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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03051750 |
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Date of registration:
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08/02/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of Techniques for Breast Cancer-Related Lymphedema.
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Scientific title:
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Complex Physical Therapy Plus Pressotherapy Versus Kinesio Taping in Breast Cancer-Related Lymphedema. Randomized Crossover Trial. |
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Date of first enrolment:
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February 1, 2016 |
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Target sample size:
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43 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03051750 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Violeta Pajero Otero, MRes |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario 12 de Octubre |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Submit BCRL
2. Be a patient of the Breast Pathology Rehabilitation at Hospital Universitario 12 de
Octubre.
3. Signing the informed consent.
Exclusion Criteria:
1) Breast Cancer metastasis or other active tumor. 2) Intravenous chemotherapy or
radiotherapy actually. 3) Heart or kidney failure. 4) Use diuretics. 5) active infection
(erysipelas) or any cutaneous disease in UL or back. 5) Bilateral lymphadenectomy. 6)
present deterioration or cognitive delay that would prevent understanding instructions and
purpose of the study.
7) Have performed treatment for BCRL during the 3 months prior to the start of the study
(previous washing phase).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer Lymphedema
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Intervention(s)
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Other: Complex Physical Therapy plus Pressotherapy
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Other: Kinesio Taping
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Primary Outcome(s)
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Changes in the volume difference between the upper limb with lymphedema and the healthy upper limb before and after treatment.
[Time Frame: Four weeks during each treatment phase]
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Secondary Outcome(s)
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Score of the TTDL questionnaire.
[Time Frame: Four weeks during each treatment phase]
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Symptoms associated with BCRL (pain, heaviness, pressure and hardness) using modified visual analogue scale (VAS).
[Time Frame: Four weeks during each treatment phase]
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Stage of the lymphedema.
[Time Frame: Four weeks during each treatment phase]
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Body Mass Index.
[Time Frame: Four weeks during each treatment phase]
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Goniometry of Upper Limb.
[Time Frame: Four weeks during each treatment phase]
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Score on the DASH Outcome Measure.
[Time Frame: Four weeks during each treatment phase]
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Secondary ID(s)
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InveCuidRh150316
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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