Lymphoedema Clinical Trial
Official title:
A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
Hypothesis:
To know the utility of manual lymph drainage (MLD) as part of the Physical Complex Therapy
has turn out relevant because of the exclusive dedication that it supposes to the therapist.
To date, the evidence-base for MLD is very limited and only two studies analyze its
relevance. The first study measured the effect of compression bandage with or without MLD.
The group receiving compression and MLD had a significant reduction in limb volume and
decreased pain, despite the fact the MLD was given only for one week (Johansson et al.,
1999). A further study investigated the effect of eight sessions of MLD over two weeks in 42
women with breast cancer-related lymphoedema, and the findings suggested that MLD do not
contribute significantly to oedema reduction, although the MLD course was relatively short
and the study group was limited to those with mild to moderate swelling (20-30 % of
difference). Information about the quality of life, using the questionnaire EORT QLQ-C30 was
gathered but the results were not considered in the final assessment (Andersen and Cabbage
2000).
Similar studies would provide comparative and enlightening information with regard to the
previous results. The investigators could determine if the MLD, in spite of not obtaining an
improvement in the volume of the lymphoedema, provides a benefit in the reduction of the
symptoms related to it.
The investigators hypothesized that MLD does not contribute significantly in volume limb
reduction but it provides a clinical improvement regarding the quality of life according to
the questionnaire EORT QLQ-C30.
For the calculation of the sample size the investigators depart from the following
assumptions:
The effect of the standard treatment on the control group control will produce an average
volume limb reduction of 5 %.
The effect of the treatment in the experimental group will be an average of the 25 % (a minor
difference of effects would indicate a discreet effect of the tested treatment). The
investigators also assume that, the standard deviation will be similar in both groups and
near to 25 %. With this information and for an alpha risk of 0.05 and a power of 0.80 the
calculation of the sample size is 20 patients in every group. Considering a rate of
withdrawal of 30 % in every group, the appropriate sample size is 58 patients assigned in two
groups of 29 patients.
Main aim:
To analyze the effectiveness of Manual Lymph Drainage (MLD) in the treatment of
postmastectomy lymphoedema in order to reduce the volume of lymphoedema
Secondary aims:
To analyze the duration of the reduction of the lymphoedema in the time. To analyze the
improvement in the concomitant symptomatology of the lymphoedema using the results of two
quality of life tests validated in Spanish: EORTC QLQ-C30 version 2.0, for the cancer in
general and EORTC QLQ-BR23 specifically for the breast cancer. In particular, the items
refering to the upper extremity (47, 48, 49) and to the corporal image (39, 40, 41, 42) and
in which the higher the score the worse the result.
Methodology:
Researching Project with methodology of randomized, controlled clinical trial. Group A or
Control: patients with standard treatment (care the skin, exercise and measures of
compression -bandage for one month and later a sleeve of compression).
Group B or Experimental: patients with standard treatment (care of the skin, exercise and
measures of compression (bandage for one month and later a sleeve for lymphoedema) and in
addition they receive Manual Lymph Drainage Main variable: Volume reduction of the affected
arm after the treatment expressed in percentage.
Number of patients: 58 women.
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