Effect of Kinesio® Taping in Total Knee Replacement Surgery

NCT05226195 | Completed

• 1 other identifier: KA21/464
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Total knee replacement, which is the gold standard surgical treatment method applied in today's conditions, in order to maintain the patient's daily life without pain, to provide the knee joint range of motion, to eliminate the deformity and instability in the knee joint in advanced stage (Stage 3-4) knee osteoarthritis (OA) that does not benefit from conservative treatment. Obtaining the best clinical outcome for the patient after surgery is only possible with the implementation of post-surgical physical therapy and rehabilitation programs. Edema and pain occurring in the early post-surgical period prevent patients from moving freely, and as a result, the psychological state of the patients is also affected. With effective physiotherapy, besides relieving pain and edema, patients' sensorimotor performances, proprioceptive senses and body balances are restored, and thus the brain is taught how to maintain joint functions. For this reason, new physiotherapy methods are being developed every day for this purpose. "Kinesio Taping" (KT) is one of the modern physiotherapy methods that has been widely used in sports orthopedics in recent years. It was developed by Kenzo Kase in 1973 and is used clinically to relieve pain and edema, and to increase motor function in musculoskeletal diseases. In this method, an adhesive cotton-based tape called kinesio tape is used. The elastic structure of this band, which allows it to extend 130-140% of its original length, similar to the skin, together with its three-dimensional "fingerprint" texture specific to the band, causes the formation of microfolds on the skin. The formation of these folds; It is known that it increases the proprioceptive perception of the related joint by stimulating skin mechanoreceptors. It also reduces the pressure under the skin and helps relieve pain by increasing lymphatic drainage. The Epidermis-Dermis-Fascia (EDF) taping method is a KB method that has been developed in recent years. It provides less tension and is more easily applied to painful areas. The narrow strips of the applied tape provide more stimulation in the most superficial tissues5. Although studies on the effect of other application methods on rehabilitation after knee replacement surgery are available in the literature, there is no study in the literature showing the effects of the EDF technique. In this study, it is aimed to evaluate the effect of KT applied with EDF technique on clinical results in the early postoperative period in patients who have undergone total knee replacement surgery. The hypothesis of this study is; It was determined that "pain and edema decrease and functional gain increases in patients who underwent KT after total knee prosthesis surgery".

Conditions

Knee Osteoarthritis; Post-Surgical Complication

Keywords

Kinesiotape; Post-Surgical Functional Outcomes; Total Knee Replacement Surgery

Outcome Measures

Primary Outcomes (3)

• Change from Baseline at 15th, 45th and 90th days in Pain

  Visual analogue scale will be used for pain assessment in rest, activity and sleep. The patient will be asked to define the severity of pain in a 10 cm line, from 0 to 10. 0 means no pain and 10 means unbearable pain.

  The clinical evaluation will be made on the 15th, 45th and 90th days

• Change from Baseline at 15th, 45th and 90th days in Range of Motion Assessment

  range of motion of knee flexion and extension will be measured with digital inclinometer

  The evaluation will be made on the 15th, 45th and 90th days

• Change from Baseline at 15th, 45th and 90th days in Edema

  edema will be made with measurement of the opposite extremity which will be compared with the tape measure

  The evaluation will be made on the 15th, 45th and 90th days

Secondary Outcomes (8)

• Change from Baseline at 15th, 45th and 90th days in Complications

  The evaluation will be made on the 15th, 45th and 90th days

• Change from Baseline at 15th, 45th and 90th days in Functional Assessment of knee

  The evaluation will be made on the 15th, 45th and 90th days

• Change from Baseline at 15th, 45th and 90th days in Functional Assessment for osteoarthritis.

  The evaluation will be made on the 15th, 45th and 90th days

• Change from Baseline at 15th, 45th and 90th days in Thermographic measurement

  The evaluation will be made on the 15th, 45th and 90th days

• Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Interleukin 6 (IL-6)

  The evaluation will be made on the 15th, 45th and 90th days

Study Arms (2)

Group 1: Sterile Kinesio tape application

EXPERIMENTAL

The standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months.

Other: Sterile Kinesio Taping

Group 2: Control group

NO INTERVENTION

The standard post-surgical protocol applied in our clinic will be applied to Group 2. The clinical evaluation will be made on the 15th, 45th and 90th days; functional measurements will be taken. The follow-up period was determined as 3 months.

Interventions

Sterile Kinesio Taping OTHER

The standard post-surgical protocol and sterile EDF kinesio-taping will be applied to this group in the operating room at the end of the surgery in a sterile manner according to the epidermis-dermis-fascia (EDF) technique previously described in the literature (without tension). Original KinesioTex® Tape will be used in the study. The day of taping will be considered as Day 0 and the tapes will be changed on the 4th day, the 7th day.

Group 1: Sterile Kinesio tape application

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to be volunteered to participate in the study.
• It will be performed in patients who have stage 3-4 osteoarthritis according to the "Kellgren-Lawrence" classification and therefore undergo total knee replacement surgery in a ligament-cutting design in the Department of Orthopedics and Traumatology of Baskent University Ankara Hospital.

You may not qualify if:

• Patients who underwent total knee prosthesis surgery in a hinge-preserving and hinged design
• Patients who underwent simultaneous bilateral total knee prosthesis surgery
• Patients with lymphedema
• Skin lesions at the place where the taping will be applied
• Local sensitivity in the skin sensitivity test to be performed the day before the application
• Chronic kidney failure patients
• Patients with congestive heart failure
• Patients with a body mass index of 30 and above
• Patients who underwent surgery for pathological fractures
• Patients who underwent total knee replacement revision surgery
• Patients who had previously undergone high tibial osteotomy or unicondylar knee replacement surgery
• Patients who underwent surgery due to traumatic arthrosis

Sponsors & Collaborators

• Baskent University: lead

Study Sites (1)

Baskent University

Ankara, 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Proffesor

Model Details: Prospective randomized controlled clinical trial

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: February 7, 2022
• Study Start: January 13, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: July 27, 2023

Record last verified: 2023-07

Locations

TU (1)