Protocol summary
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Study aim
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Comparison the Therapeutic Effect of One-Time Injection with Three Ozone Under Sonography on Patients with Knee Strengthening
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Design
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Patients are randomly and evenly divided into two groups: group A or ozonotherapy group in one session; group B or ozone therapy group in three sessions. Before injection of one cc of lidocaine 2% for local skin anesthetic and the underlying tissues are used in both groups. Then, under sterile conditions, in a group of patients, a dose of 15g / ml (5 cubic cubic meters) of ozone-oxygen is injected into the knee joint (in one session) by ultrasound.
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Settings and conduct
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Patients are randomly divided into two groups: group A or ozone therapy group in one session and group B or ozone therapy group in three sessions
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Participants/Inclusion and exclusion criteria
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Knee osteoarthritis based on the CRC of the American College of Rheumatology in Grades 1, 2 and 3, consistent with the Lowrence-Kellergan Criteria; knee pain for at least six months; age 18 to 75 years old; the absence of any acute or chronic infection; no tend to become pregnant or not to decide on pregnancy; to tending to perform any intra-articular injection of the knee during the last three months; absence of joint inflammatory diseases or secondary osteoarthritis; no history of knee surgery; lack of severe underlying disease such as uncontrolled diabetes, anti-coagulant use, and no daily intake of opioid and non-opioid analgesics.
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Intervention groups
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Group A or ozone therapy group in a session-group B or ozone therapy group in three sessions.
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Main outcome variables
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Severity of pain; knee range of motion; individual performance
General information
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Reason for update
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Correction of expected date of start and end of recriutment of patients.
Correction of persons who are blinded.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20151017024572N18
Registration date:
2018-09-01, 1397/06/10
Registration timing:
prospective
Last update:
2020-01-19, 1398/10/29
Update count:
1
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Registration date
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2018-09-01, 1397/06/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2018-09-11, 1397/06/20
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Expected recruitment end date
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2019-05-10, 1398/02/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison the therapeutic effect of one-time with three-times ozone injection under ultrasound guidance in patients with knee osteoarthritis
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Public title
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Comparison of ozone effect on knee osteoarthritis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with mild to moderate OA of the knee (Kellgren Lawrence grade I, II and III)
Knee pain for at least six months
Age 40 to 75 years old
The absence of any acute or chronic infection
No pregnancy or lack of planning to get pregnant
No history of any intra articular knee injection in three months ago
The absence of inflammatory articular disease or secondary osteoarthritis
No history of knee surgery (3 months ago)
No severe underlying disease such as uncontrolled diabetes
Use of anticoagulants
Lack of daily use of opioid and non opioid analgesics
Absence of contraindications of ozone therapy (deficiency G6PD, uncontrolled hyperthyroidism, leukemia).
Exclusion criteria:
The willingness of patients to exit from the study at any stage of the study
Not coming patients for follow up and evaluation during the follow up period
Daily use of any type of analgesic medication by patients during the follow up period
Occurring a pathology in the knee, such as meniscus tear during the follow up period
Occurring 4th and 7th inclusion criteria, during the study.
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Age
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From 40 years old to 75 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random assignment to intervention and control groups
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients are randomly divided into two groups in closed packaging
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Block randomization
Ethics committees
1
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Ethics committee
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Approval date
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2018-07-23, 1397/05/01
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Ethics committee reference number
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IR.IUMS.REC.1397.120
Health conditions studied
1
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Description of health condition studied
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Primery gonrthrosis,bilatral
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ICD-10 code
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M17.0
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ICD-10 code description
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Bilateral primary osteoarthritis of knee
Primary outcomes
1
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Description
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The severity of pain
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Timepoint
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Zero, one, four and twelve weeks after
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Method of measurement
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Visual Analog Scale(VAS)
2
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Description
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The severity of symptoms and functional limitations
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Timepoint
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Zero, one, four and twelve weeks after
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Method of measurement
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By using WOMAC questioner
3
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Description
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Sonographic criteria (efusion)
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Timepoint
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Zero, one, four and twelve weeks after
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Method of measurement
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By using sonographic device
4
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Description
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Range of motion
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Timepoint
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Zero, one, four and twelve weeks after
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Method of measurement
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Goniometer
5
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Description
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Side effects
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Timepoint
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one, four weeks after
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Method of measurement
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Physical examination
Intervention groups
1
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Description
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Intervent group: three times ozon injectione with a one-week interval by a physician and rhabilition spesialist under the ultrasound guide in the knee joint through a supra patellar approach
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Category
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Treatment - Other
2
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Description
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Control group: ozon injection will be performed under the ultrasound guid in the knee joint which will be done by an experienced physical medicine and rehabilitation specialis.using supra patellar approach
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Iran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available