Physical Therapies in the Decongestive Treatment of Lymphedema
1 other identifier
interventional
194
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 6, 2012
CompletedFirst Posted
Study publicly available on registry
December 12, 2012
CompletedDecember 18, 2012
December 1, 2012
5.9 years
December 6, 2012
December 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
the Percentage of Volume reduction (PRV)
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
Other Outcomes (1)
Adverse events related to the treatment
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
Study Arms (3)
Standard trimodality therapy with MLD
ACTIVE COMPARATORManual Lymphatic Drainage (MLD) followed by intermittent pneumatic compression (IPC) and followed by multilayer, multicomponent bandages (MB) until next day.
Trimodality therapy with LPD
EXPERIMENTALPneumatic massage with Lymphapress-Plus(TM) device (LPD) followed by intermittent pneumatic compression (IPC) and followed by multilayer, multicomponent bandages (MB) until next day
Bimodality therapy without MLD
EXPERIMENTALintermittent pneumatic compression (IPC) followed by multilayer, multicomponent bandages (MB) until next day.
Interventions
MLD with Földi's technique by an expert therapist during 45 minutes
Generic intermittent pneumatic compression with multicompartmental pump between 50 to 80 mmHg during 30 minutes.
multilayer, multicomponent bandages (MB) until next day.
Pneumatic massage with Lymphapress-Plus(TM)device that was lent during the duration of the study during 20 minutes.
Eligibility Criteria
You may qualify if:
- primary or secondary lymphedema,
- lymphedema stages II or III
- affecting unilateral upper or lower limb
- Excess volume (EV) \> 10%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital La Fe
Valencia, Valencia, 46026, Spain
Related Publications (3)
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.
PMID: 9664269BACKGROUNDMcNeely 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. doi: 10.1023/B:BREA.0000032978.67677.9f.
PMID: 15319562BACKGROUNDBadger 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. doi: 10.1002/14651858.CD003141.pub2.
PMID: 15495042BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Isabel I Forner-Cordero, MD, Phd
University Hospital La Fe
- PRINCIPAL INVESTIGATOR
Jose J Muñoz-Langa, MD, Phd
University Hospital Dr Peset
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant in Physical Medicine and Rehabilitation at the Lymphedema Unit
Study Record Dates
First Submitted
December 6, 2012
First Posted
December 12, 2012
Study Start
February 1, 2004
Primary Completion
January 1, 2010
Study Completion
June 1, 2012
Last Updated
December 18, 2012
Record last verified: 2012-12