Manual Lymph Drainage (MLD)

January 8, 2018 updated by: Anne Arundel Health System Research Institute

Manual Lymph Drainage for Patients With Acute Total Knee Replacement

Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease various forms of edema. This technique promotes reuptake of interstitial fluid along the pathways of the lymphatic system. This technique promotes healing, decrease swelling, and decrease pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease various forms of edema. Edema can limit function, range of motion (ROM) and increase pain after surgery. Studies have shown that decreasing edema can increase knee strength and functional performance on various standardized measures. MLD has been shown to be effective in patients with hind foot operations and increases ROM post total knee replacement (TKR) surgery. The aim of this study is to determine whether MLD on a sample of patients with TKR will decrease edema, increase ROM and decrease pain as compared to TKR patients who do not receive MLD.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Anne Arundel Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • s/p total knee replacement
  • Primary diagnosis of osteoarthritis or degenerative joint disease
  • Able to read and understand English to consent
  • Acceptance of the study protocol procedure

Exclusion Criteria:

  • Active infection
  • Tumor
  • Metastatic or systemic malignancy
  • Acute thrombus
  • History of pulmonary embolism
  • Major cardiac pathology such has angina
  • Heart attack or uncompensated congestive heart failure (CHF)
  • Body mass index (BMI) > 40
  • Pregnant or lactating women
  • Renal dysfunction
  • Joint revision
  • Hospitalization length of stay less than or greater than 3 days
  • Previous knee replacement
  • Bilateral knee replacement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Patients randomized to this arm will follow the current standard for post-operative care.
Other: Physical Therapy
All patients will participate in joint physical therapy classes during their inpatient stay.
Experimental: Experimental
Patients randomized to this arm will follow the current standard for post-operative care as well as 2 daily sessions of manual lymphatic drainage.
Other: Physical Therapy
All patients will participate in joint physical therapy classes during their inpatient stay.
Other: Manual Lymphatic Drainage
Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease various forms of edema. This technique promotes reuptake of interstitial fluid along the pathways of the lymphatic system. This technique promotes healing, decrease swelling, and decrease pain.
Other Names:
  • MLD
  • Manual Lymph Drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Scores
Time Frame: 3 days
Determine if performing MLD after TKR surgery decreases pain in the knee as compared to controls
3 days
Range of Motion
Time Frame: 3 days
Determine if performing MLD after TKR surgery increases range of motion as compared to the standard of care
3 days
Girth
Time Frame: 3 days
Determine if performing MLD after TKR surgery decreases girth and swelling in the knee as compared to the standar of care
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anne Arundel Health System Research Institute

Investigators

  • Principal Investigator: Paul King, M.D., Anne Arundel Medical Center, OSMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 11, 2016

Study Completion (Actual)

October 11, 2016

Study Registration Dates

First Submitted

January 29, 2015

First Submitted That Met QC Criteria

February 6, 2015

First Posted (Estimate)

February 11, 2015

Study Record Updates

Last Update Posted (Actual)

January 9, 2018

Last Update Submitted That Met QC Criteria

January 8, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • MLD-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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