Injection Therapy in Patients With Lateral Epicondylitis: Hyaluronic Acid or Prolotherapy?
Phase: NA
Conditions: Lateral Epicondylitis, Tennis Elbow
Sponsor: Hacettepe University

Injection Therapy in Patients with Lateral Epicondylitis 
ID: 2018/12     
Document Date: 05/13/2018 
 
 
Study Protocol  
The study was a single-blind randomized clinical trial with parallel group and allocation ratio 
was 1:1. Ethical approval of the study was obtained from the Inonu University Clinical 
Research Ethics Committee (No.2018/12). Volunteers meeting eligibility criteria gave 
informed written consent prior to enrolment by the trial administrator. The patients who met 
the inclusion criteria randomly assigned into two groups (PrT group, HA group) in a ratio of 
1:1 through the stratified block randomization method. The patients and the researcher who 
were responsible for the analyzing of the data were blinded to the randomization results. All 
data were collected at baseline, 6 and 12 weeks. Furthermore, patients were monitored if they 
had any side effects from the injection such as ecchymosis, redness, increasing pain or reduced 
range of motion. 
 
 
Statistical Analysis Plan 
The SPSS (version23; SPSSInc., Chicago, IL, USA) was used to conduct the analysis. 
Descriptive statistics were presented as mean ± standard deviation and percentage. In the 
evaluation of categorical variables, Pearson Chi-Square Test and Fisher's Final Test were used. 
Suitability of variables to normal distribution were analyzed using visual (histogram and 
probability graphics) and analytical methods (Shapiro-Wilk Test). Differences between the two 
groups at baseline and at six and twelve weeks were tested by Independent-samples t test. Paired 
t tests were used for within-group analyses. P values <0.05 were considered significant.