Establishing Guidelines for Manual Lymphatic Drainage

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

Detailed Description
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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.

Official Title
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Establishing Guidelines for Manual Lymphatic Drainage

Conditions
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Lymphedema of Leg

Intervention / Treatment
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* Procedure: Pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Treatment Group 1 Treatment Group 2 Treatment Group 3
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Light Tactile Pressure<br>light tactile pressure with 5-10 mmHg without skin stretch | Procedure: Pressure<br>* Subjects are randomized to one of three treatment groups<br>|
| Active Comparator: Medium Tactile Pressure<br>medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position | Procedure: Pressure<br>* Subjects are randomized to one of three treatment groups<br>|
| Active Comparator: Firm Tactile Pressure<br>firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift | Procedure: Pressure<br>* Subjects are randomized to one of three treatment groups<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (%). | 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 (%). | 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 (%). | 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 (%) | 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 (%) | 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 (%). | 18 Months | 
| Change in Basal Metabolic Rate (BMR) in lbs | Daily amount of energy a person's body burns when at complete rest. Expressed in calories. | 18 Months | 
| Change in Basal Metabolic Rate in kg/m^2 | A relationship between weight and height that is associated with body fat and health risks. BMI = weight / height2. | 18 months |