- diabetes I,II type
- anemia
- Alcohol intake for 12 hours prior.
About this study
Official title: Ninth Dorsal Osteopathic Visceral Manipulation D9 Affects Pancreas Blood Levels
The aims of this study is to verify that the vertebral manipulation of dorsal level D9 influences the pancreas biochemical and endocrinology blood values.
Read the detailed description
A longitudinal experimental study was conducted in which the osteopathic thrust maneuver was applied. In this research, 87 healthy subjects participated, of which 56.3% (n = 49) are men and 43.7% (n = 38) are women aged 19-29 who study at the Catholic University of Murcia.The blood analytical values of insulin and glycemia have been measured in 4 different times: at baseline, after 2,5 and 10 minutes of the technique application with the purpose to verify any possible change.
- Conditions
- Osteopathia, Manipulation
- Being tested
- Manipulation
- Keywords
- Thrust technique, Blood levels, Pancreas, Ninth vertebra, Manipulation
- Medical subject headings
- Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ManipulationOther
Thrust technique application
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The control group did not received any treatment |
| Manipulation | Experimental | Experimental group received the osteopathic maneuver and the blood value were measured at baseline, after 2,5 and 10 minutes. Receives: Other: Manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Basal insulin laboratory value change
The normal values of basal insulin measured with the imunoanalysis method are ˂ at 25.0 mU / l. If these values are exceeded, the effect of the manipulation in the study is verified
Measured: 10 minutes
Basal glycemia laboratory value change
The normal values of basal glycemia measured with the enzymatic method vary between 60 - 105 mg / dl. The change of these values according to the reference laboratory has been the basis of the study.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study startDec 2014
- Primary completionJun 2015
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopathiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasemin Todri, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852212
- Sponsor's protocol ID
- 5548
- Status last verified
- Feb 2019
- First submitted
- 20 Feb 2019
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ninth Dorsal Osteopathic Visceral Manipulation D9 Affects Pancreas Blood Levels
- ClinicalTrials.gov ID
- NCT03852212
- Acronym / sponsor ID
- 5548
- Conditions
- Osteopathia, Manipulation
- Keywords
- Thrust technique, Blood levels, Pancreas, Ninth vertebra, Manipulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 25 Feb 2019 (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.
The aims of this study is to verify that the vertebral manipulation of dorsal level D9 influences the pancreas biochemical and endocrinology blood values.
Detailed description
A longitudinal experimental study was conducted in which the osteopathic thrust maneuver was applied. In this research, 87 healthy subjects participated, of which 56.3% (n = 49) are men and 43.7% (n = 38) are women aged 19-29 who study at the Catholic University of Murcia.The blood analytical values of insulin and glycemia have been measured in 4 different times: at baseline, after 2,5 and 10 minutes of the technique application with the purpose to verify any possible change.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The control group did not received any treatment |
| Manipulation | Experimental | Other: ManipulationExperimental group received the osteopathic maneuver and the blood value were measured at baseline, after 2,5 and 10 minutes. |
Who may qualify
- Ages
- 18 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- students between 18-27 years old
- healthy persons
- Acceptance of informed consent
Key exclusion criteria (4 listed)
- pancreatitis
- diabetes I,II type
- anemia
- Alcohol intake for 12 hours prior.
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 |
|---|---|---|
| ManipulationThrust technique application | Other | Manipulation |
Primary outcome
Basal insulin laboratory value change
Time frame: 10 minutes
The normal values of basal insulin measured with the imunoanalysis method are ˂ at 25.0 mU / l. If these values are exceeded, the effect of the manipulation in the study is verified
Basal glycemia laboratory value change
Time frame: 10 minutes
The normal values of basal glycemia measured with the enzymatic method vary between 60 - 105 mg / dl. The change of these values according to the reference laboratory has been the basis of the study.
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 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation in people with Osteopathia and Manipulation, run by Universidad Católica San Antonio de Murcia.
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 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 25 Feb 2019. 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. 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?
Basal insulin laboratory value change (time frame: 10 minutes). The study lists 2 primary outcomes in all. 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 25 Feb 2019.