Establishing Guidelines for Manual Lymphatic Drainage

Lymphedema of Leg Clinical Trial

— MLD  

Official title:

Establishing Guidelines for Manual Lymphatic Drainage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05509062
• Other study ID #: 22-0733
• Status: Completed
• Phase: N/A
• Start date: July 20, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Leg

Intervention

Procedure:
• Pressure
Subjects are randomized to one of three treatment groups

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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