Investigating the effects of ozone injection combined with hyaluronic acid compared to hyaluronic injection in the treatment of knee osteoarthritis in patients referred to the orthopedic clinic and the pain clinic of Fatemi Ardabil Hospital.
Investigating the effects of ozone injection combined with hyaluronic acid compared to hyaluronic injection in the treatment of knee osteoarthritis
Design
Clinical trial with a control group, parallel groups, double-blind, randomized, phase 3, on 60 patients. Simple randomization and lottery will be used for randomization.
Settings and conduct
This study aims to investigate the effects of intra-articular injection of ozone along with hyaluronic acid compared to hyaluronic acid on pain intensity, quality of life and sleep quality of patients with knee osteoarthritis in Fatemi Ardabil Hospital. One group received 2 cc of intra-articular hyaluronic acid (Nitka company, 2 mg) three times with an interval of one week, and the other group received 2 cc of intra-articular hyaluronic acid (Nitka company, 2 mg) and 10 cc They will receive 25% ozone in three times with an interval of one week. Pain, quality of life and sleep quality of patients will be evaluated. Patients and those evaluating the outcome will not know about the grouping done and the study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with grade 1 and 2 osteoarthritis. Exclusion criteria: Pregnancy or breastfeeding; use of anticoagulants; use of intra-articular drugs in the last 6 months and history of knee surgery.
Intervention groups
The intervention groups will include patients with grade 1 and 2 osteoarthritis, in one group, ozone medicine will be injected with hyaluronic acid, and in the other group, hyaluronic acid will be injected intra-articularly.
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059241N1
Registration date:2023-09-27, 1402/07/05
Registration timing:prospective
Last update:2023-09-27, 1402/07/05
Update count:0
Registration date
2023-09-27, 1402/07/05
Registrant information
Name
maryam asayeshi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3373 1691
Email address
maryamasayeshi88@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-05-21, 1403/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effects of ozone injection combined with hyaluronic acid compared to hyaluronic injection in the treatment of knee osteoarthritis in patients referred to the orthopedic clinic and the pain clinic of Fatemi Ardabil Hospital.
Public title
Ozone injection combined with hyaluronic acid compared to hyaloronic injection in the treatment of knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Osteoartitis grade 1&2
Exclusion criteria:
Pregnancy or breastfeeding
Taking anticoagulants
Intra-articular drug use during the last 6 months
History of knee surgery
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into two groups receiving hyaluronic acid and ozone with hyaluronic acid. Simple randomization and lottery will be used for randomization. Cards and envelopes are prepared according to the number of the research sample and an equal number of names of groups A and B are recorded on each card. The cards are placed inside the letter envelopes. The lid of the letter envelopes is glued and placed inside a box. At the start of the study, according to the order of entry of the participants, the patient will take one of the envelopes from the box and will be placed in one of the two study groups based on the group written on the card.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients in one group will receive hyaluronic acid and patients in the other group will receive ozone along with hyaluronic acid. Patients and doctors who evaluate the outcome will be unaware of the type of drug received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2023-07-22, 1402/04/31
Ethics committee reference number
IR.ARUMS.REC.1402.108
Health conditions studied
1
Description of health condition studied
Osteoartritis in knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
The moment of entry, the second week, the second month and the sixth month after the intervention
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
Quality of Life
Timepoint
The moment of entry, the second week, the second month and the sixth month after the intervention
Method of measurement
SF-36 questionnaire
2
Description
Sleep quality
Timepoint
The moment of entry, the second week, the second month and the sixth month after the intervention
Method of measurement
Pittsburgh Questionnaire
Intervention groups
1
Description
Intervention group: 2 cc of intra-articular hyaluronic acid (Nitca company, 2 mg) on three occasions with an interval of one week
Category
Treatment - Drugs
2
Description
Intervention group: 2 cc of intra-articular hyaluronic acid (Nitca company, 2 mg) and 10 cc of 25% ozone in three sessions with an interval of one week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemi Hospital in Ardabil
Full name of responsible person
Maryam Asayeshi
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
fatemi@arums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Farhad Pourfarzi
Street address
Vice chancellor for research, Ardabil University of Medical Sciences, Daneshgah Ave, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3353 4757
Email
research@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil University of Medical Sciences
Full name of responsible person
Maryam Asayeshi
Position
Resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
maryamasayeshi88@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Maryam Asayeshi
Position
Resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
maryamasayeshi88@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Maryam Asayeshi
Position
Resident of ansthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Fatemi hospital, Imam Khomeini street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5614733775
Phone
+98 45 3323 2520
Email
maryamasayeshi88@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available