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临床试验/NCT05226195
NCT05226195已完成不适用

The Effect of Kinesio® Taping on Post-Surgical Functional Outcomes in Patients Undergoing Total Knee Replacement Surgery

Baskent University2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2022年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90
试验地点
2
主要终点
Change from Baseline at 15th, 45th and 90th days in Pain

研究概览

简要总结

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".

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

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

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

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.

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

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

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

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

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

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

次要结局

  • 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 Inflammatory markers as Interleukin 6 (IL-6)(The evaluation will be made on the 15th, 45th and 90th days)
  • 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 Thermographic measurement(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 Inflammatory markers as C-reactive protein (CRP)(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 Sedimentation rate(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 Creatine Kinase (CK)(The evaluation will be made on the 15th, 45th and 90th days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nihan Ozunlu Pekyavas

Associated Proffesor

Baskent University

研究点 (2)

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