"Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover Study"

"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"

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.

Study Overview

• Status: Completed
• Conditions: Lymphatic Diseases; Blood Pressure; Heart Rate Low; Nervous System Diseases, Sympathetic
• Intervention / Treatment: Other: terminus; Other: Placebo; Other: Control group; Other: cervical stimuli

Detailed Description

Differentes drainage manoeuvres suggest changes at nervous system (sympathetic and parasympathetic nervous system) and other vital constants

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28670
    • Angela

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cervical stimuli; Godoy´s maneuver with traction-sliding in supraclavicular fossa	Other: terminus; Manouvres Vodder; Other: Placebo; placebo manouvre; Other: Control group; lie down
Experimental: terminus; Vodder´s maneuver with medial and anterior traction in supraclavicular fossa	Other: Placebo; placebo manouvre; Other: Control group; lie down; Other: cervical stimuli; Manouvres Godoy
Sham Comparator: placebo; maneuver with sliding ON clavicular	Other: terminus; Manouvres Vodder; Other: Control group; lie down; Other: cervical stimuli; Manouvres Godoy
No Intervention: Control group; only lying down

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Measured by validated tensiometer.	8 times for 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of movement	Measured by validated goniometer CROM. 2 times for 4 weeks	8 times for 4 weeks
pain pressure threshold	Measured by validated analogical algometer	8 times for 4 weeks
Respiratory rate	Measured by observation	8 times for 4 weeks
oxygen saturation	Measured by validated pulseoximeter	8 times for 4 weeks
Heart rate	Measured by validated tensiometer and pulseoximeter	8 times for 4 weeks

Collaborators and Investigators

• Sponsor: Universidad Europea de Madrid
• Investigators: Principal Investigator: Angela Rio, Universidad Europea de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): March 19, 2020
• Study Completion (Actual): March 19, 2020

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: October 13, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 24, 2020
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Nervous System Diseases; Bradycardia; Autonomic Nervous System Diseases; Lymphatic Diseases
• Other Study ID Numbers: CIPI/029/17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No