Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03762044 |
| Other study ID # |
Lymphedema Rehabilitation |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2019 |
| Est. completion date |
February 1, 2022 |
Study information
| Verified date |
September 2023 |
| Source |
Hospital Universitario Reina Sofia de Cordoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Lymphedema is defined as the abnormal accumulation of tissue proteins, which is accompanied
of edema and chronic inflammation of a limb, so post-mastectomy lymphedema is one of the most
serious sequelae of Breast Cancer (BC) that affects the quality of life of women operated for
breast cancer. Its incidence is approximately between 6 and 30% of patients and its
prevalence varies between 15-20%. It is considered a process without spontaneous resolution
that involves the application of a palliative therapy conservative for life, with preventive
measures to reduce it and prevent complications and an expected increase in the number of
patients with lymphedema in the next years
Changes in work performance resulting from lymphedema vary from minor temporary changes to
significant difficulties in the ADL, depending on the chronicity and severity of the
affectation. It could affect physical components and psychological, as well as social and
economic environment. In these limitations on activities and / or restrictions of
participation, the Occupational Therapists (OT) provide a unique approach, since they are
professionals specifically enabled for the use of the therapeutic potential of the activity
and graduation of its control parameters in favor of the best occupational performance
possible of the person. Furthermore, there are some research that support the inclusion of OT
in the cancer rehabilitation and reveal a significant need for more research to explore ways
in which the OT favorably influences the results of the cancer survivors.
The anamnesis, clinical exploration and complementary studies if necessary, allow us confirm
the diagnosis of lymphedema, stage, possibilities of progression and approach the most
indicated therapeutic in each case.
The conservative therapeutic of upper limb lymphoedema secondary to breast cancer plan
includes preventive exercises and lifestyle habits, complete decongestive therapy (CDT) and
compression garments.
The CDT comprises a series of measures, a first intensive phase consists of:
- Skin care.
- Kinesitherapy
- Manual lymphatic drainage (MLD)
- Multilayer bandage. The maintenance phase is based on self-care and the use of
compression garments.
Despite the consensus of the experts in the evidence of decongestive therapy in lymphedema,
there is still a lack of evidence to inform the optimal doses of treatment and the level of
evidence about its efficacy in the treatment of lymphedema is only moderately strong, due to
the scarcity of randomized trials with control group, well interventions controlled, accurate
measures of volume, mobility or function and quality of life.
Likewise, the prescription of compression garments for lymphoedema is very varied and it may
be due to the lack of underlying evidence to inform about the treatment. The evidence also
suggests that the comprehensiveness and effectiveness of rehabilitation post-operative BC
should also consider the self-control (empowerment) of patients, approaches to redesign the
lifestyle and incorporate aspects of the promotion of health.
On the other hand, there are studies that confirm that women with lymphedema and pain after
BC may present alterations in neural mechanosensitivity, neuropathic pain, as a result of
nerve compression or peripheral neuropathy induced by chemotherapy and that it is worth
conducting a clinical trial to evaluate the techniques of Neural mobilization (NM) oriented
to the functionality of upper extremities, supporting the clinical mechanism of NM in the
reduction of intraneural edema.
Published research suggests incorporating proprioceptive neuromuscular facilitation (PNF)
with the traditional NM method, to facilitate the process of treatment for patients with
lymphoedema, because it induces powerful synergistic effects on the volume of edema, range of
motion (ROM) of the shoulder, pain and depression. That treatment independently or in
combination with laser also improves these variables and even the speed of blood circulation
in the armpit. Furthermore, in a study in which bandaging could not be used and CDT was
combined with PNF and respiration, reducing lymphedema and improving ROM too, which could
improve performance of activities, level of participation and, therefore, quality of life.
There are research supporting use of Coban®3M bandage as early start of pressotherapy in the
rehabilitation treatment of lymphedema to reduce prolonged edema (agent cause of multiple
complications and functional loss), we consider the possibility of testing the efficacy of a
bandage with similar characteristics, in terms of elasticity and self-adherence, more
economical, applying it from distal to proximal, with a low level of compression, in order to
provide proprioceptive information, but avoiding compressive syndrome, reducing pain and
edema and improving the performance of ADL through the practice of them. It consists in only
two thin layers and it is fast (10 minutes) and simple placement (can be self-administered by
the patient and / or caregiver), improving cost- effectiveness of treatments combined with
three other techniques whose evidence has been previously reviewed. We have agreed to call
this therapy we propose in this study Activity-oriented Proprioceptive Antiedema Therapy
(TAPA in Spanish):
- Health education / patient empowerment.
- Neurodynamic activities oriented to ADL.
- Proprioceptive neuromuscular facilitation exercises oriented to ADL.
- Self-adherent self-adhesive antiedema of low compression.
Given the consensus of the CDT as a gold standard treatment in lymphedema, we consider that
our experimental treatment TAPA should make the comparison with it. So, half of patients will
receive TAPA treatment while the other half will receive CDT standard treatment.
