Blood PressureNCT03709407
"Effects of Manual Lymphatic Drainage in the Neck in Healthy Subjects. Experimental Randomized Crossover Study"
A study testing cervical stimuli and terminus in people with Blood Pressure and Nervous System Diseases, Sympathetic, run by Universidad Europea de Madrid at 1 site in Spain.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Nervous System Diseases, Sympathetic, Heart Rate Low
- What is being tested?
- cervical stimuli and terminus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 19 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women, physiotherapy students, to accept voluntarily participate and sign informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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"
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.
Read the detailed description
Differentes drainage manoeuvres suggest changes at nervous system (sympathetic and parasympathetic nervous system) and other vital constants
- Being tested
- cervical stimuli, terminus, Placebo, Control group
- Medical subject headings
- Autonomic Nervous System Diseases, Bradycardia, Lymphatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cervical stimuliOther
Manouvres Godoy
terminusOther
Manouvres Vodder
PlaceboOther
placebo manouvre
Control groupOther
lie down
| Study group | Role | What they receive |
|---|---|---|
| cervical stimuli | Experimental | Godoy´s maneuver with traction-sliding in supraclavicular fossa Receives: Other: terminus; Other: Placebo; Other: Control group |
| terminus | Experimental | Vodder´s maneuver with medial and anterior traction in supraclavicular fossa Receives: Other: cervical stimuli; Other: Placebo; Other: Control group |
| placebo | Sham comparator | maneuver with sliding ON clavicular Receives: Other: cervical stimuli; Other: terminus; Other: Control group |
| Control group | No intervention | only lying down |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Measured by validated tensiometer.
Measured: 8 times for 4 weeks
Secondary outcomes (5)
range of movement
Measured by validated goniometer CROM. 2 times for 4 weeks
Measured: 8 times for 4 weeks
pain pressure threshold
Measured by validated analogical algometer
Measured: 8 times for 4 weeks
Respiratory rate
Measured by observation
Measured: 8 times for 4 weeks
oxygen saturation
Measured by validated pulseoximeter
Measured: 8 times for 4 weeks
Heart rate
Measured by validated tensiometer and pulseoximeter
Measured: 8 times for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2018
- Study start1 Jun 2018
- Primary completion19 Mar 2020
- Study completion19 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Europea de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Angelo Rio, Universidad Europea de Madrid
- Investigators
- Angela Rio, Principal investigator, Universidad Europea de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03709407
- Sponsor's protocol ID
- CIPI/029/17
- Status last verified
- Oct 2018
- First submitted
- 10 Oct 2018
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT03709407
- Acronym / sponsor ID
- CIPI/029/17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Europea de MadridUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 19 Mar 2020 (actual)
- Study completion
- 19 Mar 2020 (actual)
- First posted
- 17 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cervical stimuli | Experimental | Other: terminus, Other: Placebo, Other: Control groupGodoy´s maneuver with traction-sliding in supraclavicular fossa |
| terminus | Experimental | Other: cervical stimuli, Other: Placebo, Other: Control groupVodder´s maneuver with medial and anterior traction in supraclavicular fossa |
| placebo | Sham comparator | Other: cervical stimuli, Other: terminus, Other: Control groupmaneuver with sliding ON clavicular |
| Control group | No intervention | –only lying down |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men and women, physiotherapy students, to accept voluntarily participate and sign informed consent
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cervical stimuliManouvres Godoy | Other | placebo, terminus |
| terminusManouvres Vodder | Other | cervical stimuli, placebo |
| Placeboplacebo manouvre | Other | cervical stimuli, terminus |
| Control grouplie down | Other | cervical stimuli, placebo, terminus |
Primary outcome
Blood pressure
Time frame: 8 times for 4 weeks
Measured by validated tensiometer.
5 secondary outcomes
range of movement
Time frame: 8 times for 4 weeks
pain pressure threshold
Time frame: 8 times for 4 weeks
Respiratory rate
Time frame: 8 times for 4 weeks
oxygen saturation
Time frame: 8 times for 4 weeks
Heart rate
Time frame: 8 times for 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angela Rio principal investigator
Universidad Europea de Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cervical stimuli and terminus in people with Blood Pressure and Nervous System Diseases, Sympathetic, run by Universidad Europea de Madrid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: 8 times for 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.