Determining the effect of radiofrequency with intra-articular ozone on the symptoms of osteoarthritis of the knee joint
Design
Clinical trial with 2 groups ozone and radioferequency, single blind, randomized trial
Settings and conduct
This study will be performed as a single-blind randomized clinical trial in Imam Reza Hospital on patients with osteoarthritis of the knee.A total of 70 patients with inclusion criteria are first examined by a colleague for pain intensity and limited mobility of the knee and the result is recorded.The patient is then referred to the project colleague to be randomly assigned to one of two groups of 35-frequency radiofrequency or ozone.At the end of the treatment period, the patient is re-examined and the result is recorded by the same colleague who is blind to the treatment method.At the end, the results of the therapeutic intervention in improving the disease are compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Median knee osteoarthritis (Grade 2 or 3 based on Kellegren and Lawrence knee radiography);
Patients over 45 years old;
Satisfaction of patients participating in the study;
Exclusion criteria:
Severe osteoarthritis ;
Rheumatic disease;
Received previous corticosteroids 3 months ago;
Clearly visible deformity of the varus or valgus of the knee;
Severe knee flexion contraction;
Psychological disorders;
Drug dependence;
Pregnancy.
Intervention groups
First Intervention group (ozone therapy): In this group, patients undergoing ozone therapy with ozone gas at 15 cc with a concentration of 35 microcc per cc twice a week; They will be in total for 4 sessions.
Intervention group 2 (radiofrequency group):In this group, patients will be exposed to PRF once a week for 2 sessions at a temperature of 42 ° C and a pulse width of 20 milliseconds, 2 Hz for 15 minutes.
Main outcome variables
Physical function, pain, patient satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180518039700N3
Registration date:2021-09-12, 1400/06/21
Registration timing:registered_while_recruiting
Last update:2021-09-12, 1400/06/21
Update count:0
Registration date
2021-09-12, 1400/06/21
Registrant information
Name
Solmaz Fakhari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6124
Email address
fakharis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-23, 1400/05/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Radioferequency and intraarticular ozone on improving the osteoarthritis symptoms of knee joint
Public title
Comparison of radiofrequency with ozone in improving the symptoms of knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Median knee osteoarthritis (Grade 2 or 3 based on Kellegren and Lawrence knee radiography)
Patients over 45 years old
Satisfaction of patients participating in the study
Failure to respond to conservative and physiotherapy treatments over the past 6 months
Exclusion criteria:
Severe osteoarthritis (Grade 4 candidates for joint replacement surgery)
Rheumatic disease
Received previous corticosteroids 3 months ago
Clearly visible deformity of the varus or valgus of the knee
Severe knee flexion contraction
Ankylosis
Psychological disorders
Drug dependence
Hyperthyroidism
Thrombocytopenia
Pregnancy
Age
From 45 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using GraphPad online randomization software (https://www.graphpad.com/quickcalcs/randomize1), 70 patients will be randomly allocated into two groups (n=35) A (ozone group) and B (radio-frequency group). According to this list, the patients referred to the study will be considered as group A or B, respectively. In the ozone group, intra-articular injection of ozone and in the radio-frequency group, radio frequency therapy will be applied intra-articularly.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blinded study and in this trial 70 patients with study inclusion criteria, first examined by one of coworkers due to knee pain and functional limitation, and the results are recorded. The patients are referred to the principle investigator and they randomly assigned to one of the two groups; Radioferequency or ozone (n=35). At the end of the treatment, the patients will be examined again by the same coworker, who will be kept blind to the treatment, and the result is recorded. At the end of the study, the two groups will be compared due to their pain and functional status.
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
Vice chancellor for research, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5183915881
Approval date
2021-01-25, 1399/11/06
Ethics committee reference number
IR.TBZMED.REC.1399.1022
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M15.0
ICD-10 code description
Primary generalized (osteo)arthritis
Primary outcomes
1
Description
Physical performance
Timepoint
At the beginning of the study, in 4th session of ozone therapy and 2nd session of radio frequency (at the end of sessions of both methods) and one month after the end of sessions.
Method of measurement
WOMAC questionnaire(Western Ontario and McMaster Universities Osteoarthritis Index questionnaire)
2
Description
Intensity of pain
Timepoint
At the beginning of the study, in 4th session of ozone therapy and 2nd session of radio frequency (at the end of sessions of both methods) and one month after the end of sessions.
Method of measurement
VAS (Visual Analog Scale) will be measured at rest and after 6 meters of walking.
3
Description
Patient satisfaction
Timepoint
At the beginning of the study, in 4th session of ozone therapy and 2nd session of radio frequency (at the end of sessions of both methods) and one month after the end of sessions.
Method of measurement
Question from the patient (excellent, good, acceptable and unsatisfactory)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Ozone group: 15 cc of ozone 35 micro-grams per millilitre will be injected. After injection, flexion and extension movements will be performed for better distribution of gas in the knee.When finished, the place is bandaged and it is transferred to the recovery and stays in the recovery for 30 minutes, then it is transferred to the ward and will be released after 4 hours.This action will be done twice a week for a total of 4 sessions.
Category
Treatment - Drugs
2
Description
Intervention group: Radiofrequency group: Radiofrequency needle with 100 mm length and 10 mm active tip is inserted into the joint, then PRF with a temperature of 42 ° C and a pulse width of 20 milliseconds, 2 Hz is applied for 15 minutes. This action is done twice. It is done in 2 weeks (once a week).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Fakhari
Street address
Imam Reza Hospital, Golgasht St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
solmaz_fakhari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Abolghasem Joiban
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Golghast St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Phone
+98 41 3335 7310
Fax
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Fakhari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht St., Azadi Blvd
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
solmaz_fakhari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Fakhari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
solmaz_fakhari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Fakhari
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Imam Reza Hospital, Golgasht St., Azadi Blvd.
City
Tabriz
Province
East Azarbaijan
Postal code
5138947979
Phone
+98 41 3334 1994
Fax
+98 41 3334 1994
Email
solmaz_fakhari@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All potential data can be shared after making peoples unrecognizable
When the data will become available and for how long
Starting 6 months after publication.
To whom data/document is available
Documents will be available for people working in academic institutions and also people working in businesses.
Under which criteria data/document could be used
There will be no specific limitations to the utilization of the data
From where data/document is obtainable
Dr .Solmaz Fakhari , Department of Anesthesiology, Faculty of Medicine, Golgasht Street, Tabriz East Azarbaijan Islamic Republic of Iran ,Phone+98 413 3341994, Fax+98 41 33341994 , solmaz_fakhari@yahoo.com
What processes are involved for a request to access data/document
Applicants will access the data from the present study by sending an email to the responsible author for a maximum of one week.