Total Knee ArthroplastyMLDNCT02360735
Manual Lymph Drainage
A study testing Manual Lymphatic Drainage and Physical Therapy in people with Total Knee Arthroplasty and Post-operative Edema, run by Anne Arundel Health System Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Total Knee Arthroplasty, Post-operative Edema
- What is being tested?
- Manual Lymphatic Drainage and Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to 11 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Active infection
- Tumor
- Metastatic or systemic malignancy
- Acute thrombus
- History of pulmonary embolism
- Major cardiac pathology such has angina
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Anne Arundel Medical Center
Annapolis, Maryland, 21401
About this study
Official title: Manual Lymph Drainage for Patients With Acute Total Knee Replacement
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.
Read the 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.
- Conditions
- Total Knee Arthroplasty, Post-operative Edema
- Being tested
- Manual Lymphatic Drainage, Physical Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Lymphatic DrainageOther
Also called MLD, Manual Lymph 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 TherapyOther
All patients will participate in joint physical therapy classes during their inpatient stay.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Patients randomized to this arm will follow the current standard for post-operative care. Receives: 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. Receives: Other: Manual Lymphatic Drainage; Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
Determine if performing MLD after TKR surgery decreases pain in the knee as compared to controls
Measured: 3 days
Range of Motion
Determine if performing MLD after TKR surgery increases range of motion as compared to the standard of care
Measured: 3 days
Girth
Determine if performing MLD after TKR surgery decreases girth and swelling in the knee as compared to the standar of care
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2015 (estimated)
- Study startJan 2015
- Primary completion11 Oct 2016
- Study completion11 Oct 2016
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anne Arundel Health System Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul King, M.D., Principal investigator, Anne Arundel Medical Center, OSMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02360735
- Sponsor's protocol ID
- MLD-2014
- Acronym
- MLD
- Status last verified
- Jan 2018
- First submitted
- 29 Jan 2015
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 12879732Holm 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.
PubMed 21044725Ebert 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.
PubMed 23810354Shimoyama 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.
PubMed 23006595Watanabe 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.
PubMed 21316910Januel 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.
PubMed 22253396
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Lymph Drainage for Patients With Acute Total Knee Replacement
- ClinicalTrials.gov ID
- NCT02360735
- Acronym / sponsor ID
- MLD / MLD-2014
- Conditions
- Total Knee Arthroplasty, Post-operative Edema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Anne Arundel Health System Research InstituteUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 11 Oct 2016 (actual)
- Study completion
- 11 Oct 2016 (actual)
- First posted
- 11 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Physical TherapyPatients randomized to this arm will follow the current standard for post-operative care. |
| Experimental | Experimental | Other: Manual Lymphatic Drainage, Other: Physical TherapyPatients randomized to this arm will follow the current standard for post-operative care as well as 2 daily sessions of manual lymphatic drainage. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (14 listed)
- Active infection
- Tumor
- Metastatic or systemic malignancy
- Acute thrombus
- History of pulmonary embolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Lymphatic DrainageAlso: MLD, Manual Lymph DrainageManual 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. | Other | Experimental |
| Physical TherapyAll patients will participate in joint physical therapy classes during their inpatient stay. | Other | Control, Experimental |
Primary outcome
Pain Scores
Time frame: 3 days
Determine if performing MLD after TKR surgery decreases pain in the knee as compared to controls
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
Results and safety
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
- Background: PubMed 12879732Kessler 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.
- Background: PubMed 21044725Holm 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.
- Background: PubMed 23810354Ebert 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.
- Background: PubMed 23006595Shimoyama 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.
- Background: PubMed 21316910Watanabe 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.
- Background: PubMed 22253396Januel 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.
Related trials for Total Knee Arthroplasty
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul King, M.D. principal investigator
Anne Arundel Medical Center, OSMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Lymphatic Drainage and Physical Therapy in people with Total Knee Arthroplasty and Post-operative Edema, run by Anne Arundel Health System Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02360735, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2018.