Osteoarthritis is the most common chronic disorder that causes pain and disability associated with chronic and ultimately quality of life. Various medical and non medical methods are used to treat this disease. Nowadays the effect of vitamin E and vitamin B in the treatment of rheumatic diseases is discussed. In this study, the effectiveness of vitamins B and E, along with drug diclofenac in reducing pain in patients with knee osteoarthritis will be compared and analysed. In this double-blind clinical trial, 120 patients with knee osteoarthritis referring to training clinic of rheumatology and orthopedic of Shahrekord university of medical sciences are selected and randomly divided into 3 groups of (oral diclofenac plus oral vitamin B, oral diclofenac plus oral vitamin E and oral diclofenac plus oral placebo). Pain reduction of patients was analysed based on a visual analog scale (VAS) and the extent of morning stiffness and physical function based on the Western Ontario and McMaster standard questionnaire in 3 periods of admission : (check one), two weeks and three weeks after attending the assessment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408306480N7
Registration date:2014-10-03, 1393/07/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-03, 1393/07/11
Registrant information
Name
Mohammad Taghi Moradi
Name of organization / entity
Shahrekord University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1334 9509
Email address
mtmoradi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Shahrekord University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-11-10, 1393/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of vitamin B and E with diclofenac in reducing pain from osteoarthritis of the knee
Public title
Effectiveness of vitamin B and E in reducing pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria included : having 30 to 60 years of age, a diagnosis of primary osteoarthritis of the knee by an orthopedic doctor( based on history, clinical signs, physical examination, and radiographic diagnosis of the disease and diagnostic criteria related to this disease) . Exclusion criteria included : secondary osteoarthritis, infection or inflammatory disease of the knee joint, crystal-induced arthritis, tumors, intra-articular, knee ligament instability, previous fracture, intra-articular, knee surgery (arthroscopic or other in the past 12 months, an intra-articular injection, visual analog score less than 3 on the knee therapy in the treatment , severe concurrent disorders such as metabolic disorders and a history of certain diseases, including stroke in the past, uncontrolled hypertension, gastritis, infectious diseases, kidney failure, stomach ulcers, allergies to medications (vitamin B complex, vitamin E, vitamin B and E and the other contradictions receptor of vitamin E and B
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahrekord University of Medical Sciences
Street address
Vice Chancellor for research of Shahrekord University of Medical Sciences, Kashani Boulevard
City
Shahrekord
Postal code
Approval date
2013-12-15, 1392/09/24
Ethics committee reference number
11-8-92
Health conditions studied
1
Description of health condition studied
Osteoarthritis of the knee
ICD-10 code
M19.9
ICD-10 code description
Arthrosis, unspecified
Primary outcomes
1
Description
Morning stiffness
Timepoint
Intervention, two weeks and three weeks later
Method of measurement
Western Ontario MacMaster questionnaire
2
Description
pain
Timepoint
Intervention, two weeks and three weeks later
Method of measurement
Visual analog scale (VAS)
3
Description
Physical function
Timepoint
Intervention, two weeks and three weeks later
Method of measurement
Western Ontario MacMaster questionnaire
Secondary outcomes
1
Description
Consent to treatment
Timepoint
Three weeks after treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Oral diclofenac 50 mg , 2 times daily and vitamin B complex tablets 2 times a day
Category
Treatment - Drugs
2
Description
Oral diclofenac 50 mg 2 times a day, and vitamin E at a dose of 100 mg daily
Category
Treatment - Drugs
3
Description
Oral diclofenac 50 mg 2 times a day plus a placebo pill
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Educational clinic of rheumatology and orthopedics
Full name of responsible person
Doctor Morteza Dehghan
Street address
Imam Ali Subspecialty Clinic, Shariati boulevard
City
Shahrekord
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Mahmoud Mobasheri
Street address
Vice Chancellor for research, Shahrekord University of Medical Sciences, Kashani Bld
City
Shahrekord
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Dr Morteza Dehghan
Position
Specialist in Orthopedics
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani boulevard
City
Shahrekord
Postal code
Phone
+98 38 1333 0061
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Doctor Morteza Dehghan
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahrekord University of Medical Sciences, Kashani bolvard
City
Shahrekord
Postal code
Phone
+98 38 1333 0061
Fax
Email
dehghan_mortaza@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)