The Comparison of High intensity and Low intensity "High TENS" Effect on Pain relief and Functional activity Improvement in Patients with Knee Osteoarthritis
The comparison of high intensity and low intensity "High TENS" effect on pain relief and functional activity improvement in patients with knee osteoarthritis
Design
36 patients were divided randomly in 2 groups. Therapeutic protocol done on both groups was the same. Patients were under physiotherapy for 10 sessions, 3 times a week.
Settings and conduct
Patients were treated in physiotherapy clinic of Semnan University of medicine. Therapeutic protocol for patients includes applying electrical flow of high tens, ultrasound waves and heating modality. Also a practicing program was being prescribed for the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 50;
Osteoarthritis of the knee joint diagnosed by Orthopedist or Rheumatologist;
Feeling pain in knee in most days of the late month;
Morning stiffness in knee joint for less than 30 minutes;
Exclusion criteria:
Other connective tissue and rheumatism diseases that can affect the knee;
Acute neurological disorders or mental disorders;
Injection of steroid inside the knee in the last 3 months;
Having heart or other electrical implants;
Having physiotherapy programs in the last 3 months.
Intervention groups
Both groups of attended patients in study, received high tens interference; in one with high intensity, in the other with low intensity.
Main outcome variables
Measuring the pain in the patient’s knee will be conducted according to VAS standard and also evaluation of patient’s functional activity levels according to WOMAC questionnaire.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190108042292N1
Registration date:2019-02-14, 1397/11/25
Registration timing:prospective
Last update:2019-02-14, 1397/11/25
Update count:0
Registration date
2019-02-14, 1397/11/25
Registrant information
Name
Cyrus Taghizadeh Delkhosh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
cyrustaghizadeh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-04, 1398/01/15
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of High intensity and Low intensity "High TENS" Effect on Pain relief and Functional activity Improvement in Patients with Knee Osteoarthritis
Public title
The Effect of High TENS Intensity on Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 50
Osteoarthritis of the knee joint diagnosed by Orthopedist or Rheumatologist
Feeling pain in knee in most days of the last month
Morning stiffness in knee joint for less than 30 minutes
Exclusion criteria:
Other connective tissue and rheumatism diseases that can affect the knee
Acute neurological disorders or mental disorders
Injection of steroid inside the knee in the last 3 months
Operation in knee joint
Having heart or other electrical implants
Having physiotherapic programs in the last 3 months
Age
From 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be divided in two groups with same numbers by simple random sampling. Each patient will be placed in a group by flipping a coin, so that if one of the groups was filled sooner, other patients will be taking place in the other group
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 Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Approval date
2018-03-14, 1396/12/23
Ethics committee reference number
IR.SEMUMS.REC.1396.265
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
Pain Intensity in VAS
Timepoint
First Session, Fifth Session, Tenth Session
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 10 sessions of physiotherapy (3 sessions per week) including the modalities below:-20 minutes of high TENS electrical flow, with high voltage, 100Hz frequency and 50µs pals duration on the knee -Ultrasound waves with 1MHz frequency and 0.8 watt per square centimeters insolation on inner and outer surface of the knee for 6 minutes -Applying heat by infrared bulbs on knee for 15 minutes-Stretching exercises for the muscles around the knee
Category
Rehabilitation
2
Description
Intervention group: 10 sessions of physiotherapy (3 sessions per week) including the modalities below:-20 minutes of high TENS electrical flow, with low voltage, 100Hz frequency and 50µs pals duration on the knee -Ultrasound waves with 1MHz frequency and 0.8 watt per square centimeters insolation on inner and outer surface of the knee for 6 minutes -Applying heat by infrared bulbs on knee for 15 minutes -Stretching exercises for the muscles around the knee
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebn Sina Rehabilitation Clinic
Full name of responsible person
Mohsen Pakdaman
Street address
Ebn Sina Clinic, 17 Shahrivar Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3332 2332
Email
mohsen.pkdmn.1376@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Parviz Kokhaie
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
p_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr Syrus Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Semnan University of Medical Sciences, Damghan Rd, Swmnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Email
cyrustaghizadeh@semums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Syrus Tghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Semnan University of Medical Sciences, Damghan Rd, Swmnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Email
cyrustaghizadeh@semums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Syrus Taghizadeh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
School of Rehabilitation, Semnan University of Medical Sciences, Damghan Rd, Swmnan
City
Semnan
Province
Semnan
Postal code
3519899951
Phone
+98 23 3365 4180
Email
cyrustaghizadeh@semums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD