Platelet-rich plasma injection plus oral celecoxib vs saline injection plus oral celecoxib to treat knee osteoarthritis:a randomized single-blind clinical trial.
Aim: Evaluation of efficacy of Platelet-rich plasma injection to treat
knee osteoarthritis.
Design: A single-blinded, Placebo controlled, single center, randomized clinical trial
Studied population: patients with the age between 40-65 with chronic pain more than 6 months whom are suffered from knee osteoarthritis (Kellgren Lawrence score 2 or 3)
Sample size: 60 cases
Intervention:
-In intervention group: injection of Plasma-rich Platelet (5 cc) in suffered knee plus administration of oral celecoxib 100 mg two times a day for 3 weeks
-In control group: injection of Saline (5 cc) in suffered knee plus administration of oral celecoxib 100 mg two times a day for 3 weeks
Outcomes: patients will be assessed pre-treatment, 1 week, 3 and 6 month post treatment follow up visits with regards to pain intensity using VAS (visual Analogue Scale) and functional score using Knee Injury and Osteoarthritis Outcome Score (KOOS).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201301167274N6
Registration date:2013-02-16, 1391/11/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-16, 1391/11/28
Registrant information
Name
Mohsen Mardani Kivi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1321 1470
Email address
mardani@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Guilan University of Medical Science
Expected recruitment start date
2012-06-04, 1391/03/15
Expected recruitment end date
2012-09-05, 1391/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Platelet-rich plasma injection plus oral celecoxib vs saline injection plus oral celecoxib to treat knee osteoarthritis:a randomized single-blind clinical trial.
Public title
Evaluation of efficacy of Platelet-rich plasma injection plus oral celecoxib to treat
knee osteoarthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 40-65 years old, patients with a history of chronic (for at least 6 months) knee pain and imaging findings of degenerative changes of the joint (Kellgren Lawrence II or III at X-ray evaluation), no intra-articular injection in the last 3 months, no history of previous knee trauma or surgery.
Exclusion criteria: irregular follow-up visits, taking other NSAIDs during the trial, systemic disorders such as diabetes, rheumatoid arthritis, hematological diseases (coagulopathy), severe cardiovascular diseases, infections, pregnancy, secondary osteoarthritis, patients in therapy with anticoagulants or anti-aggregants, use of NSAIDs in the last week before blood donation and patients with Hb values lower than 11 g/dl and platelet values lower than 150,000/mm 3.
Age
From 40 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee, Guilan University of Medical Sciences
Street address
Vice chancellor for research, Guilan University of Medical Sciences, Namjou avenue
City
Rasht
Postal code
Approval date
2012-05-23, 1391/03/03
Ethics committee reference number
1910095603
Health conditions studied
1
Description of health condition studied
Degenerative Joint Disease
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
Pain intensity
Timepoint
Baseline assessment, 1 week and 3 month and 6 month post treatment
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Functional outcome and quality of life
Timepoint
Baseline assessment, 1 week and 3 month and 6 month post treatment
Method of measurement
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Intervention groups
1
Description
Intervention Group: Single injection of Platelet-Rich Plasma (5 cc) plus administration of oral celecoxib 100 mg two times a day for 3 weeks
Category
Treatment - Drugs
2
Description
Control group: Injection of Saline plus administration of celecoxib 100 mg two times a day for 3 weeks