Ninth Dorsal Osteopathic Visceral Manipulation D9
Primary Purpose
Osteopathia, Manipulation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manipulation
Sponsored by
About this trial
This is an interventional treatment trial for Osteopathia focused on measuring Thrust technique, Blood levels, Pancreas, Ninth vertebra, Manipulation
Eligibility Criteria
Inclusion Criteria:
- students between 18-27 years old
- healthy persons
- Acceptance of informed consent
Exclusion Criteria:
- pancreatitis
- diabetes I,II type
- anemia
- Alcohol intake for 12 hours prior.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group
Manipulation
Arm Description
The control group did not received any treatment
Experimental group received the osteopathic maneuver and the blood value were measured at baseline, after 2,5 and 10 minutes.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03852212
First Posted
February 20, 2019
Last Updated
February 21, 2019
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT03852212
Brief Title
Ninth Dorsal Osteopathic Visceral Manipulation D9
Official Title
Ninth Dorsal Osteopathic Visceral Manipulation D9 Affects Pancreas Blood Levels
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopathia, Manipulation
Keywords
Thrust technique, Blood levels, Pancreas, Ninth vertebra, Manipulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
The control group did not received any treatment
Arm Title
Manipulation
Arm Type
Experimental
Arm Description
Experimental group received the osteopathic maneuver and the blood value were measured at baseline, after 2,5 and 10 minutes.
Intervention Type
Other
Intervention Name(s)
Manipulation
Intervention Description
Thrust technique application
Primary Outcome Measure Information:
Title
Basal insulin laboratory value change
Description
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
Time Frame
10 minutes
Title
Basal glycemia laboratory value change
Description
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.
Time Frame
10 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
27 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
students between 18-27 years old
healthy persons
Acceptance of informed consent
Exclusion Criteria:
pancreatitis
diabetes I,II type
anemia
Alcohol intake for 12 hours prior.
12. IPD Sharing Statement
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Ninth Dorsal Osteopathic Visceral Manipulation D9
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