Protocol summary

Summary
AfterThe accurate diagnosis of osteoarthritis (clinical and radiographic) , And evaluation of patient inclusion &exclusion criteria for the study, Details of treatment is described and the patient's written consent is obtained.Other drug treatments (NSAID, corticosteroids and other anti-inflammatory drugs) and non pharmacological (knee physiotherapy modalities are included, TENS, laser, etc.) will be discontinued 48 hours before the start of the intervention. Then initial knee x-ray is taken. And according to radiographic criteria, grading is done and initial patient questionnaire is completed.Then knee joint range of motion (ROM) measured by Goniometr &Medial and lateral joint line tenderness is reviewed & Pain intensity on VAS (state separation as the rest, walking, sitting, etc.) And according to the WOMAC questionnaire is assessed. The grouping is done, the other person does the first Hyalgan injections and hypertonic dextrose or 20% .A total of 3 patients were injected into the knee joint to be considered. Injections in patients treated with Hyalgan, at intervals of one week (vials 2 ml prepared hyaluronic acid) and in patients treated Prolotherapy three injections at intervals of one month (compound 9 ml of glucose 20% with 1 cc of lidocaine 2% in a syringe 10 cc) is done. After injection, it is recommended that patients have a relative rest for 48 hours, it increases the duration of maintaining and enhancing the response to treatment. for sterility , sterile gloves & sterile infusion sets are used. Before each injection, patients were reassessed for pain (VAS and a questionnaire based on numerical criteria WOMAC), range of motion, tenderness of the joint line (medial and lateral) and injection complications (infection, Hemartrosis,...) are checked. Patients can be followed during the course of the pain, take acetaminophen 325, But the 12 hours prior to treatment to follow, do not use acetaminophen. After treatment protocol (three injections and in each stage of the assessment), range of motion, pain and joint line tenderness is measured.

General information

Acronym
Comparison of prolotherapy with hyalgan
IRCT registration information
IRCT registration number: IRCT2013031712831N1
Registration date: 2013-08-28, 1392/06/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-28, 1392/06/06
Registrant information
Name
Masoumeh Bahrami Asl
Name of organization / entity
Army University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8833 7915
Email address
masoomehbahrami@yahoo.com
Recruitment status
Recruitment complete
Funding source
Army University of Medical Sciences
Expected recruitment start date
2013-06-11, 1392/03/21
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of long term efficacy of dextrose prolotherapy with hyalgan in knee Osteoarthritis
Public title
Comparison of long term efficacy of dextrose prolotherapy with hyalgan in knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 50 years old; cripitation or morning stiffness less than 30 min & radiologic criteria of OA. Exclusion criteria: diabetes mellitus; other joint disease ( RA,...); surgery in knee; fx history;recent corticosteroid injection; immunosuppression and massive knee effusion.
Age
From 50 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 110
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
army university of medical science
Street address
Imam reza( 501) hospital - Etemad Zadeh street-Fatem
City
tehran
Postal code
Approval date
2013-06-11, 1392/03/21
Ethics committee reference number
9204

Health conditions studied

1

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

Primary outcomes

1

Description
pain severity (pain score)
Timepoint
1 week, 1 month, 3 month , 8 month and 12 month
Method of measurement
VAS ruller

2

Description
knee joint range of motion
Timepoint
1 week, 1 month, 3 month , 8 month and 12 month
Method of measurement
goniometr

3

Description
quality of life
Timepoint
1 week, 1 month, 3 month and 8 month
Method of measurement
WOMAC questionary

Secondary outcomes

1

Description
infection
Timepoint
1 week, 1 month, 3 month , 8 month and 12 month
Method of measurement
physical exam

Intervention groups

1

Description
intervention:in prolotherapy group we use ,9cc of 20% dextrose + 1cc lidocaine in strill condition & in knee joint space
Category
Treatment - Drugs

2

Description
control: we use prepared vial of 2 cc hyalgan in strill condition & in knee joint space
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital (501)
Full name of responsible person
Dr. Masoumeh Bahrami Asl
Street address
Imam reza( 501) hospital - Etemad Zadeh street-Fatem
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr Zahra Reza Soltani
Street address
Imam reza( 501) hospital - Etemad Zadeh street-Fatem
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Army 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
Army University of Medical Sciences
Full name of responsible person
Dr Masoumeh Bahrami Asl
Position
Assistant of physical medicine and rehabilitation
Other areas of specialty/work
Street address
Imam reza( 501) hospital - Etemad Zadeh street-Fatem
City
Tehran
Postal code
Phone
+98 21 8833 7915
Fax
Email
masoomehbahrami@yahoo.com; m.bahrami.asl@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr. Masoumeh Bahrami Asl
Position
Assistant of physical medicine & rehabilitation
Other areas of specialty/work
Street address
Imam reza( 501) hospital - Etemad Zadeh street-Fatem
City
Tehran
Postal code
Phone
+98 21 8833 7915
Fax
Email
masoomehbahrami@yahoo.com; m.bahrami.asl@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Army University of Medical Sciences
Full name of responsible person
Dr Masoumeh Bahrami Asl
Position
assistant of physical medicine & rehaabilitation
Other areas of specialty/work
Street address
Imam reza( 501) hospital - Etemad Zadeh street-Fatem
City
tehran
Postal code
Phone
+98 21 8833 7915
Fax
Email
masoomehbahrami@yahoo.comm.bahrami.asl@gmail.com
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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