Arthroplasty ComplicationsNCT05013879

Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

A study of Arthroplasty Complications and Arthroplasty, Replacement, Knee, run by Montefiore Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to determine if kinesiotaping for edema management will decrease post-operative edema in patients with bilateral total knee arthroplasty. The leg receiving kinesiotaping during inpatient rehabilitation may have decreased edema and pain and improved movement and function when compared to… Read more about this study

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Arthroplasty Complications, Arthroplasty, Replacement, Knee
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 18 Oct 2021to 24 Nov 2023
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 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty;
50-85 years of age;
able to read and understand English or a hospital-provided translator when consenting for the study;
free from contraindications for kinesiotaping (see below); and,
able to tolerate an active rehabilitation program.

Who cannot join

stage III or IV heart failure, stage III or IV renal failure;
fragile, very hairy or sensitive skin;
anesthesia or paraesthesia of any area of the lower extremity, except the surgical sites
active skin rashes or infections or skin lesions in the lower extremity;
prior history of allergic reactions to skin taping, bandaids, surgical tape; athletic tape or other skin-adhering electrode adhesives;
prior history of lower extremity lymphedema;3

Show all 12Show fewer

prior history of lower extremity venous or arterial disease;
post-operative complications in the surgical sites;4
partial joint arthroplasty or revision arthroplasty of one or both knees;1,5
inability to give informed consent offered in English or through a hospital-provided translator
age less than 50 years or over 85 years;
inability to tolerate an active rehabilitation program.

Trial locations and contacts

1 site in 1 country.

United States1 site

Burke Rehabilitation Hospital
White Plains, New York, 10605

Other trials in United States

About this study

Official title: Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty

Read the detailed description

After being informed about the study and potential risk, all patients undergoing inpatient rehabilitation after bilateral total knee arthroplasty will have Kinesio(R)Tape applied to one randomly selected leg while the other leg serves as a control. Measurement of bilateral leg circumference, knee range of motion, numerical rating scale for pain, and selected questions from the Knee Injury and Osteoarthritis Outcome Score will occur at regular intervals throughout the rehabilitation stay. Patients will receive standard rehabilitation.

Conditions: Arthroplasty Complications, Arthroplasty, Replacement, Knee
Being tested: Kinesio(R)Tape for edema control
Keywords: edema, arthroplasty, knee, bilateral, kinesiotaping
Medical subject headings: Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Kinesio(R)Tape for edema controlDevice
Also called kinesiotaping or kinesiological taping
Kinesio(R)Tape is an elastic, cotton tape with an adhesive backing. When applied for edema management, strips of Kinesio(R)Tape are applied to the lower leg in a criss-cross fashion by a physical therapist who is a Certified Kinesiotape Practitioner.

Study groups in NCT05013879
Study group	Role	What they receive
Kinesiotape leg plus standard rehabilitation	Experimental	Kinesio(R)Tape for edema management applied to a randomly selected lower extremity plus standard inpatient rehabilitation after bilateral total knee arthroplasty Receives: Device: Kinesio(R)Tape for edema control
Control leg with standard rehabilitation alone	No intervention	Control leg receiving standard inpatient rehabilitation alone.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities
Bilateral circumferences, in centimeters, at the following points: 10 cm above the superior pole of the patella; middle of the knee joint; calf circumference at the broadest part of the calf and at 3 inches below the fibular head landmark; figure of eight method for foot and ankle circumference - a measurement from the lateral malleolus to the navicular tuberosity, under the plantar aspect of the foot towards the tuberosity of the fifth metatarsal, around to the medial malleolus, and posterior to the leg to return to the lateral malleolus.
Measured: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8

Secondary outcomes (4)

Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale
Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable)
Measured: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Change from baseline and during 1-2-day time intervals for bilateral knee range of motion
Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer
Measured: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report
Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living
Measured: At start of study, 4 days after start of study, and day 8
Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test
Time (sec) to rise from a seated position, walk 10 m, turn, walk back to seat, and sit down. Patient will use appropriate assistive device and have appropriate guarding by a physical therapist.
Measured: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Oct 202124 Nov 2023

First posted19 Aug 2021
Study start18 Oct 2021
Primary completion24 Nov 2023
Study completion24 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Arthroplasty ComplicationsStudies of the same condition, open and under way.
More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
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: Single group
Model description: Repeated measures with two within-subjects factors: time and taped/untaped leg
Masking: None (open label)
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05013879
Sponsor's protocol ID: 2021-13203
Status last verified: Feb 2024
First submitted: 2 Aug 2021
Last updated: 23 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Tornatore L, De Luca ML, Ciccarello M, Benedetti MG. Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):240-246. doi: 10.1097/MRR.0000000000000417.
PubMed 32459670
Guney Deniz H, Kinikli GI, Onal S, Sevinc C, Caglar O, Yuksei I. Comparison of Kinesio Tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty. [Abstract]. Ann Rheum Dis. 2018; 77: 1791.
Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13.
PubMed 24819349
Sulman M, Riaz S, Khan RR, Faisal Z, Rajput R, Noor M. Effectiveness of Kinesio Taping on pain and function after total knee arthroplasty. Pak J Med Health Sci. 2020;14:1267-1270.
Oktas B, Vergili O. The effect of intensive exercise program and kinesiotaping following total knee arthroplasty on functional recovery of patients. J Orthop Surg Res. 2018 Sep 12;13(1):233. doi: 10.1186/s13018-018-0924-9.
PubMed 30208939
Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
PubMed 26223312
Hancock GE, Hepworth T, Wembridge K. Accuracy and reliability of knee goniometry methods. J Exp Orthop. 2018 Oct 19;5(1):46. doi: 10.1186/s40634-018-0161-5.
PubMed 30341552
Unver B, Ertekin O, Karatosun V. Pain, fear of falling and stair climbing ability in patients with knee osteoarthritis before and after knee replacement: 6 month follow-up study. J Back Musculoskelet Rehabil. 2014;27(1):77-84. doi: 10.3233/BMR-130422.
PubMed 23948839
Bakar Y, Ozdemir OC, Sevim S, Duygu E, Tugral A, Surmeli M. Intra-observer and inter-observer reliability of leg circumference measurement among six observers: a single blinded randomized trial. J Med Life. 2017 Jul-Sep;10(3):176-181.
PubMed 29075347
Collins NJ, Roos EM. Patient-reported outcomes for total hip and knee arthroplasty: commonly used instruments and attributes of a "good" measure. Clin Geriatr Med. 2012 Aug;28(3):367-94. doi: 10.1016/j.cger.2012.05.007. Epub 2012 Jun 22.
PubMed 22840304
DalCeredo C, LaCava J, Young R, Conklin K, Herbold J, Simsuangco C, Inostroza Millas F, Sokolow Z, Babyar S. Effectiveness of kinesiotaping for lymphatic drainage after bilateral total knee arthroplasty: A randomized controlled trial. Medicine (Baltimore). 2025 Apr 11;104(15):e41971. doi: 10.1097/MD.0000000000041971.
PubMed 40228285

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Arthroplasty Complications trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Kinesiotaping on Edema Management, Pain and Function on Patients With Bilateral Total Knee Arthroplasty
ClinicalTrials.gov ID: NCT05013879
Acronym / sponsor ID: 2021-13203
Conditions: Arthroplasty Complications, Arthroplasty, Replacement, Knee
Keywords: edema, arthroplasty, knee, bilateral, kinesiotaping
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: Montefiore Medical CenterUniversity, hospital or other
Collaborators: Burke Rehabilitation Hospital
Study start: 18 Oct 2021 (actual)
Primary completion: 24 Nov 2023 (actual)
Study completion: 24 Nov 2023 (actual)
First posted: 19 Aug 2021 (actual)
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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Repeated measures with two within-subjects factors: time and taped/untaped leg

Arm	Type	Receives
Kinesiotape leg plus standard rehabilitation	Experimental	Device: Kinesio(R)Tape for edema controlKinesio(R)Tape for edema management applied to a randomly selected lower extremity plus standard inpatient rehabilitation after bilateral total knee arthroplasty
Control leg with standard rehabilitation alone	No intervention	–Control leg receiving standard inpatient rehabilitation alone.

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

admitted to Burke Rehabilitation Hospital for inpatient rehabilitation within 5 days after same-day or staged bilateral total knee arthroplasty;
50-85 years of age;
able to read and understand English or a hospital-provided translator when consenting for the study;
free from contraindications for kinesiotaping (see below); and,
able to tolerate an active rehabilitation program.

Key exclusion criteria (12 listed)

stage III or IV heart failure, stage III or IV renal failure;
fragile, very hairy or sensitive skin;
anesthesia or paraesthesia of any area of the lower extremity, except the surgical sites
active skin rashes or infections or skin lesions in the lower extremity;
prior history of allergic reactions to skin taping, bandaids, surgical tape; athletic tape or other skin-adhering electrode adhesives;

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
Kinesio(R)Tape for edema controlAlso: kinesiotaping or kinesiological tapingKinesio(R)Tape is an elastic, cotton tape with an adhesive backing. When applied for edema management, strips of Kinesio(R)Tape are applied to the lower leg in a criss-cross fashion by a physical therapist who is a Certified Kinesiotape Practitioner.	Device	Kinesiotape leg plus standard rehabilitation

Primary outcome

Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities
Time frame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Bilateral circumferences, in centimeters, at the following points: 10 cm above the superior pole of the patella; middle of the knee joint; calf circumference at the broadest part of the calf and at 3 inches below the fibular head landmark; figure of eight method for foot and ankle circumference - a measurement from the lateral malleolus to the navicular tuberosity, under the plantar aspect of the foot towards the tuberosity of the fifth metatarsal, around to the medial malleolus, and posterior to the leg to return to the lateral malleolus.

4 secondary outcomes

Change from baseline and day-to-day changes of bilateral knee pain on numerical pain rating scale
Time frame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Change from baseline and during 1-2-day time intervals for bilateral knee range of motion
Time frame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8
Change from baseline to Day 4 to Discharge Day for selected parts of the Knee Injury and Osteoarthritis Outcome Score (KOOS) self-report
Time frame: At start of study, 4 days after start of study, and day 8
Change from baseline and during 1-2-day time intervals for Timed Up-and-Go Test
Time frame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
Background: PubMed 32459670Tornatore L, De Luca ML, Ciccarello M, Benedetti MG. Effects of combining manual lymphatic drainage and Kinesiotaping on pain, edema, and range of motion in patients with total knee replacement: a randomized clinical trial. Int J Rehabil Res. 2020 Sep;43(3):240-246. doi: 10.1097/MRR.0000000000000417.
BackgroundGuney Deniz H, Kinikli GI, Onal S, Sevinc C, Caglar O, Yuksei I. Comparison of Kinesio Tape application and manual lymphatic drainage on lower extremity oedema and functions after total knee arthroplasty. [Abstract]. Ann Rheum Dis. 2018; 77: 1791.
Background: PubMed 24819349Donec V, Krisciunas A. The effectiveness of Kinesio Taping(R) after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial. Eur J Phys Rehabil Med. 2014 Aug;50(4):363-71. Epub 2014 May 13.
BackgroundSulman M, Riaz S, Khan RR, Faisal Z, Rajput R, Noor M. Effectiveness of Kinesio Taping on pain and function after total knee arthroplasty. Pak J Med Health Sci. 2020;14:1267-1270.
Background: PubMed 30208939Oktas B, Vergili O. The effect of intensive exercise program and kinesiotaping following total knee arthroplasty on functional recovery of patients. J Orthop Surg Res. 2018 Sep 12;13(1):233. doi: 10.1186/s13018-018-0924-9.
Background: PubMed 26223312Alghadir A, Anwer S, Brismee JM. The reliability and minimal detectable change of Timed Up and Go test in individuals with grade 1-3 knee osteoarthritis. BMC Musculoskelet Disord. 2015 Jul 30;16:174. doi: 10.1186/s12891-015-0637-8.
Background: PubMed 30341552Hancock GE, Hepworth T, Wembridge K. Accuracy and reliability of knee goniometry methods. J Exp Orthop. 2018 Oct 19;5(1):46. doi: 10.1186/s40634-018-0161-5.
Background: PubMed 23948839Unver B, Ertekin O, Karatosun V. Pain, fear of falling and stair climbing ability in patients with knee osteoarthritis before and after knee replacement: 6 month follow-up study. J Back Musculoskelet Rehabil. 2014;27(1):77-84. doi: 10.3233/BMR-130422.
Background: PubMed 29075347Bakar Y, Ozdemir OC, Sevim S, Duygu E, Tugral A, Surmeli M. Intra-observer and inter-observer reliability of leg circumference measurement among six observers: a single blinded randomized trial. J Med Life. 2017 Jul-Sep;10(3):176-181.
Background: PubMed 22840304Collins NJ, Roos EM. Patient-reported outcomes for total hip and knee arthroplasty: commonly used instruments and attributes of a "good" measure. Clin Geriatr Med. 2012 Aug;28(3):367-94. doi: 10.1016/j.cger.2012.05.007. Epub 2012 Jun 22.
Derived from this study: PubMed 40228285DalCeredo C, LaCava J, Young R, Conklin K, Herbold J, Simsuangco C, Inostroza Millas F, Sokolow Z, Babyar S. Effectiveness of kinesiotaping for lymphatic drainage after bilateral total knee arthroplasty: A randomized controlled trial. Medicine (Baltimore). 2025 Apr 11;104(15):e41971. doi: 10.1097/MD.0000000000041971.
Individual participant dataSharing planned: No

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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.

Suzanne Babyar, PT, PhD principal investigator

Burke Rehabilitation Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Arthroplasty Complications and Arthroplasty, Replacement, Knee, run by Montefiore Medical Center 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 5 inclusion and 12 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: finished, as of the sponsor's last update on 23 Feb 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Change from baseline and during 1-2-day time intervals of circumferences of both knees and lower extremities (time frame: During inpatient rehabilitation stay for each subject: at baseline (day 0), day 1, day 2, and every other day until day 8). 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 NCT05013879, which also lists 11 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 23 Feb 2024.