Trial record 2 of 3 for:    "Milroy disease"

Physical Therapies in the Decongestive Treatment of Lymphedema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Isabel Forner-Cordero, MD, PhD., Hospital Universitario La Fe
ClinicalTrials.gov Identifier:
NCT01748604
First received: December 6, 2012
Last updated: December 16, 2012
Last verified: December 2012
  Purpose

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


Condition Intervention
Primary Lymphedema
Secondary Lymphedema
Other: Manual Lymphatic Drainage (MLD)
Device: Generic intermittent pneumatic compression Device (IPC)
Other: multilayer, multicomponent bandages (MB)
Device: Lymphapress-Plus(TM) device (LPD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Physical Therapies in the Decongestive Treatment of Lymphedema: A Multicenter, Randomized, Controlled Study.

Resource links provided by NLM:


Further study details as provided by Hospital Universitario La Fe:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.



Other Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    Discomfort Lymphangitis attacks Edema displacement Fibrosclerotic ring Loss of mobility


Enrollment: 194
Study Start Date: February 2004
Study Completion Date: June 2012
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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
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.
Experimental: Bimodality therapy without MLD
intermittent pneumatic compression (IPC) followed by multilayer, multicomponent bandages (MB) until next day.
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01748604

Locations
Spain
University Hospital La Fe
Valencia, Spain, 46026
Sponsors and Collaborators
Isabel Forner-Cordero, MD, PhD.
Investigators
Study Director: Isabel I Forner-Cordero, MD, Phd University Hospital La Fe
Principal Investigator: Jose J Muñoz-Langa, MD, Phd University Hospital Dr Peset
  More Information

Publications:
Responsible Party: Isabel Forner-Cordero, MD, PhD., Consultant in Physical Medicine and Rehabilitation at the Lymphedema Unit, Hospital Universitario La Fe
ClinicalTrials.gov Identifier: NCT01748604     History of Changes
Other Study ID Numbers: HULaFe-LYMPHEDEMA-04
Study First Received: December 6, 2012
Last Updated: December 16, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario La Fe:
Lymphedema
Physical Therapies
Randomized controlled study
Decongestive lymphatic therapy
Manual lymph drainage
Intermittent pneumatic compression
Multilayer bandages

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014