Protocol summary
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Study aim
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Effect of Orthokine(Autologous Conditioned Serum), platelet rich plasma(PRP) and Prolotherapy on pain and function of patient with Knee osteoarthritis
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Design
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A single blind controlled randomized clinical trail with three parallal groups
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Settings and conduct
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The target population are all patients with knee osteoarthritis referred to the specialized physical medicine clinics of Tabriz University of Medical Sciences. They will be enrolled in the study if they have included criteria and have not excluded criteria. Sampling will be done by convenience non randomized method. For concealment of allocation, the name of intervention group will be placed inside a consecutively numbered sealed opaque envelopes.
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Participants/Inclusion and exclusion criteria
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inclusion:Age between 40-75 years,
Grade I-II-III of OA (Kellgren-Lawrence),
Pain severity >4 in a 10-numbered linear scale.
Pain in more than 3 months؛ Exclusion:Grade IV of OA
,Multifactorial Knee Pain ,Lower limb Deformity.
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Intervention groups
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Control group: intra articular knee injection of dextrose prolotherapy once a week for three weeks under ultrasound guidance through suprapatellar pouch,
Intervention group: platelet rich plasma(PRP), two times intra knee articular injection of 2 ml platelet rich plasma with a seven day interval,
Intervention group: Two times injection of 2 ml Autologous Conditioned Serum under ultrasound guidance through suprapatellar pouch with a seven day interval
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Main outcome variables
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pain severity,
Functinal condition
General information
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Reason for update
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Correction of start date and completion of study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20100720004422N6
Registration date:
2019-08-07, 1398/05/16
Registration timing:
retrospective
Last update:
2020-02-22, 1398/12/03
Update count:
1
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Registration date
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2019-08-07, 1398/05/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-01-30, 1397/11/10
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Expected recruitment end date
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2019-08-01, 1398/05/10
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effects of Orthokine( Autologous Conditioned Serum), platelet rich plasma(PRP) and Prolotherapy on pain and function of patient with Knee osteoarthritis: A Randomized Clinical Trial
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Public title
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Camparison Effects of Autologous Conditioned Serum, platelet rich plasma and Prolotherapy in treatment of Knee osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age between 40-75
Grade I-II-III of OA (Kellgren-Lawrence)
Pain severity >4 in a 10-numbered linear scale
Pain in more than 3 months
Exclusion criteria:
Grade IV of OA
Multifactorial Knee Pain
Lower limb Deformity
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Age
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From 40 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
90
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Eligible ٍٍpatients were randomly assigned in to three groups receiving: 1) Dextrose Prolotherapy; 2) Autologous Conditioned Serum; 3) platelet rich plasma. Allocation sequence will be determined using random blocking of blocks 6 and 9 in Random Allocation Software (RAS) using a 1:1:1 assignment ratio. To conceal the allocation, the name of intervention group will be placed inside a consecutively numbered sealed opaque envelopes. Preparation of envelopes and sequence generation will be done by a person not involved in participant recruitment or data collection.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Because of blood sampling in the two groups, we can not able to blind all participants.
Syringes with the same size and covered with foil will be prepared by a clinical staff who will not performed injections. Therefore, the investigator will not aware of the injectable drug type. also, out come assessor and statistical analyst will be blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2018-12-03, 1397/09/12
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Ethics committee reference number
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IR.TBZMED.REC.1397.722
Health conditions studied
1
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Description of health condition studied
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Knee osteoartritis
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ICD-10 code
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M17
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ICD-10 code description
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Osteoarthritis of knee
Primary outcomes
1
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Description
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Functional condition
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Timepoint
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At the beginning of the study(before the intervention) ، one and six months after treatment
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Method of measurement
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Western Ontario and McMaster (WOMAC) questionair
2
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Description
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pain severity
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Timepoint
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Visual Analogue Scale (VAS) and Western Ontario and McMaster (WOMAC) questionnaire
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Method of measurement
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At the beginning of the study(before the intervention) and one and six months after treatment
Intervention groups
1
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Description
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Control group: intra articular knee injection of dextrose prolotherapy ( mixture of 2ml dextrose 50% and 2 ml sterile water and 1ml Lidocaine )will be done weekly for 3 weeks under ultrasound guidance through suprapatellar pouch
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Category
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Treatment - Other
2
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Description
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Intervention group: platelet rich plasma(PRP), two times intra knee articular injection of 2 ml platelet rich plasma will be done for participants with a seven day interval.( each times, 20 ml blood will be centrifuged 13 mins at 1600 rpm, then 7 mins at 3500 rpm)
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Category
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Treatment - Other
3
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Description
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Intervention group:Orthokine( Autologous Conditioned Serum),2 ml Autologous Conditioned Serum will be injected to knee under ultrasound guidance through suprapatellar pouch with a seven day interval for two times.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available