Evaluation of therapeutic effect of Electro-Acupressure stimulation in acupuncture points in reducing pain and stiffness and increasing knee joint function in patient with knee osteoarthritis: A randomized clinical trial
Determining the therapeutic effect of electrical stimulation and pressure in acupuncture points in patients with osteoarthritis of the knee referred to the physiotherapy clinic of Pasargad clinic in Shahroud in 2022 and 2023.
Design
A clinical trial with a control group, with three arm parallel groups, triple blind trial, randomized, on 126 patients. The randomizer.org instrument was used for randomization.
Settings and conduct
The intervention is performed in Pasargad physiotherapy clinic in Shahroud. During 10 sessions of treatment, depending on the group in which they are, patients receive simultaneous electrical and pressure stimulation with a TENS-Pen or only pressure stimulation. Stimulation is applied to eight acupuncture points around the knee for one minute at each point. In placebo patients, the tip of TENS-Pen touches the fake points on the skin of the knee without applying pressure or stimulation. Treatment is done daily, five days a week. In all three groups, patients' status is assessed based on WOMAC and KOOS questionnaires and VAS before the first intervention and two days after the last intervention and also in the third week after the last intervention. Only a rheumatologist and physiotherapist is aware of each patient's group. Patients, questionnaire completer and methodologist are not aware of this matter.
Participants/Inclusion and exclusion criteria
inclusion criteria: over 45 years who have suffered from knee osteoarthritis for at least three months. exclusion criteria: stimulation of acupuncture points and use of anticoagulants in the last month, the presence of wound and scratch in acupuncture points, knee surgery or joint injection, advanced neuropathy.
Intervention groups
1. Simultaneous electrical and pressure stimulation
2. Stimulation of pressure
3. Contact of the electrode tip of the device on the fake points (placebo)
Main outcome variables
knee joint pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211123053162N1
Registration date:2022-08-31, 1401/06/09
Registration timing:prospective
Last update:2022-08-31, 1401/06/09
Update count:0
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
Reza Maskani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
maskani.r@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-03, 1401/06/12
Expected recruitment end date
2023-09-03, 1402/06/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of therapeutic effect of Electro-Acupressure stimulation in acupuncture points in reducing pain and stiffness and increasing knee joint function in patient with knee osteoarthritis: A randomized clinical trial
Public title
Therapeutic effect of Electro-Acupressure stimulation in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 45 years old
Patients who have been suffering from osteoarthritis of the knee for at least three months (according to the diagnosis of a rheumatologist).
Exclusion criteria:
Patients who have had a history of acupuncture points stimulation for any purpose in the past month.
Patients who have wound, scratch or abnormality in acupuncture points.
Patients who have used anticoagulants in the past month and also patients who have had a history of coagulation diseases in the past month.
Patients with a history of knee joint surgery (knee replacement).
Patients who have advanced neuropathy (pain, burning, tingling in the toes or feet and extreme sensitivity to surface touch).
Patients who are drug abuser.
Patients who have had any injection into the knee joint in the past month.
Patients who had a knee arthroscopy (a type of knee surgery that diagnoses and treats a knee joint problem) for 30 days prior to the intervention.
Patients who have unbearable severe pain in the knee that prevents them from participating in the study.
Patients with pacemakers.
Patients with transplanted tissue.
Pregnant patients.
Age
From 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize the samples and assign them to three groups, since the sample size in each group is 42 people, the string of random numbers from 1 to 126, which are classified into three groups, was obtained through the Randomizer.org site and by The methodologist will receive and provide the researcher.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study is of the triple-blind trial, in such a way that the person completing the questionnaire and entering the data into the SPSS software is not aware of the intervention received by the patients. Also, the groups receiving the intervention and the control group are unaware of their placement in the group. For this purpose, in the control group, the electrode of the device touches the skin of the patient's knee in the areas outside the studied points, without any pressure and also without electric current. In this study, the methodologist is also unaware of the group of each patient in the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Shahroud University of Medical Sciences
Street address
Hafte Tir Square
City
shahroud
Province
Semnan
Postal code
3614773943
Approval date
2022-06-13, 1401/03/23
Ethics committee reference number
IR.SHMU.REC.1401.093
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
Timepoint
Before the first session, two days after the last session and three weeks after the last session
Method of measurement
WOMAC and KOOS questionnaire, VAS ruler
Secondary outcomes
1
Description
Knee joint stiffness
Timepoint
Before the first session, two days after the last session and three weeks after the last session
Method of measurement
WOMAC and KOOS questionnaire
2
Description
clinical manifestation of the knee joint
Timepoint
Before the first session, two days after the last session and three weeks after the last session
Method of measurement
WOMAC and KOOS questionnaire
3
Description
Ability to perform daily tasks
Timepoint
Before the first session, two days after the last session and three weeks after the last session
Method of measurement
WOMAC and KOOS questionnaire
4
Description
Physical activity
Timepoint
Before the first session, two days after the last session and three weeks after the last session
Method of measurement
KOOS questionnaire
5
Description
Quality of life
Timepoint
Before the first session, two days after the last session and three weeks after the last session
Method of measurement
KOOS questionnaire
Intervention groups
1
Description
intervention group (1): Simultaneous electrical and pressure stimulation. Patients receive both electrical pulse and pressure simultaneously at eight acupuncture points around the knee during 10 sessions of treatment with a TENS-Pen. Stimulation is performed in each point for one minute. Treatment is performed daily, five days a week for two week.
Category
Treatment - Devices
2
Description
Intervention group (2): acupressure stimulation. In 10 sessions of therapy, they only receive pressure at eight points of acupuncture around the knee with a TENS-Pen. Stimulation is performed in each point for one minute. Treatment is performed daily, five days a week for two week.
Category
Treatment - Devices
3
Description
Control group: placebo. In 10 sessions, the tip of the TENS-Pen electrode touch the fake points around the knee. Electrode contact is made in each point for one minute. This operation is performed daily, five days a week for two week.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital Specialty and subspecialty Polyclinic, Shahroud
Full name of responsible person
Fatemeh Toufan
Street address
Specialist and Subspecialty Polyclinic of Imam Hossein Hospital, Shafa Sq, 28 meter of Imam St, Shahroud, Semnan, Iran
City
Shahroud
Province
Semnan
Postal code
3616950001
Phone
+98 23 3234 2000
Email
maskany@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Hassan Emamian
Street address
Hafte Tir Square
City
shahroud
Province
Semnan
Postal code
3614773955
Phone
+98 23 3239 5054
Email
crdu@shmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mohammad Javad Hashemi
Position
General Physician Intern
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
mohammadjavad.hashemi027@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reza Maskani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 23 3239 5054
Email
maskani.r@shmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Reza Maskani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Physics
Street address
Hafte Tir Square
City
Shahroud
Province
Semnan
Postal code
3614773943
Phone
+98 21 3239 5054
Email
maskani.r@shmu.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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic data and results related to the main outcome
When the data will become available and for how long
If the report is published in open access journal, the access period starts 6 months after the article is published.
To whom data/document is available
For all researchers
Under which criteria data/document could be used
If necessary, contact correspond author and if there is a reasonable justification for use in scientific purposes
From where data/document is obtainable
Dr. Reza Maskani, Shahroud, 7thTir Square, Shahroud University of Medical Sciences; School of Nursing and Midwifery 02332395054 maskani.r@shmu.ac.ir
What processes are involved for a request to access data/document
By phone call or by email and registration of the request and stating the reason and purpose of the logical and approved up to two weeks