Sahid Method for Secondary Unilateral Lower Limb 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.

• Change in lymphoscintigraphic Transport Index (TI), 0-45 (lower better) [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 [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) [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 [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) [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 [Time frame: During the 4-week intervention (12 sessions)]
• Mean resting diastolic blood pressure during the intervention, mmHg [Time frame: During the 4-week intervention (12 sessions)]
• Mean resting heart rate during the intervention, bpm [Time frame: During the 4-week intervention (12 sessions)]
• Change in Lymphedema Quality of Life (LYMQOL)-Leg Symptoms domain score, 1-4 (higher worse) [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) [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) [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) [Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)]