Investigating of Difference Between Center-based Physical Therapy and Home-based Physical Therapy After Platelet Rich Plasm Injection in Women With Knee Osteoarthritis
Phase: NA
Conditions: Knee Osteoarthritis
Sponsor: Hacettepe University

Approved by Lokman Hekim University Non-Interventional Clinical Research Ethics 
Committee 
and Last Revised in 29.04.2021 
 
 
 
 
 
 
 
 
 
 
Study Protocol based on CONSORT Statement 
(Consolidated Standards of Reporting Trials) 
 
 
 
Investigating of Difference 
Between Center-based Physical 
Therapy and Home-based 
Physical Therapy After Platelet 
Rich Plasm Injection in Women 
with Knee Osteoarthritis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Approved by Lokman Hekim University Non-Interventional Clinical Research Ethics 
Committee 
and Last Revised in 29.04.2021 
 
 
 
 
 
 
 
 
Introduction 
 
Scientific background and explanation of rationale. 
 
 
Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of 
motion, instability and effusion in the joint. The weakness of the quadriceps as well as the hip 
muscles are commonly seem symptoms (1). Although the primary effects of the disease occur 
in articular cartilage; osteophytes, subchondral sclerosis, and cyst formation are concomitant 
complications to cartilage degradation (2). Progressive deterioration of the joint and chronic 
pain limit to perform knee functions, which result with a decline in quality of life in knee OA 
patients.  
Physical therapy applications, exercise therapy, pharmacological treatments and intra-articular 
injections are considered as effective methods to relieve the symptoms of knee OA patients (3). 
Recently, Platelet-rich Plasma (PRP) treatment has received much attention for its use in the 
treatment of knee OA (4, 5). It has been showed that PRP injection would reduce pain and 
improve knee functions in patients with knee OA in the available literature, but some studies 
are underpowered or unblinded, thus the findings have low reliability. A number of systematic 
reviews and meta-analyses’ evidence have not been exactly comprehensive and are even 
sometimes controversial (6-9). Because previous studies differed in the concentrations of 
leucocytes used for the preparation (11)  of PRP, dosage schedules, and so on. Moreover, no 
study has investigated the effect of PRP in comparison with that of a placebo injection in the 
same patient with bilateral knee OA. It is of interest to examine the effect of PRP in the same 
patient with bilateral OA. 
After PRP injection, patients with knee OA are recommended to exercise.(16). it is thought that 
home exercises combined with PRP treatment may be an effective approach in the treatment of 
knee OA, but the importance of performing exercise program under the supervision of a 

Approved by Lokman Hekim University Non-Interventional Clinical Research Ethics 
Committee 
and Last Revised in 29.04.2021 
 
 
physiotherapist is emphasized (16). Isokinetic training under the supervision of a 
physiotherapist had significant effects on pain, function and muscle strength in OA patients 
after PRP injection (17). However, the combination of PRP injection and exercise therapy under 
the guidance of a physiotherapist has yet to be established. 
Specific objectives or hypotheses 
The purpose of this study was to compare the effectiveness of supervised physiotherapy and 
home exercises after PRP injection in patients with knee OA. We hypothesized that the 
supervised physiotherapy program would be more effective in decreasing pain and improving 
muscle strength, physical function, and quality of life than home exercises following PRP 
injection in patients with knee OA. 
Methods 
 
Description of trial design (such as parallel, factorial) including allocation ratio 
 
 
This will be a randomized allocation ratio 1:1, controlled study conducted in the Hacettepe 
University, Turkey. 
 
 
Eligibility criteria for participants. 
 
Inclusion Criteria: 
- PRP injection due to knee OA, 
- The PRP injection is given at least three days ago, 
- 45- 70 years old 
- Grade 2-3 according to Kellgren Lawrence osteoarthritis classification 
 
Exclusion Criteria: 
- Being male 
- Have a neurologic, oncologic and/or rheumatologic disease  

Approved by Lokman Hekim University Non-Interventional Clinical Research Ethics 
Committee 
and Last Revised in 29.04.2021 
 
 
- Having any intra-articular application and / or physiotherapy and rehabilitation in the last 6 
months, 
- Have any other orthopedic problems involving the lower extremities 
- having cognitive problem 
 
 
Methodology of the study 
 
Patients who underwent PRP injection for knee OA were included in the study. It will be noted 
that PRP injection to the patients is done by the same physician using the same PRP kit by the 
same method at the Hacettepe University Faculty of Medicine Department of Orthopaedics and 
Traumatology. 
 
 
 
Outcome Measures 
 
 
Participants and Methods  
 
A randomized control clinic study design was used for the present study. A sample size 
calculation was conducted using G*power (v3.1.9.2, Heinrich-Heine-University, Dusseldorf, 
Germany). An estimated more than 2-point pain level changes on VAS between pre- and 
posttreatments for repeated measures analysis, a power of 0.80, a ɑ of 0.05 and a total sample 
size of 28 knee OA patients need to be included in the present study. 
 
Pain Measurement 
 
Visual Analog Scale was used to assess the subjects’ pain during rest and activity. A 10 cm line 
was driven and subjects was wanted to mark the point (0; no pain, 10; worst imaginable pain) 
as representing the pain during rest and activity (18). 
 
 

Approved by Lokman Hekim University Non-Interventional Clinical Research Ethics 
Committee 
and Last Revised in 29.04.2021 
 
 
 
Muscle Strength Measurement  
Quadriceps, hamstring muscles and the hip stability isometric test (HipSIT) strength were 
measured with a hand-held digital dynamometer (Lafayette Instrument Company, Lafayette ). 
Each subject was verbally informed  before the test in order to ensure correct movement and 
subjects were asked to perform submaximal contraction against the evaluator’s hand before 
testing (19). ‘’Break test’’ technique was performed for the strength measurement. According 
to this technique, the evaluator gradually overcomes the muscle strength and stops when the 
joint gives way (20). The quadriceps muscle strength was measured in a sitting position (Hip 
90° flexion, knee extended) with hands crossed across the chest. The hand-held dynamometer 
was positioned on the anterior surface of the lower leg proximal to the ankle during test (21) . 
Hamstring muscle group measurement was carried out on prone position (Hip neutral position, 
knee flexion 90°). The hand-held dynamometer was positioned on the posterior surface of the 
lower leg proximal to the ankle during test  (21) . The HipSIT evaluates the abductor, external 
rotator and extensor muscles of the hip together. This test was performed in a side-lying position 
(Hips 45° flexion, knees 90° flexion, heels in contact with the limb tested superior to opposing 
limb as 20° abduction). The hand-held dynamometer was placed on laterally positioned 5 cm 
above the knee joint interline during test (22). Each measurement for each muscle was 
performed 3 times at 30 sec intervals and the higher value was recorded. There was also a 
minute interval between muscle groups measurements. 
Functional Performance Measurement 
A 30-sec chair stand test and stair climb test were used to assess physical performance. The 
subjects were asked to stand up from a chair (height: 43cm) and sit down in 30 sec with their 
arms folded across the chest during the 30-sec chair stand test. The number of the repetitions 
were recorded (23). The subjects were asked to ascend and descend 10 steps (step height 20 
cm) at a safe and comfortable pace during the stair climb test. The time (sec) of stair ascend 
and descend were recorded separately (24). 
 
 
Functional Status  
The Western Ontario and McMaster Universities (WOMAC) index is a disease specific self-
administered test for OA to assess functions of the affected joints. It consists of 24 questions 

Approved by Lokman Hekim University Non-Interventional Clinical Research Ethics 
Committee 
and Last Revised in 29.04.2021 
 
 
(three subscale; pain (5 questions), stiffness (2 questions) and daily activities (17 questions) 
(25).  
Interventions 
Each subject was informed about knee OA and daily activities that negatively affect the knee 
OA. They were also asked to use cold press 3 times (10-15 min) a day for 6 weeks. Supervised 
physiotherapy group performed exercises 3 times a week for 6 weeks under supervision of a 
physiotherapist after the first evaluation. The subjects in home exercise group were taught 
exercises and they were informed to do exercises 3 times a week for 6 weeks. Home exercise 
group was telephoned to motivate them to do exercise or to find out if they have any problem 
about the exercises once a week for 6 weeks. The exercise programs for each group consisted 
of these parts: warm up, strengthening, balance and cool down period (Appendix 1).  The 
standard exercises were performed by all of the subjects in each group in order to standardize 
the exercise procedure. We used OMNI Resistance Exercise Scale for perceived effort to 
standardize elastic-band (Thera-Band; The Hygenic Corporation, Akron, OH) resistance among 
subjects (26). Subjects were asked to do 3 repetitions for each exercise starting with lowest 
resistance elastic band, and the resistance of the elastic band was increased until it reached 5 on 
the 11-point scale to determine the appropriate elastic band.    Second measurements were 
performed at the end of 6 weeks, the day of routine doctor control for PRP injection. All 
assessments were performed by the same physiotherapist. 
 
Statistical Analysis 
A two-way repeated-measures analysis was initially used to investigate differences in the 
primary outcome variable (muscle strength) between the supervised physiotherapy group  and 
home exercise group over 6- week period; followed by secondary outcomes measures (VAS, 
WOMAC ). In the occurrence of significant main or interaction effects, a Bonferroni post hoc 
correction was used to assess significant findings between the groups at specific assessment 
time points. Statistical analysis was performed using SPSS software (version 22.0). The 
significance level was set at an alpha of 0.05. 
 
 
 
 
 

Approved by Lokman Hekim University Non-Interventional Clinical Research Ethics 
Committee 
and Last Revised in 29.04.2021 
 
 
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