Therapeutic effects of Prolotherapy with intraarticular injection of dextrose solution in patients with moderate knee osteoarthiritis-a prelimminary intrventional pilot study
The purpose of this study is to evaluate the therapeotic effects of prolotherapy whit interaarticular injection of dexterose solution in patient with moderate knee osteoarthritis.This is a prelimminary interventional pilot study.Study population is 20 patients. We will recruit twenty patients who have our inclusion criterias and don`t have our exclusion criterias. At first, patients osteoarthritis is evaluated with WOMAC questionnaire, which is a valid questionnaire for osteoarthritis and knee range of motion is determined with goniometer. Also patients demonstrate there level of pain intensity with VAS. When a patient have our inclusion criteria in both knees, just one knee is evaluated by our study. For each patient 3 intraarticular injection in the manner of time 0, time 1, time 2 will done. Each injected solution content is composed of 7 c.c dexterose (20%) plus 2 c.c Lidocaine (1%) and will inject with inferomedial approach.At the end of month one, two, three and six from time 0 injection patients will gone under evaluation with WOMAC, they demonstrate their VAS grade again and also range of motion will be detected with goniometer. It is to said VAS determination will be in two position: at rest and after walking for six meters.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210213217N4
Registration date:2012-10-24, 1391/08/03
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-10-24, 1391/08/03
Registrant information
Name
Fariba Eslamian
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3337 3967
Email address
eslamiyanf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Reesearch Chancellor of Tabriz University of Medical Science - Physical Medicine and rehabilitation researches center
Expected recruitment start date
2012-10-26, 1391/08/05
Expected recruitment end date
2013-04-26, 1392/02/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic effects of Prolotherapy with intraarticular injection of dextrose solution in patients with moderate knee osteoarthiritis-a prelimminary intrventional pilot study
Public title
Therapeutic effects of Prolotherapy in patients with moderate knee osteoarthiritis
Purpose
Treatment
Inclusion/Exclusion criteria
1- Moderate knee osteoarthritis (grade 2 or 3 based on knee radiographic classification of kellgeren and Lawrence )
2-No history of inflamatory Rheumatologic disease such as RA
3-Patient in the range of 45-75 years old
4-No reception of systemic or IV corticosteroid in two weeks before treatment and along treatment
5-Satisfactory of patients involved in study
6- NO response to conservative and physiotherapic treatments during 3 past month
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
Research chancellar of Tabriz University of Medical Science
Street address
3rd floor- Central Building Number 2 - Tabriz University of Medical Scineces- Golgasht Avenue
City
Tabriz
Postal code
51656
Approval date
2012-04-16, 1391/01/28
Ethics committee reference number
2060/4/5
Health conditions studied
1
Description of health condition studied
Primary gonarthrosis, bilateral
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before intervention and one month , two month ,three month and six month after intervention
Method of measurement
Using VAS grading score
Secondary outcomes
1
Description
knee range of motion
Timepoint
Before intervention and one month , two month ,three month and six month after intervention
Method of measurement
Using goniometer
2
Description
Daily functional ability
Timepoint
Before intervention and one month , two month ,three month and six month after intervention
Method of measurement
Using WOMAC questionnaire
Intervention groups
1
Description
Interaarticular injection of 7c.c dexterose 20% plus 2% lidocaine 1% with inferomedial approach in each injection time.
For each patient three interaarticular injection in the manner of time 0 , time 1 and time 2 will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Reza hospital of Tabriz
Full name of responsible person
Bahman Amouzandeh
Street address
Daneshgah Ave.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Physical medicine and rehabilitation researches center
Full name of responsible person
Dr.Salim Vahedi
Street address
Emam Reza hospital - Department of Physical medicine and rehabilitation researches center
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical medicine and rehabilitation researches center
Proportion provided by this source
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
2
Sponsor
Name of organization / entity
Research chancellor of Tabriz University of medical sciences
Full name of responsible person
Azam Saafi
Street address
Research chancellor- 3rd floor-central building number 2 -Tabriz university of medical sciences -Golgasht Ave.
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research chancellor of Tabriz University of medical sciences
Proportion provided by this source
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
Tabriz University of Medical Science
Full name of responsible person
Bahman Amouzandeh
Position
Physician , Resident of Physical Medicine anr Rehabilitation
Other areas of specialty/work
Street address
Physical medicine and rehabilitation ward , Imam Reza Hospital ,Golgasht Ave.
City
Tabriz
Postal code
Phone
+98 41 1337 3967
Fax
Email
bahman.amouzandeh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Fariba Eslamiyan
Position
Assistant professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
physical medicine and rehabilitation ward - Imam Reza Hospital- Golgasht Ave.
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
Email
eslamiyanf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Fariba Eslamiyan
Position
Assistant professor of physical medicine and rehabilitation
Other areas of specialty/work
Street address
physical medicine and rehabilitation ward- Imam Reza Hospital-Golgasht Ave.
City
Tabriz
Postal code
51656
Phone
+98 41 1337 3967
Fax
Email
eslamiyanf@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)