Assessing the effects of autologous conditioned serum (orthokine) on pain intensity, clinical symptoms, quality of life and work productivity in patients with knee osteoarthritis
This study is a before-after interventional study which is conducted in knee osteoarthritis patients referred to the clinics related to Tabriz University of Medical Sciences. 50 patients are selected randomly according to the inclusion/exclusion criteria and the written informed consent obtain. Orthokine injection 2 ml each time (4-6 injection) are conducted. Patients are followed 3, 6, 12, 24 and 48 weeks and 2 year and 3 years after injection and related questionnaires are completed for them. Pain intensity is measured using NRS. Clinical symptoms (pain, stiffness and physical function) are determined using WOMAC. Quality of life is determined using SF-36 and work productivity is measured with WPAI.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201707046934N3
Registration date:2017-07-23, 1396/05/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-23, 1396/05/01
Registrant information
Name
Susan Kolahi
Name of organization / entity
Tabriz Medical Science University
Country
Iran (Islamic Republic of)
Phone
+98 914 310 4072
Email address
kolahis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences- Drug applied Reseach center
Expected recruitment start date
2017-03-21, 1396/01/01
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effects of autologous conditioned serum (orthokine) on pain intensity, clinical symptoms, quality of life and work productivity in patients with knee osteoarthritis
Public title
Assessing the effects of autologous conditioned serum (orthokine) on pain intensity, clinical symptoms, quality of life and work productivity in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 30-80, having knee osteoarthritis grade II-IV according to Kellgren-Lawrence, having moderate to severe knee pain in the past 4 weeks, being interested to participate in the study.
Exclusion criteria: history of knee surgery or arthroscopy in the last six months, history of trauma, history of knee injection during the past 3 months (steroids, hyaluronate, PRP, ACS, ACP), having rheumatoid arthritis or other systemic bone or joint diseases, active inflammation of patellofemoral, BMI>30 kg/m2, malignancy, infection, pregnancy
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht St., Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2017-05-08, 1396/02/18
Ethics committee reference number
IR.TBZMED.REC.1396.127
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M15, M16,
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
Pain intensity
Timepoint
baseline, weeks 3,6,12,24, 48 and after 2 and 3 year