The Effects of Intra-articular injection of dexamethasone and vitamin D compared to injection of just dexamethasone on signs of knee osteoarthritis with grade 2 and 3_ a randomized double-blind clinical trial
Evaluation of the effect of intra-articular injection of vitamin D3 with dexamethasone in the knee joint of patients with grade 2 and 3 osteoarthritis to reduce the need for analgesia, increase range of motion and reduce joint pain compared to intra-articular injection of dexamethasone alone.
Design
This is a double-blind, randomized clinical trial on 154 patients with a case and a control group with 77 patients each. Randomization will be applied through permuted balance block randomization technique(1:1 ratio) in quadruple blocks.
Settings and conduct
The study is performed on patients with bilateral osteoarthritis in the orthopedic clinic of Shahid Madani Hospital in Karaj. For double-blinding the injecting physician and the patient are both unaware of the contents of the vial and the vials of both case and control groups have the same color.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age between 40 to 65
2. Bilateral knee osteoarthritis
3. Having score 2 and 3 of KL (Kellgren Lawrence) system radiography
4. Completion of informed consent form
Exclusion criteria:
1. Presence of secondary cause for knee osteoarthritis
2. Allergic history to dexamethasone or vitamin D3
3. History of diabetes or coagulopathy
4. History or manifestation of joint infection or deformity
Intervention groups
After reviewing inclusion and exclusion criteria, 154 patients will be selected and divided into a case and a control group with 77 patients in each after completing the questionnaire of general information and WOMAC score questionnaire. In the case group, we inject 4 mg of dexamethasone with 150000 IU of vitamin D3 in each intra-articular space of the knee; and in the control group, we inject 4 mg of dexamethasone alone.
Main outcome variables
Change in osteoarthritis symptoms, the need for analgesia, the range of motion of the knee and knee pain.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220526054993N1
Registration date:2022-06-29, 1401/04/08
Registration timing:prospective
Last update:2022-06-29, 1401/04/08
Update count:0
Registration date
2022-06-29, 1401/04/08
Registrant information
Name
Ehsan Seif
Name of organization / entity
Alborz University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 26 3341 6589
Email address
seif.eche@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-21, 1401/05/30
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effects of Intra-articular injection of dexamethasone and vitamin D compared to injection of just dexamethasone on signs of knee osteoarthritis with grade 2 and 3_ a randomized double-blind clinical trial
Public title
Evaluation of the effect of intra-articular injection of dexamethasone and vitamin D compared to injection of dexamethasone alone on signs of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 40 to 65
Bilateral knee osteoarthritis
Having score 2 and 3 of KL system radiography
Completion of informed consent form to enter the study
Exclusion criteria:
Presence of secondary cause for knee osteoarthritis
Allergic history to dexamethasone or vitamin D
History of diabetes or coagulopathy
History or manifestation of joint infection or deformity
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
154
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation of patients to case and control groups is done using "permuted balance block randomization technique" with a ratio of (1: 1).
The blocks considered in this study include 4 patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
For the two-sided blindness of the study, after randomly assigning the patient to one of the two groups, one of the colleagues fills the syringe from one of the two types of vial that both have the same color.
(Vitamin D and dexamethasone or dexamethasone alone).
Both the physician and the patient are not informed of the contents of the syringe.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics committee of Alborz University of Medical Science
Street address
N.528 - 120 street - Eram boulvard - Mehrshahr - Karaj
City
Karaj
Province
Alborz
Postal code
۳۱۸۵۷۴۶۹۵۷
Approval date
2022-04-16, 1401/01/27
Ethics committee reference number
IR.ABZUMS.REC.1401.018
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis with grade 2 and 3
ICD-10 code
M16.30
ICD-10 code description
Primary outcomes
1
Description
The score obtained in the WOMAC knee score to evaluate the degree of osteoarthritis
Timepoint
Before intervention and 1, 3, and 6 month after intervention
Method of measurement
WOMAC knee score
Secondary outcomes
1
Description
The amount of analgesic consumption
Timepoint
Before intervention and 1, 3, and 6 mouths after intervention
Method of measurement
Questionnaire to assess the number of analgesics consumed per week
2
Description
Range of motion of the knee
Timepoint
Before intervention and 1, 3, and 6 mouths after intervention
Method of measurement
Clinical examination
3
Description
Joint pain
Timepoint
Before intervention and 1, 3, and 6 mouths after intervention
Method of measurement
The size of joint pain in millimeters on the scaled ruler
Intervention groups
1
Description
Intervention group: After randomization , 4 mg of dexamethasone plus one hundred and fifty thousand international units (IU) of vitamin D3 will be injected into the intra-articular space of the patient's knees separately (right and left knee). The pharmacological form of vitamin D3 which we use is Cholecalciferol from AburaihanCo.Iran .
Category
Treatment - Drugs
2
Description
Control group: After randomization, 4 mg of dexamethasone is injected separately into the intra-articular space of the knees of control patients separately (right knee and left knee). To double-blinding, the drug is injected in the same condition as the intervention group.