Objectives:The aim of this study is to compare efficacy and safety of ozone therapy versus hyaluronic acid (HA) intra articular injection in patients with knee OA.
Study Design: Double blind Randomized controlled clinical trial
Setting and Conduct: In this study a total of 174 patients with more than three months of chronic pain in the knee joints along with consistent imaging findings (Kellgren-Lawrence score of Ⅱ&Ⅲ) would be enrolled and randomly allocated into two groups of ozone and HA.
Participants: Patients suffering from mild to moderate knee OA refered to Shahid Modarres Hospital of Saadat Abad in Tehran in 2016
Interventions: Three weekly injections of Hyalgan® in one group and 10 ml of a 30 µg/ml ozone solution in other group.
Outcome measuers: Patients would be evaluated at baseline and 6 months after the last injection for pain, stiffness and function using the Visual Analog Scale (VAS) and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041513442N16
Registration date:2017-08-28, 1396/06/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-28, 1396/06/06
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical Medicine and Rehabilitation Department of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-01-01, 1394/10/11
Expected recruitment end date
2016-07-01, 1395/04/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Intra Articular Ozone or Hyaluronic Acid Injection: Which One is Superior in Patients with Knee Osteoarthritis? a 6-Month Randomized Clinical Trial
Public title
Intra Articular Ozone or Hyaluronic Acid Injection: Which One is Superior in Patients with Knee Osteoarthritis? a 6-Month Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: age between 45-75 years; symptomatic knee OA with the pain aggravated by weight bearing; symptoms lasting for at least 6 months despite conservative treatments; Kellgren-Lawrance radiologic scoring (KLS) system scores ranging from 2-3
Exclusion Criteria: history of trauma, surgery or any invasive procedure in the affected joint during the past 6 months; mal-alignment in lower limbs and abnormal blood count or impaired coagulation tests; pregnant women; patients who were under immunosuppressant treatments; those with an underlying systemic arthropathy (secondary OA); patients being treated with angiotensin converting enzyme inhibitors (ACEI) and significant deficiency in glucose 6-phosphate dehydrogenase (G6PD) level
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:
174
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
Ethic Committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, Sahahid Arabi street, Yaman street, Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2017-08-15, 1396/05/24
Ethics committee reference number
IR.SBMU.RETECH.REC.1396.237
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]
Primary outcomes
1
Description
knee pain
Timepoint
before intervention & 6 months after last intervention