The Effects of Manual Lymphatic Drainage and Self-Manual Lymphatic Drainage

NCT07814807 | Not Yet Recruiting

• 1 other identifier: Lymphatic Drainage-35
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aims to compare the effects of manual lymphatic drainage (MLD), self-manual lymphatic drainage (self-MLD), and sham MLD on autonomic nervous system activity and premenstrual symptoms in women with premenstrual syndrome (PMS). A total of 60 women with PMS will be randomly assigned to three groups: MLD, self-MLD, or sham MLD. The intervention will be conducted during the luteal phase of the menstrual cycle for 2 weeks, with three sessions per week, for a total of six sessions. Outcomes will include premenstrual symptoms, heart rate and heart rate variability, blood pressure, pain, edema, quality of life, fatigue, depression, anxiety, and stress. Assessments will be performed at predetermined time points before, during, and after the intervention to compare the acute and overall effects of the three approaches.

Conditions

Premenstrual Syndrome

Keywords

Premenstrual Syndrome; Manual Lymphatic Drainage; Self-Manual Lymphatic Drainage; Heart Rate Variability; Autonomic Nervous System; Edema; Pain

Outcome Measures

Primary Outcomes (2)

• Premenstrual Syndrome Symptoms Assessed by the Premenstrual Syndrome Scale (PMSS)

  Premenstrual symptoms will be assessed using the Premenstrual Syndrome Scale (PMSS). The PMSS consists of 44 items across nine subdimensions: depressive affect, anxiety, fatigue, irritability, depressive thoughts, pain, appetite changes, sleep changes, and bloating. Each item is scored from 1 to 5. The total score ranges from 44 to 220, with higher scores indicating greater severity of premenstrual symptoms.

  Baseline, after the third session (approximately 1 week), and immediately after the sixth session (2 weeks)

• Heart Rate Variability - High-Frequency (HF) Power

  Heart rate variability (HRV) will be assessed using a Polar H10 heart rate sensor. RR intervals will be recorded for 5 minutes using the Elite HRV smartphone application. High-frequency (HF) power will be analyzed as a frequency-domain measure of HRV and autonomic nervous system activity.

  Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

Secondary Outcomes (22)

• Heart Rate Variability - Standard Deviation of NN Intervals (SDNN)

  Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

• Heart Rate Variability - Root Mean Square of Successive Differences (RMSSD)

  Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

• Heart Rate Variability - pNN50

  Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

• Mean RR Interval

  Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

• Heart Rate Variability - Low-Frequency (LF) Power

  Baseline, immediately after the first session, before the sixth session, and immediately after the sixth session (2 weeks)

Other Outcomes (2)

• Adherence to Self-Manual Lymphatic Drainage

  Throughout the 2-week intervention period

• Satisfaction With the Assigned Lymphatic Drainage Intervention

  Immediately after completion of the 2-week intervention period

Study Arms (3)

Manual Lymphatic Drainage

EXPERIMENTAL

Participants will receive a standard manual lymphatic drainage (MLD) protocol administered by an experienced physiotherapist. The intervention will include the basic regions and the upper and lower extremities using gentle, rhythmic maneuvers consistent with classical MLD techniques. The intervention will be administered during the luteal phase for 2 weeks, three sessions per week, for a total of six sessions. Each session will last approximately 45-60 minutes.

Other: Manual Lymphatic Drainage (MLD)

Self-Manual Lymphatic Drainage

EXPERIMENTAL

Participants will be taught simple and safe self-manual lymphatic drainage (self-MLD) techniques under the supervision of a physiotherapist. They will perform the techniques at home according to the predetermined protocol, with online or face-to-face follow-up when necessary. The intervention will be performed during the luteal phase for 2 weeks, three sessions per week, for a total of six sessions.

Other: Self-Manual Lymphatic Drainage (Self-MLD)

Sham Manual Lymphatic Drainage

SHAM COMPARATOR

Participants will be positioned in the same manner as in the classical MLD intervention. Very light and irregular rhythmic touches that are not intended to increase lymphatic flow and are expected to have minimal therapeutic effect will be applied to provide tactile contact. The duration and schedule will be matched to the intervention protocol.

Other: Sham Manual Lymphatic Drainage (Sham MLD)

Interventions

Manual Lymphatic Drainage (MLD) OTHER

Manual lymphatic drainage will be administered by an experienced physiotherapist using classical MLD techniques. The intervention will include the basic regions and the upper and lower extremities using gentle, rhythmic maneuvers that support lymphatic circulation. Each session will last approximately 45-60 minutes. The intervention will be performed during the luteal phase of the menstrual cycle for 2 weeks, three sessions per week, for a total of six sessions.

Manual Lymphatic Drainage

Self-Manual Lymphatic Drainage (Self-MLD) OTHER

Participants will be taught simple and safe self-manual lymphatic drainage techniques under the supervision of a physiotherapist. They will perform the techniques at home according to the predetermined protocol. The frequency, duration, and application procedure will be explained in detail, and correct performance will be supported through online or face-to-face follow-up when necessary. The intervention will be performed during the luteal phase for 2 weeks, three sessions per week, for a total of six sessions.

Self-Manual Lymphatic Drainage

Sham Manual Lymphatic Drainage (Sham MLD) OTHER

Participants will be positioned in the same manner as for classical MLD. Very light and irregular rhythmic touches that are not intended to increase lymphatic flow and are expected to have minimal therapeutic effect will be applied solely to provide tactile contact. The duration and schedule of the sham intervention will be matched to the study intervention protocol.

Sham Manual Lymphatic Drainage

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female participants aged 18-40 years
• Having a regular menstrual cycle every 24-32 days during the last 6 months
• Having symptom severity above the cut-off score determined according to the Premenstrual Syndrome Scale (PMSS) during the premenstrual period
• Having premenstrual syndrome symptoms for at least the last 3 menstrual cycles
• Being literate and having the cognitive ability to complete the questionnaires
• Providing voluntary informed consent after being informed about the study

You may not qualify if:

• Having an irregular menstrual cycle, amenorrhea, or being in the menopausal period
• Being pregnant or breastfeeding
• Having a history of significant cardiovascular, respiratory, neurological, orthopedic, or metabolic disease
• Regular use of medications that may affect the autonomic nervous system, pain, or sleep, such as antidepressants or beta-blockers
• Having a condition that constitutes a contraindication to manual lymphatic drainage, such as acute infection, deep vein thrombosis, or advanced heart failure

Sponsors & Collaborators

• Izmir Democracy University: lead

Study Sites (1)

Cappadocia University Cappadocia Vocational College, Physiotherapy Program

Nevşehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Edema; Pain

Interventions

Manual Lymphatic Drainage

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Physical Therapy Modalities; Rehabilitation

Study Officials

• Betül TAŞPINAR, Prof. Dr.

  Izmir Democracy University

  PRINCIPAL INVESTIGATOR

• Merve KOKU, MSc PT

  Cappadocia University

  STUDY DIRECTOR

Central Study Contacts

Betül TAŞPINAR, Prof. Dr.

CONTACT

+90 506 680 44 26; ptbetul@gmail.com

Merve KOKU, MSc. PT.

CONTACT

+90 534 524 54 36; kokumrve@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start (Estimated): October 5, 2026
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): July 5, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)