The survey of the effects of Manual and Electro- Acupuncture on the clinical manifestations and cytokines of immune system in patients with knee osteoarthritis and comparing it with sham acupuncture
Investigating the effect of manual and electrical acupuncture on clinical manifestations and quality of life, as well as immune system cytokines (IL4-IL10-TNFα-TGFβ-IFNγ) of patients with knee osteoarthritis
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, on 45 patients. For randomization, the table of random numbers from the Research randomizer site is used.
Settings and conduct
This study is conducted in the Rheumatology and Acupuncture Clinics of Imam Reza Hospital in Mashhad. After the introduction of the patients by the Rheumatologist and if they are eligible to enter and do not have the exclusion criteria, the patients are randomly divided into three groups. Allocation to groups will be through sealed envelopes and the persons for evaluations and analysts will be blind. The intervention will be conducted and the results will be extracted and analyzed.
Participants/Inclusion and exclusion criteria
Entry criteria: people diagnosed with osteoarthrosis by a rheumatologist; aged 45 to 65 years old; educated and having a pain score of 4 or higher on the VAS scale. Exclusion criteria: people who have knee surgery or arthroscopy or intra-knee injection or disease affecting the immune system; pacemaker; pregnancy; coagulation disorder; mental and cognitive disorders; high weight; joint effusion or severe fear of needles.
The survey of the effects of Manual and Electro- Acupuncture on the clinical manifestations and cytokines of immune system in patients with knee osteoarthritis and comparing it with sham acupuncture
Public title
Effectiveness of acupuncture in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with knee OA based on ACR criteria (ACR=American college of Rheumatology )( OA=Osteoarthritis )
Age should be between 45 and 65 years old
Only one knee is involved
Have a VAS pain score of four or more than four.(VAS=visual Analogue scale )
Be literate (writing and reading ability)
Exclusion criteria:
The surgery has been detailed or is in the process of surgery
Knee arthroscopy has been done during the last year
Have an intra-articular injection during the last six months
Any disease that disrupts the functioning of the immune system, such as inflammatory diseases, autoimmune diseases, connective tissue diseases, diabetes, cancer, etc.
Severe physical or cognitive illness of the participant that prevents the continuation of cooperation
Have a pacemaker
Pregnancy and breastfeeding
Have done acupuncture during the last six months
Coagulation disorders and the use of anticoagulants
Participation of the candidate in other clinical studies currently or during the last three months
Getting infected with covid during the study or ... in the last month or other infectious diseases during the struggle .
BMI more than 30 (BMI =body mass index )
Any forced changes in treatment regimen
Non-cooperation in applying intervention for more than two sessions
If the joint has liquid effusion (joint effusion)
Life-threatening medical and clinical events
Extreme fear of needles( Belonephebia)
Age
From 45 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Online version of the list of random numbers through Research randomizer
Blinding (investigator's opinion)
Triple blinded
Blinding description
Except for the acupuncturist, everyone, including the patients and health personnel, and the outcome assessor and data analyzer, are all blind .First, the randomizer numbers site is asked to divide and present 45 random numbers in three groups A, B and C. Group A is the manual intervention group, and group B is the electrical intervention group, and group C is the sham acupuncture group, and only the acupuncturist intervener is aware of this division .The numbers are placed in sealed envelopes, and after being accepted into the study, the patients refer to the allocator person and take an envelope and refer to the acupuncturist, and after registering the envelope and patient's details, the intervention is performed.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Qureshi Building, University Street, Mashhad Khorasan razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2023-01-30, 1401/11/10
Ethics committee reference number
IR.MUMS.REC.1401.371
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
Primary outcome 1) changes in the level of pain based on the VAS scale before the intervention and weeks 8, 12, and 16.--- . 2) Measuring the amount of inflammatory factors: including IFN-γ (gama interferon )secreted by T-helper1 cells, IL-4 ( interleukin-4 ) secreted by T-helper-2 cells. -- and TGF-β ( transforming growth factor beta ) and IL10 ( interleukin 10 )secreted by regulatory T cells (T REG CELLS), and TNFα (tumor necrosis factor alpha )secreted by M1 macrophages before and after treatment at the end of weeks 8 .
Timepoint
0-8-12-16 weeks
Method of measurement
Based on numerical scale of vas and based on laboratory numerical values
Secondary outcomes
1
Description
Changes in the level of physical activity
Timepoint
Before intervention and weeks 8, 12 and 16
Method of measurement
WOMAC Scale( Western Ontario McMaster Universities Osteoarthritis Index)
2
Description
Changes in morning stiffness
Timepoint
Before intervention and weeks 8, 12 and 16
Method of measurement
WOMAC Scale
3
Description
Changes in quality of life
Timepoint
Before intervention and weeks 8, 12 and 16
Method of measurement
Based on the quality of life form (QoL )
Intervention groups
1
Description
Intervention group 1: manual acupuncture group. In this group, acupuncture needles of specific size are used in predetermined and identical points and are stimulated by hand every ten minutes.
Category
Treatment - Devices
2
Description
Control group: Sham acupuncture is performed in the control group, which is actually false. Special Streitberger needles are used, which are placed on the skin. There is a tingling sensation, but the needle does not enter the skin, and the points are the same as in the intervention group.
Category
Treatment - Devices
3
Description
The intervention group 2: In this group, electro-acupuncture is used. The points and needles are the same as the previous group, only the stimulation is done through an electro-acupuncture device with specific voltage and current intensity.
Vice Chancellor of Research and Technology of the University of medical science . next to Howaize cinema.University of medical science of Mashhad. University .st
City
Mashad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
1
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
Mashhad University of Medical Sciences
Full name of responsible person
َAhmad Hamzeh
Position
phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
The east door of the Ferdowsi university - second floor of Faculty of Medicine -- Faculty of Iranian and complementary Medicin
City
Mashad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3855 2189
Email
hamzeha991@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Ali Khorsand vakilzadeh
Position
Associate professo
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
The east door of the Ferdowsi university - Faculty of Medicine - the second floor.faculty of iranian and complimentary medicine
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3855 2189
Email
khorsanda@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
َAhmad Hamzeh
Position
phd student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
The east door of the Ferdowsi university - second floor of Faculty of Medicine -- Faculty of Iranian and complementary Medicin
City
mashad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3855 2189
Email
hamzeha991@mums.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
Study specific information
When the data will become available and for how long
After completing the study and publication of results
To whom data/document is available
Project supervisors and persons who have permission from the University Research Council
Under which criteria data/document could be used
Project supervisors and persons who have permission from the University Research Council
From where data/document is obtainable
University Research Council
What processes are involved for a request to access data/document
Obtaining the opinion of the research council of the university and obtaining the favorable opinion of the researcher