Overview

This trial is active, not recruiting.

Conditions total knee arthroplasty, post-operative edema
Treatments manual lymphatic drainage, physical therapy
Sponsor Anne Arundel Health System Research Institute
Start date January 2015
End date January 2018
Trial size 80 participants
Trial identifier NCT02360735, MLD-2014

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Patients randomized to this arm will follow the current standard for post-operative care.
physical therapy
All patients will participate in joint physical therapy classes during their inpatient stay.
(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.
manual lymphatic drainage MLD
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.
physical therapy
All patients will participate in joint physical therapy classes during their inpatient stay.

Primary Outcomes

Measure
Pain Scores
time frame: 3 days
Range of Motion
time frame: 3 days
Girth
time frame: 3 days

Eligibility Criteria

Male or female participants from 45 years up to 90 years old.

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

Additional Information

Official title Manual Lymph Drainage for Patients With Acute Total Knee Replacement
Principal investigator Paul King, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Anne Arundel Health System Research Institute.