Manual Lymph Drainage

NCT ID: NCT02360735

Last Updated: 2018-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-10-11

Brief Summary

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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

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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.

Conditions

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Total Knee Arthroplasty Post-operative Edema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

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

Group Type ACTIVE_COMPARATOR

Physical Therapy

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Manual Lymphatic Drainage

Intervention Type 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.

Physical Therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Physical Therapy

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

Intervention Type OTHER

Other Intervention Names

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MLD Manual Lymph Drainage

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anne Arundel Health System Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul King, M.D.

Role: PRINCIPAL_INVESTIGATOR

Anne Arundel Medical Center, OSMC

Locations

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Anne Arundel Medical Center

Annapolis, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 12879732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21044725 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23810354 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23006595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21316910 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22253396 (View on PubMed)

Other Identifiers

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MLD-2014

Identifier Type: -

Identifier Source: org_study_id

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