Clinical trial NCT05809726: The Effects of Manual Lymphatic Drainage on the Autonomic Nerve System
Official title: Does Manual Lymph Drainage Affect Autonomic Functions in Healthy Women?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: manual lymph drainage
autonomic function
heart rate variability
cold pressure test
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: randomized controlled study
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: autonomic functions assessment
timeFrame: 1 year
measure: physiological parameter
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
state: Kutahya
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.