In this clinical trial 40 patients with sever knee osteoarthritis (grade 3&4 in Kalgren Lawrence scale) with age 45-75 will be recruited. The patients would assign randomly into two groups. In control group the treatment includes routine physiotherapy procedure and in the case group the treatment includes the routine physiotherapy procedure and knee joint distraction. the sustain distraction would be applied for 20 minutes to the level of perception of the patients. The treatments in both groups will be applied for 10 sessions, 5 sessions in each week. The assessments in both groups includes: ROM measurements, the edema measurement and VAS in each session and the KOOS questionnaire and 6 minute walking test before and after 10 treatment sessions and also 1 month after the end of treatment program.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111214738N2
Registration date:2011-12-28, 1390/10/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-28, 1390/10/07
Registrant information
Name
Khosro Khademi Kalantari
Name of organization / entity
Shahid Beheshti university of medical sciences, Faculty of Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 1411
Email address
k_khademi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2011-07-11, 1390/04/20
Expected recruitment end date
2012-02-18, 1390/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of knee joint distraction on the pain and function of patients with severe knee osteoarthritis
Public title
the effect of distraction in the treatment of knee arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female patients with sever knee OA (grade 3&4 Kalgren Lawrence scale) with the age range between 45 and 75.
Exclusion criteria :
malignancy in knee joint, infection around the knee joint, metabolic disease, endocrine disorders, vascular disease, injection of corticosteroid in the last 30 days, recent start of use of anti-inflammatory medicine (in the last 30 days), open injuries in the knee, secondary osteoarthritis, history of knee fractures, surgery in the knee joint in the last 6 months, pain duration less than 1 year, knee joint hypermobility and ligamentus laxity, sever edema around the knee joint and psychological disorders.
- Feel of pain in the chest, breathlessness, leg cramps, tumbling, sever perspiration and pale appearance and inability for finishing the 6 minute walking test.
-Absence in two successive treatment sessions.
Age
From 45 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
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
shahid Beheshti university of medical sciences
Street address
Daneshjoo Ave, Evin
City
Tehran
Postal code
Approval date
2011-10-30, 1390/08/08
Ethics committee reference number
108
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis NOS
Primary outcomes
1
Description
functional ability
Timepoint
in the 1st session, 10th session and 1 month after treatment ends
Method of measurement
by 6 minute walking test
2
Description
amount of pain
Timepoint
in 1st to 10th session and 1 month after treatment ends
Method of measurement
by VAS measurement
3
Description
amount of joint effusion
Timepoint
in 1st to 10th session and 1 month after treatment ends
Method of measurement
by measurement tape over and 10 cm above and bellow knee joint line
4
Description
knee joint mobility
Timepoint
in 1st to 10th session and 1 month after treatment ends
Method of measurement
by goniometer
Secondary outcomes
1
Description
quality of life
Timepoint
in 1st and 10th session and 1 month after treatment ends
Method of measurement
questionnaire
Intervention groups
1
Description
Control group : US, TENS, HOTPACK and EXERCISEUS is applied for 5 minutes to anterior, posterior knee in each session for ten sessions Conventional TENS is applies for 20 minutes in each session for 10 sessions2 hot packs are applied to anterior and posterior knee for 20 minutes in each session and for 10 sessions.2 exercises are trained to patients in 1st session
Category
Rehabilitation
2
Description
case group interventions: US, TENS, HOTPACK and EXERCISE + distractionUS is applied for 5 minutes to anterior, posterior knee in each session for ten sessionsConventional TENS is applies for 20 minutes in each session for 10 sessions2 hot packs are applied to anterior and posterior knee for 20 minutes in each session and for 10 sessions.2 exercises are trained to patients in 1st sessionSustain joint distraction is applied for 20 minutes in each session for 10 sessions
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar clinic
Full name of responsible person
Somaye Mahmoodi Aghdam
Street address
17 shahrivar clinic, pol station, damavand Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Bbeheshti University of Medical Sciences, Vice Chancellor for Research
Full name of responsible person
Dr. Rahmati Roodsari
Street address
Daneshjoo Ave, Evin
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Bbeheshti University of Medical Sciences, Vice Chancellor for Research
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
Faculty of rehabilitation, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Somaye Mahmoodi Aghdam
Position
MSc student
Other areas of specialty/work
Street address
Damavand Ave, Faculty of rehabilitation
City
Tehran
Postal code
Phone
+98 21 7756 1411
Fax
Email
smahmoodiaghdam@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Khosro Khademi Kalantari
Position
Associate Professor/PhD
Other areas of specialty/work
Street address
Damavand Ave, Faculty of Rehabilitation
City
Tehran
Postal code
Phone
+98 21 7756 1411
Fax
Email
k_khademi@sbmu.ac.irkhosro_khademi@yahoo.co.uk
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Rehabilitation, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Khosro Khademi Kalantari
Position
PhD
Other areas of specialty/work
Street address
Damavand Ave
City
Tehran
Postal code
Phone
+98 21 7756 1411
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)