1. Home
  2. Approved trials
  3. » فارسی

Comparition the impact of intraarticular Steroid and intraarticular ozon on improving the symptoms of osteoarthritis of knee

Protocol summary

Study aim
Comparison of Clinical effects of Steroids and Intra articular Ozone in improving the symptoms of Chronic Knee Osteoarthritis
Design
The clinical trial consisted of two groups of Steroid therapy and Ozone therapy Randomised with parallel group trial and phase 2-3 ,single blind groups on 40 patients and randomization based on a random number table and RAS software.
Settings and conduct
In the ozone therapy group, 5 cc of ozone with a concentration of 30 micrograms per ml with 2 cc of lidocaine 2% will be injected into the joint.The injection will be performed in the physical medicine clinic of Imam Reza Hospital.In the steroid therapy group, patients treated with a mixture of 40 mg triamcinolone and 1 mg lidocaine 2% will be given intra-articular onceThe study is single blind because it is not possible to blind patients due to the difference in the injectable material.The researcher and data analyzer are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Moderate Knee Osteoarthritis Existence of symptoms in favor of Knee Osteoarthritis for at least 3 months Minimum score 3 in the criterion (VAS) Absence of inflammatory Rheumatic diseases Patients over 45 years Satisfaction of patients Failure to respond to Conservative treatments Exit criteria: Severe stevoarthritis Rheumatic disease Clearly visible deformity of the Knee Ankylosis Contraindications to Ozone and Steroid
Intervention groups
Steroid therapy group and Ozone therapy group
Main outcome variables
The amount of Reduce in pain after injection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100827004641N18
Registration date: 2021-11-17, 1400/08/26
Registration timing: retrospective

Last update: 2021-11-17, 1400/08/26
Update count: 0
Registration date
2021-11-17, 1400/08/26
Registrant information
Name
Bina Eftekharsadat
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 3193
Email address
binasadat@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2021-02-20, 1399/12/02
Actual recruitment start date
2019-11-03, 1398/08/12
Actual recruitment end date
2020-03-11, 1398/12/21
Trial completion date
2021-09-04, 1400/06/13
Scientific title
Comparition the impact of intraarticular Steroid and intraarticular ozon on improving the symptoms of osteoarthritis of knee
Public title
Comparition the impact of Steroid and intraarticular ozon on improving the symptoms of osteoarthritis of knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Moderate Knee Osteoarthritis (grade two or three based Radiographic classification (Kellegren and Lawrence) Existence of symptoms in favor of Knee Osteoarthritis for at least 3 months Minimum score of 3 in the criterion (VAS) Absence of Inflammatory Rheumatic diseases 45 years old and older Satisfaction of patients participating in the study Failure to respond to Conservative drug treatments and physiotherapy lasted for 6 months
Exclusion criteria:
Severe Osteoarthritis (grade 4 candidates for joint replacement surgery) Rheumatic disease Clearly Visible deformity of the knee Ankylosis Contraindications to Ozone include: Hyperthyroidism , Thrombocytopenia ,Pregnancy , Recent heart attack history ,G6PD Deficiency Definitive and partial Contraindications to Steroid injection include: Bacteremia, Sepsis, Intra articular or pre uricular infection, History of post injection Allergy, Intra articular or Osteochondral fracture at the injection site, Severe Joint destruction in Injection site , Artificial joint , Uncontrolled Coagulation disorders Specific skin lesion at the injection site
Age
From 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Actual sample size reached: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be assigned to either the steroid or ozone injection groups using block randomization using random allocation software (RAS). The size of blocks is 4 including the equal numbers of each intervention of the study in each block and a 1:1 assignment ratio. Blocking will be performed by the non-involved person in data sampling and analysis. To conceal the assignment, the type of intervention will be written on a sheet of paper coding using the letters A and B and placed inside matted, consecutively numbered envelopes. The envelopes will be arranged according to the participants' entry to the intervention, and the type of group will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study was single blind because it was not possible to blind patients due to the difference in the injection material and the volunteers will be aware of what treatment method was used in each group.The injections were performed by a physical medicine specialist.The researcher and the person conducting the follow up and data analysts and outcome assessors who are blinded and unaware of the intervention performed on each group of patients And only the final data in the form of the first and second groups and random numbers assigned to each patient will be available.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of tabriz university of medical sciences
Street address
Golgasht avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2021-10-04, 1400/07/12
Ethics committee reference number
IR.TBZMED.REC.1400.622

Health conditions studied

1

Description of health condition studied
استئو آرتریت مزمن زانو
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
The amount af Reduce in pain after injection
Timepoint
Immediately before injection and 1 month after injection and 6 months after injection
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC)questionare

Secondary outcomes

1

Description
Improvement of function of Knee
Timepoint
Immediately before injection and one and six months after injection
Method of measurement
Western Ontario and McMaster Universities Arthritis Index (WOMAC)questionare

Intervention groups

1

Description
Intervention group: In the ozone therapy group, 5 cc of ozone with a concentration of 30 micrograms per ml with 2 cc of 2% lidocaine will be injected into the joint. Ozone injections will be given to each patient once a week for 3 sessions. Consumable ozone is produced by Palaguar ozone generator, the exclusive representative of the German company Herrmann.
Category
Treatment - Drugs

2

Description
Intervention group: In the steroid therapy group, patients treated with a mixture of 40 mg triamcinolone and 1 mg lidocaine 2% will be given intra-articular once. Triamcinolone is consumed by Iran Hormone Company.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical medicine clinic of Imam Reza Hospital
Full name of responsible person
Dr. Bina Eftekharsadat
Street address
Department of Physical Medicine and rehabilitation, Imam Reza Hospital, Daneshgah Square, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 6923
Email
Binasadat@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Physical Medicibe and Rehabilitaion Research Center of Tabriz
Full name of responsible person
Yaghoub Salek Zamani
Street address
Imam Reza Hospital ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
516666471
Phone
+98 41 3337 6923
Email
Binasadat@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Physical Medicibe and Rehabilitaion Research Center of Tabriz
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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital ,Golgasht street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 6923
Email
Binasadat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associate professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Center, Imam reza hospital, The Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 6923
Email
Binasadat@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bina Eftekharsadat
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Physical Medicine and Rehabilitation Research Center, Imam reza hospital, The Golgasht street, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 6923
Email
Binasadat@yahoo.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
Loading...