Determination of the therapeutic effect of corticosteroid injection in comparison with injection of hypertonic dextrose in patients with knee osteoarthritis
Design
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
Settings and conduct
Patients with knee osteoarthritis referred to physical medicine clinics (iran university of medical sciences). Patients are randomly divided into two groups in closed packaging.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
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
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191002044951N1
Registration date:2019-11-04, 1398/08/13
Registration timing:registered_while_recruiting
Last update:2019-11-04, 1398/08/13
Update count:1
Registration date
2019-11-04, 1398/08/13
Registrant information
Name
Koorosh Mansoori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
mansoori.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of therapeutic effect of corticosteroid injection with hypertonic dextrose in patients with knee osteoarthritis
Public title
Comparison of the therapeutic effect of corticosteroid injection with hypertonic dextrose in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 40 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and analyzers are unaware of the drugs given to the control and intervention groups.
The severity of symptoms and functional limitations
Timepoint
Zero,one week,one month and three month after
Method of measurement
WOMAK questionnaire
3
Description
Range of motion
Timepoint
Zero,one week,one month and three month after
Method of measurement
Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.