NCT07378475

Brief Summary

This pilot clinical trial aims to evaluate the effectiveness of manual lymphatic drainage (MLD) in reducing symptoms associated with primary dysmenorrhea in young women. Primary dysmenorrhea is a common gynecological condition characterized by intense pelvic pain during menstruation, often accompanied by fatigue, headache, and sleep disturbances. Despite its high prevalence, it is frequently underestimated, negatively impacting quality of life and daily activities. The intervention consists of three monthly sessions of MLD performed during the late luteal phase, prior to menstruation. Outcome measures include pain intensity, abdominal circumference, pressure pain threshold, sleep quality, and health-related quality of life.

Trial Health

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Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
2mo left

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress64%
Jan 2026Jul 2026

First Submitted

Initial submission to the registry

December 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 30, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

29 days

First QC Date

December 20, 2025

Last Update Submit

February 3, 2026

Conditions

Keywords

Manual Lymphatic Drainagephysiotherapy

Outcome Measures

Primary Outcomes (1)

  • VAS

    Change in pain intensity measured by Visual Analog Scale (VAS). Visual Analog Scale (0-10 cm) to assess menstrual pain intensity. Scores are classified as mild dysmenorrhoea (1-3 points), moderate dysmenorrhoea (4-7 points) and severe dysmenorrhoea (8-10 points).

    baseline assessment, in the menstrual assessment of the first, second, and third months, and in the follow-up (fourth month)

Secondary Outcomes (7)

  • Pressure Pain Threshold (Algometry)

    pre and post-intervention measurement in first month, pre and post-intervention measurement in the second month, pre and postintervention measurement in the third month, and in forth month (follow up)

  • Abdominal Circumference (Circumferential Measurement)

    second day of menstruation in the first month (baseline), second day of menstruation in the second month, second day of menstruation in the third month, and second day of menstruation in the fourth month (follow-up)

  • Pittsburgh Sleep Quality Index questionnaire.

    baseline assessment, post intervention in third month, and fourth month (follow-up)

  • Health-Related Quality of Life (EQ-5D-5L)

    baseline assessment, post intervention in third month, and fourth month (follow-up)

  • Dysmenorrhea Severity (WaLIDD Score)

    baseline assessment, post intervention in third month, and fourth month (follow-up)

  • +2 more secondary outcomes

Other Outcomes (7)

  • Age

    baseline

  • Characteristics of dysmenorrhoea. Regularity

    baseline

  • Characteristics of dysmenorrhoea. Menarche

    baseline

  • +4 more other outcomes

Study Arms (1)

Manual Lymphatic Drainage Group

EXPERIMENTAL

All enrolled participants (N=20) will receive the intervention consisting of manual lymphatic drainage (MLD) following the Vodder method. The treatment will be applied during the late luteal phase (5-7 days before menstruation) in three consecutive menstrual cycles. Each session will last approximately 30-45 minutes and will include preparatory maneuvers (terminus, solar plexus, inguinal chains) and abdominal drainage sequence. No control group is included in this pilot study.

Other: Manual Lymphatic Drainage (MLD)

Interventions

This method, part of complex decongestive physiotherapy, involves gentle massage techniques that stimulate lymphatic circulation and venous return. Participants will receive three sessions of MLD during the late luteal phase (5-7 days before menstruation) over three consecutive menstrual cycles. Each session will last approximately 30-45 minutes and will follow the Vodder method, including preparatory maneuvers (terminus, solar plexus, inguinal chains) and abdominal drainage sequence. Frequency: One session per cycle for three months.

Manual Lymphatic Drainage Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged 18-25 years
  • Confirmed diagnosis of primary dysmenorrhea
  • Regular menstrual cycles
  • Ability to provide informed consent

You may not qualify if:

  • Secondary dysmenorrhea
  • Use of hormonal contraceptives
  • Presence of pelvic pathology (endometriosis, polycystic ovary syndrome, fibroids)
  • Irritable bowel syndrome
  • Use of analgesics or anti-inflammatory drugs within 12 hours prior to intervention
  • Any therapy for dysmenorrhea in the previous month
  • Pregnancy or suspected pregnancy
  • Irregular menstrual cycles

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Manual Lymphatic Drainage

Intervention Hierarchy (Ancestors)

MassageTherapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsDrainagePhysical Therapy ModalitiesRehabilitation

Study Officials

  • Edurne Úbeda Docasar, Doctor

    University Camilo José Cela

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Edurne Úbeda Docasar, Doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

December 20, 2025

First Posted

January 30, 2026

Study Start

January 30, 2026

Primary Completion

February 28, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 5, 2026

Record last verified: 2026-02