Sahid Method for Secondary Unilateral Lower Limb Lymphedema
NCT ID: NCT07198698
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
32 participants
INTERVENTIONAL
2025-11-01
2026-03-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Experimental study group
Women aged 30 to 65 years diagnosed with lymphedema classified as stage I or II.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Presence of chronic illnesses such: pulmonary, cardiac, autoimmune disease or diabetes mellitus
* Absence from more than two consecutive sessions
30 Years
65 Years
FEMALE
No
Sponsors
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University Diego Portales
OTHER
Responsible Party
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Principal Investigators
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Paloma Sahid, Bachelor
Role: PRINCIPAL_INVESTIGATOR
University Diego Portales
Locations
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Av. La Dehesa 1201, Torre Norte, Of. 616
Santiago, , Chile
Countries
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Central Contacts
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Facility Contacts
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References
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Young SS, Schilling AM, Skeans S, Ritacco G. Short duration anaesthesia with medetomidine and ketamine in cynomolgus monkeys. Lab Anim. 1999 Apr;33(2):162-8. doi: 10.1258/002367799780578363.
Yue H, Devidas S, Guggino WB. The two halves of CFTR form a dual-pore ion channel. J Biol Chem. 2000 Apr 7;275(14):10030-4. doi: 10.1074/jbc.275.14.10030.
Kincaid HL Jr, Jirgensons B. Circular dichroism of kappa- and lambda type Bence-Jones proteins at various pH values and temperatures. Biochim Biophys Acta. 1972 Jun 22;271(1):23-33. doi: 10.1016/0005-2795(72)90129-8. No abstract available.
Binkley JM, Stratford PW, Lott SA, Riddle DL. The Lower Extremity Functional Scale (LEFS): scale development, measurement properties, and clinical application. North American Orthopaedic Rehabilitation Research Network. Phys Ther. 1999 Apr;79(4):371-83.
Hwang JH, Choi JY, Lee JY, Hyun SH, Choi Y, Choe YS, Lee KH, Kim BT. Lymphscintigraphy predicts response to complex physical therapy in patients with early stage extremity lymphedema. Lymphology. 2007 Dec;40(4):172-6.
International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2013 Consensus Document of the International Society of Lymphology. Lymphology. 2013 Mar;46(1):1-11.
Yamamoto T, Matsuda N, Doi K, Oshima A, Yoshimatsu H, Todokoro T, Ogata F, Mihara M, Narushima M, Iida T, Koshima I. The earliest finding of indocyanine green lymphography in asymptomatic limbs of lower extremity lymphedema patients secondary to cancer treatment: the modified dermal backflow stage and concept of subclinical lymphedema. Plast Reconstr Surg. 2011 Oct;128(4):314e-321e. doi: 10.1097/PRS.0b013e3182268da8.
Arrive L, Derhy S, El Mouhadi S, Monnier-Cholley L, Menu Y, Becker C. Noncontrast Magnetic Resonance Lymphography. J Reconstr Microsurg. 2016 Jan;32(1):80-6. doi: 10.1055/s-0035-1549133. Epub 2015 Mar 31.
Cormier JN, Askew RL, Mungovan KS, Xing Y, Ross MI, Armer JM. Lymphedema beyond breast cancer: a systematic review and meta-analysis of cancer-related secondary lymphedema. Cancer. 2010 Nov 15;116(22):5138-49. doi: 10.1002/cncr.25458.
DiSipio T, Rye S, Newman B, Hayes S. Incidence of unilateral arm lymphoedema after breast cancer: a systematic review and meta-analysis. Lancet Oncol. 2013 May;14(6):500-15. doi: 10.1016/S1470-2045(13)70076-7. Epub 2013 Mar 27.
Thomas C, Le JT, Benson E. Managing Lymphedema in Fracture Care: Current Concepts and Treatment Principles. J Am Acad Orthop Surg. 2020 Sep 15;28(18):737-741. doi: 10.5435/JAAOS-D-19-00722.
Basta MN, Gao LL, Wu LC. Operative treatment of peripheral lymphedema: a systematic meta-analysis of the efficacy and safety of lymphovenous microsurgery and tissue transplantation. Plast Reconstr Surg. 2014 Apr;133(4):905-913. doi: 10.1097/PRS.0000000000000010.
Related Links
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Pereira N.,Venegas J. y Cifuentes I. Calidad de Vida en pacientes sometidos al tratamiento quirúrgico del linfedema. Validación lingüística y adaptación transcultural del Lymphedema Quality of Life Score (LeQOLiS). Rev. cir. 2020, vol. 72, n. 2, pp. 113-
Orientación Técnica Programa de Salud Cardiovascular 2017.Criterios programa salud cardiovascular. ANEXO 5. Perfil de presión arterial. Técnica estandarizada de medición automática de la presión arterial.
Other Identifiers
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UDP_SAHID_2025
Identifier Type: -
Identifier Source: org_study_id
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