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Comparison prolotherapy with erythropoietin and ozone with injections of sodium hyaluronate, chondroitin sulfate and ozone in reducing pain in patients with knee osteoarthritis

Protocol summary

Study aim
Comparison of prolotherapy with erythropoietin and ozone with injections of sodium hyaluronate, chondroitin sulfate and ozone in reducing pain in patients with knee osteoarthritis
Design
The clinical trial without control group, with parallel groups, non blinded, non-randomized, and in phase 3 of clinical trial studies.
Settings and conduct
This study was carried out as a non blinded clinical trial at the pain clinic of zahedan university of medical sciences. Patients with inclusion criteria are considered as study group, in this study 100 cases with inclusion criteria were selected. They divided into two intervention group.
Participants/Inclusion and exclusion criteria
Patients with knee osteoarthritis, informed consent to participate in the study, complications of pain, crepitus and knee stiffness for at least three months and visual analogue scale more than 3 included for study, and patients with infection, any knee injections in the last three months, diabetes mellitus, history of rheumatoid arthritis, injection of steroid drugs over the past two months, drug addiction, arthroplasty, body mass index more than 42, history of cancer, pregnancy, radiculopathy, neuropathy and nnticoagulant use excluded from study.
Intervention groups
In the first intervention group, erythropoietin was used twice with a dose of 4000 international units / ml made in Iran in Razavi Pharmaceutical Company in collaboration with the Austrian company with 7 cc ozone 25 µg / ml, in the second intervention group, 3 cc injection of a mixture of sodium hyaluronate and chondroitin sulfate solution produced by Raha Pharmaceutical Company in collaboration with France was used once with 7 cc ozone 25 µg / ml.
Main outcome variables
Knee pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190503043450N1
Registration date: 2020-01-18, 1398/10/28
Registration timing: registered_while_recruiting

Last update: 2020-01-18, 1398/10/28
Update count: 0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Seyyed Amirreza Alavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5575
Email address
alavi.amirreza@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2020-05-21, 1399/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison prolotherapy with erythropoietin and ozone with injections of sodium hyaluronate, chondroitin sulfate and ozone in reducing pain in patients with knee osteoarthritis
Public title
Comparison of the effect of erythropoietin and ozone on joint function in patients with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Knee osteoarthritis Informed consent to participate in the study Complications of pain, crepitus and knee stiffness for at least three months Visual Analogue Scale score more than 3
Exclusion criteria:
infection Any knee injections in the last three months Diabetes mellitus History of rheumatoid arthritis Injection of steroid drugs over the past two months. Drug addiction Arthroplasty Body mass index more than 42 History of cancer Pregnancy Radiculopathy Neuropathy Anticoagulant use
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not 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 Zahedan University of Medical Sciences
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Approval date
2019-06-30, 1398/04/09
Ethics committee reference number
IR.ZAUMS.REC.1398.124

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site

Primary outcomes

1

Description
knee pain
Timepoint
Measurement of pain before injection and 3, 6, 9 and 12 months after injection
Method of measurement
With visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Erythropoietin injection twice with 3 weeks intervals with dose as 4000 International Units per milliliter made in Iran in Razavi pharmaceutical company in cooperation with Austria country, with 7 cc ozone 25 µg / ml in knee joint.
Category
Treatment - Drugs

2

Description
Intervention group 2: Injection of 3 cc mixture of sodium hyaluronate and chondroitin sulfate solution produced by Raha Pharmaceutical Company in collaboration with France country once with 7 cc ozone 25 µg / ml in knee joint.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Pain Clinic of Zahedan University of Medical Sciences
Full name of responsible person
Asadollah Shakeri
Street address
9816743463, Edalat Clinic, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2149
Email
Asadollahshakeri@zaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Noormohammad Bakhshani
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
Bakhshani@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Amirreza Alavi
Position
Anesthesiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Ali Ibn Abi Talib Hospital, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743111
Phone
+98 54 3329 5570
Email
Amirrezaalavi@zaums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Amirreza Alavi
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Ali Ibn Abi Talib Hospital, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5744
Email
Amirrezaalavi@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Amirreza Alavi
Position
Anesthesiology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
9816743463, Zahedan University of Medical Sciences, Dr. Hesabi Square, Persian Gulf Blvd, Zahedan, Sistan and Baluchestan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5570
Email
Amirrezaalavi@zaums.ac.ir

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
Main outcome information
When the data will become available and for how long
12 months after publishing results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
To verify the results and prevent repetition in similar research
From where data/document is obtainable
Library and website of Zahedan University of Medical Sciences
What processes are involved for a request to access data/document
Refer to the library and website of Zahedan University of Medical Sciences and have access to a maximum of one week
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