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 muscle. The aim of this study is comparing the effects of electroacupuncture and low level laser on knee osteoarthritis. This study is a double blind clinical trial because both of patient and assessor are not aware of kind of treatment methods but therapist is aware kind of treatment methods. Sixty patients will refer to clinic of Fattemieh physiotherapy in Rafsanjan. Assessor evaluates the patients based on inclusion criteria, then he divided them to random permuted blocks methods in 3 equal groups and refers to therapist. Three interventions of this study are electroacupuncture (acupuncture associated with electricity), low level laser (Gallium, Aluminum- Arsenide, 810 nm, 100mv) and Placebo. Intensity of pain, movement, inflammation and 6 minutes walking test of knee osteoarthritis assessed during 1st, 5th, 10th sessions and one month after end of treatment. Inclusion criteria are having 45-75 year, knee pain more than 3 months, ability of walking, osteophyte in knee, reduction of joint space, crepitation of knee movement, grade 2 and 3 osteoarthritis of the knee and primary osteoarthritis of the knee. Exclusion criteria are injection of corticosteroids during previous 1 month, fracture, dislocation and previous surgery of the knee, pregnancy, rheumatoid arthritis and sever knee osteoarthritis (grade 4).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606173220N7
Registration date: 2016-09-21, 1395/06/31
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-09-21, 1395/06/31
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
2016-06-05, 1395/03/16
Expected recruitment end date
2017-04-05, 1396/01/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of electroacupancture and low level laser in the treatment of the knee joint osteoarthritis
Public title
The effect of electroacupuncture and laser on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion: having 45-75 years, knee pain more than 3 months, ability of walking, osteophyte in knee, reduction of joint space, crepitation of knee movement, grade 2 and 3. osteoarthritis of the knee. Exclusion criteria are injection of corticosteroids during previous 1 month, fracture, dislocation and previous surgery of the knee, pregnancy, rheumatoid arthritis and sever knee osteoarthritis (grade 4).
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
None

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The ethics committee of Rafsanjan University of Medical sciences
Street address
Centeral Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Postal code
7717893591
Approval date
2016-07-20, 1395/04/30
Ethics committee reference number
IR.Rums.Rec.1395.61

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, 10th session and 1 month after end of treatment
Method of measurement
By Visual Analogue Scale (VAS)

2

Description
Inflamation around knee joints
Timepoint
1st, 5th, 10th session and 1 month after end of treatment
Method of measurement
By meter (cm)

3

Description
Knee movements
Timepoint
1st, 5th, 10th session and 1 month after end of treatment
Method of measurement
By goniameter

4

Description
6 minutes walking test
Timepoint
1st, 5th, 10th session and 1 month after end of treatment
Method of measurement
By chronometer

Secondary outcomes

empty

Intervention groups

1

Description
First group will receive electroacupuncture (needle is inserted to acupuncture points of knee osteoarthritis , then electrical stimulation through simulator set, connect to patients body, Ying Di, KWD 808, made in china, 3Hz and 20 minutes).
Category
Rehabilitation

2

Description
Second group will receive low level laser (Ga Al As, 810nm, 100mv) 6j intensity and 10 minutes per session during 10 session on 10 acupuncture points of the knee joints).
Category
Rehabilitation

3

Description
Third group (placebo): the sets of electroacupuncture and laser are turn on but no radiation or electricity don't receive on knee osteoarthritis.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Fattemieh Physiotherapy Clinic
Full name of responsible person
Dadollah Shahimoridi
Street address
Alley 17, Moalem street
City
Rafsanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical sciences
Full name of responsible person
Hamid Hekimi
Street address
Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
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 (Academic member)
Other areas of specialty/work
Street address
Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Postal code
7717893591
Phone
+98 34 3426 2926
Fax
+98 34 3428 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 (Academic member)
Other areas of specialty/work
Street address
Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Postal code
7717893591
Phone
+98 34 3435 5286
Fax
+98 34 3428 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 (Academic member)
Other areas of specialty/work
Street address
Educational Assistant, Central Organization of Rafsanjan University of Medical Sciences, Emam Ali Blvd
City
Rafsanjan
Postal code
7717893591
Phone
+98 34 3426 2926
Fax
+98 34 3428 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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