HealthyNCT05809726
The Effects of Manual Lymphatic Drainage on the Autonomic Nerve System
A study testing Manual lymph drainage in people with Healthy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Forty healthy women who met the inclusion criteria were included in the study. In the single-blind randomized controlled study, the participants were divided into 3 groups manual lymphatic drainage(MLD), sham MLD, and control group. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Manual lymph drainage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2021to 15 May 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- being over 18 years of age
- being voluntary to participate in the study
Who cannot join
- having advanced cardiorespiratory diseases
- orthopedic and neurological problems
- using medication related to pain
- cardiovascular system, having skin disorders that prevent skin contact
- having cold urticaria
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University
Kütahya, Kütahya, 43100
About this study
Official title: Does Manual Lymph Drainage Affect Autonomic Functions in Healthy Women?
Forty healthy women who met the inclusion criteria were included in the study. In the single-blind randomized controlled study, the participants were divided into 3 groups manual lymphatic drainage(MLD), sham MLD, and control group. After evaluating the demographic information, blood pressure, and heart rate variability (HRV) of the participants, the cold pressure test was applied. Immediately after the test, blood pressure and HRV were re-evaluated. The MLD group received short neck, abdominal, and lymph node stimulation and right arm MLD applications. A sham protocol was applied to the sham MLD group. The control group was asked to lie on their back for 10 minutes. After the application, blood pressure and HRV were re-evaluated.
Read the detailed description
The participants included in the study were randomly divided into 3 groups; manual lymph drainage, sham manual lymph drainage, and a control group in the computer program.
Participants rested for 5 minutes before the first evaluation. The first evaluation was made after the demographic information of the participant was obtained. Within the scope of this evaluation, blood pressure, heart rate, and heart rate variability were evaluated. All assessments were performed on the patient's dominant upper extremity. After the evaluation, cold pressure test was applied to the dominant extremity. A second assessment was made immediately after the test. All of the parameters examined within the scope of the first evaluation were examined for the second time. Appropriate treatment was applied to the group to which the participant belonged. After the treatment, the third evaluation was made and the study was terminated. All participants were asked to avoid exercise, caffeine, energy drinks, and heavy meals at least 1 hour before the test. Environmental noise, light, and temperature were controlled during the test.
- Conditions
- Healthy
- Being tested
- Manual lymph drainage
- Keywords
- manual lymph drainage, autonomic function, heart rate variability, cold pressure test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual lymph drainageOther
Also called Sham manual lymph drainage
one session 20 minutes
| Study group | Role | What they receive |
|---|---|---|
| Manual lymph drainage group | Experimental | Manual lymph drainage; neck drainage, abdominal drainage, stimulation of axillary lymph nodes, and right arm drainage were performed by following a special technique and sequence. MLD was applied in a comfortable position while the patient was lying in the supine position. It took an average of 20 minutes. Receives: Other: Manual lymph drainage |
| Sham manual lymph drainage group | Sham comparator | Sham manual lymph drainage; deep pressure was applied from distal to proximal with rapid movements to the right extremity to which the cold pressure test was applied. Fingers, dorsal and palmar surfaces of the hand, forearm, elbow, and upper arm were applied in order. The application was performed while the patient was lying in the supine position and lasted an average of 20 minutes. Receives: Other: Manual lymph drainage |
| Control Group | No intervention | Participants in the control group were asked to lie on their backs for 10 minutes without speaking in a quiet, calm environment. At the end of 10 minutes, the patient was placed in a sitting position again and the third evaluation was performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
autonomic functions assessment
heart rate variability
Measured: 1 year
physiological parameter
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start15 Jul 2021
- Primary completion15 Jan 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- randomized controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05809726
- Sponsor's protocol ID
- 2021/03-06
- Status last verified
- Jan 2023
- First submitted
- 25 Jan 2023
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SJ, Kwon OY, Yi CH. Effects of manual lymph drainage on cardiac autonomic tone in healthy subjects. Int J Neurosci. 2009;119(8):1105-17. doi: 10.1080/00207450902834884.
PubMed 19922342Honguten A, Mekhora K, Pichaiyongwongdee S, Somprasong S. Effects of lymphatic drainage therapy on autonomic nervous system responses in healthy subjects: A single blind randomized controlled trial. J Bodyw Mov Ther. 2021 Jul;27:169-175. doi: 10.1016/j.jbmt.2021.03.019. Epub 2021 Mar 28.
PubMed 34391230Schingale FJ, Esmer M, Kupeli B, Unal D. Investigation of the Less Known Effects of Manual Lymphatic Drainage: A Narrative Review. Lymphat Res Biol. 2022 Feb;20(1):7-10. doi: 10.1089/lrb.2019.0091. Epub 2021 Mar 22.
PubMed 33751912
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Manual Lymph Drainage Affect Autonomic Functions in Healthy Women?
- ClinicalTrials.gov ID
- NCT05809726
- Acronym / sponsor ID
- 2021/03-06
- Conditions
- Healthy
- Keywords
- manual lymph drainage, autonomic function, heart rate variability, cold pressure test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 12 Apr 2023 (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.
Forty healthy women who met the inclusion criteria were included in the study. In the single-blind randomized controlled study, the participants were divided into 3 groups manual lymphatic drainage(MLD), sham MLD, and control group. After evaluating the demographic information, blood pressure, and heart rate variability (HRV) of the participants, the cold pressure test was applied. Immediately after the test, blood pressure and HRV were re-evaluated. The MLD group received short neck, abdominal, and lymph node stimulation and right arm MLD applications. A sham protocol was applied to the sham MLD group. The control group was asked to lie on their back for 10 minutes. After the application, blood pressure and HRV were re-evaluated.
Detailed description
The participants included in the study were randomly divided into 3 groups; manual lymph drainage, sham manual lymph drainage, and a control group in the computer program.
Participants rested for 5 minutes before the first evaluation. The first evaluation was made after the demographic information of the participant was obtained. Within the scope of this evaluation, blood pressure, heart rate, and heart rate variability were evaluated. All assessments were performed on the patient's dominant upper extremity. After the evaluation, cold pressure test was applied to the dominant extremity. A second assessment was made immediately after the test. All of the parameters examined within the scope of the first evaluation were examined for the second time. Appropriate treatment was applied to the group to which the participant belonged. After the treatment, the third evaluation was made and the study was terminated. All participants were asked to avoid exercise, caffeine, energy drinks, and heavy meals at least 1 hour before the test. Environmental noise, light, and temperature were controlled during the test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Manual lymph drainage group | Experimental | Other: Manual lymph drainageManual lymph drainage; neck drainage, abdominal drainage, stimulation of axillary lymph nodes, and right arm drainage were performed by following a special technique and sequence. MLD was applied in a comfortable position while the patient was lying in the supine position. It took an average of 20 minutes. |
| Sham manual lymph drainage group | Sham comparator | Other: Manual lymph drainageSham manual lymph drainage; deep pressure was applied from distal to proximal with rapid movements to the right extremity to which the cold pressure test was applied. Fingers, dorsal and palmar surfaces of the hand, forearm, elbow, and upper arm were applied in order. The application was performed while the patient was lying in the supine position and lasted an average of 20 minutes. |
| Control Group | No intervention | –Participants in the control group were asked to lie on their backs for 10 minutes without speaking in a quiet, calm environment. At the end of 10 minutes, the patient was placed in a sitting position again and the third evaluation was performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- being over 18 years of age
- being voluntary to participate in the study
Key exclusion criteria (5 listed)
- having advanced cardiorespiratory diseases
- orthopedic and neurological problems
- using medication related to pain
- cardiovascular system, having skin disorders that prevent skin contact
- having cold urticaria
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 |
|---|---|---|
| Manual lymph drainageAlso: Sham manual lymph drainageone session 20 minutes | Other | Manual lymph drainage group, Sham manual lymph drainage group |
Primary outcome
autonomic functions assessment
Time frame: 1 year
heart rate variability
physiological parameter
Time frame: 1 year
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
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 12 Apr 2023.
- Results publication: PubMed 19922342Kim SJ, Kwon OY, Yi CH. Effects of manual lymph drainage on cardiac autonomic tone in healthy subjects. Int J Neurosci. 2009;119(8):1105-17. doi: 10.1080/00207450902834884.
- Results publication: PubMed 34391230Honguten A, Mekhora K, Pichaiyongwongdee S, Somprasong S. Effects of lymphatic drainage therapy on autonomic nervous system responses in healthy subjects: A single blind randomized controlled trial. J Bodyw Mov Ther. 2021 Jul;27:169-175. doi: 10.1016/j.jbmt.2021.03.019. Epub 2021 Mar 28.
- Results publication: PubMed 33751912Schingale FJ, Esmer M, Kupeli B, Unal D. Investigation of the Less Known Effects of Manual Lymphatic Drainage: A Narrative Review. Lymphat Res Biol. 2022 Feb;20(1):7-10. doi: 10.1089/lrb.2019.0091. Epub 2021 Mar 22.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual lymph drainage in people with Healthy, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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 12 Apr 2023. 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 Turkey (Türkiye). 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?
autonomic functions assessment (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05809726, which also lists 3 linked publications.
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 12 Apr 2023.