Kinesio Taping Versus Compression Garments for Breast Cancer-Related Lymphedema
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|ClinicalTrials.gov Identifier: NCT03051776|
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Lymphedema||Other: Kinesio Taping Other: Compression Garment||Not Applicable|
Primary end points: to evaluate whether the decrease in BCRL volume is different for a 4-week treatment with KT than with CG.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||
Two treatmet phases, with a four week wash out period bewtween them:
|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.|
|Official Title:||Kinesio Taping Versus Compression Garments in the Treatment of Breast Cancer-Related Lymphedema. Randomized Crossover Trial.|
|Actual Study Start Date :||January 3, 2016|
|Actual Primary Completion Date :||March 30, 2016|
|Actual Study Completion Date :||March 30, 2016|
Experimental: Kinesio Taping
It was done a four week phase with Kinesio Taping in the arm affected with lymphedema.
Other: Kinesio Taping
Active Comparator: Compression garment
It was done a four week phase with Compression garment in the arm affected with lymphedema.
Other: Compression Garment
- Estimated volumen of the upper limb. [ Time Frame: Four weeks during each treatment phase ]Truncated Cone Formula.
- Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS). [ Time Frame: Four weeks during each treatment phase ]Wong-Baker faces pain rating scale.
- Goniometry of Upper Limb. [ Time Frame: Four weeks during each treatment phase ]Goniometry of shoulder, elbow, wrist and hand.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051776
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Principal Investigator:||Violeta Pajero Otero, MRes||Hospital Universitario 12 de Octubre|