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New Therapeutic Approach in Upper Limb Lymphedema Secondary to Breast Cancer: Activity-oriented Proprioceptive Antiedema Therapy (TAPA)

NCT03762044 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-09-22

No results posted yet for this study

Summary

This study evaluates the effectiveness of an experimental proposal therapy for upper limb lymphedema secondary to breast called Activity-oriented proprioceptive antiedema therapy (TAPA) facing the consensual gold standard treatment, the complete decongestive therapy. TAPA consists in:

* Health education / patient empowerment.
* Neurodynamic activities oriented to Activities of Daily Living (ADL).
* Proprioceptive neuromuscular facilitation exercises oriented to ADL.
* Self-adherent self-adhesive antiedema of low compression.

Half of patients will receive TAPA treatment while the other half will receive CDT standard treatment.

Conditions

  • Breast Cancer Lymphedema
  • Post-Mastectomy Secondary Lymphedema

Interventions

OTHER

Activity-oriented Proprioceptive Antiedema Therapy (TAPA)

* Health education / patient empowerment. * Neurodynamic activities oriented to ADL. * Proprioceptive neuromuscular facilitation exercises oriented to ADL. * Self-adherent self-adhesive antiedema of low compression.

OTHER

Complete Decongestive Therapy (CDT)

* Skin care. * Kinesitherapy * Manual lymphatic drainage (MLD) * Multilayer bandage. The maintenance phase is based on self-care and the use of compression garments.

Sponsors & Collaborators

  • Hospital Universitario Reina Sofia de Cordoba

    lead OTHER_GOV

Principal Investigators

  • María N Muñoz Alcaraz · Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.

  • María V Olmo Carmona · UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía

  • Antonio J Jiménez Vílchez · UGC de Medicina Física y Rehabilitación IN. Hospital Universitario Reina Sofía

  • Luis A Pérula de Torres · Unidad Docente de Medicina Familiar y Comunitaria de Córdoba

  • Jesús Serrano Merino · Distrito Sanitario Córdoba Guadalquivir. Servicio Andaluz de Salud.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2021-09-01
Completion
2022-02-01

Countries

  • Spain

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 NCT03762044 on ClinicalTrials.gov