Manual Lymph Drainage

NCT02360735 | Terminated

• 1 other identifier: MLD-2014
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty; Post-operative Edema

Outcome Measures

Primary Outcomes (3)

• Pain Scores

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

  3 days

• Range of Motion

  Determine if performing MLD after TKR surgery increases range of motion as compared to the standard of care

  3 days

• Girth

  Determine if performing MLD after TKR surgery decreases girth and swelling in the knee as compared to the standar of care

  3 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Other: Physical Therapy

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; Other: Physical Therapy

Interventions

Manual Lymphatic Drainage OTHER

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.

Also known as: MLD, Manual Lymph Drainage

Experimental

Physical Therapy OTHER

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

Control; Experimental

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Anne Arundel Health System Research Institute: lead

Study Sites (1)

Anne Arundel Medical Center

Annapolis, Maryland, 21401, United States

Location

Related Publications (6)

• 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. doi: 10.1002/pri.277.

  PMID: 12879732 BACKGROUND

• 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.

  PMID: 21044725 BACKGROUND

• 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.

  PMID: 23810354 BACKGROUND

• 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.

  PMID: 23006595 BACKGROUND

• 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.

  PMID: 21316910 BACKGROUND

• 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.

  PMID: 22253396 BACKGROUND

MeSH Terms

Interventions

Manual Lymphatic Drainage; Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Massage; Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Drainage; Rehabilitation

Study Officials

• Paul King, M.D.

  Anne Arundel Medical Center, OSMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 11, 2015
• Study Start: January 1, 2015
• Primary Completion: October 11, 2016
• Study Completion: October 11, 2016
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

US (1)