Evaluating the efficacy of methotrexate in pain severity reduction and improvement of quality of life in patients with moderate to severe knee osteoarthritis
We aim to evaluate the efficacy of methotrexate in controlling pain and improving quality of life in patients with moderate to severe osteoarthritis.
Design
In this research, 100 patients with moderate to severe knee osteoarthritis with inclusion criteria and not having exclusion criteria referring to rheumatology clinics will be included. Patients will be randomly allocated to methotrexate and placebo groups and each patient will be given a specific code.
Settings and conduct
After patients selection, they will be randomly allocated to methotrexate or placebo groups. Patients in both groups will be treated for 6 months and will be evaluated before intervention and 3 and 6 months later for pain severity according to visual analogue scale (VAS), functional status according to WOMAC questionnaire and quality of life according to SF-12 questionnaire. Patients and the person evaluating the treatment outcome will be unaware of the allocated groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Knee osteoarthritis with effusion; age between 45-75 years; ability to walk; having pain score of >5 according to VAS and >48 according to WOMAC questionnaire;
Exclusion criteria: Other knee disorders; concomitant hip and ankle osteoarthritis; bursitis and perarticular disease; radicular pains; physiotherapy or intraarticular injection during the past 6 months; psychological disease; history of knee surgery; inflammatory joint disease; rheumatoid arthritis; fibromyalgia; active or recurrent pseudogoat; malignancy; systemic diseases including renal of hepatic failure, uncontrolled blood pressure, diabetes mellitus; asthma in need of corticosteroids; corticosteroid use in less than 5 weeks prior to study
Intervention groups
In both groups, glucosamine sulfate 1500 mg will be administered daily and in intervention group, methotrexate will be given 7.5 mg (3 pills) weekly and would increase to 15 mg. In placebo group, placebo will be given 3 pills weekly.
Main outcome variables
The main outcomes of the study are evaluating patients functional status using WOMAC (Western Ontario and McMaster Universities Osteoarthritis), pain severity using visual analogue scale and quality of life using SF-12 quality of life questionnaire which will be evaluated before intervention and 3 and 6 months after intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170716035126N1
Registration date:2017-12-22, 1396/10/01
Registration timing:registered_while_recruiting
Last update:2017-12-22, 1396/10/01
Update count:0
Registration date
2017-12-22, 1396/10/01
Registrant information
Name
Afshin Habibzadeh
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3352 2391
Email address
a.habibzade@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
none
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy of methotrexate in pain severity reduction and improvement of quality of life in patients with moderate to severe knee osteoarthritis
Public title
Evaluating the efficacy of methotrexate in pain severity reduction and improvement of quality of life in patients with moderate to severe knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria: Knee osteoarthritis with effusion; age between 45-75 years; ability to walk; having pain score of >5 according to VAS and >48 according to WOMAC questionnaire
Exclusion criteria:
Exclusion criteria: Other knee disorders; concomitant hip and ankle osteoarthritis; bursitis and perarticular disease; radicular pains; physiotherapy or intraarticular injection during the past 6 months; psychological disease; history of knee surgery; inflammatory joint disease; rheumatoid arthritis; fibromyalgia; active or recurrent pseudogoat; malignancy; systemic diseases including renal of hepatic failure, uncontrolled blood pressure, diabetes mellitus; asthma in need of corticosteroids; corticosteroid use in less than 5 weeks prior to study
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into two groups using random number blocks and using sealed envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the person evaluating the treatment outcome will be blinded to the allocated groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
Ardabil University of Medicine Sciences, Daneshgah St.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.ARUMS.REC.1396.150
Health conditions studied
1
Description of health condition studied
Knee osthoarthritis
ICD-10 code
M19.9
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
before intervention and three and six months after intervention
Method of measurement
using visual analogue scale (VAS)
Secondary outcomes
1
Description
functional status
Timepoint
before intervention and three and six months after intervention
Method of measurement
using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire
2
Description
quality of life
Timepoint
before intervention and three and six months after intervention
Method of measurement
using SF-12 quality of life questionnaire
Intervention groups
1
Description
Both groups will be administered glucoseamine sulfate 1500 mg daily and then in intervention group, methotrexate with the dose of 7.5 mg (3 pills) weekly will be administered and then increased to 15 mg weekly.
Category
Treatment - Drugs
2
Description
both groups will be administered glucoseamine sulfate 1500 mg daily and in placebo group, placebo will be administered 3 pills weekly.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ardabil Imam Khomeini Hospital
Full name of responsible person
Afshin Habibzadeh
Street address
Imam Khomeini Hospital, Ataei Ave.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Email
afshin.habibzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Masoud Entezari Asl
Street address
Ardabil University of Medical Science, Daneshgah St.,
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Phone
+98 45 3352 2083
Email
m.entezari@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arabil University of Medical Sciences
Full name of responsible person
Afshin Habibzadeh
Position
Internal medicine resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini hospital, Ataei Ave.,
City
Ardavbil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Fax
Email
afshin.habibzadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afsaneh Enteshari Moghaddam
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ataei ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Fax
Email
afsanehenteshary@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Afshin Habibzadeh
Position
Internal Medicine Resident
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Imam Khomeini Hospital, Ataei ave.,
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2391
Fax
Email
afshin.habibzadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available