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Dextrose prolotherapy effects on the Pain of Knee Osteoarthritis: Comparison of Injection in Acupuncture Points versus Non-Acupuncture points

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History
# Registration date Revision Id
6 2020-03-04, 1398/12/14 125378
5 2020-02-23, 1398/12/04 124288
4 2020-02-07, 1398/11/18 121181
3 2019-04-14, 1398/01/25 86657
2 2018-12-08, 1397/09/17 86103
1 2018-12-08, 1397/09/17 69934
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  • Protocol summary

    In the first intervention group, 8 ml of dextrose 5% and 2 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points and in the second intervention group, 8 ml of dextrose 5% and 2 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
    In the first intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points and in the second intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
    در گروه مداخله اول مقدار 8 میلی لیتر دکستروز 5 درصد و 2 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط طب سوزنی تزریق می شود.و در گروه مداخله دوم مقدار 8 میلی لیتر دکستروز 5 درصد و 2 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط غیرطب سوزنی تزریق می شود.
    در گروه مداخله اول مقدار 5 میلی لیتر دکستروز 20 درصد و 5 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط طب سوزنی تزریق می شود.و در گروه مداخله دوم مقدار 5 میلی لیتر دکستروز 20 درصد و 5 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط غیرطب سوزنی تزریق می شود.

  • General information

    2018-12-22, 1397/10/01
    2019-04-04, 1398/01/15
    2019-03-20, 1397/12/29
    2019-07-06, 1398/04/15

  • Intervention groups

    #1
    Intervention group: In the first intervention group, 8 ml of dextrose 5% and 2 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points.
    Intervention group: In the first intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points.
    گروه مداخله: در گروه مداخله اول مقدار 8 میلی لیتر دکستروز 5 درصد و 2 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط طب سوزنی تزریق می شود.
    گروه مداخله: در گروه مداخله اول مقدار 5 میلی لیتر دکستروز 20 درصد و 5 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط طب سوزنی تزریق می شود.
    #2
    Intervention group: In the second intervention group, 8 ml of dextrose 5% and 2 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
    Intervention group: In the second intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
    گروه مداخله: در گروه مداخله دوم مقدار 8 میلی لیتر دکستروز 5 درصد و 2 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط غیر طب سوزنی تزریق می شود.
    گروه مداخله: در گروه مداخله دوم مقدار 5 میلی لیتر دکستروز 20 درصد و 5 میلی لیتر لیدو کایین 1 درصد، سه بار به فواصل یک هفته در نقاط غیر طب سوزنی تزریق می شود.

  • Person responsible for general inquiries


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arash barghi
    Full name of responsible person - Persian: آرش برقی
    Position - English: Resident of Anesthesiology
    Position - Persian: رزیدنت بیهوشی
    Latest degree: med_doctor
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
    Street address - Persian: خیابان پاسداران، دانشگاه علوم پزشکی کردستان
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 66177-13446
    Phone: +98 87 3366 4653
    Mobile: +98 914 454 9141
    Fax:
    Email: drarash1979@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arash Barghi
    Full name of responsible person - Persian: آرش برقی
    Position - English: Resident of Anesthesiology
    Position - Persian: رزیدنت بیهوشی
    Latest degree: med_doctor
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
    Street address - Persian: خیابان پاسداران، دانشگاه علوم پزشکی کردستان
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 66177-13446
    Phone: +98 87 3366 4653
    Mobile: +98 914 454 9141
    Fax:
    Email: drarash1979@gmail.com
    Web page address:

  • Person responsible for updating data


    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arash barghi
    Full name of responsible person - Persian: آرش برقی
    Position - English: Resident of Anesthesiology
    Position - Persian: رزیدنت بیهوشی
    Latest degree: med_doctor
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
    Street address - Persian: خیابان پاسداران، دانشگاه علوم پزشکی کردستان
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 66177-13446
    Phone: +98 87 3366 4653
    Mobile: +98 914 454 9141
    Fax:
    Email: drarash1979@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Arash Barghi
    Full name of responsible person - Persian: آرش برقی
    Position - English: Resident of Anesthesiology
    Position - Persian: رزیدنت بیهوشی
    Latest degree: med_doctor
    Area of specialty/work: 24
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
    Street address - Persian: خیابان پاسداران، دانشگاه علوم پزشکی کردستان
    City - English: Sanandaj
    City - Persian: سنندج
    Province: Kurdistan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 66177-13446
    Phone: +98 87 3366 4653
    Mobile: +98 914 454 9141
    Fax:
    Email: drarash1979@gmail.com
    Web page address:

Protocol summary

Study aim
The purpose of this study is to compare the effect of Dextrose prolotherapy on the severity of knee pain in acupuncture points and non-acupuncture points in patients with knee osteoarthritis.
Design
Twenty-five patients with bilateral knee osteoarthritis were selected based on inclusion criteria. Different intervention will be performed on each knee. This study is double blinded, patients and those who study the outcomes of the study are unaware of the grouping and type of intervention.
Settings and conduct
The site of this study is a special clinic of Kurdistan University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: patients with knee osteoarthritis, Over 50 years of age, Less than 30 minutes of morning stiffness, Crepitus on active motion, Bony tenderness, Bony enlargement and no palpable warmth of synovium. Exclusion criteria include:Injection of steroid drugs in the last 2 months, Diabetes, Candidate for knee surgery, Previous treatment with dextrose injection, Knee Infections in the last three months, Knee inflammation, Daily opioid Use, History of arthritis, Arthritis after infection, Joint dysplasia, Congenital anomaly, Crystalopathy, Arthritis after injury, Malignancy, Vascular necrosis and bmi more than 30.
Intervention groups
In the first intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points and in the second intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
Main outcome variables
Knee pain severity;morning Stiffness; physical activity

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181114041657N1
Registration date: 2018-12-08, 1397/09/17
Registration timing: prospective

Last update: 2019-04-12, 1398/01/23
Update count: 5
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Arash Barghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3375 1307
Email address
drarash1979@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dextrose prolotherapy effects on the Pain of Knee Osteoarthritis: Comparison of Injection in Acupuncture Points versus Non-Acupuncture points
Public title
The effect of injection of dextrose solution on the severity of knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with knee osteoarthritis Over 50 years of age Less than 30 minutes of morning stiffness Crepitus on active motion Bony tenderness Bony enlargement No palpable warmth of synovium
Exclusion criteria:
Injection of steroid drugs in the last 2 months Diabetes Candidate for knee surgery Previous treatment with dextrose injection Knee Infections in the last three months Knee inflammation Daily opioid Use History of arthritis Arthritis after infection Joint dysplasia Congenital anomaly Crystalopathy Arthritis after injury Malignancy Vascular necrosis bmi>30
Age
From 50 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 25
More than 1 sample in each individual
Number of samples in each individual: 25
Patients are enrolled in the study, with both knees suffering from osteoarthritis. Different interventions are performed on each knee.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were selected using randomized blocking method and entered the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and collaborators who evaluate the outcomes of the study are blind to the study
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Approval date
2018-09-05, 1397/06/14
Ethics committee reference number
IR.MUK.REC.1397.141

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
Knee pain severity
Timepoint
Before the intervention, one month and two months after the last injection
Method of measurement
Using the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

2

Description
Morning Stiffness
Timepoint
Before the intervention, one month and two months after the last injection
Method of measurement
Using the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

3

Description
Physical activity
Timepoint
Before the intervention, one month and two months after the last injection
Method of measurement
Using the Western Ontario & McMaster Universities Osteoarthritis Index (WOMAC)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In the first intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at acupuncture points.
Category
Treatment - Drugs

2

Description
Intervention group: In the second intervention group, 5 ml of dextrose 20% and 5 ml of lidocaine 1% were injected three times at intervals of one week at non-acupuncture points.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Special Clinic of Kurdistan University of Medical Sciences
Full name of responsible person
Arash Barghi
Street address
Keshavarz St., Special Clinic of Kurdistan University of Medical Sciencses
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3328 5910
Email
drarash1979@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Ebrahim Ghaderi
Street address
Pasdaran St., Kurdistan University of Medical Sciences, sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
ebrahimghaderi@yahoo.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
Arash Barghi
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
drarash1979@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Shahrokh Ebnrasooli
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran St., Kurdistan University of Medical Sciences, sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4654
Email
drsheb@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Arash Barghi
Position
Resident of Anesthesiology
Latest degree
Medical doctor
Other areas of specialty/work
Anesthesiology
Street address
Pasdaran St., Kurdistan University of Medical Sciences, Sanandaj, Iran
City
Sanandaj
Province
Kurdistan
Postal code
66177-13446
Phone
+98 87 3366 4653
Email
drarash1979@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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