Protocol summary

Study aim
In this study, we aim to compare the efficacy of Gabapentine compared to duloxetine in pain reduction and improvement of quality of life in patients with knee osteoarthritis.
Design
In this research, 150 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 gabapentine, duloxetine and acetaminophen groups and each patient will be given a specific code.
Settings and conduct
After patients selection, they will be randomly allocated to mgabapentine, duloxetine and acetaminophen groups. Patients in both groups will be treated for 3 months and will be evaluated before intervention and 1 and 3 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 dulexetine group, treatment will began with 30 mg daily and will increase to 60 mg daily. In Gabapentine group, treatment will began with 300 mg daily and will increase to 600 mg daily. The third group will receive acetaminophen 1000 mg daily which could be increased to 2000 mg daily.
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 1 and 3 months after intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170716035126N2
Registration date: 2018-02-17, 1396/11/28
Registration timing: prospective

Last update: 2018-02-17, 1396/11/28
Update count: 0
Registration date
2018-02-17, 1396/11/28
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
Expected recruitment start date
2018-03-06, 1396/12/15
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 duloxetine and gabapentin in pain reduction in patients with knee osteoarthritis
Public title
Evaluating the efficacy of duloxetine and gabapentin in pain reduction in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
idiopathic knee osteoarthritis 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
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomized into three 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
Not 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
56189-85991
Approval date
2017-12-31, 1396/10/10
Ethics committee reference number
IR.ARUMS.REC.1396.190.

Health conditions studied

1

Description of health condition studied
Knee osthoarthritis
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site

Primary outcomes

1

Description
Pain
Timepoint
Before intervention and one and three months after intervention
Method of measurement
Using visual analogue scale (VAS)

Secondary outcomes

1

Description
Functional status
Timepoint
Before intervention and one and three 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 one and three months after intervention
Method of measurement
Using SF-12 quality of life questionnaire

Intervention groups

1

Description
Intervention group: In Duloxetine group, patients will be treated with 30 mg daily which will be increased to 60 mg daily.
Category
Treatment - Drugs

2

Description
Intervention group: In gabapentine group, treatment will began with 300 mg daily and will be increased to 600 mg daily.
Category
Treatment - Drugs

3

Description
Control group: Patients will be treated with 1000 mg acetaminophen which will be increased to 2000 mg daily.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil Imam Khomeini Hospital
Full name of responsible person
Hamed Mohebi
Street address
Imam Khomeini Hospital, Ataei Ave.,
City
Ardabil
Province
Ardabil
Postal code
56189-85991
Phone
+98 45 3352 2083
Email
dr.hmohebbi93@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
56189-85991
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
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
Email
afshin.habibzadeh@gmail.com

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
Email
afsanehenteshary@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Hamed Mohebi
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
Email
dr.hmohebbi93@gmail.com

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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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