This is a Double-Blinded randomized clinical study to compare the effect of a topical formulation of linseed oil with Diclofenac gel in patients with clinical symptoms of knee osteoarthritis. 94 patients after taking signed informed consent, according to American College of Rheumatology classification criteria for osteoarthritis and Kellegren-Lawrence system of classification by the doctor, in the age range 35-70 years are accepted. They will allocate to two arms using block randomization. 100 acetaminophen 500 milligrams tablets also given to the patients to use for pain relief if needed. Drugs will be encoding and without the name.it will be prescribed three times a day for 4 weeks in intervention groups. Patients at the beginning and every 2 weeks from the beginning of the study will be evaluated by the KOOS questionnaire until the forth week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082011341N9
Registration date:2017-09-19, 1396/06/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-09-19, 1396/06/28
Registrant information
Name
Mohammad Hashem Hashempur
Name of organization / entity
Fasa University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1233 8476
Email address
hashempurm@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Fasa University of Medical Sciences
Expected recruitment start date
2017-10-02, 1396/07/10
Expected recruitment end date
2018-03-01, 1396/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of a topical formulation of linseed oil with Diclofenac gel in patients with mild to moderate knee osteoarthritis
Public title
The evaluation of effectiveness of a topical formulation of linseed oil in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: the age between 35-70 years;at least having pain in one knee for past 3 months;recognition of osteoarthritis by the doctor according to American college of rheumatology classification criteria; recognition of grade I to III osteoarthritis by the doctor according to Kellegren-Lawrence(K-L)grading scale;absence of any congenital abnormality in lower extremity;written informed consent for inclusion.
Exclusion Criteria: sensitivity and allergy to linseed or diclofenac gel or acetaminophen;skin disease in knee;patients with secondary osteoarthritis due to other bone joint disorders like rheumatoid arthritis, gout, infected arthritis, metabolic arthritis, traumatic arthritis; joint replacement; oral and topical use of corticostreoid in past 14 days;knee corticosteroid or hyaluronic acid injection in the past 90 days; other articular corticosteroid or hyaluronic acid injection in the past 1 month;topical or oral usage of painkillers in past 3 days;concomitant use of glucosamin or chondroitin sulfate;pregnancy and lactation; alcohol or drug addiction; disability to cooperate in filling the forms (cognitive or language disorder); patients with active peptic ulcer diseases and inflammatory bowl disease(IBD);BMI ≥ 35 kg/m^2;physical modality in knee joint in past 2 weeks like physical therapy,acupuncture and Transcutaneous Electrical Nerve Stimulator (TENS).
Age
From 35 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
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
Ethics Comimtte of Fasa University of Medical Sciences
Street address
Vice Chancellor of Research and Technology,Fasa University of Medical Sciences,Ebn-Sina square,Fasa
City
Fasa
Postal code
Approval date
2017-07-26, 1396/05/04
Ethics committee reference number
IR.FUMS.REC.1396215
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M-17
ICD-10 code description
Gonarthrosis
Primary outcomes
1
Description
Visual analogue scale
Timepoint
At the beginning of intervention,after2 weeks then after 4 weeks from the beginning of intervention
Method of measurement
Asking the patients
Secondary outcomes
1
Description
Function in daily living (ADL)
Timepoint
At the beginning of intervention,after 2 weeks then 4 weeks afterthe beginning of intervention
Method of measurement
KOOS questionnaire
2
Description
Other Symptoms
Timepoint
At the beginning of intervention,after 2 weeks then 4 weeks afterthe beginning of intervention
Method of measurement
KOOS questionnaire
3
Description
pain
Timepoint
At the beginning of intervention,after 2 weeks then 4 weeks afterthe beginning of intervention
Method of measurement
KOOS questionnaire
4
Description
Function in sport and recreation(Sport/Rec)
Timepoint
At the beginning of intervention,after 2 weeks then 4 weeks afterthe beginning of intervention
Method of measurement
KOOS questionnaire
5
Description
Knee related quality of life(QOL)
Timepoint
At the beginning of intervention,after 2 weeks then 4 weeks afterthe beginning of intervention
Method of measurement
KOOS questionnaire
Intervention groups
1
Description
linseed oil,three times a day on,topically on painful knee
Category
Treatment - Drugs
2
Description
Diclofenac gel 1%,three times a day,topically on painful knee
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamzeh clinic
Full name of responsible person
Dr.Shadan Shirazi Zadeh Mehraban
Street address
City
Fasa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Fasa University of Medical Sciences
Full name of responsible person
Dr.Mojtaba Farjam
Street address
Vice Chancellor of Research and Technology,Fasa University of Medical Sciences,Ebn-Sina square,Fasa
City
Fasa
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,Fasa 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
Fasa Universityof Medical Sciences
Full name of responsible person
Dr.Alireza Askari
Position
Professor of Orthopedics
Other areas of specialty/work
Street address
Chancellor Department Office ,Fasa university of Medical scinces,Ebn-Sina square,Fasa
City
Fasa
Postal code
7461686668
Phone
+98 71 5335 0994
Fax
Email
aaskari60@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Mohammad Hashem Hashempur
Position
Professor of Traditional Medicine
Other areas of specialty/work
Street address
Traditional Medicine Departmen Office,Fasa University of Medical Sciences, Ebn-Sina square,Fasa
City
Fasa
Postal code
7461686668
Phone
+98 71 5335 0996
Fax
Email
hashempur@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hashem Hashempur
Position
Professor of Traditional Medicine
Other areas of specialty/work
Street address
Traditional Medicine Department Office, Fasa University of Medical Sciences ,Ebn-Sina square, Fasa
City
Fasa
Postal code
Phone
Fax
Email
hashempur@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)