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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Light Tactile Pressure | Active Comparator | light tactile pressure with 5-10 mmHg without skin stretch |
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| Medium Tactile Pressure | Active Comparator | medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position |
|
| Firm Tactile Pressure | Active Comparator | firm tactile pressure (> 21 mmHg) and maximal skin stretch with therapist weight shift |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pressure | Procedure | Subjects are randomized to one of three treatment groups |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marco Del Chiaro | University of Colorado Denver | Anschutz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D011312 | Pressure |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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Treatment Group 1 Treatment Group 2 Treatment Group 3
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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 |