Back to results"Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover Study"
Primary Purpose
Blood Pressure, Nervous System Diseases, Sympathetic, Heart Rate Low
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cervical stimuli
terminus
Placebo
Control group
Sponsored by
About this trial
This is an interventional treatment trial for Blood Pressure
Eligibility Criteria
Inclusion Criteria:
- healthy men and women, physiotherapy students, to accept voluntarily participate and sign informed consent
Exclusion Criteria:
- systemic diseases, trauma history, neurological diseases, subjects with chronic pain, cardiovascular history of importance, depression, individuals who know the technique of MLD or that are under any medical treatment.
Sites / Locations
- Angela
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Sham Comparator
No Intervention
Arm Label
cervical stimuli
terminus
placebo
Control group
Arm Description
Godoy´s maneuver with traction-sliding in supraclavicular fossa
Vodder´s maneuver with medial and anterior traction in supraclavicular fossa
maneuver with sliding ON clavicular
only lying down
Outcomes
Primary Outcome Measures
Blood pressure
Measured by validated tensiometer.
Secondary Outcome Measures
range of movement
Measured by validated goniometer CROM. 2 times for 4 weeks
pain pressure threshold
Measured by validated analogical algometer
Respiratory rate
Measured by observation
oxygen saturation
Measured by validated pulseoximeter
Heart rate
Measured by validated tensiometer and pulseoximeter
Full Information
NCT ID
NCT03709407
First Posted
October 10, 2018
Last Updated
March 24, 2020
Sponsor
Universidad Europea de Madrid
1. Study Identification
Unique Protocol Identification Number
NCT03709407
Brief Title
"Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover Study"
Official Title
"Effects of Different Manoeuvres of Manual Lymphatic Drainage in the Neck on Systems Nervous, Cardiovascular, Respiratory and Lymphatic in Healthy Subjects. Experimental Randomized Crossover Study"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
March 19, 2020 (Actual)
Study Completion Date
March 19, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Europea de Madrid
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Drainage manoeuvres described in different Manual Lymphatic Drainage methods, suggest modificactions in vital signs, by changes at nervous system, that would involve modifications to heart rate, breathing rate, blood pressure, cardiac vascular level (arteries and lymphatics). In addition this hypothetical relaxing effect could be beneficial for other types of pathologies associated with the presence of stress, cardiac problems, respiratory pathology, muscle tension, muscle trigger points, etc. With this study investigators compare different manoeuvres in the neck area to observe the results in the participants regarding the basal state.
Detailed Description
Differentes drainage manoeuvres suggest changes at nervous system (sympathetic and parasympathetic nervous system) and other vital constants
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Nervous System Diseases, Sympathetic, Heart Rate Low, Lymphatic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cervical stimuli
Arm Type
Experimental
Arm Description
Godoy´s maneuver with traction-sliding in supraclavicular fossa
Arm Title
terminus
Arm Type
Experimental
Arm Description
Vodder´s maneuver with medial and anterior traction in supraclavicular fossa
Arm Title
placebo
Arm Type
Sham Comparator
Arm Description
maneuver with sliding ON clavicular
Arm Title
Control group
Arm Type
No Intervention
Arm Description
only lying down
Intervention Type
Other
Intervention Name(s)
cervical stimuli
Intervention Description
Manouvres Godoy
Intervention Type
Other
Intervention Name(s)
terminus
Intervention Description
Manouvres Vodder
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
placebo manouvre
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
lie down
Primary Outcome Measure Information:
Title
Blood pressure
Description
Measured by validated tensiometer.
Time Frame
8 times for 4 weeks
Secondary Outcome Measure Information:
Title
range of movement
Description
Measured by validated goniometer CROM. 2 times for 4 weeks
Time Frame
8 times for 4 weeks
Title
pain pressure threshold
Description
Measured by validated analogical algometer
Time Frame
8 times for 4 weeks
Title
Respiratory rate
Description
Measured by observation
Time Frame
8 times for 4 weeks
Title
oxygen saturation
Description
Measured by validated pulseoximeter
Time Frame
8 times for 4 weeks
Title
Heart rate
Description
Measured by validated tensiometer and pulseoximeter
Time Frame
8 times for 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy men and women, physiotherapy students, to accept voluntarily participate and sign informed consent
Exclusion Criteria:
systemic diseases, trauma history, neurological diseases, subjects with chronic pain, cardiovascular history of importance, depression, individuals who know the technique of MLD or that are under any medical treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Angela Rio
Organizational Affiliation
Universidad Europea de Madrid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Angela
City
Madrid
ZIP/Postal Code
28670
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
"Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover Study"
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