Protocol summary
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Study aim
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Determination of the therapeutic effect of corticosteroid injection in comparison with injection of hypertonic dextrose in patients with knee osteoarthritis
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Design
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Random sampling,convenience sampling and then patients will be assigned to two groups by block randomization.The study is double blind (patients and analyzer
sample size:48
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Settings and conduct
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Patients with knee osteoarthritis referred to physical medicine clinics (iran university of medical sciences). Patients are randomly divided into two groups in closed packaging.
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Participants/Inclusion and exclusion criteria
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The main inclusion criteria: Patients with Knee Osteoarthritis Based on American College of Rheumatology Criteria 2 and 3 in accordance with Lowrence Criteria - Kellergan, Knee pain for at least six months,Age 40 to 75 years, absence of any acute or chronic infection, Pregnancy or no pregnancy decision,Failure to perform any intra-articular injection of the knee during the past three months,absence of inflammatory arthritis or secondary osteoarthritis, No history of knee surgery, Not having a severe underlying disease such as uncontrolled diabetes, taking anti-coagulants, Not taking opioid and non-opioid analgesics daily
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Intervention groups
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Under sterile conditions, in one group of patients 40 mg triamcinolone is injected via suprapetellar patch into the knee joint (in one session) and in another group of patients, 5cc dextrose hypertonic 20% is injected through the supra patellar patch into the knee joint.
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Main outcome variables
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outcomes: Before injection, patients' pain severity, WOMAC score, and clinical evaluation (range of motion) will be determined in both groups of patients, and these criteria will be assessed one week, one month, and three months after injection.The results will be compared before and after injection in each group and between the two groups.
General information
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Reason for update
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Correction of sampling date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191002044951N1
Registration date:
2019-11-04, 1398/08/13
Registration timing:
prospective
Last update:
2020-07-04, 1399/04/14
Update count:
1
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Registration date
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2019-11-04, 1398/08/13
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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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2019-11-05, 1398/08/14
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Expected recruitment end date
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2019-12-05, 1398/09/14
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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 of therapeutic effect of corticosteroid injection with hypertonic dextrose in patients with knee osteoarthritis
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Public title
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Comparison of the therapeutic effect of corticosteroid injection with hypertonic dextrose in patients with 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:
All knee osteoarthritis patients with Grade 1 and 2
All knee osteoarthritis patients between the ages of 1 and 2 years
Exclusion criteria:
Age less than 2 years and more than 5 years
Osteoarthritis with Grade 1 and 2
Pregnancy
Severe underlying disease
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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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3
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Groups that have been masked
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Sample size
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Target sample size:
54
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization, in which each member of the community has an equal chance of being independent, is chosen. The randomization method will be used with random and binary blocks. Regarding the sample size of 54 people, 13 quadruple blocks and 1 binary block will be generated and numbered using the permutations method. Using the random number table , blocks will be placed together to form a patient allocation sequence to treatment groups. Providers will be unaware of the type of treatment that will be received, as well as the random sequences generated in The length of the study will be unpredictable.
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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 and analyzers are unaware of the drugs given to the control and intervention groups.
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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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Ethics committees
1
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Ethics committee
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Approval date
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2019-01-15, 1397/10/25
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Ethics committee reference number
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IR.IUMS.FMD.REC.1397.226
Health conditions studied
1
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Description of health condition studied
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Knee Osteoarthritis
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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 week,one month and three month 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 week,one month and three month after
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Method of measurement
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WOMAK questionnaire
3
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Description
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Range of motion
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Timepoint
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Zero,one week,one month and three month after
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Method of measurement
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Goniometer
Intervention groups
1
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Description
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Intervention group 1 : Under sterile conditions, 5cc dextrose hypertonic 20% is injected into the knee joint through the supra peltar patch.Injection with 25 gage needle is performed . Before injection, pain severity and WOMAC score and clinical evaluation (ROM) were determined in both groups of patients and these criteria were evaluated one week, one month and three months after injection.
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Category
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Treatment - Drugs
2
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Description
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Intervention group 2: Under sterile conditions, 40 mg triamcinolone is injected via suprapetellar patch into the knee joint (in one session).Injection with 25 gage needle is performed . Before injection, pain severity and WOMAC score and clinical evaluation (ROM) were determined in both groups of patients and these criteria were evaluated one week, one month and three months after injection.
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Category
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Treatment - Drugs
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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available