1. Home
  2. Approved trials
  3. » فارسی

The comparison of effects of intra - articular injection of Platelet Rich Plasma (PRP), Plasma Rich in Growth Factor (PRGF), Hyaluronic Acid (HA), and Ozone Gas on pain, stiffness, and function of patients with knee osteoarthritis

Protocol summary

Summary
120 patients with knee osteoarthritis with a specific age range and duration of symptoms more than 3 months and having Inclusion criteria, are included in the study. Evidence and method of injection of PRGF, Ozone, PRP and HA, as well as the potential benefits and complications of the study are presented by a physiatrist. Patients are screened at the first visit, including history, physical examinations, laboratory requests (CBC, ESR, CRP) and knee AP and Lateral x-Ray view in standing position and patient medications. Then patients are randomized to four groups receiving PRGF, Ozone, PRP, and HA. For each group appropriate exercise therapy is prescribed . At the beginning of the study, and in order to measure the outcome of the patients in the 6th and 12th months after the completion of the injections, WOMAC and VAS questionnaires were used to assess joint stiffness, functional limitation and pain intensity.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017082013442N17
Registration date: 2017-11-11, 1396/08/20
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-11, 1396/08/20
Registrant information
Name
Seyed Ahmad Raeissadat
Name of organization / entity
Modares Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 2273 1112
Email address
a_raeissadat@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Physical Medicine and Rehabilitation Research Center of Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-03-19, 1397/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of effects of intra - articular injection of Platelet Rich Plasma (PRP), Plasma Rich in Growth Factor (PRGF), Hyaluronic Acid (HA), and Ozone Gas on pain, stiffness, and function of patients with knee osteoarthritis
Public title
The comparison of effects of different intra-articular injections on the symptoms of patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with knee osteoarthritis according to the American College of Rheumatology criteria aged between 50-70 years and with symptoms that have been diagnosed for more than 3 months and radiologic evidence of articular damage (grade 1-4 of Kellgren-Lawrence scale) Exclusion criteria: 1- systemic diseases such as diabetes mellitus, Immunodeficiency and collagen vascular disorders 2- history or presence of cancer or malignant disorders 3- any infection and active wound of the knee 4-presence of autoimmune diseases and platelet disorders 5- use of NSAIDs 2 days before injection 6- treatment with anticoagulant and anti-platelet medications 10 days before injection 7-history of knee articular injections of corticosteroids 3 weeks or use of systemic corticosteroids 2 weeks before injections 8-hemoglobin measures of less than 12 g/dl and platelet counts of less than 150,000 per micro liter 9- recent history of severe trauma to the knee 10-age less than 40 or over 75 years 11- history of vasovagal shock 12-pregnancy and breastfeeding 13- genu valgum/varum greater than 20 degrees 14-Allergy to chicken or egg protein or hypersensitivity to hyaluronate 15-patients treated with ACE inhibitors. 16-G6PD deficiency
Age
From 50 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Random table number is used to randomize. This is a single blind study and patients are not aware of the type of injected drug.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ٍEthics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Arabi Ave., Yaman St., Shahid Chamran highway
City
Tehran
Postal code
1985717443
Approval date
2017-02-21, 1395/12/03
Ethics committee reference number
IR.SBMU.MSP.REC.1396.230

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Gonarthrosis [arthrosis of knee]

Primary outcomes

1

Description
knee pain
Timepoint
before intervention,6 months & 12months after intervention
Method of measurement
changes of WOMAC and VAS questionnaires scores

2

Description
Joint Stiffness
Timepoint
before intervention,6 months & 12months after intervention
Method of measurement
change of WOMAC questionnaire scores

3

Description
function
Timepoint
before intervention,6 months & 12months after intervention
Method of measurement
change of WOMAC questionnaire scores

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: plasma rich in growth factor, knee intraarticular injection, 4 to 6 milliliter, 2 times, 3 weeks interval
Category
Treatment - Drugs

2

Description
Intervention group 2: platelet rich in plasma , knee intraarticular injection, 4 to 6 milliliter, 2 times, 3 weeks interval
Category
Treatment - Drugs

3

Description
Intervention group 3: Hyaluronic acid (500,000 to 730000 Daltons),3times, weekly
Category
Treatment - Drugs

4

Description
Intervention group 4: Ozone Gas, knee intraarticuar injection,10 ml with a concentration of 30 μg per cc 3 times, weekly
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Saadat Abad St.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Street address
Tehran, Saadat Abad, Kaj Square, Shahid Modarres Hospital
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, Shahid Beheshti 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
Shahid Modarres Hospital
Full name of responsible person
Parsaa Ghazi hosseini
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Saadat Abad St.
City
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
rrshamsi@yahoo.com; modarres@sbmu.ac.ir
Web page address
http://www.sbmu.ac.ir/?fkeyid=&siteid=101&pageid=225

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti Univeraity of Medical Sciences
Full name of responsible person
Seyed Ahmad Raeissadat
Position
Associate Professor of Physical Medicine and Rehabilitation departmen, Shahid Beheshti University of
Other areas of specialty/work
Street address
Shahid Arabi Ave., Yaman St., Shahid Chamran Highway
City
Tehran
Postal code
1985717443
Phone
+98 21 23871
Fax
Email
a_raeissadat@sbmu.ac.ir; info@sbmu.ac.ir
Web page address
http://www.sbmu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti university of medical sciences
Full name of responsible person
Parsa Ghazi Hosseini
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Saadat Abad St.
City
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
rrshamsi@yahoo.com; modarres@sbmu.ac.ir
Web page address
http://www.sbmu.ac.ir/?fkeyid=&siteid=101&pageid=225

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
Loading...