Determination of therapeutic effect and treatment difference in administration of celecoxib with intravenous injection in patients with osteoarthritis
Design
Blocked randomized, Parallel group trial with blinded outcome assessment, Clinical trial with control group
Settings and conduct
In this method, patients suffering from knee DJD refer to orthopedic clinic of Hamadan Besat Hospital because of knee pain.
First, an experienced person is examined the patients and a radiologic imaging (lateral,AP,rozenberg view)have be done for the patient. Before a patient is injected, a questionnaire is based on VAS sacore and the test and the patient's pain intensity is given and filled. Patients are then re-visited at intervals of three weeks, six weeks, and three months, and their VAS is measured. During this period, the investigator is not aware of the injected drug
Participants/Inclusion and exclusion criteria
1. Patients with knee osteoarthritis with grade of 2 and 3
2. Agree to participate in the study
1. osteoarthritis degrees 0, 1, 4
2. Unstable joint
3. Hemorrhagic disorders
4. Knee joint infections in injection site
5. The history of surgery in the last year
6. History of knee infection in the last year
7. Failure to follow the patient
Intervention groups
The first group (A) received celecoxib 200 mg twice daily with intradermal injection of placebo.
The second group (B) uses the same selcocide distraction with intra-articular injection of a 40-mg depotmedol injection.
The third group (C) received celecoxib 200 mg twice daily with an injection of hyaluronic acid (a medicine containing 10 mg in 2.5 cc)
The fourth group (D) of celecoxib with the same dose, with injection of depotomeric ampoules, receives hyaluronic acid (combination) ampoules.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190114042360N1
Registration date:2019-08-19, 1398/05/28
Registration timing:registered_while_recruiting
Last update:2019-08-19, 1398/05/28
Update count:0
Registration date
2019-08-19, 1398/05/28
Registrant information
Name
Maryam Zamanirafe
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3821 8792
Email address
zamanirafe.maryam@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-08-20, 1398/05/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of four conservative treatments for patients with knee osteoarthritis
Public title
Study of four conservative treatment of osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with knee osteoarthritis grade of 2 and 3
Agree to participate in the study
Exclusion criteria:
Osteoarthritis grade 0, 1, 4
Unstable joint
Bleeding disorders
Joint and pathogenic infection of injection site
Surgery history in the last year
History of knee infection in the last year
Unable to follow the patient
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to one of four groups: the first group (A) receives 200 mg of celecoxib twice daily with intradermal injection of placebo (distilled water). The second group (B) is the same as the intracellular injection of celecoxib A 40-mm dipomedulum ampoule is used jointly. The third group (C) received celecoxib 200 mg twice daily with an injection of hyaluronic acid (a medicine containing 10 mg in 2.5 cc). The fourth group (D) of celecoxib with the same dose was injected with depotomeric ampoules, hyaluronic acid Combination).
The 8th block means that the first patient is treatment A, the second patient treatment C, the patient D treatment, the fourth patient B treatment, the patient the treatment B, the sixth patient D treatment, the seventh patient C treatment, the eighth patient A, and until the end of the work Until all samples are completed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the researcher only receives the received code of the injected drug into the knee joint and carries out follow-up follow-up.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences,Park Blvd, Hamadan Town
City
Hamedan
Province
Hamadan
Postal code
6517838698
Approval date
2019-04-27, 1398/02/07
Ethics committee reference number
IR.UMSHA.REC.1398.036
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
before and 1,3 and 6 weeks after of injection
Method of measurement
use of Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Injection of placebo in the knee
Category
Placebo
2
Description
Intervention group: First intervention group: Injection of Ampule-40, 1 vial of 1 ml of pharmaceutical Exir Company-Iran in knee
Category
Treatment - Drugs
3
Description
Intervention group: Second Intervention group: Injection of Ampule-40, 1 vial of 1 ml of pharmaceutical Exir Company-Iran in knee and Injections of 20 mg 2 ml intrajoint hyaline ampoule made by Fidia Italy
Category
Treatment - Drugs
4
Description
Intervention group: Third intervention group: Injections of 20 mg 2 ml intrajoint hyaline ampoule made by Fidia Italy