Comparison of effectiveness of an etiologic-based exercise and conventional strengthening exercises on knee loading, pain and functional activity in individuals with Knee osteoarthritis: A randomized clinical trials.
This study is designed to compare the effectiveness of a reduction knee adduction moment exercise (etiologic-based exercise) and conventional strengthening exercises on biomechanical and clinical measures in individuals with Knee osteoarthritis.
Thirty patients with knee osteoarthritis, who have been referred by a rheumatologist to Mowafaghian Research Center of Intelligent Neuro-Rehabilitation Technologies, allocate into strengthening training or etiologic-based exercise groups randomly. Inclusion criteria included having mild to moderate chronic osteoarthritis of tibiofemoral joint and 45-76 years old. Reporting other diseases and use of invasive treatments in the lower extremities consider as exclusion criteria.
After signing the consent form both groups receive an educational leaflet, continues ultrasound therapy, hot pack, TENS and exercises protocol. The treatment will be performed 3 times a week for 4 weeks. Strengthening training include flexion and extension exercise of knee joint with the quadriceps chair. The etiologic-based exercise includes medial thrust gait and maintaining goddess and warrior postures.
All measurements will be performed by a blind assessor to the groups of study before and after intervention and one month after intervention. The measurements include: pain by means of a visual analogue scale and the short WOMAC scale, functional activity by the 2 minute walking test and knee adduction moment by means the tree-dimensional motion analysis and two force plates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201702222793N4
Registration date:2017-06-27, 1396/04/06
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-06-27, 1396/04/06
Registrant information
Name
Shahla Zahednejad
Name of organization / entity
School Of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3102
Email address
snejad@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jundishapur University of Medical Sciences
Expected recruitment start date
2017-05-22, 1396/03/01
Expected recruitment end date
2017-12-22, 1396/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of an etiologic-based exercise and conventional strengthening exercises on knee loading, pain and functional activity in individuals with Knee osteoarthritis: A randomized clinical trials.
Public title
Comparison of an etiologic-based exercise and conventional strengthening exercises on knee loading in individuals with Knee osteoarthritis.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: having mild to moderate chronic osteoarthritis of unilaterally or bilaterally tibiofemoral joint according to the method of Kellgren and Lawrance; 45-76 years old; a history of symptoms more than a month; being able to walk without assistant devices; having the recent anterior and lateral x-ray image of knee.
Exclusion criteria: Reporting other diseases such as: diabetes, diseases of musculoskeletal, neuromuscular and uncontrolled diseases of cardiovascular, respiratory and hypertension; the use of injections or other invasive treatments (such as surgery) in the lower extremities during the last three months; having an artificial hip or knee joints; taking painkiller; history of trauma to knee joint during last week; performing regular professional exercise; extreme physical weakness.
Age
From 45 years old to 76 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization by sealed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Sciences Ethics Committee
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Postal code
Approval date
2017-06-17, 1396/03/27
Ethics committee reference number
IR.AJUMS.REC.1396..317
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Knee joint loading
Timepoint
pre and post treatment and 1 month after treatment
Method of measurement
assesment of knee aduction moment by 3D motion analysis and force plate
Secondary outcomes
1
Description
functional activity
Timepoint
pre and post intervention and one month after intervention
Method of measurement
using of 2 minute walking test
2
Description
pain
Timepoint
study pre and post intervention and one month after intervention
Method of measurement
using of visual analogue scale and the short WOMAC scale
Intervention groups
1
Description
intervention group: Patients will be treated for 4 weeks and 3 sessions per week by electrical stimulation, educational leaflet, continues ultrasoundtherapy, hot pack and strengthening training include flexion and extension exercise of knee joint.
Category
Treatment - Other
2
Description
intervention group: Patients will be treated for 4 weeks and 3 sessions per week by electrical stimulation, educational leaflet, continues ultrasoundtherapy, hot pack and etiologic-based exercise includes medial thrust gait and maintaining goddess and warrior postures.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Mowafaghian Research Centre of Intelligent Neuro-Rehabilitation Technologies
Full name of responsible person
Dr. Farahmand
Street address
No 11, Khark Street, Enghelab Street
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Zahednejad
Position
Faculty member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
dr.shzahed@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Zahednejad
Position
fuclty member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
dr.shzahed@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Zahednejad
Position
fuclty member
Other areas of specialty/work
Street address
Ahvaz Jundishapur University of Medical Sciences, Esfand Avenue, Golestan
City
Ahvaz
Postal code
Phone
+98 61 3161
Fax
Email
dr.shzahed@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)