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Comparison of low power laser and %1 hydrocortisone phonophoresis in the treatment of Knee osteoarthritis

Protocol summary

Summary
The knee is affected to osteoarthritis more than any other joints. Knee osteoarthritis causes pain, inflammation, quadriceps muscle atrophy and tightness of hamstring muscles. The aim of this study is to compare the effects of low power laser and %1 hydrocortisone phonophoresis on knee osteoartritis. This study is a double-blinded randomized clinical trial. 90 patients will refer to clinic of Fattemieh physiotherapy in Rafsanjan. They will be divided into three equal groups randomly. Three interventions of this study are low power laser (GaALAS,810nm, 100mv), %1 hydrocortisone phonophoresis (Ultrasound, ITO with %1 hydrocortisone ointment) and control (%1 hydrocortisone ointment). Intensity of pain, improvement of movement and reduction of inflammation are assessed during 1st, 5th and 10th sessions. Inclusion criteria are knee pain more than 3 months, osteophyte in knee joint, cripitation and reduction of joint space. Exclusion criteria are injection of corticosteroids during previous 1 month, fracture, dislocation and severe contracture of the knee joint.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107293220N2
Registration date: 2011-09-21, 1390/06/30
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-09-21, 1390/06/30
Registrant information
Name
Dadollah Shahimoridi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 39 1822 0040
Email address
d_shahimoridi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2011-07-06, 1390/04/15
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of low power laser and %1 hydrocortisone phonophoresis in the treatment of Knee osteoarthritis
Public title
Comparison of laser and phonophoresis in the treatment of Knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: Knee pain more than 3 months; knee osteophyte; sclerosis under cartilage; decrease of joint space; cripitation. Exclusion: Corticosteroide injection during previous 1 month; fracture and dislocation of Knee; severe osteoarthritis of Knee; pregnancy; severe joint stiffness.
Age
From 30 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Rafsanjan University of Medical Sciences
Street address
Emam Ali street
City
Rafsanjan
Postal code
7717893591
Approval date
2011-08-09, 1390/05/18
Ethics committee reference number
492/20/9

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis of other joints

Primary outcomes

1

Description
Pain intensity at rest
Timepoint
1st, 5th and 1oth sessions
Method of measurement
by Visual Analogue Scale (VAS)

2

Description
Inflammation around Knee joint
Timepoint
1st, 5th and 10th sessions
Method of measurement
By meter (cm)

3

Description
knee movements
Timepoint
1st, 5th and 10th sessions
Method of measurement
by Goniameter

Secondary outcomes

empty

Intervention groups

1

Description
First group will receive low power laser (GaALAS, 810 nm, 100mv) through 6J intensity and 5 minutes per session during 10 sessions on the knee joint (10 points)
Category
Rehabilitation

2

Description
Second group will receive %1 hydrocortisone phonophoresis by ultrasound (ITO, 7P, 1 MHZ, Japan) that is apply through 1/5 watt/cm2 intensity, continous wave and 5 minutes per session plus %1 hydrocortisone ointment during 10 sessions on around knee joint.
Category
Rehabilitation

3

Description
Third group (control): %1 hydrocortisone ointment and jell massage around knee. Ultrasound and then laser is on but intensity (dose) of both sets are zero and apply on knee joint.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Fattemieh physiotherapy clinic
Full name of responsible person
Dadollah Shahimoridi
Street address
Moalem street, alley 17
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazerinejad
Street address
Emam Ali street
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor (Acadmic member)
Other areas of specialty/work
Street address
Rafsanjan University of Medical Sciences, Emam Ali street
City
Rafsanjan
Postal code
Phone
+98 39 1523 2926
Fax
+98 39 1822 0097
Email
d_shahimoridi@rums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor (Acadmic member)
Other areas of specialty/work
Street address
Rafsanjan University of medical Sciences, Emam Ali street
City
Rafsanjan
Postal code
Phone
+98 39 1322 7928
Fax
+98 39 1822 0097
Email
d_shahimoridi@rums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical sciences
Full name of responsible person
Dadollah Shahimoridi
Position
Instructor (Acadmic member)
Other areas of specialty/work
Street address
Rafsanjan university of medical sciences, Emam Ali street
City
Rafsanjan
Postal code
Phone
+98 39 1322 7928
Fax
+98 39 1822 0097
Email
d_shahimoridi@rums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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