Establishing Guidelines for Manual Lymphatic Drainage
- Conditions
- Lymphedema of Leg
- Interventions
- Procedure: Pressure
- Registration Number
- NCT05509062
- Lead Sponsor
- University of Colorado, Denver
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- All adults between the age of 30 - 75 years
- Lower extremity lymphedema
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Light Tactile Pressure Pressure light tactile pressure with 5-10 mmHg without skin stretch Medium Tactile Pressure Pressure medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position Firm Tactile Pressure Pressure firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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 (%)
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 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 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.
Trial Locations
- Locations (1)
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States