A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
18 Years
N/A
Female
Lymphoedema
Trial Information
A Randomized, Controlled Clinical Trial About the Contribution of Manual Lymph Drainage in Complex Physical Therapy for Patients With Lymphoedema Secondary to Mastectomy
Inclusion Criteria:
- women older than 18 years, intervented of unilateral breast neoplasia with
ipsilateral axillar lymphadenectomy
- Patients with ipsilateral lymphoedema with a volume difference of at least 200ml
compared to the lateral limb
- Patients who have finished the treatment with Radiotherapy and / or chemotherapy at
least six months before the study started
- Informed acceptance has to be signed
Exclusion Criteria:
- Bilateral affectation of both extremities.
- Malignant Active disease
- Acute Lymphoedema (in the first three months postintervention)
- Patients with previous paralysis or vascular alteration in the affected arm
- Patients with a major limitation of 30 º in any of the arches of movement of the
ipsilateral shoulder
- Patients with contraindication for Lymphatic Manual Drainage (cellulite, deep venous
thrombosis, heart failure, not controlled hypertension, renal failure and important
radiodermatitis)
- Patients who have been managed with treatment of rehabilitation in three months
previous to the recruitment.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Statistical analysis
Outcome Description:
All the patients included in the study will be analyzed and all the analyses will be performed for " intention of treating " except that related to the withdrawal of the treatment that will be done by protocol. Firstly an analysis of comparability of the groups using the test of the T de Student or Mann-Withney's Test and test of Fischer´s exact test will be performed. Efficacy analysis:means differences and / or reason of medians for the quantitative variables and reason of risks and NNT for the quantitative variables.
Outcome Time Frame:
1 year after the clinical trial ends
Safety Issue:
Yes
Authority:
Spain: Ethics Committee
Study ID:
TFCDLM-07
NCT ID:
NCT01152099
Start Date:
September 2007
Completion Date:
April 2014
Related Keywords:
- Lymphoedema
- Postmastectomy
- Lymphedema
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