LymphedemaNCT07198698
Sahid Method for Secondary Unilateral Lower Limb Lymphedema
A study testing Paloma Sahid Method, a patented technique (PCT/CL2023/050061) in people with Lymphedema, run by University Diego Portales at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Paloma Sahid Method, a patented technique (PCT/CL2023/050061)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Lymphatic Drainage Using the Paloma Sahid Method on Secondary Unilateral Lower Limb Lymphedema in Chilean Adult Women: A Single-Arm Clinical Trial
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Lymphedema
- Being tested
- Paloma Sahid Method, a patented technique (PCT/CL2023/050061)
- Keywords
- Lymphedema, Manual Lymph Drainage, Lower Extremity
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental study group | Experimental | Women aged 30 to 65 years diagnosed with lymphedema classified as stage I or II. Receives: Other: Paloma Sahid Method, a patented technique (PCT/CL2023/050061) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Semi-quantitative TI derived from visual criteria on lymphoscintigraphy; range 0-45, with values <10 typical of normal transport; lower scores = better transport. Outcome is pre-post change in TI.
Measured: 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
Infrared thermography of predefined regions; ΔT (°C) = affected - contralateral. Positive values indicate higher temperature on the affected limb. Outcome is change in ΔT.
Measured: 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)
LEFS: 20 items scored 0-4; total 0-80; higher scores indicate better function. Outcome is change in total score.
Measured: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in knee extensor isometric strength, kg
Handheld dynamometry in standardized position; three trials, maximum value (kg) retained. Outcome is change in kg.
Measured: 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)
FTND total score 0-10; higher scores indicate greater nicotine dependence. Outcome is change in total score.
Measured: 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
Measured each session after ≥5 min seated rest; two readings averaged per session. Outcome is the per-participant mean (mmHg) across 12 sessions.
Measured: During the 4-week intervention (12 sessions)
Mean resting diastolic blood pressure during the intervention, mmHg
Measured each session after ≥5 min seated rest; two readings averaged per session. Outcome is the per-participant mean (mmHg) across 12 sessions.
Measured: During the 4-week intervention (12 sessions)
Mean resting heart rate during the intervention, bpm
Measured each session after ≥5 min seated rest; outcome is the per-participant mean (bpm) across 12 sessions.
Measured: During the 4-week intervention (12 sessions)
Change in Lymphedema Quality of Life (LYMQOL)-Leg Symptoms domain score, 1-4 (higher worse)
LYMQOL-Leg domain mean score; 1-4; higher = worse. Outcome is change in domain score.
Measured: 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)
Domain mean; higher = worse. Outcome is change in domain score.
Measured: 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)
Domain mean; higher = worse. Outcome is change in domain score.
Measured: 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)
Domain mean; higher = worse. Outcome is change in domain score.
Measured: 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)
Self-rated overall QoL on 0-10 VAS; higher = better. Outcome is change in VAS.
Measured: 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
BMI = weight/height² (kg/m²). Outcome is change in BMI.
Measured: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in body fat percentage, %
Bioelectrical impedance under standardized pretest conditions. Outcome is change in % body fat.
Measured: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in skeletal muscle mass, kg
Derived from bioelectrical impedance; outcome is change in kg.
Measured: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in body weight, kg
Calibrated digital scale; outcome is change in kg.
Measured: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Standing height, cm (baseline only)
Stadiometer; height recorded in cm at baseline for BMI calculation.
Measured: Baseline (within 7 days prior to first session)
Change in pain intensity, Visual Analog Scale (VAS), 0-10 (higher worse)
10-cm VAS anchored at 0 = no pain and 10 = worst imaginable; outcome is change in score.
Measured: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Participants with intervention-related adverse events
Number of participants reporting events plausibly related to treatment (e.g., musculoskeletal discomfort, dizziness, falls), recorded during sessions and between-session reports.
Measured: From first intervention session through Week 4 (study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Mar 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A Single-Arm Clinical Trial
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Diego Portales
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paloma Sahid, Bachelor, Principal investigator, University Diego Portales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198698
- Sponsor's protocol ID
- UDP_SAHID_2025
- Status last verified
- Sep 2025
- First submitted
- 18 Jul 2025
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. The cohort is small and potentially re-identifiable, and the informed consent and ethics approval (UDP CEI 01-2025) do not authorize external sharing of individual-level data. Aggregate results will be reported. Study documents (e.g., protocol, analysis code, data dictionary) may be provided upon request.
Publications
Lopez-Gomez JJ, Ramos-Bachiller B, Primo-Martin D, Calleja-Fernandez A, Izaola-Jauregui O, Jimenez-Sahagun R, Gonzalez-Gutierrez J, Lopez Andres E, Pinto-Fuentes P, Pacheco-Sanchez D, De Luis-Roman DA. Effect on Body Composition of a Meal-Replacement Progression Diet in Patients 1 Month after Bariatric Surgery. Nutrients. 2023 Dec 28;16(1):106. doi: 10.3390/nu16010106.
PubMed 38201936Kesztyus D, Brucher S, Wilson C, Kesztyus T. Use of Infrared Thermography in Medical Diagnosis, Screening, and Disease Monitoring: A Scoping Review. Medicina (Kaunas). 2023 Dec 9;59(12):2139. doi: 10.3390/medicina59122139.
PubMed 38138242Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.
PubMed 26509265Binkley 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.
PubMed 10201543Hwang 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.
PubMed 18365531International 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.
PubMed 23930436Yamamoto 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.
PubMed 21921744Arrive 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.
PubMed 25826439Cormier 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.
PubMed 20665892DiSipio 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.
PubMed 23540561Thomas 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.
PubMed 32618680Basta 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.
PubMed 24352208
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lymphatic Drainage Using the Paloma Sahid Method on Secondary Unilateral Lower Limb Lymphedema in Chilean Adult Women: A Single-Arm Clinical Trial
- ClinicalTrials.gov ID
- NCT07198698
- Acronym / sponsor ID
- UDP_SAHID_2025
- Conditions
- Lymphedema
- Keywords
- Lymphedema, Manual Lymph Drainage, Lower Extremity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University Diego PortalesUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A Single-Arm Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental study group | Experimental | Other: Paloma Sahid Method, a patented technique (PCT/CL2023/050061)Women aged 30 to 65 years diagnosed with lymphedema classified as stage I or II. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Experimental study group |
Primary outcome
Change in lower-limb volume, mL (tape-derived)
Time frame: 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).
20 secondary outcomes
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)
Change in Lymphedema Quality of Life (LYMQOL)-Leg overall quality of life, Visual Analog Scale (VAS), 0-10 (higher better)
Time frame: 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
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in body fat percentage, %
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in skeletal muscle mass, kg
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Change in body weight, kg
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Standing height, cm (baseline only)
Time frame: Baseline (within 7 days prior to first session)
Change in pain intensity, Visual Analog Scale (VAS), 0-10 (higher worse)
Time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)
Participants with intervention-related adverse events
Time frame: From first intervention session through Week 4 (study completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Results publication: PubMed 38201936Lopez-Gomez JJ, Ramos-Bachiller B, Primo-Martin D, Calleja-Fernandez A, Izaola-Jauregui O, Jimenez-Sahagun R, Gonzalez-Gutierrez J, Lopez Andres E, Pinto-Fuentes P, Pacheco-Sanchez D, De Luis-Roman DA. Effect on Body Composition of a Meal-Replacement Progression Diet in Patients 1 Month after Bariatric Surgery. Nutrients. 2023 Dec 28;16(1):106. doi: 10.3390/nu16010106.
- Results publication: PubMed 38138242Kesztyus D, Brucher S, Wilson C, Kesztyus T. Use of Infrared Thermography in Medical Diagnosis, Screening, and Disease Monitoring: A Scoping Review. Medicina (Kaunas). 2023 Dec 9;59(12):2139. doi: 10.3390/medicina59122139.
- Results publication: PubMed 26509265Mentiplay BF, Perraton LG, Bower KJ, Adair B, Pua YH, Williams GP, McGaw R, Clark RA. Assessment of Lower Limb Muscle Strength and Power Using Hand-Held and Fixed Dynamometry: A Reliability and Validity Study. PLoS One. 2015 Oct 28;10(10):e0140822. doi: 10.1371/journal.pone.0140822. eCollection 2015.
- Results publication: PubMed 10201543Binkley 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.
- Results publication: PubMed 18365531Hwang 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.
- Results publication: PubMed 23930436International 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.
- Results publication: PubMed 21921744Yamamoto 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.
- Results publication: PubMed 25826439Arrive 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.
- Results publication: PubMed 20665892Cormier 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.
- Results publication: PubMed 23540561DiSipio 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.
- Results publication: PubMed 32618680Thomas 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.
- Results publication: PubMed 24352208Basta 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.
- 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-Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Encuesta de hábito tabáquico en Chile-Ministerio de Salud. Test de fagerstrom.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. The cohort is small and potentially re-identifiable, and the informed consent and ethics approval (UDP CEI 01-2025) do not authorize external sharing of individual-level data. Aggregate results will be reported. Study documents (e.g., protocol, analysis code, data dictionary) may be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Paloma Sahid, Bachelor principal investigator
University Diego Portales
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Paloma Sahid Method, a patented technique (PCT/CL2023/050061) in people with Lymphedema, run by University Diego Portales at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lower-limb volume, mL (tape-derived) (time frame: Baseline (within 7 days prior to first session) and Week 4 (within 7 days after last session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07198698, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.