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

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ClinicalTrials.gov Identifier: NCT03709407
Recruitment Status : Recruiting
First Posted : October 17, 2018
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Angelo Rio, Universidad Europea de Madrid

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.

Condition or disease Intervention/treatment Phase
Blood Pressure Nervous System Diseases, Sympathetic Heart Rate Low Lymphatic Diseases Other: cervical stimuli Other: terminus Other: Placebo Other: Control group Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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"
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : July 19, 2019
Estimated Study Completion Date : July 30, 2019

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: cervical stimuli
Manouvres Godoy

Other: Placebo
placebo manouvre

Other: Control group
lie down

Sham Comparator: placebo
maneuver with sliding ON clavicular
Other: cervical stimuli
Manouvres Godoy

Other: terminus
Manouvres Vodder

Other: Control group
lie down

No Intervention: Control group
only lying down



Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 8 times for 4 weeks ]
    Measured by validated tensiometer.


Secondary Outcome Measures :
  1. range of movement [ Time Frame: 8 times for 4 weeks ]
    Measured by validated goniometer CROM. 2 times for 4 weeks

  2. pain pressure threshold [ Time Frame: 8 times for 4 weeks ]
    Measured by validated analogical algometer

  3. Respiratory rate [ Time Frame: 8 times for 4 weeks ]
    Measured by observation

  4. oxygen saturation [ Time Frame: 8 times for 4 weeks ]
    Measured by validated pulseoximeter

  5. Heart rate [ Time Frame: 8 times for 4 weeks ]
    Measured by validated tensiometer and pulseoximeter



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03709407


Contacts
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Contact: rio PT angela, PhD 0034912115566 ext 5566 angela.rio@universidadeuropea.es

Locations
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Spain
Angela Recruiting
Madrid, Spain, 28670
Contact: Angela Río-González, PhD    0034912115566 ext 5566    ci@universidadeuropea.es   
Contact       angela.rio@universidadeuropea.es   
Sponsors and Collaborators
Universidad Europea de Madrid
Investigators
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Principal Investigator: Angela Rio Universidad Europea de Madrid

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Responsible Party: Angelo Rio, Principal Investigator, Universidad Europea de Madrid
ClinicalTrials.gov Identifier: NCT03709407     History of Changes
Other Study ID Numbers: CIPI/029/17
First Posted: October 17, 2018    Key Record Dates
Last Update Posted: October 17, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Nervous System Diseases
Lymphatic Diseases
Bradycardia
Autonomic Nervous System Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes