NCT03709407

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 19, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed
Last Updated

March 25, 2020

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

October 10, 2018

Last Update Submit

March 24, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

    Measured by validated tensiometer.

    8 times for 4 weeks

Secondary Outcomes (5)

  • range of movement

    8 times for 4 weeks

  • pain pressure threshold

    8 times for 4 weeks

  • Respiratory rate

    8 times for 4 weeks

  • oxygen saturation

    8 times for 4 weeks

  • Heart rate

    8 times for 4 weeks

Study Arms (4)

cervical stimuli

EXPERIMENTAL

Godoy´s maneuver with traction-sliding in supraclavicular fossa

Other: terminusOther: PlaceboOther: Control group

terminus

EXPERIMENTAL

Vodder´s maneuver with medial and anterior traction in supraclavicular fossa

Other: cervical stimuliOther: PlaceboOther: Control group

placebo

SHAM COMPARATOR

maneuver with sliding ON clavicular

Other: cervical stimuliOther: terminusOther: Control group

Control group

NO INTERVENTION

only lying down

Interventions

Manouvres Godoy

placeboterminus

Manouvres Vodder

cervical stimuliplacebo
PlaceboOTHER

placebo manouvre

cervical stimuliterminus

lie down

cervical stimuliplaceboterminus

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men and women, physiotherapy students, to accept voluntarily participate and sign informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angela

Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Autonomic Nervous System DiseasesBradycardiaLymphatic Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Nervous System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Angela Rio

    Universidad Europea de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2018

First Posted

October 17, 2018

Study Start

June 1, 2018

Primary Completion

March 19, 2020

Study Completion

March 19, 2020

Last Updated

March 25, 2020

Record last verified: 2018-10

Locations