## Protocol Section
### Identification Module
**NCT ID:** NCT05013879

**Brief Title:** Kinesiotape for Edema After Bilateral Total Knee Arthroplasty

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

#### Organization Study ID Info
**ID:** 2021-13203
#### Organization
**Class:** OTHER
**Full Name:** Montefiore Medical Center
### Status Module
#### Completion Date
**Date:** 2023-11-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-02-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-02-21

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-11-24

**Type:** ACTUAL

#### Start Date
**Date:** 2021-10-18

**Type:** ACTUAL

**Status Verified Date:** 2024-02

#### Study First Post Date
**Date:** 2021-08-19
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-02
**Study First Submit QC Date:** 2021-08-18
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Burke Rehabilitation Hospital

#### Lead Sponsor

**Class:** OTHER

**Name:** Montefiore Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief 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 the leg not receiving kinesiotape.

**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 Module

**Conditions:**

- Arthroplasty Complications

- Arthroplasty, Replacement, Knee

**Keywords:**

- edema

- arthroplasty, knee, bilateral

- kinesiotaping

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

**Intervention Model Description:** Repeated measures with two within-subjects factors: time and taped/untaped leg

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 65

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Kinesio(R)Tape for edema management applied to a randomly selected lower extremity plus standard inpatient rehabilitation after bilateral total knee arthroplasty

**Intervention Names:**

- Device: Kinesio(R)Tape for edema control

**Label:** Kinesiotape leg plus standard rehabilitation

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Control leg receiving standard inpatient rehabilitation alone.

**Label:** Control leg with standard rehabilitation alone

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Kinesiotape leg plus standard rehabilitation

**Description:** 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.

**Name:** Kinesio(R)Tape for edema control

**Other Names:**

- kinesiotaping or kinesiological taping

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**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

#### Secondary Outcomes

**Description:** Patient self-report: Pain rating for each leg on a integer scale of 0 (no pain) to 10 (worst pain imaginable)

**Measure:** 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

**Description:** Physical therapist's measurement of active and active assistive knee range of motion (degrees) for flexion and extension using a standard goniometer

**Measure:** 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

**Description:** Patient self-report using the KOOS sections relating to pain, stiffness, activities of daily living

**Measure:** 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

**Description:** 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.

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* 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.

**Maximum Age:** 85 Years

**Minimum Age:** 50 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** White Plains

**Country:** United States

**Facility:** Burke Rehabilitation Hospital

**State:** New York

**Zip:** 10605

#### Overall Officials

**Official 1:**

**Affiliation:** Burke Rehabilitation Hospital

**Name:** Suzanne Babyar, PT, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

**Citation:** 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.

**PMID:** 32459670

**Citation:** 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.

**Citation:** 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.

**PMID:** 24819349

**Citation:** 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.

**Citation:** 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.

**PMID:** 30208939

**Citation:** 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.

**PMID:** 26223312

**Citation:** 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.

**PMID:** 30341552

**Citation:** 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.

**PMID:** 23948839

**Citation:** 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.

**PMID:** 29075347

**Citation:** 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.

**PMID:** 22840304

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M7657

- Name: Edema

- Relevance: HIGH

- As Found: Edema

### Condition Browse Module - Meshes

- ID: D000004487

- Term: Edema

### Misc Info Module

- Version Holder: 2024-05-24
