Comparison of the two techniques of acupuncture stainless steel and gold needle on pain and disability in patient with knee osteoarthritis
Design
Randomized , blind clinical trial with three arm parallel groups with 15 patients in each groups .
Settings and conduct
In patient with knee osteoarthritis we do acupuncture at five points in ten session in first group with stainless steel needle , in second group with gold needle and in third group with placebo needle . then we will evaluate the pain score and disability with the WOMAC questionnaire .
Participants/Inclusion and exclusion criteria
Inclusion criteria
symptomatic knee osteoarthritis according to American college of Rheumatology criteria.
patients with knee injection during the previous 6 month, neurologic or musculoskeletal diseases or history of knee surgery were excluded .
Intervention groups
In patient with knee osteoarthritis we do acupuncture at five point , SP 9, ST 34, ST 35 , ST 36, GB 34 , for 20 minute in ten session in first group with stainless steel needle , in second group with gold needle and in third group with placebo needle .
Main outcome variables
pain score and disability .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140907019073N3
Registration date:2020-02-13, 1398/11/24
Registration timing:retrospective
Last update:2020-02-13, 1398/11/24
Update count:0
Registration date
2020-02-13, 1398/11/24
Registrant information
Name
Ali Mazaherinezhad
Name of organization / entity
IUMS
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
mazaherinezhad.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-29, 1398/07/07
Expected recruitment end date
2020-01-27, 1398/11/07
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the two techniques of acupuncture stainless steel and gold needle on pain and disability in patient with knee osteoarthritis.
Public title
Effect of the acupuncture in treatment of knee osteoarthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient with symptomatic knee osteoarthritis
Exclusion criteria:
use of perednisolone more than 10 mg /d
history of knee surgery
have knee exercise therapy or physiotherapy in 3 month ago
injection in knee joint in 6 month ago
patient with any neuroskeletal disease
Age
From 40 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Patients who met the inclusion criteria will be randomly assigned to three groups with computer-assisted block randomization. Each block included 3 groups .
Blinding (investigator's opinion)
Single blinded
Blinding description
Patient and Data Safety and Monitoring Committee. we will use placebo needle that we patch it on the skin without insertion .
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of iran university of medical scirnces
Street address
Hemmat Highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613131
Approval date
2019-07-22, 1398/04/31
Ethics committee reference number
IR.IUMS.FMD.REC.1398.193
Health conditions studied
1
Description of health condition studied
pain and disability in patient with knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
pain
Timepoint
In the end of intervention - in the 4 weeks- in the 12 weeks
Method of measurement
Visual Analogue Scale score
2
Description
knee function
Timepoint
In the end of intervention - in the 4 weeks- in the 12 weeks
Method of measurement
Western Ontario and McMaster Universities Osteoarthritis Index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 1 Acupuncture with stainless steel needle for 20 minute at ST 35 , GB 34, ST 36, SP 9, ST 34 points in 10 session.
Category
Treatment - Other
2
Description
Intervention group: 2 Acupuncture with gold needle for 20 minute at ST 35 , GB 34, ST 36, SP 9, ST 34 points in 10 session.
Category
Treatment - Other
3
Description
Control group: attached the needle to the skin with foam pad without penetration of the skin for 20 minute at ST 35 , GB 34, ST 36, SP 9, ST 34 points in 10 session.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Ali mazaherinezhad
Street address
Niayesh Ave., Sattar khan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2446
Email
Mazaherinezhad.a @iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali mazaherinezhad
Street address
Niayesh Ave., Sattarkhan St. tehran
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2446
Email
Mazaherinezhad.a @iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Ali Mazaherinezhad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Niayesh Ave., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2446
Email
Mazaherinezhad.a@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali mazaherinezhad
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Niayesh Ave., Sattar Khan St
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2446
Email
Mazaheri.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elham mousavi
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Niayesh Ave., Sattarkhan St.
City
Tehran
Province
Tehran
Postal code
1458843337
Phone
+98 21 6435 2446
Email
mazaheri.a@iums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collection for the primary and secondary outcomes
When the data will become available and for how long
immediately after publication
To whom data/document is available
people working in academic institution
Under which criteria data/document could be used
the result of further analysis may not be presented to public without permission
From where data/document is obtainable
Mazaherinezhad.a@iums.ac.ir
What processes are involved for a request to access data/document
A reasonable request from an academic source will be responded within 10 working days