The comparison of platelet rich plasma injection versus exercise therapy with TENS modality in improvement of sign and symptoms among patients with osteoarthritis of knee, a randomized clinical trial in Rasoul Akram hospital
patients who suffer from knee osteoarthritis according to diagnostic clinical findings and radiological criteria will be divided to two groups randomly. All patients fill consent forms before enter the study and after that all of them fill VAS and KOOS evaluating forms and do treadmill test. In case group the patients will be injected by PRP two times in 4 weeks and we will use TENS and exercise therapy for control group and 4 and 8 weeks after beginning of the study; all patients will be reavulated by VAS and KOOS and treadmill test. Finally two groups will be compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012110611382N1
Registration date:2012-12-04, 1391/09/14
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-04, 1391/09/14
Registrant information
Name
Hooman Angoorani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
h-angoorani@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2012-12-01, 1391/09/11
Expected recruitment end date
2013-11-30, 1392/09/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of platelet rich plasma injection versus exercise therapy with TENS modality in improvement of sign and symptoms among patients with osteoarthritis of knee, a randomized clinical trial in Rasoul Akram hospital
Public title
Effect of platelet rich plasma on treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female with knee pain in stage 1-3 kellgren Lawrence؛no history of intraknee injection of steroids within last three months; no history of spinal stenosis; no history of blood discrasy and consumption of anticuagulative drugs
Exclusion criteria :
Inability for physical activity; patient's request to leave study; intraknee injection of steroids during study; suffering debilitating diseases during study that interfere with patient's physical activity; applying pacemaker due to physical condition during the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, poursina،keshavarz blv.
City
Tehran
Postal code
Approval date
2012-07-11, 1391/04/21
Ethics committee reference number
130/666/د/91
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Primary gonarthrosis
Primary outcomes
1
Description
knee pain
Timepoint
before the intervention then 4 and 8 weeks after the begining of the intervention
Method of measurement
vas form
2
Description
morning stifness
Timepoint
before the intervention then 4 and 8 weeks after the begining of the intervention
Method of measurement
standardized koos questionnaire
3
Description
ROM improvement
Timepoint
before the intervention then 4 and 8 weeks after the begining of the intervention
Method of measurement
standardized koos questionnaire
4
Description
intolerable pain inception time in treadmill walking test
Timepoint
before the intervention then 4 and 8 weeks after the begining of the intervention
Method of measurement
walking on tredmill
Secondary outcomes
empty
Intervention groups
1
Description
intraknee injection of platelet rich plasma
Category
Treatment - Other
2
Description
Trans Epidermal Nerve Stimulation(TENS)
Exercise Therapy