The objective of this randomized clinical trial is to evaluate the efficacy of exercise as a easy and non expensive protocol on knee pain and function and evaluation of compliance in Iranian patients. The patients aged more than 40 years who are suffering from knee pain more than 3 months, grade II or III of knee arthrosis, VAS more than 30 mm, BMI =18-30, and no contraindications of exercise therapy will be studied. The intervention group will receive 3 months strengthening and stretching exercises as well as routine medicine for knee pain and 10 sessions physical modality. The control group only will receive medicine and physical. Knee pain will be measured by using VAS and physical function will be measured by using KOOS and other physical function tests before and 1, 3, and 6 months after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904274409N1
Registration date:2010-08-23, 1389/06/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-08-23, 1389/06/01
Registrant information
Name
Parisa Nejati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 0361
Email address
parisanejati@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences
Expected recruitment start date
2010-08-23, 1389/06/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of strengthening and stretching exercises on knee pain and function of patients with arthrosis
Public title
The effect of exercise on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 40 years, knee pain for more than 3 months, grade II, III of arthrosis of kellegren-lawrence in radiography, VAS more than 30mm, BMI=18-30, patients who like to participate in exercise therapy
Exclusion criteria: presence of any contraindication (uncontrolled HTN, uncontrolled CHF, uncontrolled arrhythmia, uncontrolled metabolic diseases, severe valvular diseases)
Age
From 40 years old to 149 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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
Iran University of Medical Science
Street address
Between Sheikh fazlolah and Chamran Highway, Hemmat Highway
City
Tehran
Postal code
Approval date
2010-07-25, 1389/05/03
Ethics committee reference number
891/8
Health conditions studied
1
Description of health condition studied
Knee osteoarthritis
ICD-10 code
M15, M16,
ICD-10 code description
Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Pain
Timepoint
before intervention and 1 months and 3 months and 6 months after intervention
Method of measurement
Visual analog scale
2
Description
function
Timepoint
before intervention and 1 months and 3 months and 6 months after intervention
Method of measurement
KOOS questionnaire
Secondary outcomes
1
Description
physical function test
Timepoint
before intervention and 1 months and 3 months and 6 months after intervention
Method of measurement
5 times sit and stand of chair, 4 steps up and down stairs, 6 minutes walk test
Intervention groups
1
Description
strengthening and stretching exercises for quadriceps and hamstring and gastrocnemius muscles for 3 months . strengthening exercises one other day but stretching exercises everyday+ 10 sessions physical modality ( U/S,Heat , TENS) + Acetaminophen or NSAID in painful conditions for intervention group.
Category
Other
2
Description
10 sessions physical modality ( U/S,heat , TENS) + Acetaminophen or NSAID in painful conditions for control group.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Abbas Motavalian
Street address
Between Sheikh fazlolah and Chamran Highway, Hemmat Highway
City
Tehran
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 Science
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
Rasoul Akram hospital, Iran University of Medical Science,
Full name of responsible person
Dr. Parisa Nejati
Position
Sports medicine specialisi, Assistant Professor
Other areas of specialty/work
Street address
Sports medicine department, Rasoul Akram hospital, Niayesh Avenue, Satarkhan street,
City
Tehran
Postal code
Phone
+98 66515001
Fax
Email
parisanejati@iums.ac.ir parisanejati@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasoul Akram hospital, Iran University of Medical Science,
Full name of responsible person
Dr. Parisa Nejati
Position
Sports Medicine Specialist, Assistant Professor
Other areas of specialty/work
Street address
Sports medicine department, Rasoul Akram hospital, Niayesh Avenue, Satarkhan street,
City
Tehran
Postal code
Phone
+98 66515001
Fax
Email
parisanejati@iums.ac.ir,parisanejati@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Science
Full name of responsible person
Dr. Parisa Nejati
Position
Assistant Professor of sports medicine
Other areas of specialty/work
Street address
Rasoul Akram hospital, Sports medicine department
City
Tehran
Postal code
Phone
Fax
Email
parisanejati@iums.ac.irpaisanejati@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)