The main objective of the study, to compare the effect of periarticular versus intraarticular injection for pain of knee osteoarthrosis.
In a double-blind randomized clinical trial, 104 patients with knee pain for at least 3 months (who have not responded adequately to conservative treatment) and in accordance with the inclusion and exclusion criteria, were enrolled. Patients were randomly divided to two groups.
In group I, 8 ml of Dextrose 10% + lidocaine 1% was injected (inside the knee joint) through the infra patellar approach by a 23 G needle. Injections were repeated at 1 and 2 weeks after the first injections. In group II, 10 ml of Dextrose 10% +lidocaine 1% was injected subcutaneously at 4 points of periarticular area around the knee. The injections were performed fan wise by 2.5 ml of drug at each point with a 23G needle. Injections were repeated at 1 and 2 weeks after the first injections.
After injections, patients were scheduled for follow up at 1, 2 and 3 months after the first injections.
Pain-scale was measured with using visual analogue scale (VAS) (0-100), and disability index was measured with using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score, flexion range of motion and patient satisfaction were measured, at each visit. All pain killers were discontinued at 48 hours before of the procedure to 2 weeks after that (Except acetaminophen). Physician injecting drug and the one evaluating patients in follow-up were different and were blind to patients group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102713364N3
Registration date:2016-11-02, 1395/08/12
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-02, 1395/08/12
Registrant information
Name
Mehrdad Taheri
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 7840
Email address
m.taheri@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology,Shahid Beheshti University Of Medical Sciences, Tehran,Iran.
Expected recruitment start date
2015-04-20, 1394/01/31
Expected recruitment end date
2016-01-15, 1394/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of periarticular & intrarticular Dextrose prolotherapy for pain relief in knee O.A.
Public title
Dextrose effect in the treatment of pain in osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with chronic osteoarthritis;age over 50 years;grade 2 or higher of OA in radiology;morning stiffness less than 30 minutes;3 month unresponsiveness to conservative therapy.
Exclusion criteria:severe underlying disease;coagulopathy;history of rheumatologic disorders;diabetes; history of corticosteroid therapy in past year;history of prolotherapy in past year;history of intraarticular injection in past year;indication for surgical arthroplasty.
Age
From 50 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
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
Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences
Street address
shahid Abbas Arabi Street, yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
Tehran
Postal code
Approval date
2015-10-18, 1394/07/26
Ethics committee reference number
ir.sbmu.ram.rec.1394.297
Health conditions studied
1
Description of health condition studied
Gonarthrosis [arthrosis of knee]
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
pain
Timepoint
Each month for 3 months
Method of measurement
VAS
2
Description
WOMAC Index
Timepoint
Each month for 3 months
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Secondary outcomes
1
Description
Patient satisfaction
Timepoint
Each month for 3 months
Method of measurement
0 = absolutely no pain, 1 = sometimes moderate pain, 2 = moderate pain ever 3 = Only sometimes severe pain, 4 = always moderate pain and sometimes severe pain 5 = Always sharp pain
Intervention groups
1
Description
In group I, 8 ml of Dextrose 10% + lidocaine 1% were injected (inside the knee joint) through a infra patellar approach by a 23 G needle. Injection was repeated at 1 and 2 weeks after first injection.
Category
Treatment - Other
2
Description
In group II, 10 ml of Dextrose 10% + lidocaine 1% was injected subcutaneously at 4 points of periarticular area around the knee.The injection was performed fan wise by 2.5 ml of drug at each point with an 23G needle. Injections were repeated at 1 and 2 weeks after first injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospitalʼs pain clinic
Full name of responsible person
Mehrdad Taheri
Street address
Shahid Madani street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences
Full name of responsible person
Mostafa Alavimoghaddam
Street address
shahid Abbas Arabi Street, yemen Street, Shahid Chamran highway, Shahid Beheshti University Of Medical Sciences
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7756 7840
Fax
Email
taheri.1352@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7756 7840
Fax
Email
taheri.1352@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mehrdad Taheri
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Postal code
Phone
+98 21 7756 7840
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)