The aim of the present study is to compare the efficacy of platelet-rich plasma and hyaluronic acid injections in the treatment of knee osteoarthritis.
Design
The patients are assigned into three groups of at least 27 people. The assignment into the three groups of single PRP injection, double PRP injections and hyaluronic acid is conducted by random allocation.
Settings and conduct
This single-blinded controlled trial, in which the researcher is blinded, is performed on the patients aged 40-80 years old with osteoarthritis who are referred to Shahid Beheshti Hospital in Babol.
Participants/Inclusion and exclusion criteria
The inclusion criteria are as follows: Patients with diagnosis of bilateral knee osteoarthritis based on American college of Rheumatology, morning stiffness lasting less than 30 minutes, radiographic evidence of osteoarthritis, and symptoms lasting at least 3 months.
Intervention groups
Three groups: Single PRP injection, double PRP injections, hyaluronic acid
Main outcome variables
Primary objective: Change in Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) pain sub-scale.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180129038548N1
Registration date:2018-08-11, 1397/05/20
Registration timing:registered_while_recruiting
Last update:2018-08-11, 1397/05/20
Update count:0
Registration date
2018-08-11, 1397/05/20
Registrant information
Name
Seyed Mokhtar Esmaeilnezhad Ganji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3219 9936
Email address
smsnganji@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-26, 1397/02/06
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the outcome of Platelet-rich plasma and hyaluronic acid injections in the treatment of degenerative joint disease of knee
Public title
Comparison of the Platelet-rich plasma and hyaluronic acid injections in treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with diagnosis of bilateral knee osteoarthritis based on American college of Rheumatology.
Morning stiffness lasting less than 30 minutes
Radiographic evidence of osteoarthritis
Symptoms lasting at least 3 months
Exclusion criteria:
Other knee joint diseases, like rheumatoid arthritis and gout.
Intra-articular knee joint corticosteroid injection over the past two weeks
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Investigator
Sample size
Target sample size:
81
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly divided by using a computer-generated random number list. The subjects are assigned into different groups by random allocation. Allocation concealment is obtained by maintaining the randomization list by study statistician.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the researcher is blinded.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, Ganjafrooz Street, Babol, Mazandaran, Iran.
City
Babol
Province
Mazandaran
Postal code
۴۷۱۷۶-۴۷۷۴۵
Approval date
2018-07-08, 1397/04/17
Ethics committee reference number
IR.MUBABOL.HRI.REC.1397.082
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Polyosteoarthritis, unspecified
Primary outcomes
1
Description
Change in Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) pain sub-scale.
Timepoint
Weeks 4, 8 and 12 of treatment.
Method of measurement
Based on Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC) and Visual Analogue Scale (VAS).
Secondary outcomes
1
Description
Change in global Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC).
Timepoint
Weeks 4, 8 and 12 of treatment.
Method of measurement
Based on Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC).