Protocol summary

Summary
Osteoarthritis is one of the most common diseases and knee is the most commonly affected joint. It has been a while that intra-articular prolotherapy is being utilized in acute and chronic pain management . setting. One of the recent methods for treating acute and chronic joint pain is utilization of intra-articular prolotherapy. In this method through insertion of growth stimulants, the inflammatory cascade is activated, which leads to inflammatory factors release, cellular growth and acceleration of cartilage growth. The most commonly used stimulant is dextrose. Nowadays, using different blood components such as platelets and whole blood has been taken into consideration as well. Erythropoietin, released from kidney, a growth stimulant and red blood cells proliferator has stimulus effects on bone marrow cells’ growth.Moreover, in several studies pulsed radiofrequency has been reported as a suitable method with minor side effects for treating many painful conditions. Pulsed radiofrequency is a method in which a particular voltage is applied next to the nerve. This study designed to compare the efficacy of the three methods of intra-articular knee joint therapies with prescribing erythropoietin, dextrose, and pulsed radiofrequency to estimate their therapeutic effect and find a more practical solution to more effective pain management while minimizing side effects. Methods and materials: After approval by the ethics committee 70 patients selected. Inclusion criteria were: aged 40-70 ASA I-II, who were suffering from pain in the knee due to primary osteoarthrosis according to the American College of Rheumatology’s criteria and had come to the Rasoul Akram pain clinic, if the written conssent signed by them went through one of the treatment methods.First, the patients were examined for pain level based on visual analogue scale (VAS); and the amount of knee joint motion range through goniometric method which were recorded in the pertinent form. Afterwards, the patient was randomly scheduled by the second colleague for one of the aforementioned methods in the operating room using robust (pseudo-) random number generation software. Furthermore, patients’ satisfaction was assessed through pre-designed forms before and after prolotherapy and pulsed radiofrequency in weeks 2, 4, and 12. through anteroposterior method from the superolateral part of patella with an angle of about 45 degrees, was entered into the articular area. Erythropoietin group (group 1) receives intra-articular injection of 5 cc of ropivacaine 0.5% together with 4000 international units of erythropoietin .). Dextrose group (group 2) receives fluoroscopically guided intra-articular injection of 5 cc 0.5% ropivacaine together with 5 cc dextrose 25% .. In the pulsed radiofrequency group (group 3), under aseptic conditions and local anestesia with fluoroscopic guidance, through anteroposterior method from the superolateral part of patella with an angle of about 45 degrees, RF needle number 22, 100 millimeter long and 10 millimeter active tip (OWL, Diros Tech, Ontario, Canada) enters the articular area. From the anteroposterior fluoroscopic view the needle tip was embedded at the center of patella. Then, probe (Diros Tech, Ontario, Canada) was entered the articular area and the patients underwent pulsed radiofrequency(20 msec, 2 HZ, 45 V, 15 min,42° C, 2cycles). Following the operation, the patients were transferred to recovery room for one hour to be monitored for any possible side effectsFollowing the operation, the patients transfer to recovery room for one hour to be monitored for any possible side effects, in case there were not any, the patient will discharge. During the second, fourth, and twelfth following weeks they would examined for level of pain according to the expressed pain rate (0 for no pain at all, 10 for worst pain imaginable), and knee joint’s motion range was examined through goniometry .

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013092210336N4
Registration date: 2013-10-27, 1392/08/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-10-27, 1392/08/05
Registrant information
Name
Poupak Rahimzadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2226 4036
Email address
p_rahimzadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2013-10-23, 1392/08/01
Expected recruitment end date
2014-03-21, 1393/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the Efficacy of Intra-articular Prolotherapy With Erythropoietin and Dextrose and Intra-articular Pulsed Radiofrequency on the Primary Osteoarthritis of Knee: Patients’ Level of Pain and Knee Joint’s Range of Motion
Public title
Investigation of the Efficacy of Intra-articular Prolotherapy on the Primary Osteoarthritis of Knee: Patients’ Level of Pain and Knee Joint’s Range of Motion
Purpose
Treatment
Inclusion/Exclusion criteria
The inclusion criteria were: osteoarthritis according to the American College of Rheumatology’s (formerly, American Rheumatology Association) criteria; age 40-70 years old; clinical class I-III; radiology stage 1-3 based on Kellgren-Lawrence criteria. The exclusion criteria were: drugs or alcohol addiction; hemophilia; rheumatoid arthritis or other rheumatologic disease.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Iran University of Medical Sciences
Street address
Cross of Hemmat and Sheykh Fazlollah express wayو Tehran
City
Tehran
Postal code
Approval date
2013-07-23, 1392/05/01
Ethics committee reference number
13840

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Knee pain amount
Timepoint
Weeks 2, 4 and 12
Method of measurement
Visual analogue scale(VAS)

2

Description
Range of motion of knee
Timepoint
Weeks 2, 4 and 12
Method of measurement
Goniometry

Secondary outcomes

empty

Intervention groups

1

Description
Prolotherapy with dextrose
Category
Treatment - Drugs

2

Description
Prolotherapy with erythropoetine
Category
Treatment - Drugs

3

Description
Intraarticular radiofrequency
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasul Medical Complex
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr Abbas Motevallian
Street address
Cross of Hemmat and Sheykh Fazlollah express way
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, Iran 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
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Assistanr professor of anesthesiology & pain
Other areas of specialty/work
Street address
Hazrat Rasul Medical Complex
City
Tehran
Postal code
Phone
+98 912 106 4483
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Assistant professor of anesthesiology & pain
Other areas of specialty/work
Street address
Hazrat rasul medical complex
City
Tehran
Postal code
Phone
+98 912 106 4483
Fax
Email
p-rahimzadeh@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Poupak Rahimzadeh
Position
Assistant professor of anesthesiology
Other areas of specialty/work
Street address
Hazrat Rasul medical complex
City
Tehran
Postal code
Phone
Fax
Email
p-rahimzadeh@sina.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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