This study is to compare two new therapeutic methods of radiofrequency and intraperiarticular ozone injection to improve knee function osteoarthritis (OA).
The patients between 30 -70 years old with moderate to severe knee pain at least for 3 months with no response to usual conservative treatments and not appropriate candidates for surgery enrolled to the study. They are divided in two groups Radiofrequency (RF) and ozone (O) by triple blocks. In RF group after diagnostic genicular nerve block and sensory and motor testing undergoing to conventional radiofrequency and then intra articular pulse radiofrequency and in (O) group received intra and periarticular ozone injection. The evaluation of pain severity and knee function is based on VAS and Oxford Knee Score (OKS) that is filled before and 12 weeks after treatment. Outcome is improved knee function in osteoarthritis disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201412156186N6
Registration date:2015-01-17, 1393/10/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-01-17, 1393/10/27
Registrant information
Name
Bahram Naderi Nabi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 3323 4600
Email address
naderi_bahram@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of two therapeutic methods, Radiofrequency and Ozone therapy in knee ostheoartritis
Public title
The comparison of two therapeutic methods, Radiofrequency and Ozone therapy in knee ostheoartritis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the patients between 30 to 75 years old; moderate to severe knee pain; at least for 3 months with no response to usual conservative treatments.
Exclusion criteria: intraarticular steroid injection during the previous 3 months; secondary osteoarthritis; sciatic pain.
Age
From 30 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan university of Medical Science
Street address
Namjoo Street
City
Rasht
Postal code
4193893345
Approval date
2014-08-19, 1393/05/28
Ethics committee reference number
1930231625
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis of other joints
Primary outcomes
1
Description
Pain
Timepoint
Before treatment and twelve weeks after treatment
Method of measurement
Visual Analog Scale (VAS); Questionnaire
2
Description
Knee function
Timepoint
Before treatment and 12 weeks after treatment
Method of measurement
Oxford Knee score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1: Ozone group, ozone group patients received intra articular ozone injection (10 cc O2-O3 mixture 40µg/ml) and periarticular injection (5 cc O2-O3 mixture 10µg/ml) by Ozone Generator HERRMANN.
Category
Treatment - Other
2
Description
Intervention2: Radiofrequency group, Diros3AP RF generatorrising electrode tip temperature to 70˚c for 90 seconds The procedure was carried out for each genicular nerve and then intra-articular PRF having a pulse width of 10 milliseconds at 2 HZ and 65 volt.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina Hospital
Full name of responsible person
Bahram Naderi Nabi
Street address
Parastar Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh
Street address
Shahid beheshti Highway
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Guilan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Bahram Naderi Nabi
Position
Anesthesiologist and pain fellowship/ Associated Professor
Other areas of specialty/work
Street address
PoorsinaHospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Bahram Naderi Nabi
Position
Anesthesiologist and pain fellowship/Assosiated proffessor
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4139638459
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
arcguilan1392@gmail.com
Web page address
www.arc.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Hedieh Nemati
Position
Medical laboratory Sciences Technician/ Bachelor's Degree
Other areas of specialty/work
Street address
Poursina Hospital
City
Rasht
Postal code
4193713194
Phone
+98 13 3331 0434
Fax
+98 13 3334 5132
Email
nematihedieh@gmail.com
Web page address
www.arc.gums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)