The Effects of Manual Lymphatic Drainage on the Autonomic Nerve System

March 30, 2023 updated by: Kutahya Health Sciences University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kutahya
      • Kütahya, Kutahya, Turkey, 43100
        • Kutahya Health Sciences University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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 manual lymph drainage
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:
  • Sham manual lymph drainage
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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2021

Primary Completion (Actual)

January 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

March 30, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

March 30, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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