NCT05809726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
Last Updated

April 12, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 25, 2023

Last Update Submit

March 30, 2023

Conditions

Healthy

Keywords

manual lymph drainageautonomic functionheart rate variabilitycold pressure test

Outcome Measures

Primary Outcomes (2)

  • autonomic functions assessment

    heart rate variability

    1 year

  • physiological parameter

    Systolic blood pressure (mmHg) and diastolic blood pressure (mmHg)

    1 year

Study Arms (3)

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.

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.

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.

Interventions

Manual lymph drainageOTHER

one session 20 minutes

Also known as: Sham manual lymph drainage
Manual lymph drainage groupSham manual lymph drainage group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being over 18 years of age
  • being voluntary to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, Kütahya, 43100, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 19922342RESULT

  • 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.

    PMID: 34391230RESULT

  • 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.

    PMID: 33751912RESULT

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2023

First Posted

April 12, 2023

Study Start

July 15, 2021

Primary Completion

January 15, 2022

Study Completion

May 15, 2022

Last Updated

April 12, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)