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Manual Lymph Drainage (MLD)

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ClinicalTrials.gov Identifier: NCT02360735
Recruitment Status : Terminated (Lack of enrollment)
First Posted : February 11, 2015
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Anne Arundel Health System Research Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Total Knee Arthroplasty Post-operative Edema Other: Manual Lymphatic Drainage Other: Physical Therapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Manual Lymph Drainage for Patients With Acute Total Knee Replacement
Study Start Date : January 2015
Actual Primary Completion Date : October 11, 2016
Actual Study Completion Date : October 11, 2016

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: 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

Other: Physical Therapy
All patients will participate in joint physical therapy classes during their inpatient stay.




Primary Outcome Measures :
  1. Pain Scores [ Time Frame: 3 days ]
    Determine if performing MLD after TKR surgery decreases pain in the knee as compared to controls

  2. 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. 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



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Ages Eligible for Study:   45 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360735


Locations
United States, Maryland
Anne Arundel Medical Center
Annapolis, Maryland, United States, 21401
Sponsors and Collaborators
Anne Arundel Health System Research Institute
Investigators
Principal Investigator: Paul King, M.D. Anne Arundel Medical Center, OSMC

Publications:

Responsible Party: Anne Arundel Health System Research Institute
ClinicalTrials.gov Identifier: NCT02360735     History of Changes
Other Study ID Numbers: MLD-2014
First Posted: February 11, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018