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Comparison of the effect of two types of intra-articular injections including hyaluronic acid and corticosteroids in patients with mild to moderate knee osteoarthritis

Protocol summary

Study aim
Comparison of the effect of intra-knee injections in patients with knee osteoarthritis including injection of corticosteroids and hyaluronic acid over 6 weeks and determining the best injection therapy for patients with mild to moderate osteoarthritis
Design
They will be randomly divided into two groups. Assignment of patients in two groups using the method of table of numbers will be random. The first group is hyaluronic acid injection and the second group is corticosteroid injection.Sample size of 50 patients
Settings and conduct
The first group will be treated with injectable glucocorticoids and the second group with hyaluronic acid (HA). One injection will be given. Patients of all groups will be evaluated at the beginning of treatment and 6 weeks later by the visual pain scale and WOMAC score. The correction will be done using a random number table. Location of specialized clinic of Imam Reza Hospital and doctors' office
Participants/Inclusion and exclusion criteria
Eligible individuals must meet all of the following criteria: Osteoarthritis of the knee, age 70-50 years, Visual Pain Scale (VAS) score greater than 4 at the beginning of treatment, no inflammatory joint disease, patients with a WOMAC score of at least 60 96 and enrollment satisfaction Exclusion criteria: Rheumatic disease, Chronic diseases such as diabetes and hypertension, Secondary osteoarthritis, Systemic disorders, Inflammatory joint disease, Visual pain scale (VAS) score less than 4 in the joint at the beginning of treatment, Major deviation Axial , coagulopathies, severe cardiovascular disease, active infection, and immune disorders.
Intervention groups
Intervention group: The group in which hyaluronic acid is injected into the knee Control group: The group in which corticosteroids are injected into the knee
Main outcome variables
Visual analog scale score Osteoarthritis index score of Western Universities(WOMAC)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210511051258N1
Registration date: 2022-02-13, 1400/11/24
Registration timing: retrospective

Last update: 2022-02-13, 1400/11/24
Update count: 0
Registration date
2022-02-13, 1400/11/24
Registrant information
Name
Alireza Ghoreishi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5000
Email address
alireza.ghoreishi@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-10, 1400/04/19
Expected recruitment end date
2021-08-10, 1400/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of two types of intra-articular injections including hyaluronic acid and corticosteroids in patients with mild to moderate knee osteoarthritis
Public title
Comparison of the effect of two types of intra-articular knee injections
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be between 50 and 70 years old. Have a visual acuity scale (VAS) score greater than 4 in the knee joint at the start of treatment. Absence of inflammatory joint disease Proof of osteoarthritis in patients with a WOMAC score of at least 60 out of 96
Exclusion criteria:
Withdraw from the study Existence of severe cardiovascular diseases Existence of active infection and immune disorders People who are very young People with chronic diseases such as diabetes and hypertension, secondary osteoarthritis, systemic disorders, coagulopathies
Age
From 50 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 2
Intra-articular injection of both knees
Randomization (investigator's opinion)
Randomized
Randomization description
Assignment of patients in two groups will be using the random number table method. In this way, the researcher puts his hand on one of the numbers and starts moving in the right direction and records the numbers and assigns them to different groups. If he reaches an even number on the way, the person goes to the treatment group and if he reaches the number, the patient Will be placed in the control group. Based on the sample size of the research, a number of envelopes with aluminum wrappers are prepared in order to obscure the contents of the envelopes, and each of the random sequences created is recorded on a card, and the cards are placed in the envelopes respectively. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface, and finally the letter envelopes are glued and placed in a box, respectively, at the beginning of the registration of participants. According to the order of entry of eligible participants in the study, one of the envelopes will be opened in order and the assigned group of the participant will be revealed, the first group will be treated with glucocorticoids and the second group will be treated with hyaluronic acid.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Birjand University of Medical Sciences
Street address
Ghaffari blvd, birjand medical university
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2021-03-01, 1399/12/11
Ethics committee reference number
IR.BUMS.REC.1399.522

Health conditions studied

1

Description of health condition studied
Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
The amount of pain in the knee joints
Timepoint
Visual analog scale score measurement at the beginning of the study and 6 weeks later
Method of measurement
visual analog scale

2

Description
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)
Timepoint
WOMAC score set at the beginning of the study and 6 weeks later
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index questionnaire (WOMAC)

Secondary outcomes

1

Description
Pain intensity score
Timepoint
Pain intensity measurement at the beginning of the study and 6 weeks later
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

2

Description
Intensity of joint stiffness
Timepoint
Measurement of joint stiffness at the beginning of the study and 6 weeks later
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

3

Description
Ability to perform daily activities score
Timepoint
Scoring the ability to perform daily activities at the beginning of the study and 6 weeks later
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC)

Intervention groups

1

Description
Intervention group: Injection of hyaluronic acid into the knee joint. Hyaluronic acid will be high molecular weight and will be injected once. The hyaluronic acid used will be of Iranian type and with Viscor brand from Nitka company. All injections will be performed by a physician to reduce any discrepancies in the type of injection to zero .
Category
Treatment - Drugs

2

Description
Control group: Intra-knee corticosteroid injection. The glucocorticoid used to treat these people is triamcinolone acetonide, which is FDA approved. In this group, 1 injection of corticosteroids in the amount of 1ml and 40mg is performed. The corticosteroid used is of the Iranian type and will be from Exir Company.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand Emam reza hospital
Full name of responsible person
Seyed Alireza ghoreishi
Street address
Taleghani blvd, Emam reza hospital
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3222 2600
Email
alireza.ghoreishi@bums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Toobi Kazemi
Street address
Ghaffari St. Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyed Alireza ghoreishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
098 56 32395000
Email
alireza.ghoreishi@bums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyed Alireza ghoreishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3239 5000
Email
alireza.ghoreishi@bums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Seyed Alireza ghoreishi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Ghaffari St., Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
098 56 32395000
Email
alireza.ghoreishi@bums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts 3 months after the results are published
To whom data/document is available
Study data will be available to researchers working in academia and in industry, and who can apply for it.
Under which criteria data/document could be used
The use of documents in articles and industry and medical applications will be allowed. Analyzes on data are also allowed.
From where data/document is obtainable
To receive the required documents and data, you can send your request via the following e-mail: nn.mahdy10@gmail.com alireza.ghoreighi@bums.ac.ir
What processes are involved for a request to access data/document
After submitting the application in the announced manner and stating the reason for the request, the applicant must wait for the researcher to respond and obtain permission from the sponsoring body, after which, if agreed, the documents and data will be sent to him.
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