Effect of Lymphatic Drainage Using the Paloma Sahid Method on Secondary Unilateral Lower Limb Lymphedema in Chilean Adult Women: A Single-Arm Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in lower-limb volume, mL (tape-derived)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 30-65 year
- •Diagnosed with secondary unilateral lower limb lymphedema less or equal to two years due:surgery, infection, cancer or trauma
- •Residing in the Metropolitan Region , Chile
- •Having signed informed consent
排除标准
- •Inability to understand or respond t questionnaires
- •Presence of chronic illnesses such: pulmonary, cardiac or diabetes mellitus
- •Uncontrolled: hypertension (blood pressure ≥140/90 mmHg) hyperthyroidism (suppressed TSH with elevated free T4/T3), and hypothyroidism (elevated TSH with low free T4).Uncontrolled autoimmune disease(worsening symptoms and/or signs of exacerbation)
- •Absence from more than two consecutive sessions
研究组 & 干预措施
Experimental study group
Women aged 30 to 65 years diagnosed with lymphedema classified as stage I or II.
干预措施: Paloma Sahid Method, a patented technique (PCT/CL2023/050061) (Other)
结局指标
主要结局
Change in lower-limb volume, mL (tape-derived)
时间窗: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
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).
次要结局
- Change in lymphoscintigraphic Transport Index (TI), 0-45 (lower better)(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(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)(Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session))
- Change in knee extensor isometric strength, kg(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)(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(During the 4-week intervention (12 sessions))
- Mean resting diastolic blood pressure during the intervention, mmHg(During the 4-week intervention (12 sessions))
- Mean resting heart rate during the intervention, bpm(During the 4-week intervention (12 sessions))
- Change in Lymphedema Quality of Life (LYMQOL)-Leg Symptoms domain score, 1-4 (higher worse)(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)(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)(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)(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)(Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session))
- Change in body fat percentage, %(Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session))
- Change in skeletal muscle mass, kg(Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session))
- Change in body weight, kg(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(Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session))
- Standing height, cm (baseline only)(Baseline (within 7 days prior to first session))
- Change in pain intensity, Visual Analog Scale (VAS), 0-10 (higher worse)(Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session))
- Participants with intervention-related adverse events(From first intervention session through Week 4 (study completion))