Sahid Method for Secondary Unilateral Lower Limb Lymphedema

NCT07198698 | Not Yet Recruiting

• 1 other identifier: UDP_SAHID_2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Lymphedema; Manual Lymph Drainage; Lower Extremity

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)

Secondary Outcomes (20)

• 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)

Study Arms (1)

Experimental study group

EXPERIMENTAL

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)

Interventions

Paloma Sahid Method, a patented technique (PCT/CL2023/050061) OTHER

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.

Experimental study group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• 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

You may not qualify if:

• Inability to understand or respond t questionnaires
• Presence of chronic illnesses such: pulmonary, cardiac, autoimmune disease or diabetes mellitus
• Absence from more than two consecutive sessions

Sponsors & Collaborators

• University Diego Portales: lead

Study Sites (1)

Av. La Dehesa 1201, Torre Norte, Of. 616

Santiago, Chile

Location

Related Publications (12)

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  PMID: 4624940 BACKGROUND

• 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.

  PMID: 10201543 BACKGROUND

• 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.

  PMID: 18365531 BACKGROUND

• 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.

  PMID: 23930436 BACKGROUND

• 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.

  PMID: 21921744 BACKGROUND

• 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.

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  PMID: 23540561 BACKGROUND

• 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.

  PMID: 32618680 BACKGROUND

• 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.

  PMID: 24352208 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Paloma Sahid, Bachelor

  University Diego Portales

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paloma A Sahid, Bachelor's degree

CONTACT

+56955132545; palomasahid@gmail.com

Astrid A von Oetinger, Master

CONTACT

+56 226762256; astrid.edlevonoetinger@mail.udp.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Single-Arm Clinical Trial

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: September 30, 2025
• Study Start: November 1, 2025
• Primary Completion: December 30, 2025
• Study Completion: March 30, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)