Establishing Guidelines for Manual Lymphatic Drainage

University of Colorado, Denver64 enrolled

Overview

The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.

To determine if there is a difference in L-Dex Score and Segmental Limb Volume in participants with lower extremity lymphedema as measured in liters by the SOZO machine between participants who receive Manual Lymphatic Drainage (MLD) techniques utilizing light tactile pressure with 5-10 mmHg without skin stretch versus medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position, versus firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lymphedema of Leg

Interventions

PressurePROCEDURE

Subjects are randomized to one of three treatment groups

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * All adults between the age of 30 - 75 years * Lower extremity lymphedema Exclusion Criteria: * Pregnant women * Participants who are unable to stand independently for up to 2 mins * Participants who cannot make their own decisions * Participants undergoing cancer treatment * Participants with an Infection (active cellulitis) * Participants with a known Iodine Allergy * Participants who weigh more than 375 lbs * Participants with cardiac arrhythmias or implanted electronic equipment * Participants who have undergone joint replacement in involved extremity * Participants with cardiac insufficiency

Locations (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Change in The L-dex (Lymphedema Index).

The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb.

Time frame: 18 months

Secondary Outcomes

Change in Total body weight in liters

All the water within a person's body, including both intracellular and extracellular fluid. Expressed as volume (liters or pints) and percentage of total weight (%).

Time frame: 18 Months

Change in Extracellular Fluid in liters

All fluid that is not contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).

Time frame: 18 months

Change in Intracellular Fluid in liters

• Description: All fluid contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%).

Time frame: 18 Months

Change in Skeletal Muscle Mass in lbs

The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)

Time frame: 18 Months

Change in Fat Mass in lbs

The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%)

Time frame: 18 Months

Change in Free Fat Mass in lbs

The amount of mass a person has that contains no fat (lean body mass). Includes muscle, connective tissue, organs, body water and bone. Expressed in kgs or lbs and percentage of total weight (%).

Data from ClinicalTrials.gov

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