Clinical trial NCT05226195: Effect of Kinesio® Taping in Total Knee Replacement Surgery
Official title: The Effect of Kinesio® Taping on Post-Surgical Functional Outcomes in Patients Undergoing Total Knee Replacement Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Post-Surgical Complication
Keywords: Kinesiotape
Post-Surgical Functional Outcomes
Total Knee Replacement Surgery
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized controlled clinical trial
Primary purpose: TREATMENT

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".


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from Baseline at 15th, 45th and 90th days in Pain
timeFrame: The clinical evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Range of Motion Assessment
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Edema
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
Secondary outcomes:
measure: Change from Baseline at 15th, 45th and 90th days in Complications
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Functional Assessment of knee
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Functional Assessment for osteoarthritis.
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Thermographic measurement
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Interleukin 6 (IL-6)
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Sedimentation rate
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as C-reactive protein (CRP)
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
measure: Change from Baseline at 15th, 45th and 90th days in Inflammatory markers as Creatine Kinase (CK)
timeFrame: The evaluation will be made on the 15th, 45th and 90th days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
References: