Evaluation of the Effectiveness of Manual Lymphatic Drainage in Young Women With Primary Dysmenorrhea (EDLMDP)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dysmenorrhea Primary
• Intervention / Treatment: Other: Manual Lymphatic Drainage (MLD)

Detailed Description

Primary dysmenorrhea (PD) is defined as menstrual pain of uterine origin occurring in the absence of pelvic pathology. It typically affects adolescents and young women with regular ovulatory cycles. The pathophysiology involves hormonal changes during the late luteal phase, leading to increased prostaglandin synthesis, uterine hypercontractility, ischemia, and heightened nociceptive sensitivity.

Non-pharmacological interventions such as physical therapy techniques have shown promising results in alleviating symptoms. Manual lymphatic drainage (MLD), based on the Vodder method, uses gentle, rhythmic maneuvers to stimulate lymphatic flow, reduce tissue congestion, and promote parasympathetic activation, potentially improving pain perception and associated symptoms.

This study will assess whether MLD reduces pain intensity, abdominal swelling, and improves sleep quality and overall quality of life in women with PD.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Edurne Úbeda Docasar, Doctor; Phone Number: 918153131; Email: eubeda@ucjc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Manual Lymphatic Drainage Group; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold (Algometry)	Measured bilaterally at L2 and S2 esclerotomes using a Fischer algometer (FPK-20). The tests will be carried out in the late luteal phase.	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)	Measured at supraumbilical and infraumbilical levels using a flexible tape.	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.	The Pittsburgh Sleep Quality Index (PSQI) was used to assess sleep quality, which allows the impact of menstrual pain on rest to be determined.The total score ranges from 0 to 21, where values greater than 5 indicate poor quality and values equal to or less than 5 reflect adequate rest.	baseline assessment, post intervention in third month, and fourth month (follow-up)
Health-Related Quality of Life (EQ-5D-5L)	EuroQol questionnaire assessing mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.This scale ranges from 0 to 100, with 0 being the worst possible health status and 100 being the best health status.	baseline assessment, post intervention in third month, and fourth month (follow-up)
Dysmenorrhea Severity (WaLIDD Score)	Validated tool assessing work ability, pain location, intensity, and duration. The severity level is classified as: no dysmenorrhea (0), mild (1-4), moderate (5-7), and severe (8-12).	baseline assessment, post intervention in third month, and fourth month (follow-up)
Andersh and Milsom dysmenorrhoea scale	The severity of dysmenorrhoea will be assessed using the Andersch and Milsom Scale, which classifies pain into four grades (0-3): grade 0 (no pain or limitation), grade 1 (mild pain with minimal interference), grade 2 (moderate pain with some interference with activities and relief with analgesics) and grade 3 (severe pain with marked limitation and poor response to treatment).	baseline assessment, post intervention in third month, and fourth month (follow-up)
Menstrual Symptom Questionnaire (MSQ)	The Menstrual Symptom Questionnaire (MSQ) allows two forms of dysmenorrhoea to be assessed: spasmodic and congestive. The first 24 items assess symptoms characteristic of each type, with responses on a scale from 1 ('never') to 5 ('always'). Items associated with spasmodic dysmenorrhoea (S) are scored directly, while those associated with congestive dysmenorrhoea (C) are scored inversely. The final item (25) allows the participant to identify the type of dysmenorrhoea that best describes her experience. The total score ranges from 29 to 125 points, with higher values reflecting greater intensity of menstrual symptoms.	baseline assessment, post intervention in third month, and fourth month (follow-up)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	body mass index	baseline
Age	Age (years)	baseline
Characteristics of dysmenorrhoea. Regularity	Regularity of the menstrual cycle	baseline
Characteristics of dysmenorrhoea. Menarche	Age at menarche	baseline
Characteristics of dysmenorrhoea. Duration.	Duration of menstruation.	baseline
Characteristics of dysmenorrhoea. History.	gynaecological history and use of cycle-related medication (contraceptives, analgesics, anti-inflammatories) or other medical indications.	baseline
Weight	weight, measured in kilograms	baseline

Collaborators and Investigators

• Sponsor: Camilo Jose Cela University
• Investigators: Principal Investigator: Edurne Úbeda Docasar, Doctor, University Camilo José Cela

Study record dates

Study Major Dates

• Study Start (Estimated): January 30, 2026
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: December 20, 2025
• First Submitted That Met QC Criteria: January 27, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): February 5, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: physiotherapy; Manual Lymphatic Drainage
• Additional Relevant MeSH Terms: Therapeutics; Complementary Therapies; Physical Therapy Modalities; Rehabilitation; Therapy, Soft Tissue; Musculoskeletal Manipulations; Massage; Drainage; Manual Lymphatic Drainage
• Other Study ID Numbers: UCJCDLMDP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No