Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2026-02-08 @ 8:08 PM
Study NCT ID:
NCT02360735
Status:
TERMINATED
Last Update Posted:
2018-01-09
First Post:
2015-01-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Manual Lymph Drainage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073297', 'term': 'Manual Lymphatic Drainage'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}], 'ancestors': [{'id': 'D008405', 'term': 'Massage'}, {'id': 'D064746', 'term': 'Therapy, Soft Tissue'}, {'id': 'D026201', 'term': 'Musculoskeletal Manipulations'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004322', 'term': 'Drainage'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-10-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-08', 'studyFirstSubmitDate': '2015-01-29', 'studyFirstSubmitQcDate': '2015-02-06', 'lastUpdatePostDateStruct': {'date': '2018-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': '3 days', 'description': 'Determine if performing MLD after TKR surgery decreases pain in the knee as compared to controls'}, {'measure': 'Range of Motion', 'timeFrame': '3 days', 'description': 'Determine if performing MLD after TKR surgery increases range of motion as compared to the standard of care'}, {'measure': 'Girth', 'timeFrame': '3 days', 'description': 'Determine if performing MLD after TKR surgery decreases girth and swelling in the knee as compared to the standar of care'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Total Knee Arthroplasty', 'Post-operative Edema']}, 'referencesModule': {'references': [{'pmid': '12879732', 'type': 'BACKGROUND', '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. doi: 10.1002/pri.277.'}, {'pmid': '21044725', 'type': 'BACKGROUND', '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.'}, {'pmid': '23810354', 'type': 'BACKGROUND', 'citation': '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': '23006595', 'type': 'BACKGROUND', '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.'}, {'pmid': '21316910', 'type': 'BACKGROUND', '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.'}, {'pmid': '22253396', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* s/p total knee replacement\n* Primary diagnosis of osteoarthritis or degenerative joint disease\n* Able to read and understand English to consent\n* Acceptance of the study protocol procedure\n\nExclusion Criteria:\n\n* Active infection\n* Tumor\n* Metastatic or systemic malignancy\n* Acute thrombus\n* History of pulmonary embolism\n* Major cardiac pathology such has angina\n* Heart attack or uncompensated congestive heart failure (CHF)\n* Body mass index (BMI) \\> 40\n* Pregnant or lactating women\n* Renal dysfunction\n* Joint revision\n* Hospitalization length of stay less than or greater than 3 days\n* Previous knee replacement\n* Bilateral knee replacement'}, 'identificationModule': {'nctId': 'NCT02360735', 'acronym': 'MLD', 'briefTitle': 'Manual Lymph Drainage', 'organization': {'class': 'OTHER', 'fullName': 'Anne Arundel Health System Research Institute'}, 'officialTitle': 'Manual Lymph Drainage for Patients With Acute Total Knee Replacement', 'orgStudyIdInfo': {'id': 'MLD-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Patients randomized to this arm will follow the current standard for post-operative care.', 'interventionNames': ['Other: Physical Therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental', 'description': 'Patients randomized to this arm will follow the current standard for post-operative care as well as 2 daily sessions of manual lymphatic drainage.', 'interventionNames': ['Other: Manual Lymphatic Drainage', 'Other: Physical Therapy']}], 'interventions': [{'name': 'Manual Lymphatic Drainage', 'type': 'OTHER', 'otherNames': ['MLD', 'Manual Lymph Drainage'], 'description': '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.', 'armGroupLabels': ['Experimental']}, {'name': 'Physical Therapy', 'type': 'OTHER', 'description': 'All patients will participate in joint physical therapy classes during their inpatient stay.', 'armGroupLabels': ['Control', 'Experimental']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21401', 'city': 'Annapolis', 'state': 'Maryland', 'country': 'United States', 'facility': 'Anne Arundel Medical Center', 'geoPoint': {'lat': 38.97859, 'lon': -76.49184}}], 'overallOfficials': [{'name': 'Paul King, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Anne Arundel Medical Center, OSMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anne Arundel Health System Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}