Lymphedema of Leg
Conditions
Brief summary
The purpose of this study is to establish optimal guidelines for Manual Lymphatic Drainage in participants with lower extremity lymphedema.
Detailed description
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.
Interventions
PROCEDUREPressure
Subjects are randomized to one of three treatment groups
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Treatment Group 1 Treatment Group 2 Treatment Group 3
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The L-dex (Lymphedema Index). | 18 months | The L-DEX score represents the difference in the amount of extracellular fluid in an at-risk limb compared to an unaffected limb. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Extracellular Fluid in liters | 18 months | All fluid that is not contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%). |
| Change in Intracellular Fluid in liters | 18 Months | • Description: All fluid contained within the cells. Expressed as volume (liters or pints) and percentage of TBW (%). |
| Change in Skeletal Muscle Mass in lbs | 18 Months | The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%) |
| Change in Total body weight in liters | 18 Months | 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 (%). |
| Change in Free Fat Mass in lbs | 18 Months | 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 (%). |
| Change in Basal Metabolic Rate (BMR) in lbs | 18 Months | Daily amount of energy a person's body burns when at complete rest. Expressed in calories. |
| Change in Basal Metabolic Rate in kg/m^2 | 18 months | A relationship between weight and height that is associated with body fat and health risks. BMI = weight / height2. |
| Change in Fat Mass in lbs | 18 Months | The amount of mass a person has that is made up of fat. Expressed in kgs or lbs and percentage of total weight (%) |
Countries
United States
Outcome results
None listed