Breast Cancer Lymphedema
Conditions
Keywords
Compression garments, Kinesio Taping, Breast Cancer-Related Lymphedema
Brief summary
Breast cancer-related lymphedema (BCRL) tends to become chronic and progressive. Current therapies have modest results for this condition. Compression garments (CG) prevent the worsening of lymphedema and even improve it, during periods between treatments of physical therapy. Kinesio Taping(KT) is being recently used for lymphedema, although little evidence backs it. The aim of this study is to compare the reduction of lymphedema volume with both therapies.
Detailed description
Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG. Research design: Randomized quasi-experimental clinical pilot study: initial sample randomly balanced into two groups . The initial sample was selected among the patients of Breast Pathology Rehabilitation at Hospital Universitario 12 de Octubre . The planned sample size was 30. Cross Design: it made possible to evaluate two different treatments in the same patient, cancelling intragroup variability. Open design: it was impossible to blind patients and physiotherapist researcher because of patent visual differences between the two therapies, CG or KT, both during application and while being worn, and even in the hours after its removal, due to the marks left on the skin. However, at least one external evaluator suitably trained was implemented and performed the randomisation of the groups and collected all patient data. Statistical study was also made by others (staff of the Clinique Investigation Unit (i+12) of Hospital Universitario 12 de Octubre) with coded variables to blind the analyst.
Interventions
OTHERKinesio Taping
OTHERCompression Garment
Sponsors
Hospital Universitario 12 de Octubre
University of Castilla-La Mancha
Violeta Pajero Otero
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The statistical analysis will be supervised by staff of the Scientific Support Unit: Epidemiology and Biostatistics (i+12), Hospital Universitario 12 de Octubre with the variables coded to blind the analyst.
Intervention model description
Two treatmet phases, with a four week wash out period bewtween them: * A four week phase with Kinesio Taping * A four week phase with compression garments.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Suffering from clinically significant breast cancer-related lymphedema at least since three months ago. 2. Having a Compression Garment suitable for the lymphedema arm
Exclusion criteria
1. Physiotherapy treatment for lymphedema during the 4 weeks before study start (pre-wash phase). 2. Metastasis breast cancer or other tumour. 3. Treated with systemic chemotherapy and /or radiotherapy at that time 4. Heart Failure or Renal Failure. 5. Using Diuretics. 6. Bilateral axillary lymphadenectomy. 7. Cognitive impairment or delay that impedes understanding the study's instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimated volumen of the upper limb. | Four weeks during each treatment phase | Truncated Cone Formula. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS). | Four weeks during each treatment phase | Wong-Baker faces pain rating scale. |
| Goniometry of Upper Limb. | Four weeks during each treatment phase | Goniometry of shoulder, elbow, wrist and hand. |
Countries
Spain
Outcome results
None listed