Protocol summary

Study aim
Determining the effectiveness of three treatment methods: TENS, embedding acupuncture and drug therapy on the level of interleukin-6 and the pain of patients suffering from knee osteoarthritis.
Design
In this study, 60 patients with mild to moderate osteoarthritis of the knee (based on Kellogg's Scor2-3 and maximum VAS (visual analogue scale) of 5) were selected and after completing the informed consent form, they were numbered and divided into three groups of 20 people with the help of computer sorting software.
Settings and conduct
All three groups are treated and examined for 8 weeks: Embedding group A is done with cut-gut thread at different points and in a sterile way. Group B is subjected to TENS ligh frequency Group C is treated with 400 mg ibuprofen twice a day at home Each of the patients before the start of the treatment (beginning of the first week) and at the end of the intervention (the end of 8 weeks), 5 cc of venous blood from each patient was taken in three 1.5 cc tubes and transferred to the immunology laboratory while maintaining the cold chain and the level of IL-6 It will be reviewed
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1) Patients diagnosed with knee OA based on ACR 2) Age 50 to 65 years 3) Only one knee is involved 4) Have a VAS pain score of 4 or higher 5) Consent to participate in the study Non-entry criteria: 1) Conflict of 2 knees 1) The surgery has been detailed or is in the process of surgery 2) Knee arthroscopy has been performed in the last year 3) In the last six months, have any therapeutic intervention such as intra-articular injection or acupuncture
Intervention groups
group A, TENS group and group C receive ibuprofen.
Main outcome variables
Changes in the amount of pain; Inflammatory factors; The amount of physical activity; Quality of Life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20121228011912N7
Registration date: 2023-10-21, 1402/07/29
Registration timing: registered_while_recruiting

Last update: 2023-10-21, 1402/07/29
Update count: 0
Registration date
2023-10-21, 1402/07/29
Registrant information
Name
Hamidreza Bahrami Taghanaki
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1841 5666
Email address
bahramihr@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of three treatment methods, TENS, embedding, acupuncture and drug therapy on the level of interleukin 6 and knee osteoarthritis pain.
Public title
Comparison of the effectiveness , TENS, embedding, acupuncture and drug therapy .
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Treatment with the diagnosis of knee OA based on the criteria of ACR (American College of Rheumatology) Age 50 to 65 years Only one knee is involved Have a VAS pain score of 4 or higher (visual analogue scale) Be literate Consent to participate in the study
Exclusion criteria:
Conflict of 2 knees The surgery has been detailed or is in the process of surgery Knee arthroscopy has been performed in the last year In the last six months, have any therapeutic intervention such as intra-articular injection or acupuncture Having any kind of disease that causes malfunction of the immune system, such as: auto-immune, connective tissue diseases, diabetes, cancer, etc. Have a pacemaker
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
Using the online site https://www.sealedenvelope.com random allocation of three classes are placed in a.b.c groups. Randomization based on block randomization will be done with blocks of 4 and 6. The prepared blocks will be placed in envelopes. One of the envelopes will be randomly selected according to the order of patients' arrival, and patients will be assigned to groups based on the obtained blocks.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not 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
Vakilabad, Ferdowsi University campus.
City
Mashhad
Province
Razavi Khorasan
Postal code
9613885698
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.MUMS.REC.1402.101

Health conditions studied

1

Description of health condition studied
Osteoartritis knee
ICD-10 code
M 17. 9
ICD-10 code description
Gonarthrosis, unspecified

Primary outcomes

1

Description
Changes in pain
Timepoint
before intervention and weeks 8, 12 and 16
Method of measurement
on the VAS form

2

Description
Measurement of inflammatory factors: IL-6
Timepoint
before intervention and weeks 8, 12 and 16
Method of measurement
bleeding

Secondary outcomes

1

Description
Changes in the amount of physical activity
Timepoint
before intervention and weeks 8, 12 and 16
Method of measurement
based on the WOMAC form

2

Description
Change in quality of life
Timepoint
before intervention and weeks 8, 12 and 16
Method of measurement
questionnaire

Intervention groups

1

Description
Intervention group: Embedding with cut-gut thread in 6 points in a sterile way.The duration of treatment is 8 weeks.
Category
Treatment - Drugs

2

Description
Intervention group: 4 times a week and each time for 30 minutes, they are subjected to TENS ligh frequency by the med device with a frequency of 50-100 Hz by the physiotherapist.The duration of treatment is 8 weeks.
Category
Treatment - Devices

3

Description
Control group: They are treated with ibuprofen at a dose of 400 mg twice a day at home. The duration of treatment is 8 weeks.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Ortopedi
Full name of responsible person
Mohammad nematshahi
Street address
Nuclear martyrs boulevard of Vasi hospital
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613885697
Phone
+98 51 4422 4519
Email
9151737407mn@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majeed ghauor
Street address
Pardis ferdovssi
City
Mashhad
Province
Razavi Khorasan
Postal code
9613885967
Phone
+98 51 4422 4519
Email
bahramihr@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
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
Mashhad University of Medical Sciences
Full name of responsible person
hamid reza bahrami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
acupanccher
Street address
pardis ferdovssi
City
mashhad
Province
Razavi Khorasan
Postal code
9613885967
Phone
+98 51 4422 4519
Email
bahramihr@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamidreza Bahrami
Position
Professor,
Latest degree
Ph.D.
Other areas of specialty/work
Acupanccher
Street address
Pardis ferdovssi
City
Mashhad
Province
Razavi Khorasan
Postal code
9618385697
Phone
+98 51 4422 4519
Email
bahramihr@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
hamidreza bahrami
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Others
Street address
pardis ferdovssi
City
mashhad
Province
Razavi Khorasan
Postal code
9613883968
Phone
+98 51 4422 4519
Email
bahramihr@mums.ac.ir

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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