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Completed

NCT Number: NCT05037708

Effects of Physiotherapy in the Treatment of Lymphedema After Breast Cancer

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physiotherapy

Pontevedra, 36005, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Lymphatic Drainage

Procedure

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

Primary outcomes

  1. circometry

    Time frame: 1 day

    measurement of upper limb perimeters

  2. circometry

    Time frame: 1 month

    measurement of upper limb perimeters

  3. circometry

    Time frame: 3 month

    measurement of upper limb perimeters

  4. circometry

    Time frame: 4 month

    measurement of upper limb perimeters

  5. Volumetry by water displacement

    Time frame: 1 day

    weight of water extravasated when introducing the upper limb into a container with water

  6. Volumetry by water displacement

    Time frame: 1 month

    weight of water extravasated when introducing the upper limb into a container with water

  7. Volumetry by water displacement

    Time frame: 3 month

    weight of water extravasated when introducing the upper limb into a container with water

  8. Volumetry by water displacement

    Time frame: 4 month

    weight of water extravasated when introducing the upper limb into a container with water

  9. Measurement of edema thickness by ultrasound

    Time frame: 1 day

    measurement of subcutaneous tissue thickness

  10. Measurement of edema thickness by ultrasound

    Time frame: 1 month

    measurement of subcutaneous tissue thickness

  11. Measurement of edema thickness by ultrasound

    Time frame: 3 month

    measurement of subcutaneous tissue thickness

  12. Measurement of edema thickness by ultrasound

    Time frame: 4 month

    measurement of subcutaneous tissue thickness

Secondary outcomes

  1. Assessment of the sensation of heaviness

    Time frame: 1 day

    Visual analogic scale

  2. Assessment of the sensation of heaviness

    Time frame: 1 month

    Visual analogic scale

  3. Assessment of the sensation of heaviness

    Time frame: 3 month

    Visual analogic scale

  4. Assessment of the sensation of heaviness

    Time frame: 4 month

    Visual analogic scale

  5. Assessment of the sensation of pain

    Time frame: 1 day

    Visual analogic scale

  6. Assessment of the sensation of pain

    Time frame: 1 month

    Visual analogic scale

  7. Assessment of the sensation of pain

    Time frame: 3 month

    Visual analogic scale

  8. Assessment of the sensation of pain

    Time frame: 4 month

    Visual analogic scale

  9. Assessment of the sensation of tension in the upper limb

    Time frame: 1 day

    Visual analogic scale

  10. Assessment of the sensation of tension in the upper limb

    Time frame: 1 month

    Visual analogic scale

  11. Assessment of the sensation of tension in the upper limb

    Time frame: 3 month

    Visual analogic scale

  12. Assessment of the sensation of tension in the upper limb

    Time frame: 4 month

    Visual analogic scale

  13. dynamometry

    Time frame: 1 day

    Assessment of muscle grip strength by dynamometry

  14. dynamometry

    Time frame: 1 month

    Assessment of muscle grip strength by dynamometry

  15. dynamometry

    Time frame: 3 month

    Assessment of muscle grip strength by dynamometry

  16. dynamometry

    Time frame: 4 month

    Assessment of muscle grip strength by dynamometry

Sponsors and collaborators

Lead sponsor

University of Vigo

Other

Collaborators

  • Asociación Gallega de Linfedema

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 8, 2021
Registry last updated
Apr 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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