Secondary Lymphedema Clinical Trial
Official title:
Physical Therapies in the Decongestive Treatment of Lymphedema: A Multicenter, Randomized, Controlled Study.
The purpose of this multicenter randomised controlled study is to determine whether manual lymphatic drainage (MLD) brings any benefit when added to intermittent pneumatic compression (IPC) plus multilayer, multicomponent bandages (MB) in the decongestive lymphatic therapy (DLT) in patients with lymphedema
Status | Completed |
Enrollment | 194 |
Est. completion date | June 2012 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - primary or secondary lymphedema, - lymphedema stages II or III - affecting unilateral upper or lower limb - Excess volume (EV) > 10% Exclusion Criteria: - malignancy or active neoplasm disease or lack of information about it. - active lymphangitis - known contraindications for Decongestive Lymphatic Therapy (DLT): renal insufficiency, uncontrolled hypertension, cardiac disease and venous thrombosis. - a course of DLT during last year. - anything that could alter the patient's capability to consent truly to participate in this study |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | University Hospital La Fe | Valencia |
Lead Sponsor | Collaborator |
---|---|
Isabel Forner-Cordero, MD, PhD. |
Spain,
Badger C, Preston N, Seers K, Mortimer P. Physical therapies for reducing and controlling lymphoedema of the limbs. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003141. Review. — View Citation
Johansson K, Lie E, Ekdahl C, Lindfeldt J. A randomized study comparing manual lymph drainage with sequential pneumatic compression for treatment of postoperative arm lymphedema. Lymphology. 1998 Jun;31(2):56-64. — View Citation
McNeely ML, Magee DJ, Lees AW, Bagnall KM, Haykowsky M, Hanson J. The addition of manual lymph drainage to compression therapy for breast cancer related lymphedema: a randomized controlled trial. Breast Cancer Res Treat. 2004 Jul;86(2):95-106. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events related to the treatment | Discomfort Lymphangitis attacks Edema displacement Fibrosclerotic ring Loss of mobility | at 10 sessions of DLT (2 weeks), at 20 sessions of DLT (4 weeks) and at 1, 6 and 12 months after the end of DLT | Yes |
Primary | Percentage reduction in Excess Volume (PREV) | It is obtained with the following formula: [(Initial EV - Final EV)/ Initial EV] x 100; where Excess Volume (EV) is the difference between Lymphedematous (VL) and Healthy limb volume (VH). Volumes were calculated with tape perimeter measurements (C) taken from the dorsum of the hand (C1) and repeated for every 4 cm proximally until the axilla (Cn), using Kuhnke formula, as the disk model is considered the method of choice in clinical practice. We assessed the change from baseline in PREV during Decongestive Lymphedema Treatment (DLT)and during 12 months of follow-up after DLT. |
at 10 sessions of DLT (2 weeks), at 20 sessions of DLT (4 weeks) and at 1, 6 and 12 months after the end of DLT | No |
Secondary | the Percentage of Volume reduction (PRV) | it was calculated with the following formula: [(Initial VL - Final VL)/ Initial VL] x 100. We assessed the change from baseline in PRV during Decongestive Lymphedema Treatment (DLT)and during 12 months of follow-up after DLT. |
at 10 sessions of DLT (2 weeks), at 20 sessions of DLT (4 weeks) and at 1, 6 and 12 months after the end of DLT | No |
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