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Physical Therapies in the Decongestive Treatment of Lymphedema

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ClinicalTrials.gov Identifier: NCT01748604
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : December 18, 2012
Sponsor:
Information provided by (Responsible Party):
Isabel Forner-Cordero, MD, PhD., Hospital Universitario La Fe

Tracking Information
First Submitted Date  ICMJE December 6, 2012
First Posted Date  ICMJE December 12, 2012
Last Update Posted Date December 18, 2012
Study Start Date  ICMJE February 2004
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2012)
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 Measures  ICMJE
 (submitted: December 11, 2012)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2012)
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 Measures  ICMJE
 (submitted: December 11, 2012)
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.
Current Other Pre-specified Outcome Measures
 (submitted: December 11, 2012)
Adverse events related to the treatment [ 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 ]
Discomfort Lymphangitis attacks Edema displacement Fibrosclerotic ring Loss of mobility
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Physical Therapies in the Decongestive Treatment of Lymphedema
Official Title  ICMJE 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 Description

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.
  • Group B: Pneumatic massage with Lymphapress-Plus(TM) device that was lent during the duration of the study during 20 minutes, and was supposed to open the proximal lymphatics at the root of the limb; IPC (50 to 80 mmHg during 30 minutes), followed by MB until next day.
  • Group C: IPC (50 to 80 mmHg during 30 minutes) followed by MB until next day.

All patients were planned to receive 20 sessions of treatment (5 per week in consecutive days during 4 consecutive weeks) and were trained in skin care and daily exercises.

After DLT, garments were prescribed and their adaptation was checked to warrant the maintenance of the results. The garments were flat knitted, custom made, generally class 2 (18-21 mmHg) for upper limb, and class 3 (36-46 mmHg) for lower limb.

Sample Size and Statistical analyses: This trial compares the efficacy of two treatment modalities without MLD (experimental group B and C) with a standard trimodal therapy (control group A). The expected effect size in percentage reduction in excess volume (PREV), primary end point, for the control group (MLD+IPC+MB) was defined from the review of literature and was 50 to 70% (mean 60%) with a standard deviation of 20 to 30 (mean 25). Our hypothesis was that there are no differences between experimental and standard treatment.

The required sample size for the study was 177 patients or 59 subjects per group to detect differences greater than or equal 15% in the percentage reduction in excess volume (PREV) between control and experimental groups, if exists; considering differences less than 15% as not clinically significant. It was based on an alpha error of 5% and a power of 90%. We estimated a drop-out rate of 10%. Therefore, 17 patients were added, resulting in a sample size of 194 subjects.

To compare baseline characteristics between three groups we use two-way ANOVA test for continuous variable and Pearson's chi2 for categorical data, to detect potential confounding factors. Outcome data were analyzed utilizing a two-way ANOVA test to assess differences between treatment groups with a 5% level of significance (p≤0.05) and two-tailed tests.

An exploratory subgroup analysis was made to identify factors associated with response (PREV). Factors for initial screening were identified by univariate linear regression model with a p value <0.1. In order to determine the independent predictive factors, a multivariate linear regression analysis was applied.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Primary Lymphedema
  • Secondary Lymphedema
Intervention  ICMJE
  • Other: Manual Lymphatic Drainage (MLD)
    MLD with Földi's technique by an expert therapist during 45 minutes
  • Device: Generic intermittent pneumatic compression Device (IPC)
    Generic intermittent pneumatic compression with multicompartmental pump between 50 to 80 mmHg during 30 minutes.
  • Other: multilayer, multicomponent bandages (MB)
    multilayer, multicomponent bandages (MB) until next day.
  • Device: Lymphapress-Plus(TM) device (LPD)
    Pneumatic massage with Lymphapress-Plus(TM)device that was lent during the duration of the study during 20 minutes.
Study Arms  ICMJE
  • Active Comparator: Standard trimodality therapy with MLD
    Manual Lymphatic Drainage (MLD) followed by intermittent pneumatic compression (IPC) and followed by multilayer, multicomponent bandages (MB) until next day.
    Interventions:
    • Other: Manual Lymphatic Drainage (MLD)
    • Device: Generic intermittent pneumatic compression Device (IPC)
    • Other: multilayer, multicomponent bandages (MB)
  • Experimental: Trimodality therapy with LPD
    Pneumatic massage with Lymphapress-Plus(TM) device (LPD) followed by intermittent pneumatic compression (IPC) and followed by multilayer, multicomponent bandages (MB) until next day
    Interventions:
    • Device: Generic intermittent pneumatic compression Device (IPC)
    • Other: multilayer, multicomponent bandages (MB)
    • Device: Lymphapress-Plus(TM) device (LPD)
  • Experimental: Bimodality therapy without MLD
    intermittent pneumatic compression (IPC) followed by multilayer, multicomponent bandages (MB) until next day.
    Interventions:
    • Device: Generic intermittent pneumatic compression Device (IPC)
    • Other: multilayer, multicomponent bandages (MB)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 11, 2012)
194
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2012
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01748604
Other Study ID Numbers  ICMJE HULaFe-LYMPHEDEMA-04
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Isabel Forner-Cordero, MD, PhD., Hospital Universitario La Fe
Study Sponsor  ICMJE Isabel Forner-Cordero, MD, PhD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Isabel I Forner-Cordero, MD, Phd University Hospital La Fe
Principal Investigator: Jose J Muñoz-Langa, MD, Phd University Hospital Dr Peset
PRS Account Hospital Universitario La Fe
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP