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Clinical Trials/NCT02360735
NCT02360735TerminatedNot Applicable

Manual Lymph Drainage for Patients With Acute Total Knee Replacement

Anne Arundel Health System Research Institute2 sites in 1 country4 target enrollmentStarted: January 1, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
4
Locations
2
Primary Endpoint
Range of Motion

Study Overview

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.

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
45 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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

Arms & Interventions

Control

Active Comparator

Patients randomized to this arm will follow the current standard for post-operative care.

Intervention: Physical Therapy (Other)

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.

Intervention: Manual Lymphatic Drainage (Other)

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.

Intervention: Physical Therapy (Other)

Outcomes

Primary Outcomes

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

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

Pain Scores

Time Frame: 3 days

Determine if performing MLD after TKR surgery decreases pain in the knee as compared to controls

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Anne Arundel Health System Research Institute
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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