Establishing Guidelines for Manual Lymphatic Drainage (MLD)

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Lymphedema of Leg

Treatments: Procedure: Pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT05509062

22-0733

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

64 participants in 3 patient groups

Light Tactile Pressure

Active Comparator group

Description:

light tactile pressure with 5-10 mmHg without skin stretch

Treatment:

Procedure: Pressure

Medium Tactile Pressure

Active Comparator group

Description:

medium tactile pressure of 11-20 mmHg and medium skin stretch with therapist in a stationary position

Treatment:

Procedure: Pressure

Firm Tactile Pressure

Active Comparator group

Description:

firm tactile pressure (\> 21 mmHg) and maximal skin stretch with therapist weight shift

Treatment:

Procedure: Pressure