Clinical Trial: Physical Therapies in the Decongestive Treatment of Lymphedema

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Physical Therapies in the Decongestive Treatment of Lymphedema: A Multicenter, Randomized, Controlled Study.

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

Detailed Summary:

Study Design: the study was a multicenter, randomized controlled study conducted at three university hospitals in Spain. Potential subjects were identified at Rehabilitation Department where physicians were responsible for screening subjects for eligibility and enrolling into the study.

Patients that fulfilled the inclusion criteria and signed up the informed consent were stratified within 2 stratums, upper and lower limb lymphedema, and then were randomized to one of the three treatment groups.

The type of randomization was a total randomization with ratio 1:1:1 and the method used to generate the random allocation sequence was a computer-generated random numbers table. Adequate randomization includes calling a central office once eligibility has been determined.

The physicians that assessed the outcome and the statistic who analyzed de data were blinded to the subjects' treatment assignment.

The study was approved by the Research Ethics Committee of the University Hospital La Fe. It was conducted according to the ethical principles laid down in the declaration of Helsinki (52nd World Medical Association General Assembly, Edinburgh, Scotland, October 2000) and the rules of best clinical practice.

Treatment Regimens: Patients were randomized to one of the following treatment groups:

• Group A or control group: Manual Lymphatic Drainage (MLD) with Földi's technique by an expert therapist during 45 minutes; intermittent pneumatic compression (IPC) with multicompartmental pump between 50 to 80 mmHg during 30 minutes, followed by multilayer, multicomponent bandages (MB) until next day.
• Sponsor: Isabel Forner-Cordero, MD, PhD.
  

  Current Primary Outcome: Percentage reduction in Excess Volume (PREV) [ Time Frame: 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 ]

  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.

  
  
  

  Original Primary Outcome: Percentage reduction in Excess Volume (PREV) [ Time Frame: 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 ]

  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 Lymphedemna Treatment (DLT)and during 12 months of follow-up after DLT.

  
  
  

  Current Secondary Outcome: the Percentage of Volume reduction (PRV) [ Time Frame: 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 ]

  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.

  
  
  

  Original Secondary Outcome: the Percentage of Volume reduction (PRV) [ Time Frame: 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 ]

  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 Lymphedemna Treatment (DLT)and during 12 months of follow-up after DLT.

  
  
  Information By: Hospital Universitario La Fe
  

  Dates:
  Date Received: December 6, 2012
  Date Started: February 2004
  Date Completion:
  Last Updated: December 16, 2012
  Last Verified: December 2012