Dysmenorrhea PrimaryEDLMDPNCT07378475
Evaluation of the Effectiveness of Manual Lymphatic Drainage in Young Women With Primary Dysmenorrhea
A study testing Manual Lymphatic Drainage (MLD) in people with Dysmenorrhea Primary, run by Camilo Jose Cela University at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Dysmenorrhea Primary
- What is being tested?
- Manual Lymphatic Drainage (MLD)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 30 Jan 2026to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female participants aged 18-25 years
- Confirmed diagnosis of primary dysmenorrhea
- Regular menstrual cycles
- Ability to provide informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Dysmenorrhea Primary
- Being tested
- Manual Lymphatic Drainage (MLD)
- Keywords
- Manual Lymphatic Drainage, physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Manual Lymphatic Drainage (MLD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured bilaterally at L2 and S2 esclerotomes using a Fischer algometer (FPK-20). The tests will be carried out in the late luteal phase.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: baseline assessment, post intervention in third month, and fourth month (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start30 Jan 2026
- Primary completion28 Feb 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysmenorrhea PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Camilo Jose Cela University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edurne Úbeda D'Ocasar, Camilo Jose Cela University
- Investigators
- Edurne Úbeda Docasar, Doctor, Principal investigator, University Camilo José Cela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378475
- Sponsor's protocol ID
- UCJCDLMDP
- Acronym
- EDLMDP
- Status last verified
- Jul 2026
- First submitted
- 20 Dec 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Manual Lymphatic Drainage in Young Women With Primary Dysmenorrhea
- ClinicalTrials.gov ID
- NCT07378475
- Acronym / sponsor ID
- EDLMDP / UCJCDLMDP
- Conditions
- Dysmenorrhea Primary
- Keywords
- Manual Lymphatic Drainage, physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Camilo Jose Cela UniversityUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Manual Lymphatic Drainage Group | Experimental | Other: Manual Lymphatic Drainage (MLD)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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female participants aged 18-25 years
- Confirmed diagnosis of primary dysmenorrhea
- Regular menstrual cycles
- Ability to provide informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Manual Lymphatic Drainage Group |
Primary outcome
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).
7 secondary outcomes
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)
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)
Pittsburgh Sleep Quality Index questionnaire.
Time frame: baseline assessment, post intervention in third month, and fourth month (follow-up)
Health-Related Quality of Life (EQ-5D-5L)
Time frame: baseline assessment, post intervention in third month, and fourth month (follow-up)
Dysmenorrhea Severity (WaLIDD Score)
Time frame: baseline assessment, post intervention in third month, and fourth month (follow-up)
Andersh and Milsom dysmenorrhoea scale
Time frame: baseline assessment, post intervention in third month, and fourth month (follow-up)
Menstrual Symptom Questionnaire (MSQ)
Time frame: baseline assessment, post intervention in third month, and fourth month (follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edurne Úbeda Docasar, Doctor principal investigator
University Camilo José Cela
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage (MLD) in people with Dysmenorrhea Primary, run by Camilo Jose Cela University at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: baseline assessment, in the menstrual assessment of the first, second, and third months, and in the follow-up (fourth month)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.