The aim of this study is evaluation of the effectiveness of prolotherapy with hypertonic dextrose versus hypertonic saline on patients with knee osteoarthritis. This is a multicenter, double blind randomized clinical trial. We will enroll 60 patients with knee osteoarthritis. Participants will randomly be assigned into intervention and control groups and will receive intra-articular injection with 4mL of 50% dextrose and 4mL of 2% lidocaine and intra-articular injection with 4mL of 5% sodiumchloride and 4mL of 2% lidocaine respectively. As the primary outcome of our study, the Visual Analog Scale (VAS) questionnaire will be measured before and 2 weeks and 4 weeks after intervention. We will also measure Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC), and Oxford Knee Scale (OKS) before and 2 weeks and 4 weeks after intervention. Finally, we will compare the results between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016122931458N1
Registration date:2017-02-06, 1395/11/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-02-06, 1395/11/18
Registrant information
Name
Ebrahim Mostaghni
Name of organization / entity
International Branch_Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3635 0446
Email address
emostaghni@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2017-01-20, 1395/11/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of prolotherapy with hypertonic dextrose versus hypertonic saline on patients with knee osteoarthritis
Public title
Effect of prolotherapy with hypertonic dextrose versus hypertonic saline on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with osteoarthritis of knee who experience joint symptoms (pain, stiffness and reduced function) during one recent month; aged between 40-70 years. Exclusion criteria: rheumatology diseases; radiculopathy; history of trauma and fracture in knees; diabetes; coagulopathy disorders; pregnant women; body mass index (BMI) more than 42.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz
City
Shiraz
Postal code
Approval date
2016-11-02, 1395/08/12
Ethics committee reference number
IR.SUMS.MED.REC.1395.51
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
Questionnaire of Visual Analog Scale
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Questionnaire of Western Ontario & McMaster Universities Osteoarthritis Index
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention
Method of measurement
Questionnaire
2
Description
Questionnaire of Oxford Knee Scale
Timepoint
Before intervention, 2 weeks after intervention, 4 weeks after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: Intra-articular injection with 4mL of 50% dextrose and 4mL of 2% lidocaine
Category
Treatment - Drugs
2
Description
Control group: Intra-articular injection with 4mL of 5% Sodium Chloride and 4mL of 2% lidocaine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran Hospital
Full name of responsible person
Hamid Reza Farpour
Street address
Shahid Chamran blvd
City
Shiraz
2
Recruitment center
Name of recruitment center
Emam Reza Clinic
Full name of responsible person
Hamid Reza Farpour
Street address
Namazi square
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University Of medical Science
Full name of responsible person
Dr Seyed Baser Hashemi
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University Of medical Science
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
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Reza Farpour
Position
assistant Professor
Other areas of specialty/work
Street address
Bone and Joint Diseases Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3623 4504
Fax
Email
farporh@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid Reza Farpour
Position
Assistant Professor
Other areas of specialty/work
Street address
Bone and Joint Diseases Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
City
Shiraz
Postal code
Phone
+98 71 3623 4504
Fax
Email
farporh@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
International Branch_Shiraz University of Medical Sciences
Full name of responsible person
Ebrahim Mostaghni
Position
Medical Student
Other areas of specialty/work
Street address
City
Shiraz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)