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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Age | Age (years) | baseline |
| Characteristics of dysmenorrhoea. Regularity | Regularity of the menstrual cycle | baseline |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edurne Úbeda Docasar, Doctor | Contact | 918153131 | eubeda@ucjc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Edurne Úbeda Docasar, Doctor | University Camilo José Cela | Principal Investigator |
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| ID | Term |
|---|---|
| D000073297 | Manual Lymphatic Drainage |
| ID | Term |
|---|---|
| D008405 | Massage |
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
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|
| 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) |
| 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 |
| BMI | body mass index | baseline |
| D013812 |
| Therapeutics |
| D004322 | Drainage |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |