An interventional study of Paloma Sahid Method, a patented technique (PCT/CL2023/050061) in Lymphedema, sponsored by University Diego Portales. Enrolling by invitation at 1 site in Chile. Open to female participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by University Diego Portales · Not applicable, Interventional, and Treatment
Manual lymphatic drainage (MLD) is a non-invasive technique frequently used in the management of lymphedema. The Paloma Sahid Method is a patented approach to lymphatic drainage that combines specific manual and mechanical maneuvers and compression. This single-arm clinical trial will evaluate its effects on lower-limb circumference, functional capacity, and quality of life in adult women with secondary unilateral lymphedema.
Thirty-two women aged 30-65 years with stage I-II secondary lymphedema affecting one lower limb will be enrolled through referrals from vascular physicians in public and private centers in the Metropolitan Region of Santiago, Chile. Participants will attend two pre-intervention visits: (1) study information and informed consent; (2) baseline assessments including thermography, body composition and BMI (bioimpedance), blood pressure and heart rate, limb volume by circumferential tape measurements, muscle strength by handheld dynamometry, quality of life (LYMQOL), and function (Lower Extremity Functional Scale, LEFS). A randomized subsample of 10 participants will undergo lymphoscintigraphy before and after treatment to characterize lymphatic circulation.
The intervention consists of 12 sessions of lymphatic drainage using the Paloma Sahid Method, delivered three times per week over one month (about 80 minutes per session). Maneuvers follow linear sliding patterns directed toward regional lymph nodes and are complemented by compression therapy. After completing the 12 sessions, all baseline assessments are repeated.
The primary objective is to determine change in lower-limb circumference from pre- to post-intervention. Secondary objectives include changes in functional capacity, quality of life, thermographic patterns, body composition, muscle strength, hemodynamic measures, and, in the subsample, lymphoscintigraphy findings. The study aims to provide rigorous clinical evidence on a promising, non-surgical option for individuals living with lymphedema.
Background and Rationale Lymphedema involves accumulation of protein-rich interstitial fluid due to impaired lymph transport, commonly leading to limb swelling, tissue changes, recurrent infections, functional limitations, and reduced quality of life. Management is typically multidisciplinary, and non-surgical strategies remain essential. The Paloma Sahid Method (patent code PCT/CL2023/050061) integrates manual and mechanical drainage with standardized linear sliding movements directed toward relevant lymph-node basins, complemented by compression therapy. Despite growing clinical use, robust, prospective evidence on its effects is needed.
Objectives
Primary: Evaluate the effect of lymphatic drainage using the Paloma Sahid Method on lower-limb circumference in adult women with secondary unilateral lymphedema.
Secondary: Assess changes in functional capacity (LEFS), quality of life (LYMQOL), thermographic patterns, body composition and BMI (bioimpedance), muscle strength (handheld dynamometry), resting blood pressure and heart rate, and, in a subsample, lymphoscintigraphy-based lymphatic flow characteristics.
Design and Setting Single-arm clinical trial conducted in Santiago, Chile. Participants attend two pre-intervention visits (consent and baseline testing), receive 12 treatment sessions over \~4 weeks, and complete post-intervention testing.
Participants Women aged 30-65 years with medically diagnosed secondary unilateral lower-limb lymphedema of ≤2 years' duration, classified as stage I or II, able to understand and complete study instruments, and providing informed consent. Key exclusions include inability to complete questionnaires, chronic conditions judged to contraindicate participation (e.g., unstable cardiovascular, pulmonary, autoimmune disease, or diabetes), and absence from more than two consecutive sessions.
Intervention Twelve sessions of lymphatic drainage using the Paloma Sahid Method, delivered three times weekly for one month, approximately 80 minutes per session. The protocol includes manual and mechanical maneuvers with linear sliding toward regional lymph nodes and prescribed compression parameters applied to the limb. Sessions are performed in an outpatient medical center; missed sessions are rescheduled within the same week when possible.
Assessments and Outcomes
Baseline and post-intervention evaluations include:
Anthropometry and composition: BMI and bioimpedance-based body composition.
Hemodynamics: Resting blood pressure and heart rate.
Limb volume: Circumferential tape measurements using a standardized protocol.
Muscle strength: Handheld dynamometry with standardized instructions.
Thermography: Infrared imaging of the lower extremities to describe temperature distribution patterns.
Function and quality of life: LEFS and LYMQOL questionnaires.
Lymphoscintigraphy (subsample, n=10): Pre- and post-intervention imaging to explore lymphatic circulation characteristics.
Primary Outcome Change in lower-limb circumference (affected limb) from pre- to post-intervention.
Secondary Outcomes Changes in LEFS, LYMQOL, thermographic patterns, body composition, muscle strength, blood pressure, heart rate, and lymphoscintigraphy indicators (subsample).
Sample Size and Recruitment A non-probability snowball strategy will be used to recruit 32 women via referrals from peripheral vascular physicians in public and private healthcare centers in the Metropolitan Region. The intervention will be delivered at a medical center located at Avenida La Dehesa 1201, Torre Norte, Office 616, Lo Barnechea.
Statistical Analysis Data will be checked for completeness and plausibility. Normality will be examined (e.g., Shapiro-Wilk). Pre- versus post-intervention changes will be analyzed with Student's t-test or Wilcoxon signed-rank test, as appropriate. Exploratory subgroup analyses (e.g., by age group or lymphedema stage) may be conducted. Two-sided tests and conventional significance levels will be used; effect sizes and confidence intervals will be reported.
Data Management and Quality Assurance Data will be captured in a secure, centralized database with routine backups, anonymization via coded identifiers, and access restricted to authorized personnel. Real-time validation checks will be used to minimize entry errors.
Ethics The protocol was approved by the Interfaculty Scientific Ethics Committee of Universidad Diego Portales on April 16, 2025 (protocol 01-2025). All participants will provide informed consent.
Registration Note Text intentionally omits in-text citations; supporting literature is listed in the References → Citations module of this record.
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 32 is below the median of 50 across 369 interventional studies indexed under Lymphedema.
Browse Lymphedema studies →University Diego Portales is the lead sponsor of 8 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women aged 30 to 65 years diagnosed with lymphedema classified as stage I or II.
Other: Paloma Sahid Method, a patented technique (PCT/CL2023/050061)
The participants will receive treatment that integrates manual and mechanical lymphatic drainage through linear sliding movements directed toward relevant lymph nodes. Each session lasts approximately one hour. This intervention was complemented by compression therapy, applying 30-40 mmHg at the ankle, 70% compression at the calf, and 30% compression at the thigh.
Change in lower-limb volume, mL (tape-derived)
Total limb volume (mL) from circumferences every 10 cm (standing). Segmental volume estimated with a truncated-cone approach using adjacent circumferences and 10 cm segment length; total volume is the sum of segments. Higher values indicate greater swelling (worse).
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in lymphoscintigraphic Transport Index (TI), 0-45 (lower better)
Semi-quantitative TI derived from visual criteria on lymphoscintigraphy; range 0-45, with values \<10 typical of normal transport; lower scores = better transport. Outcome is pre-post change in TI.
Time frame: Baseline (within 7 days prior to first session) and Post-intervention (within 7 days after last session)
Change in limb temperature difference (ΔT, °C) between affected and contralateral lower limb
Infrared thermography of predefined regions; ΔT (°C) = affected - contralateral. Positive values indicate higher temperature on the affected limb. Outcome is change in ΔT.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in Lower Extremity Functional Scale (LEFS) total score, 0-80 (higher better)
LEFS: 20 items scored 0-4; total 0-80; higher scores indicate better function. Outcome is change in total score.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in knee extensor isometric strength, kg
Handheld dynamometry in standardized position; three trials, maximum value (kg) retained. Outcome is change in kg.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in Fagerström Test for Nicotine Dependence (FTND) total score, 0-10 (higher worse)
FTND total score 0-10; higher scores indicate greater nicotine dependence. Outcome is change in total score.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Mean resting systolic blood pressure during the intervention, mmHg
Measured each session after ≥5 min seated rest; two readings averaged per session. Outcome is the per-participant mean (mmHg) across 12 sessions.
Time frame: During the 4-week intervention (12 sessions)
Mean resting diastolic blood pressure during the intervention, mmHg
Measured each session after ≥5 min seated rest; two readings averaged per session. Outcome is the per-participant mean (mmHg) across 12 sessions.
Time frame: During the 4-week intervention (12 sessions)
Mean resting heart rate during the intervention, bpm
Measured each session after ≥5 min seated rest; outcome is the per-participant mean (bpm) across 12 sessions.
Time frame: During the 4-week intervention (12 sessions)
Change in Lymphedema Quality of Life (LYMQOL)-Leg Symptoms domain score, 1-4 (higher worse)
LYMQOL-Leg domain mean score; 1-4; higher = worse. Outcome is change in domain score.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in Lymphedema Quality of Life (LYMQOL)-Leg Function domain score, 1-4 (higher worse)
Domain mean; higher = worse. Outcome is change in domain score.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in Lymphedema Quality of Life (LYMQOL)-Leg Appearance domain score, 1-4 (higher worse)
Domain mean; higher = worse. Outcome is change in domain score.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in Lymphedema Quality of Life (LYMQOL)-Leg Emotion domain score, 1-4 (higher worse)
Domain mean; higher = worse. Outcome is change in domain score.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in Lymphedema Quality of Life (LYMQOL)-Leg overall quality of life, Visual Analog Scale (VAS), 0-10 (higher better)
Self-rated overall QoL on 0-10 VAS; higher = better. Outcome is change in VAS.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in body mass index (BMI), kg/m²
BMI = weight/height² (kg/m²). Outcome is change in BMI.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in body fat percentage, %
Bioelectrical impedance under standardized pretest conditions. Outcome is change in % body fat.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in skeletal muscle mass, kg
Derived from bioelectrical impedance; outcome is change in kg.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in body weight, kg
Calibrated digital scale; outcome is change in kg.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Standing height, cm (baseline only)
Stadiometer; height recorded in cm at baseline for BMI calculation.
Time frame: Baseline (within 7 days prior to first session)
Change in pain intensity, Visual Analog Scale (VAS), 0-10 (higher worse)
10-cm VAS anchored at 0 = no pain and 10 = worst imaginable; outcome is change in score.
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Participants with intervention-related adverse events
Number of participants reporting events plausibly related to treatment (e.g., musculoskeletal discomfort, dizziness, falls), recorded during sessions and between-session reports.
Time frame: From first intervention session through Week 4 (study completion)
Plan to share: No — Individual participant data (IPD) will not be shared. The cohort is small and potentially re-identifiable, and the informed consent and ethics approval (UDP CEI 01-2025) do not authorize external sharing of individual-level data. Aggregate results will be reported. Study documents (e.g., protocol, analysis code, data dictionary) may be provided upon request.
Started Mar 2026 (actual). Primary completion is estimated for Dec 2026, 9 months after the start.
Of 175 non-industry interventional studies with no phase under Lymphedema, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 68. This study's planned 9 months is below that.
Counting every sponsor, half of 197 studies reached it within 25 months; a quarter within 9 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
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