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Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer

NCT05037708 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-04-06

No results posted yet for this study

Summary

Lymphedema related to breast cancer is one of the main complications after breast cancer treatment. Manual lymphatic drainage appears as a technique which could be applied in the treatment of lymphedema along with other techniques. The aim of this study is to analyze the effects of a physiotherapy program based on manual lymphatic drainage on the treatment of lymphedema after breast cancer, during the stabilization or maintenance phase of complex decongestant therapy. Therefore, a randomized, blinded, crossover clinical trial is suggested to assess the effect of an intensive physiotherapy intervention on the treatment of lymphedema in its maintenance phase, in comparison with a control group without physiotherapy treatment. The cytometry, displaced water volume, thickness of the lymphedema with ultrasound, dynamometry and sensation of heaviness, pain and tension of the upper limb will be evaluated.

Conditions

  • Lymphedema of Upper Limb

Interventions

PROCEDURE

Manual lymphatic drainage

Subjects are randomly assigned to group 1. Group 1 receives treatment A\* for 4 weeks. Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment B\*\* was applied to group 1 for 4 weeks. \*Treatment A consists of manual lymphatic drainage. \*\*Treatment B consists of no treatment

PROCEDURE

Manual lymphatic drainage

Subjects are randomly assigned to group 2. Group 2 receives treatment B\*\* for 4 weeks. Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment A\* was applied to group 2 for 4 weeks. \*Treatment A consists of manual lymphatic drainage. \*\*Treatment B consists of no treatment

Sponsors & Collaborators

  • Asociación Gallega de Linfedema

    collaborator UNKNOWN

  • University of Vigo

    lead OTHER

Principal Investigators

  • Eva M Lantarón_Caeiro, Dra · Physiotherapy Group (FS1) - Faculty of Physiotherapy -University of Vigo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-07-01
Completion
2022-10-27

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 NCT05037708 on ClinicalTrials.gov