Ultrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for treatment of knee osteoarthritis: A randomized, double-blind, multi-center study.
To compare effect of ultrasound guided Corticosteroid, Ozone and Dextrose injection in patients with knee osteoarthritis. Non-surgical treatments are the first line in treatment of this condition. Corticosteroid injections are one of the treatment options for knee osteoarthritis. Recently, ozone and dextrose injections has been used as a treatment for these patients. These injections lack many of the disadvantages of corticosteroid injections.
Design
A phase 3, umulticenteral, randomized, double blinded, clinical trial with a parallel group design with one week and two months followed ups. 1cc lidocaine 2% will be used for local anesthesia (skin) in all groups. Then, under sterile condition, one group will be received ultrasound guided Ozone injection from Pes Anserine burs at medial below knee. Injections will be performed with 25G needle and other groups will receive corticosteroid or dextrose prolotherapy.
Settings and conduct
Patients with knee osteoarthritis referred to physiatrists clinics in Iran and Tabriz (University of Medical Sciences)
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with mild to moderate osteoarthritis of the knee (Kellgren Lawrence grade I, II and III)
Knee pain for at least six months.
Exclusion criteria: History of knee surgery or fracture
History of knee meniscus or ligaments tear (ACL/PCL/MCL/LCL)
Pregnancy
History of allergic reaction to Corticosteroid, Dextrose or Ozone
Infection at the injection site
Uncontrolled diabetes
History of systemic inflammatory or connective tissue disease
History of knee injections in the last three months
History of gout
Secondary knee osteoarthritis
Contraindications of ozone therapy (deficiency G6PD, uncontrolled hyperthyroidism, leukemia)
Intervention groups
Three ultrasound guided injection groups : 1.Corticosteroid, 2.Ozone 3.Dextrose
Main outcome variables
Visual Analogue Scale, WOMAC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151017024572N23
Registration date:2020-08-01, 1399/05/11
Registration timing:prospective
Last update:2020-08-01, 1399/05/11
Update count:0
Registration date
2020-08-01, 1399/05/11
Registrant information
Name
Arash Babaei-Ghazani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2683
Email address
babaei-ghazani.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2021-08-22, 1400/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Ultrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for treatment of knee osteoarthritis: A randomized, double-blind, multi-center study.
Public title
Ultrasound-guided Prolotherapy, Oxygen-ozone and corticosteroid injection for treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate osteoarthritis of the knee (Kellgren Lawrence grade I, II and III)
Knee pain for at least six months
Exclusion criteria:
History of knee surgery or fracture
History of knee meniscus or ligaments tear (ACL/PCL/MCL/LCL)
Pregnancy
History of allergic reaction to Corticosteroid, Dextrose or Ozone
Infection at the injection site
Uncontrolled diabetes
History of systemic inflammatory or connective tissue disease
History of knee injections in the last three months
History of gout
Secondary knee osteoarthritis
Contraindications of ozone therapy (deficiency G6PD, uncontrolled hyperthyroidism, leukemia)
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly divided into three treatment groups using a table of random numbers and a centralized randomization method. In order to execute the randomization process to create a random sequence and to perform the random allocation process we will use RAS software which will be created by statisticians. Two hours before the patient's visit for injection, the person responsible for injection will contact the statistician by phone or text message and will ask her about the random assignment of the participant to a specific group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The injection material is prepared in the syringe without informing the patient and the syringes will be covered with an aluminum foil so that the participant does not know the type of injection material. Patients will be prohibited from receiving any NSAIDs or analgesics for a 15-day wash-out period prior to enrollment and intervention. Due to the different nature of ozone (gas), during the injection, there is a possibility that the injector will acknowledge the nature of this medical substance. The person responsible for outcome measures and the person responsible for the statistical analysis are also kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad Tower, Shahid Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-03-17, 1398/12/27
Ethics committee reference number
IR.IUMS.REC.1398.1414
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Visual Analog Scale (VAS)
Timepoint
Before intervention, 1 and 8 weeks after intervention
Method of measurement
Visual Analogue Scale Questionnaire
Secondary outcomes
1
Description
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint
Before intervention and 1, 8 weeks after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group one: Corticosteroid, 40 mg Methylprednisolone, one time injection inside knee joint at suprapatellar recess
Category
Treatment - Other
2
Description
Intervention group: Intervention group two: Ozone (O2-O3), 12 micro-gram, one time injection inside knee joint at suprapatellar recess
Category
Treatment - Other
3
Description
Intervention group three: Prolotherapy (Dextrose 20 %), one time injection inside knee joint at suprapatellar recess
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasool Akram Hospital, Iran University of Medical Sciences, Neuromusculoskeletal Research Center
Full name of responsible person
Arash Babaei-Ghazani
Street address
Sattarkhat St, ShahrAra, Rasool Akram Hospital
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2683
Email
arashbabaie@gmail.com
2
Recruitment center
Name of recruitment center
Shohada & Emam Reza Hospitals, Tabriz University of Medical Sciences
Full name of responsible person
Bina Eftekharsadat
Street address
Elgoli Av., Golshahr St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 5921
Email
binasadat@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Seyed Abas Motavallian
Street address
5th floor central building, Iran University of Medical Sciences, Shahid Hemmat Highway,
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86709
Email
PR@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?