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Sahid Method for Secondary Unilateral Lower Limb Lymphedema

NCT07198698 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-09-30

No results posted yet for this study

Summary

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.

Conditions

  • Lymphedema

Interventions

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.

Sponsors & Collaborators

  • University Diego Portales

    lead OTHER

Principal Investigators

  • Paloma Sahid, Bachelor · University Diego Portales

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2025-12-30
Completion
2026-03-30

Countries

  • Chile

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07198698 on ClinicalTrials.gov