This double blind study was done on 40 patients diagnosed with early knee osteoarthritis in Hazrat Rasoul hospital, Tehran, Iran. inclusion criteria: knee osteoarthritis; 40 to 70 years of age. Exclusion criteria: addiction to alcohol or drugs; coagulopathic states such as hemophilia; rheumatoid arthritis; other verified rheumatologic diseases. Then the patients were checked for the visual analog scale of pain score and recorded. then group of them were randomized by computer and divided in two 20 patients for each groups. the patients in group one were injected with 5 milliliter of ropivacaine 0.5% and 4000 Unite of erythropoietin 2 milliliter and 3 milliliter of normal saline under ultrasound guidance in the knee. Group two patients were injected with 5 milliliter of ropivacaine 0.5% and 5cc of dextrose 25% under ultrasound guidance in the knee. the patients were examined, by an expert physician blinded to their group, on the second, fourth and twelfth weeks to record the Visual analog scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051320112N6
Registration date:2016-06-11, 1395/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-11, 1395/03/22
Registrant information
Name
Pooya Derakhshan
Name of organization / entity
Birjand Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3234 1410
Email address
pooya_derakhshan@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences
Expected recruitment start date
2015-01-01, 1393/10/11
Expected recruitment end date
2016-01-01, 1394/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of erythropoietin versus dextrose prolotherapy in pain relief of knee osteoarthritis
Public title
Erythropoietin versus dextrose prolotherapy in pain relief of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: knee osteoarthritis; 40 to 70 years of age. Exclusion criteria: addiction to alcohol or drugs; coagulopathic states such as hemophilia; rheumatoid arthritis; other verified rheumatologic diseases.
Age
From 40 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran univercity of medical siences
Street address
Iran univercity of medical siences, hemmat highway, tehran, iran.
City
tehran
Postal code
Approval date
2014-11-02, 1393/08/11
Ethics committee reference number
1393-09-21
Health conditions studied
1
Description of health condition studied
Arthrosis of first carpometacarpal joint
ICD-10 code
M18
ICD-10 code description
Arthrosis of first carpometacarpal joint
Primary outcomes
1
Description
pain
Timepoint
second, fourth and twelfth weeks post injection
Method of measurement
Visual Analuge Scale
Secondary outcomes
empty
Intervention groups
1
Description
5 mililiter of ropivacaine 0.5% (Naropin® Fresenius Kabi USA) and 5 mililiter of dextrose 25% (Shahid ghazi, iran)
Category
Treatment - Drugs
2
Description
5 milliliter of ropivacaine 0.5% (Naropin® Fresenius Kabi USA) and 4000 unite of erythropoietin (osvepoietin, osve, Tehran, iran) 2 milliliter and 3 milliliter of normal saline
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rsool Akram Hospital
Full name of responsible person
Dr Pooya Derakhshan
Street address
Niyayesh St., Satarkhan St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pain Research Center, Iran University of Medical Sceinces
Full name of responsible person
Dr Farnad Imani
Street address
department of pain research, Iran University of Medical Sieances, Thran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pain Research Center, Iran University of Medical Sceinces
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of medical sience
Full name of responsible person
Dr Pooya Derakhshan
Position
Assitant Professor
Other areas of specialty/work
Street address
No. 51, Sasan St., Velnenjak ST.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran Univecity of medical siences
Full name of responsible person
Pooya Derakhshan
Position
Assistant professor
Other areas of specialty/work
Street address
Rasol Akram hospital, Satarkhan St.
City
Thran
Postal code
Phone
+98 21 6435 2326
Fax
Email
pooyaderakh@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran university of medical sciences
Full name of responsible person
Pooya Derakhshan
Position
Assistant professor
Other areas of specialty/work
Street address
Rasool Akram Hospital, Satarkhan St.
City
Tehran
Postal code
Phone
+98 21 6435 2326
Fax
Email
pooyaderakh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)