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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-25
SponsorCamilo Jose Cela University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female participants aged 18-25 years

Confirmed diagnosis of primary dysmenorrhea

Regular menstrual cycles

Ability to provide informed consent

Disqualifiers

Secondary dysmenorrhea

Use of hormonal contraceptives

Presence of pelvic pathology (endometriosis, polycystic ovary syndrome, fibroids)

Irritable bowel syndrome

Trial design

Design model

Single group

Treatments tested in this trial

  • Manual Lymphatic Drainage (MLD)

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Manual Lymphatic Drainage GroupExperimental treatment 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

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.

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)
2

Abdominal Circumference (Circumferential Measurement)

Measured at supraumbilical and infraumbilical levels using a flexible tape.

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)
3

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.

Time frame
baseline assessment, post intervention in third month, and fourth month (follow-up)
4

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.

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

Other outcomes

1

Age

Age (years)

Time frame
baseline
2

Characteristics of dysmenorrhoea. Regularity

Regularity of the menstrual cycle

Time frame
baseline
3

Characteristics of dysmenorrhoea. Menarche

Age at menarche

Time frame
baseline
4

Characteristics of dysmenorrhoea. Duration.

Duration of menstruation.

Time frame
baseline

Locations

This trial has no locations.

Sponsors and contacts

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