Protocol summary

Summary
1) Goals: Our goal in this study is to evaluate the effect of intra-articular radiofrequency use on patients' relief of pain and their degree of change in knee movement. 2) Design: After diagnosing knee osteoarthritis in patients, and ruling out other disorders such as rheumatoid arthritis and hemophilia and opioid or alcohol addiction, the patients will be enrolled in this study. We do not have any age limit for this procedure. We will explain to the patients about the advantages and disadvantages of this intervention which is intra-articular RF and written informed consent is achieved. Then before performing the procedure, the patient's pain with visual analogue score (VAS) and the knee joint ROM would be evaluated and recorded in the questionnaire. After performing the procedure, the patient's pain with VAS and the ROM of the joint plus the amount of used analgesic (400 mg Gelofen if VAS>3) will be assessed again after 1, 4, 8, and 12 weeks. 3) Method: Then the patient would be admitted to the pain OR and under sterile condition after prep-drape on supine position, the RF needle (50 mm) would be inserted under fluoroscopy into the joint and pulsed RF for 15 minutes and 42 degrees will be applied. After being transported to the PACU, the patients would be monitored for one hour regarding complications. 4) The inclusion criteria consist of patients diagnosed as having Knee osteoarthritis; and the other causes of knee pain have been ruled out; The exclusion criteria includes addiction to opium or alcohol ; other rheumatologic disorders ;rheumatoid arthritis; hemophilia 5) Interventions: After performing the intra-articular radiofrequency procedure, the patient's pain with VAS and the ROM of the joint plus the amount of used analgesic( 400 mg Gelofen if VAS>3) will be assessed again after 1 , 4, 8, and 12 weeks. 6) Main outcome variables: The pain score (VAS); the joint's ROM; and the amount of analgesic use by the patients are our main outcome variables.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306307984N11
Registration date: 2013-08-04, 1392/05/13
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Farnad Imani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6651 5758
Email address
farnadimani@yahoo.com
Recruitment status
Recruitment complete
Funding source
The Vice chancellor for research, tehran university of medical sciences
Expected recruitment start date
2012-05-09, 1391/02/20
Expected recruitment end date
2014-05-10, 1393/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Intra-articular Pulsed Radiofrequency on Pain and Range of Motion in primary Knee Osteoarthritis
Public title
Effect of Intra-articular Pulsed Radiofrequency on Pain and Range of Motion in primary Knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria consist of patients diagnosed as having Knee osteoarthritis; and the other causes of knee pain have been ruled out; The exclusion criteria includes addiction to opium or alcohol ; other rheumatalogic disorders ;rheumatoid arthritis; hemophilia
Age
From 40 years old to 80 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Tehran university of medical sciences
Street address
The ethics committee of Tehran university of medical sciences, Poursina St., Tehran
City
Tehran
Postal code
Approval date
2012-04-11, 1391/01/23
Ethics committee reference number
90-01-30-12978-48017

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
unilateral Primary gonarthrosis

Primary outcomes

1

Description
Pain score (VAS)
Timepoint
First, fourth, and twelfth weeks after the intervention
Method of measurement
Visual analogue score

Secondary outcomes

1

Description
The knee joint range of motion (ROM)
Timepoint
1st, 4th, and 12th weeks after the intervention
Method of measurement
Goniometry

2

Description
The amount of used analgesic
Timepoint
1st, 4th, and 12th weeks after the intervention
Method of measurement
The miligram dose of the analgesics

Intervention groups

1

Description
Pulsed radiofrequency of the knee joint at 42 degrees of centigrade and 15 minutes
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Dr Farnad Imani
Street address
Rasoul e Akram Hospital, Number 7, Nyiayesh St., Satarkhan St., Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran university of medical sciences
Full name of responsible person
Dr Akhundzadeh
Street address
Vice chancellor for research, 4th floor, Tehran university of medical sciences, Ghods St., Keshavarz Boulvard, Tehran, Iran
City
Tehran
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, Tehran 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
Rasoul Akram Medical Center
Full name of responsible person
Dr Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Department of Anesthesiology and Pain, 4th floor, Number 7, Rasoul Akram hospital, Nyiayesh St., Sattarkhan St., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
+98 21 6650 9059
Email
farimani@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences, Department of anesthesiology and Pain, Rasoul Akram Medical C
Full name of responsible person
Dr Farnad Imani
Position
Associate professor
Other areas of specialty/work
Street address
Pain OR, 4th floor, 1st building, Rasoul Akram Hospital, Nyiayesh St, Sattarkhan St, Tehran, Iran
City
Tehran
Postal code
1445613131
Phone
+98 21 6435 2107
Fax
+98 21 6650 9059
Email
farimani@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences, Rasoul Akram Hospital
Full name of responsible person
Dr Farnad Imani
Position
Anesthesiologist, Fellowship of Interventional Pain Practice, Chairman
Other areas of specialty/work
Street address
Rasoul Akram Medical Center, Number 7, Niayesh St., Sattarkhan St., Tehran
City
Tehran
Postal code
1445613131
Phone
+98 21645352107
Fax
+98 21 6650 9059
Email
farimani@tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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