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Evaluation of the effect of different concentrations of dextrose in prolotherapy on relieving knee osteoarthritis pain

Protocol summary

Study aim
Finding the best concentration of hypertonic dextrose in knee prolotherapy
Design
Clinical trial in three group without control group,parallel groups, double blinded with blinded outcome assessment, randomised, on 93 patients, for randomisation used blocked randomisation
Settings and conduct
This study evaluate the effects of different concentrations of hypertonic dextrose in 93 patients with knee osteoarthritis in sanandaj city. Patients categories in three randomised group that receive three times hypertonic dextrose injection in eight point of their knee and evaluate 1,3 and 6 month after injection. Patient, procedure performer and who evaluate are blinded about patient's group.
Participants/Inclusion and exclusion criteria
Patients with knee osteoarthritis diagnosed, with pain and at least three of this six criteria :age more than 50 years, morning stiffness less than 30 minutes, cripitation in active knee moving, bone sensitivity, bone enlarged, no warming in joint feeling. Criteria for reject: stroid drugs injection in last two weeks, diabetes mellitus, candidates for surgery (stiffness grade four ), history of dextrose injection, knee infection in last three mounts, daily opium use, history of inflammatory arthritis,heridatory or traumatic bone dissformation, vascular necrosis, body mass index more than 30.
Intervention groups
In three randomised choosen group, in eight locality of anterior and posterior of knee injection performing based on their groups, three times with two weeks distance
Main outcome variables
pain; knee stiffness and structural function; physical movement

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201214049707N1
Registration date: 2021-04-19, 1400/01/30
Registration timing: prospective

Last update: 2021-04-19, 1400/01/30
Update count: 0
Registration date
2021-04-19, 1400/01/30
Registrant information
Name
Saeid Biglary
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3362 8194
Email address
saeid.biglary@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-12-21, 1400/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of different concentrations of dextrose in prolotherapy on relieving knee osteoarthritis pain
Public title
the best concentration of injected hypertonic dextrose in knee prolotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least three of this six criteria Age more than 50 year's Morning stiffness less than 30 minutes Cripitation in knee moves Bone sensivity Bone enlarged No feeling of arther warming
Exclusion criteria:
Stroid drugs injection in the last two weeks Diabetes mellitus Candidate for knee surgery( degree's of four in stiffness ) History of dextrose injection in knees Knee infection in the last three months Knee inflammation Daily opium use History of inflammatory or infected arthritis Heridatory or traumatic injury in knee joint Vascular necrosis Body mass index more than 30
Age
From 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 93
Randomization (investigator's opinion)
Randomized
Randomization description
We use blocked randomisation method. In this method we choose nine paper that writed on three of them H, three M and three L. We mix this nine papers and take one of them for every patient randomly and categories them acording to their paper
Blinding (investigator's opinion)
Triple blinded
Blinding description
In time of procedure, patient and performer are blind about patient's category and individual that receive and write afect of procedure is blind too.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of kurdistan university of medical sciences
Street address
No.4,Khane Aftab Building, Tahmasebi street, Shark Saade phase 2, Sanandaj
City
SANANDAJ
Province
Kurdistan
Postal code
6617953775
Approval date
2021-03-17, 1399/12/27
Ethics committee reference number
IR.MUK.REC.1399.327

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Severity of pain is the most important item that is affected on disability of patients with knee osteoarthritis and in this research through the WOMAC score evaluate before and after the procedure.
Timepoint
Before intervention, one, three and six months after the first injection
Method of measurement
Via questionnaire that designed for this research plus WOMAC score questionnaire

Secondary outcomes

1

Description
Severity of the pain is the most important item and the most affected on patient's disability that evaluates. Morning stiffness is a limiter cause that evaluates. Restriction for daily activities will evaluates.
Timepoint
Before intervention, one, three and six months after the first injection
Method of measurement
Via WOMAC score questionnaire

Intervention groups

1

Description
Intervention group: first group : 16 millilitres of Dextrose 15 % plus 4 millilitres of lidocaine 2 %, inject in four points in the anterior and four points in the posterior of knee. This will be repeat two times with distance of two weeks.
Category
Treatment - Drugs

2

Description
Intervention group: Second group :16 millilitres of Dextrose 30% plus 4 millilitres of lidocaine 2 %, inject in four points in the anterior and four points in the posterior of knee. This will be repeat two times with distance of two weeks.
Category
Treatment - Drugs

3

Description
Intervention group: Third group 16 millilitres of Dextrose 50 % plus 4 millilitres of lidocaine 2 %, inject in four points in the anterior and four points in the posterior of knee. This will be repeat two times with distance of two weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kousar hospital
Full name of responsible person
Saeid Biglary
Street address
Fatehy nahid square, Pasdarn Bvld, kousar hospital
City
Sanandaj
Province
Kurdistan
Postal code
16679588
Phone
+98 87 3361 1309
Email
Dsbiglary@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr.Karim Naseri
Street address
Medical school, Pasdaran Blvd,
City
Sanandaj
Province
Kurdistan
Postal code
6616545
Email
Dsbiglary@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Saeid Biglary
Position
Assistant of anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No.4,Khane Aftab,Tahmasebi street, Shark Saadi , phase 2, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617953775
Phone
+98 87 3362 8194
Fax
Email
Saeid.Biglary@muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Saeid Biglary
Position
Assistant of anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No.4,Khane Aftab,Tahmasebi street, Shark Saadi , phase 2, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617953775
Phone
+98 87 3362 8194
Fax
Email
Saeid.Biglary@muk.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Saeid Biglary
Position
Assistant of anesthesia
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
No.4,Khane Aftab,Tahmasebi street, Shark Saadi , phase 2, Sanandaj
City
Sanandaj
Province
Kurdistan
Postal code
6617953775
Phone
+98 87 3362 8194
Fax
Email
Saeid.Biglary@muk.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
The major information of patient's chronic disease, risk factors and kind of the intervention are capable for publication after doing unrecognisable patient's identity
When the data will become available and for how long
One to three months after presentation and print the consequences in origin university
To whom data/document is available
All researchers and Co_workers in medical field
Under which criteria data/document could be used
Use of this research and deployment that is possible for researchers and those who have speciality and licence in medical field.
From where data/document is obtainable
Dsbiglary@gmail.com No: 00989183715979
What processes are involved for a request to access data/document
Applying for above addresses and presentation documents for authentication and obligation for taking necessary and legal licenses
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