Evaluating the effect of topical pregabalin 2% compared to with diclofenac 1% in patients with knee osteoarthritis: a double-blind randomized clinical trial
Determining the effect of topical pregabalin 2% in comparison with diclofenac 1% in patients with knee osteoarthritis
Design
Control-controlled clinical trial with parallel, double-blind, randomized, phase 3 groups on 93 patients used the Excel software rand function for randomization.
Settings and conduct
This project was carried out at Shahid Sadoughi Hospital in Yazd. Patients in three groups of 31 people use pregabalin 2% topical cream, diclofenac gel and placebo cream 3 times a day for 4 weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 45 to 75 years with knee osteoarthritis who have a pain score higher than 4. Exclusion criteria: other joint diseases
Allergy to NSAID or pregabalin
Severe osteoarthritis that requires surgery
Taking oral pregabalin or duloxetine
Taking narcotic painkillers
Intervention groups
In order to investigate the effectiveness of topical pregabalin in knee osteoarthritis, we will give a group of 31 people 2% topical pregabalin (manufactured in the Yazd Faculty of Pharmacy), a group of 31 people 1% topical diclofenac gel, and a group of 31 people a placebo cream (manufactured in the Yazd Pharmacy Faculty).
Main outcome variables
Severity of patient pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N12
Registration date:2023-10-14, 1402/07/22
Registration timing:retrospective
Last update:2023-10-14, 1402/07/22
Update count:0
Registration date
2023-10-14, 1402/07/22
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2023-04-20, 1402/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of topical pregabalin 2% compared to with diclofenac 1% in patients with knee osteoarthritis: a double-blind randomized clinical trial
Public title
Topical pregabalin in the treatment of osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 45 to 75 years
Pain score more than 4
Diagnosis of knee osteoarthritis based on the criteria of the American College of Rheumatology (ACR)
Exclusion criteria:
Other joint diseases
Hypersensitivity to NSAID or pregabalin
Severe osteoarthritis that requires surgery
Taking oral pregabalin or duloxetine
Taking narcotic painkillers
Age
From 45 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
93
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 93 patients were randomly divided into two treatment groups (A, B, C). In order to randomize, the block random allocation method was used, in which 10 blocks of 10 were considered. The letters A, B A and C. These permutations were generated with the help of Random software distribution software version 1. For this purpose, the list prepared by software No. 1 to 93 is in 10 blocks of ten in general to implement this I want the software output to the first eligible person number 1 and I want to select the last person number 93.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the patients, the clinical caregiver and the outcome assessor were not aware of the type of medication the patients received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Medicine- Shahid Sadoughi University of Medical Sciences
Street address
Shahid Sadoughi University of Medical Science, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.042
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
Improvement of osteoarthritis symptoms
Timepoint
The start of treatment and the fourth week
Method of measurement
Mac Master Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Patients with knee osteoarthritis use pregabalin 2% topical cream (made in Yazd Faculty of Pharmacy) topically 3 times a day and 1 gram each time for 4 weeks.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients with knee osteoarthritis use 1% diclofenac topical gel topically 3 times a day and 1 gram each time for 4 weeks.
Category
Treatment - Drugs
3
Description
Control group: Patients with knee osteoarthritis use placebo cream topically 3 times a day and 1 gram each time for 4 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi hospital
Full name of responsible person
Hossien Soleymani Salehabadi
Street address
Ibn Sina Street, Shahid Ghandi Boulevard, Safaieh, Yazd.
City
Yazd
Province
Yazd
Postal code
۸۹۱۵۸۸۷۸۵۷
Phone
+98 35 3822 4000
Email
dhsol33@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghouei
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173149
Phone
+98 35 3146 2150
Email
abargouei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnan Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz Heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Shahid Sadoughi University of Medical Sciences, Shohadaye Gomnam Blvd, Alem Sq
City
Yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.