Therapeutic Effects of Kinesiotape in the Management of Gonarthrosis: A Randomized Controlled Approach
Phase: NA
Conditions: Gonarthrosis
Sponsor: Fenerbahce University

Study Protocol and Statistical Analysis Plan 
Document Title: Therapeutic Effects of Kinesiotape in the Management of Gonarthrosis: A 
Randomized Controlled Approach  
 
NCT Number: NCTXXXXXXXX 
Document Date: November 25, 2015 
Study Protocol 
Study Design 
This study is a single-blinded, randomized controlled trial involving 38 individuals diagnosed 
with gonarthrosis according to ACR classification criteria. Participants are randomly assigned 
to two groups. Taping group (n=19) received kinesiotape application and a home exercise 
program, while participants in the control group (n=19) received only a home exercise program 
Inclusion Criteria 
 Having a diagnosis of primary gonarthrosis according to ACR classification criteria, 
 Being between 45 and 65 years of age,  
 Having a radiological diagnosis of gonarthrosis between Kellgren-Lawrence stage 1-3, 
 Signing the informed consent 
Exclusion Criteria 
 Presence of a neurological disorder affecting muscle strength or balance,  
 History of any surgical operation on the knee, hip, or spine,  
 Physiotherapy or injections for the knee within the previous year,  
 Presence of systemic conditions such as diabetes mellitus, vertigo, visual problems, 
 History of severe trauma within the previous year 
Interventions 
In the taping group, the Mechanical correction technique and the Ligament/Tendon correction 
technique were applied using kinesiotape application. The taping procedure was repeated once 
a week, starting from the first week, for a total of 6 sessions. An individualized home exercise 
program was planned, considering EULAR and ACR recommendations. Each participant was 
given a structured home exercise program at least 3 days a week. The program included 
moderate-intensity aerobic exercises (e.g., walking) and muscle-strengthening exercises 
targeting the quadriceps and hamstring muscles, along with flexibility and balance exercises.   
Outcome Measures 
The demographic characteristics (age, gender, education, body mass index) were documented 
for both groups. The patients were evaluated two times with clinical assessment scales: Visual 
Analogue Scale (VAS) was used to assess pain, Western Ontario and McMaster Universities 
Osteoarthritis Index (WOMAC) questionnaire to assess pain, stiffness and functionality, Berg 
Balance Scale (BBS) to assess balance, Short Form (SF-36) to assess physical function, 

physical role, emotional status, social function, general health, mental health, pain, quality of 
life. 
 

Statistical Analysis Plan 
Sample size was calculated using G-Power 3.1.3 software. The power and  “>” levels were set 
to 0.80 and 0.05, respectively, and the effect size (ES) was set to 0.8. A priori analysis for the 
required sample size indicated that at least 21 subjects would be needed in each group. Thus, 
23 subjects were used in each group to account for dropout cases (Cohen, 1992). The 
Kolmogorov-Smirnov and Shapiro-Wilk tests were used to determine whether the obtained 
measurements conformed to normal distribution, and the data were found to be normally 
distributed. Since the data were normally distributed, parametric tests were used in the 
comparisons. Whether there was a significant difference between the averages of these 
parameters measured before and after the treatment between the control and taping groups was 
analyzed by a t-test in independent groups, and whether there was a significant change between 
the parameters before and after the treatment in the taping and control groups separately was 
analyzed by a t-test in dependent groups. The change in parameters from pre-treatment to post-
treatment was also analyzed for significant differences between groups using a t-test in 
independent groups. The data obtained in the research were analyzed using the SPSS (Statistical 
Package for Social Sciences) for Windows 20.0 program.