Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05033977 |
| Other study ID # |
GO 2021/049 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2018 |
| Est. completion date |
April 1, 2020 |
Study information
| Verified date |
August 2021 |
| Source |
Hacettepe University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Osteoarthritis (OA) of the knee is a chronic disease characterized by pain, reduced range of
motion, instability and effusion in the joint. Moreover, no study has investigated the effect
of Platelet-rich Plasma (PRP) in comparison with that of a placebo injection in the same
patient with bilateral knee OA. The purpose of this study was to compare the effectiveness of
supervised physiotherapy and home exercises after PRP injection in patients with knee OA. The
investigator 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. A total of 30 patients with
complete follow-up to 6 weeks post-intervention; 17 patients randomized to the supervised
exercise group and 13 patients randomized to the home exercise group. Subjects were recruited
from who had radiographic evidence (Kellgren-Lawrence Grade II-III) of knee OA and ranged
from 45 to 70 years of age. Measurements including pain during rest and activity, muscle
strength assessment, self-estimated functions of the affected knee and functional performance
tests for lower extremity strength were performed.
Description:
A total of 30 patients with complete follow-up to 6 weeks post-intervention; 17 patients
randomized to the supervised exercise group and 13 patients randomized to the home exercise
group. Subjects were recruited from who had radiographic evidence (Kellgren-Lawrence Grade
II-III) of knee OA and ranged from 45 to 70 years of age. Measurements including pain during
rest and activity, muscle strength assessment, self-estimated functions of the affected knee
and functional performance tests for lower extremity strength were performed.
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.
Muscle Strength Measurement Quadriceps, hamstring muscles and the hip stability isometric
test (HipSIT) strength were measured with a hand-held digital dynamometer. 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. ''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. 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. 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. 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. 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 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 (three subscale; pain (5 questions), stiffness (2 questions) and
daily activities (17 questions).
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.
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. 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.
