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Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer

Effects of Physiotherapy in the Maintenance Phase in the Treatment of Lymphedema After Breast Cancer

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05037708
Enrollment
28
Registered
2021-09-08
Start date
2022-03-01
Completion date
2022-10-27
Last updated
2023-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema of Upper Limb

Keywords

Lymphedema of Upper Limb, Breast Neoplasms, Physical Therapy Modalities

Brief 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.

Detailed description

Complex decongestant therapy is a set of techniques which seek the treatment of lymphedema in a conservative way as described in the recent international consensus of the International Lymphology Society, published in 2020. Complex decongestant therapy in a first phase aims to reduce cutaneous edema and in a second phase it aims to preserve and optimize the results obtained. The first phase consists of skin care, manual lymphatic drainage, muscle pumping exercises, and compression techniques, typically applied with multilayer bandages. The second phase consists of compression with low elasticity, skin care exercises, and repeated manual lymphatic drainage as needed. The frequency and intensity of components of complex decongestant therapy in phase I and II should depend on the clinical findings of edema and the stage of lymphedema and could be adapted to clinical changes. Note that phase II or stabilization represents long-term therapy over many years and in the case of deterioration of edema, phase I of complex decongestant therapy may need to be repeated. In recent years, there is debate about the efficacy of manual lymphatic drainage. Sometimes it is not prescribed, being replaced by the recommendation of a self-massage. Furthermore, complex decongestant therapy was suggested to be time consuming, expensive and difficult to tolerate, and does not improve lymphatic function. In contrast, researchers such as Müller et al., in 2018, state that it is a well-tolerated and safe treatment technique, demonstrating benefits in reducing edema. Other research has also shown that manual lymphatic drainage is effective both on a preventive level and as a postoperative rehabilitation treatment, having optimal results when combined with the other elements of complex decongestant therapy. A recent systematic review published in 2020 highlights the need of more experimental studies on the effectiveness of manual lymphatic drainage on lymphedema. Thus, the purpose of this study is to analyze the effects of a physiotherapy program based on manual lymphatic drainage in the treatment of lymphedema after breast cancer, during the stabilization or maintenance phase of complex decongestant therapy. Therefore, a double-blind crossover clinical trial is proposed.

Interventions

PROCEDUREManual 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

Sponsors

Asociación Gallega de Linfedema
CollaboratorUNKNOWN
University of Vigo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)

Intervention model description

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.

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* Women included in the lymphedema treatment maintenance program through the Galician Lymphedema Association * Women with secondary unilateral lymphedema after breast cancer

Exclusion criteria

* Women undergoing chemotherapy or radiotherapy treatment. * Severe systemic or neurological disease

Design outcomes

Primary

MeasureTime frameDescription
circometry1 daymeasurement of upper limb perimeters
Volumetry by water displacement1 dayweight of water extravasated when introducing the upper limb into a container with water
Measurement of edema thickness by ultrasound1 daymeasurement of subcutaneous tissue thickness

Secondary

MeasureTime frameDescription
Assessment of the sensation of heaviness1 dayVisual analogic scale
dynamometry1 dayAssessment of muscle grip strength by dynamometry
Assessment of the sensation of pain1 dayVisual analogic scale
Assessment of the sensation of tension in the upper limb1 dayVisual analogic scale

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026