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NCT Number: NCT07378475

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

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.

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Key information

Conditions

Dysmenorrhea Primary

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Lymphatic Drainage (MLD)

Other

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.

Primary outcomes

  1. VAS

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

    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).

Secondary outcomes

  1. Pressure Pain Threshold (Algometry)

    Time frame: 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)

    Measured bilaterally at L2 and S2 esclerotomes using a Fischer algometer (FPK-20). The tests will be carried out in the late luteal phase.

  2. Abdominal Circumference (Circumferential Measurement)

    Time frame: 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)

    Measured at supraumbilical and infraumbilical levels using a flexible tape.

  3. Pittsburgh Sleep Quality Index questionnaire.

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

    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.

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

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

    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.

  5. Dysmenorrhea Severity (WaLIDD Score)

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

    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).

  6. Andersh and Milsom dysmenorrhoea scale

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

    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).

  7. Menstrual Symptom Questionnaire (MSQ)

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

    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.

Other outcomes

  1. Age

    Time frame: baseline

    Age (years)

  2. Characteristics of dysmenorrhoea. Regularity

    Time frame: baseline

    Regularity of the menstrual cycle

  3. Characteristics of dysmenorrhoea. Menarche

    Time frame: baseline

    Age at menarche

  4. Characteristics of dysmenorrhoea. Duration.

    Time frame: baseline

    Duration of menstruation.

  5. Characteristics of dysmenorrhoea. History.

    Time frame: baseline

    gynaecological history and use of cycle-related medication (contraceptives, analgesics, anti-inflammatories) or other medical indications.

  6. Weight

    Time frame: baseline

    weight, measured in kilograms

  7. BMI

    Time frame: baseline

    body mass index

Study contacts

Contact information is provided by the study sponsor or research team.

Edurne Úbeda Docasar, Doctor

CONTACT

[email protected]

918153131

Sponsors and collaborators

Lead sponsor

Camilo Jose Cela University

Other

Registry information

Acronym: EDLMDP

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 30, 2026
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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