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Comparison of the Therapeutic Effect of Transcutaneous Electrical Nerve Stimulation (TENS) with Transcranial Direct Current Stimulation (TDCS) in Patients with Knee Osteoarthritis

Protocol summary

Study aim
Determining the therapeutic effect of TENS in comparison with TDCS in patients with knee osteoarthritis
Design
This is single blinded clinical trial,with parallel groups ,with 40 patients suffering knee osteoarthritis , referring to the physical medicine and rehabilitation clinics of IRAN university of medical sciences in 1398 .The patients are divided into 2 parallel groups by block randomization using sealed envelopes, and follow up are considered for 4 and 12 weeks later.The inclusion criteria are age over 50 years and VAS ≥ 4 .Follow up is performed immediately ,4 and 12 weeks later.
Settings and conduct
Our study is performed on the patients with knee osteoarthritis, referring to physical medicine and rehabilitation clinics of Iran university medical sciences during 1398.Blinding is applied on the analyzer( Person who analyze data, do not know about 2 different methods of stimulation).The patients are divided into 2 groups by block randomization using sealed envelopes.
Participants/Inclusion and exclusion criteria
Knee Osteoarthritis based on American College of Rheumatology criteria in Grades 1, 2 and 3 according to Lowrence - Kellergan criteria People with idiopathic osteoarthritis and VAS ≥ 4 based on ACR criteria Knee pain for at least six months Over 50 years old
Intervention groups
Group A or control group in which patients treated with TENS, 6 sessions, 3 times a week, with knee-strengthening exercises, and Group B or intervention group, in which patients treated with TDCS, 6 sessions, 3 times a week ,with the mentioned exercises.
Main outcome variables
Pain intensity (VAS) and WOMAC score in both groups will be determined and then this criteria evaluated at immediately , one month and three months post treatment. the results will be compared before and after injection in each group and between the two groups.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190804044431N1
Registration date: 2019-10-18, 1398/07/26
Registration timing: registered_while_recruiting

Last update: 2019-10-18, 1398/07/26
Update count: 0
Registration date
2019-10-18, 1398/07/26
Registrant information
Name
Malihe karimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1201
Email address
karimi_malihe@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-12, 1398/07/20
Expected recruitment end date
2019-11-11, 1398/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Therapeutic Effect of Transcutaneous Electrical Nerve Stimulation (TENS) with Transcranial Direct Current Stimulation (TDCS) in Patients with Knee Osteoarthritis
Public title
Compare the effect of TDCS with TENS on osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee Osteoarthritis based on American College of Rheumatology criteria in Grades 1, 2 and 3 according to Lowrence - Kellergan criteria People with idiopathic osteoarthritis and VAS ≥ 4 based on ACR criteria No Radicular Low Back Pain The absence of any neurological and musculosceletal diseases that affect lower extremity function No diabetes No major depression disease No Drug abuse Knee pain for at least six months Over 50 years old No any acute or chronic infection No pregnancy or no pregnancy decision No inflammatory arthritis or secondary osteoarthritis No history of knee surgery No underlying disease of seizure No unstable conditions No metal objects near the electrode Patients not using Synchronous Pacemakers
Exclusion criteria:
The willingness of patients to exit from the study at any stage of the study
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization using sealed envelopes into 2 groups
Blinding (investigator's opinion)
Single blinded
Blinding description
Person who analyze data, do not know about the distribution of patients to the two treatment groups with Transcutaneous Electrical Nerve Stimulation and Transcranial Direct Current Stimulation.
Placebo
Not 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 Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway,Tehran Town
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2018-11-20, 1397/08/29
Ethics committee reference number
IR.IUMS.FMD.REC.1397.244

Health conditions studied

1

Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Bilateral primary osteoarthritis of knee

Primary outcomes

1

Description
The severity of knee pain
Timepoint
The severity of knee pain before, immediately, 1 and 3 months after study initiation
Method of measurement
Visual Analogue Scale

2

Description
The severity of symptoms and functional limitations
Timepoint
The severity of symptoms and functional limitations before, immediately, 1 and 3 months after study initiation
Method of measurement
By using WOMAC questionnaire

Secondary outcomes

1

Description
Side effects
Timepoint
4 and 12 weeks later
Method of measurement
Physical Examination

Intervention groups

1

Description
Intervention group: In this group, patients receive 6 sessions of TDCS treatment ( 2 mA intensity for 20 minutes and two 35cm2 electrodes that anode pole placed at the motor area and cathode pole positioned at the supraorbital area the opposite side of involved knee) 3 times a week combined with knee strengthening exercises (Close kinematic chain type twice a day) which are taught by a physical medicine and rehabilitation specialist
Category
Treatment - Devices

2

Description
Control group: In this group, patients receive 6 sessions of TENS treatment (100 Hz conventional TENS and 100 µs pulse width and the intensity of 10% below the patient's motor threshold, for 25 minutes) 3 times a week combined with knee strengthening exercises (Close kinematic chain type twice a day) which are taught by a physical medicine and rehabilitation specialist
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Firuzgar hospital
Full name of responsible person
Malihe karimi
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran Town
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
karimi_malihe@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevalian
Street address
Iran University of Medical Sciences, near Milad Tower, Hemmat Highway,Tehran Town
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
amotevalian@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
Malihe Karimi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran Town
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
karimi_malihe@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Simin Sajadi
Position
Associated Professor of Physical Medicine and Rehabilitation
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
Dr.Sajadi_pmr@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Malihe Karimi
Position
Resident of Physical Medicine and Rehabilitation
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran Town
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1229
Email
karimi_malihe@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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