- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05809726
The Effects of Manual Lymphatic Drainage on the Autonomic Nerve System
Does Manual Lymph Drainage Affect Autonomic Functions in Healthy Women?
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kutahya
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Kütahya, Kutahya, Turkey, 43100
- Kutahya Health Sciences University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- being over 18 years of age
- being voluntary to participate in the study
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Manual lymph drainage group
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.
|
one session 20 minutes
Other Names:
|
|
Sham Comparator: Sham manual lymph drainage group
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.
|
one session 20 minutes
Other Names:
|
|
No Intervention: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
autonomic functions assessment
Time Frame: 1 year
|
heart rate variability
|
1 year
|
|
physiological parameter
Time Frame: 1 year
|
Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)
|
1 year
|
Collaborators and Investigators
Publications and helpful links
General 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.
- Honguten 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.
- Schingale 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2021/03-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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