Manual Lymph Drainage

Total Knee Arthroplasty Clinical Trial

— MLD  

Official title:

Manual Lymph Drainage for Patients With Acute Total Knee Replacement

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02360735
• Other study ID #: MLD-2014
• Status: Terminated
• Phase: N/A
• First received: January 29, 2015
• Last updated: January 8, 2018
• Start date: January 2015
• Est. completion date: October 11, 2016

Study information

• Verified date: January 2018
• Source: Anne Arundel Health System Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 11, 2016
• Est. primary completion date: October 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Post-operative Edema
• Total Knee Arthroplasty

Intervention

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

Locations

Country	Name	City	State
United States	Anne Arundel Medical Center	Annapolis	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Anne Arundel Health System Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (6)

Ebert JR, Joss B, Jardine B, Wood DJ. Randomized trial investigating the efficacy of manual lymphatic drainage to improve early outcome after total knee arthroplasty. Arch Phys Med Rehabil. 2013 Nov;94(11):2103-11. doi: 10.1016/j.apmr.2013.06.009. Epub 2013 Jun 26. — View Citation

Holm B, Kristensen MT, Bencke J, Husted H, Kehlet H, Bandholm T. Loss of knee-extension strength is related to knee swelling after total knee arthroplasty. Arch Phys Med Rehabil. 2010 Nov;91(11):1770-6. doi: 10.1016/j.apmr.2010.07.229. — View Citation

Januel JM, Chen G, Ruffieux C, Quan H, Douketis JD, Crowther MA, Colin C, Ghali WA, Burnand B; IMECCHI Group. Symptomatic in-hospital deep vein thrombosis and pulmonary embolism following hip and knee arthroplasty among patients receiving recommended prophylaxis: a systematic review. JAMA. 2012 Jan 18;307(3):294-303. doi: 10.1001/jama.2011.2029. Review. — View Citation

Kessler T, de Bruin E, Brunner F, Vienne P, Kissling R. Effect of manual lymph drainage after hindfoot operations. Physiother Res Int. 2003;8(2):101-10. — View Citation

Shimoyama Y, Sawai T, Tatsumi S, Nakahira J, Oka M, Nakajima M, Jotoku T, Minami T. Perioperative risk factors for deep vein thrombosis after total hip arthroplasty or total knee arthroplasty. J Clin Anesth. 2012 Nov;24(7):531-6. doi: 10.1016/j.jclinane.2012.02.008. Epub 2012 Sep 21. — View Citation

Watanabe H, Sekiya H, Kariya Y, Hoshino Y, Sugimoto H, Hayasaka S. The incidence of venous thromboembolism before and after total knee arthroplasty using 16-row multidetector computed tomography. J Arthroplasty. 2011 Dec;26(8):1488-93. doi: 10.1016/j.arth.2011.01.001. Epub 2011 Feb 12. — View Citation

Outcome

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