Effect of self-management training versus no training on pain severity and drug usage in patients with knee osteoarthritis: a randomized clinical trial
To assess the effect of self-management training versus no training on pain severity and drug usage in patients with knee osteoarthritis
Design
A randomized clinical trial
Settings and conduct
The eligible patients with knee osteoarthritis who will refer to Imam Hossein Hospital in Malayer City during the study period will be enrolled into the trial
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 50 to 70 years; knee osteoarthritis; literate
Exclusion criteria: Using narcotic drugs; injection of analgesic in knee joint in the past 30 days; previous knee surgery; chronic diseases; a history of attending in workshop about osteoarthritis
Intervention groups
Intervention group: Routine treatment including analgesic and antiinflammatory drugs plus group training in 45-60 minutes sessions once a week for 3 weeks
Control group: Just routine treatment
Main outcome variables
(a) Assessing pain severity of knee 2 months after intervention via visual analog scale (VAS)
(b) Assessing analgesic drug usage 2 months after intervention via history taking
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N200
Registration date:2017-12-25, 1396/10/04
Registration timing:retrospective
Last update:2017-12-25, 1396/10/04
Update count:0
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-30, 1396/02/10
Expected recruitment end date
2017-11-01, 1396/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-management training versus no training on pain severity and drug usage in patients with knee osteoarthritis: a randomized clinical trial
Public title
Effect of self-management training versus no training on pain severity and drug usage in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 50 to 70 years
Knee osteoarthritis
Literate
Exclusion criteria:
Using narcotic drugs
Injection of analgesic in knee joint in the past 30 days
Previous knee surgery
Chronic diseases
A history of attending in workshop about osteoarthritis
Age
From 50 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
108
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through drawing of lots
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2017-02-28, 1395/12/10
Ethics committee reference number
IR.UMSHA.REC.1395.581
Health conditions studied
1
Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Assessing pain severity of knee
Timepoint
2 months after intervention
Method of measurement
Via visual analog scale (VAS)
2
Description
Assessing analgesic drug usage
Timepoint
2 months after intervention
Method of measurement
Via history taking
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Routine treatment including analgesic and antiinflammatory drugs plus group training in 45-60 minutes sessions once a week for 3 weeks
Category
Treatment - Other
2
Description
Control group: Just routine treatment including analgesic and antiinflammatory drugs
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Mostafa Jamshidi Zanganeh
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mostafa.jamshidi45@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mostafa Jamshidi Zanganeh
Position
MSc Student of Community Health
Latest degree
Master
Other areas of specialty/work
Health Promotion
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mostafa.jamshidi45@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Afsar Omidi
Position
Master of Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
afsar_omidi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
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