Protocol summary

Study aim
Comparison of Dextrose periarticular Injection versus Hyaluronic Acid Intraarticular Injection in the treatment of pain of knee osteoarthritis
Design
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, are enrolled. Patients are randomly divided to two groups. Before the main injections, lidocaine 2% used as local anesthetic. For the HA group, 2.5 mL of hyaluronic acid is injected intraarticulary. HD group, is received 10 ml of 12.5% hypertonic dextrose through four points around the knee. All injections are done by a 23-G needle subcutaneously under ultrasound guidance. The injections are done, three times within two weeks, at days 0, 7 and 14.All patients are evaluated using the VAS (0-10), WOMAC (0-100) criteria before and 3 months after the last injection. At the first injection time and Three months later, the pain intensity and the WOMAC scores are obtained for all patients and compared intra and between groups.
Settings and conduct
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, are enrolled. Patients are randomly divided to two groups. The injections are done, three times within two weeks, at days 0, 7 and 14.All patients are evaluated using the VAS (0-10), WOMAC (0-100) criteria before and 3 months after the last injection. At the first injection time and Three months later, the pain intensity and the WOMAC scores are obtained for all patients and compared intra and between groups. All analgesics were discontinued 48 hours before the procedure and for up to 2 weeks after the procedure (except acetaminophen). Physician injecting drug and the one evaluating patients in follow-up is different and is blind to patients group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with chronic osteoarthritis; grade 2 or higher of OA in radiology; age over 50 years; morning stiffness less than 30 minutes; 3 month unresponsiveness to conservative therapy Exclusion criteria: severe underlying diseases like diabetes and/or hypothyroidism; immune suppression or deficiency; serious local infectious or inflammatory knee disease; anticoagulant drug history during three last months; history of corticosteroid therapy in past year; history of prolotherapy in past year; history of intraarticular injection in past year; indication for surgical arthroplasty
Intervention groups
For the HA group, 2.5 mL of hyaluronic acid is injected intraarticulary via the inferomedial of patella. The HD group, is received 10 ml of 12.5% hypertonic dextrose through four points injection, two points at suprolateral of patella, one point at medial knee joint line and another remained point is at anterior of fibula head, via fan wise technique, 2.5 cc for each point.
Main outcome variables
pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130518013364N6
Registration date: 2018-02-20, 1396/12/01
Registration timing: retrospective

Last update: 2018-02-20, 1396/12/01
Update count: 0
Registration date
2018-02-20, 1396/12/01
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
Expected recruitment start date
2016-02-09, 1394/11/20
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
2016-02-14, 1394/11/25
Actual recruitment end date
2017-04-30, 1396/02/10
Trial completion date
empty
Scientific title
Periarticular hypertonic dextrose Vs intraarticular hyaluronic acid injections; Comparison of two minimally invasive Techniques in the treatment of symptomatic knee osteoarthritis
Public title
Comparison of dextrose and hyaluronic acid in the treatment of pain in osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with chronic osteoarthritis Grade 2 or higher of OA in radiology Age over 50 years Morning stiffness less than 30 minutes 3 month unresponsiveness to conservative therapy
Exclusion criteria:
Severe underlying diseases like diabetes and/or hypothyroidism, immune suppression or deficiency Serious local infectious or inflammatory knee disease Anticoagulant drug history during three last months 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 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 104
Actual sample size reached: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated to two group, using randomized numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
The physicians who inject the drug solutions and the ones who evaluate the patients in follow-up visits, are different and are blind to the subject.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1617763141
Approval date
2016-02-07, 1394/11/18
Ethics committee reference number
IR.SBMU.RAM.REC.1394.528

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
3 months
Method of measurement
VAS

2

Description
WOMAC Index
Timepoint
3 months
Method of measurement
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the HA group, 2.5 mL of hyaluronic acid is injected intraarticulary via the inferomedial of patella.
Category
Treatment - Other

2

Description
Intervention group: The HD group, is received 10 ml of 12.5% hypertonic dextrose through four points injection, two points at suprolateral of patella, one point at medial knee joint line and another remained point is at anterior of fibula head, via fan wise technique, 2.5 cc for each point.
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
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology of Shahid Beheshti University Of Medical Sciences
Street address
Shahid Abbas Arabi Street, Yemen Street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
mpd@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

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
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

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
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

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
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shahid Madani street-Imam Hossein Hospital
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
m.taheri@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the initial and main implications
When the data will become available and for how long
Since 2018
To whom data/document is available
Researchers working in academic institutions
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Mehrdad Taheri taheri.1352@yahoo.com
What processes are involved for a request to access data/document
Send a request by e-mail
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