To evaluate the effect of topical tramadol on osteoarthritis pain relief, this randomized, double blind, placebo control clinical trial is designed. To this purpose, tramadol powder prepared and 5% cream in eucerin base is made. Sixty number of patients referred to rheumatology clinic were selected and randomized into two 30 persons group to receive one of interventions. All patients with moderate to severe osteoarthritis pain based on Visual analog scale, enrolled in the study and patients with hypersensitivity to tramadol, history of seizures or using anticonvulsant medicines were excluded. In addition to conventional oral treatment of diclofenac tablets, patients received tramadol or placebo cream twice a day for a month. At the end of the intervention, the grade of pain reevaluated and recorded in the questionnaire. Patients are allowed to stop the treatment anytime and whenever they cannot tolerate the side effects.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609143014N14
Registration date:2016-12-22, 1395/10/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-12-22, 1395/10/02
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Mazandaran University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-09-21, 1396/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of analgesic effects of topical tramadol 5% on Osteoarthritis pain: A randomized, placebo control, double blind clinical trial
Public title
Study of analgesic effects of topical tramadol on Osteoarthritis pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patient with moderate and severe osteoartritis pain
Exclusion criteria: Patients with hypersensitivity reaction to tramadol; Patient with history of seizure; Patients taking oral anticonvulsant drug
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization is done using random number table.
We give a code number to each patient that shows the group each patient is allocated to. The list of patients and their code numbers is kept secret until the end of the trial. In this way neither the patient nor the researchers know whether it is drug or placebo.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University Medical Sciences
Street address
Moalem Sq.Vice chancellor of research
City
Sari
Postal code
Approval date
2016-09-20, 1395/06/30
Ethics committee reference number
IR.Mazums.Rec.95-2373
Health conditions studied
1
Description of health condition studied
Osteoartritis
ICD-10 code
M15, M16,
ICD-10 code description
Polyarthrosis, Coxarthrosis [arthrosis of hip], Gonarthrosis [arthrosis of knee], Arthrosis of first carpometacarpal joint, Other arthrosis
Primary outcomes
1
Description
Pain
Timepoint
Before intervention; One month after intervention
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Side effects
Timepoint
After intervention
Method of measurement
quality Questionnarie
Intervention groups
1
Description
Intervention: Tramadol 5% cream, twice daily for one month
Category
Treatment - Drugs
2
Description
Control: Cream without active ingredient, twice daily for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rhomatology Clinic of Baghbanian
Full name of responsible person
Dr Shahram Ala
Street address
Khazar Sq.
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Mazandaran University of Medical Sciences
Full name of responsible person
Dr Ahmadali Enayatifar
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 20 Khazar Abad Road
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Mazandaran 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
Mazandaran University of Medical Science, Faculty of Pharmacy
Full name of responsible person
Dr Shahram Ala
Position
Clinical pharmacy specialist, associated professor
Other areas of specialty/work
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 20 Khazar Abad Road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
sala@mazums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Science, Facualty of Pharmacy
Full name of responsible person
Dr Shahram Ala
Position
Clinical pharmacy specialist, associated professor
Other areas of specialty/work
Street address
Payambar azam University Complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 20 Khazar abad Road
City
Sari
Postal code
Phone
+98 11 3354 3082
Fax
Email
sala@mazums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Science, Faculty of Pharmacy
Full name of responsible person
Mahila Monajati
Position
Resident of clinical pharmacy
Other areas of specialty/work
Street address
Payambar azam University Complex, 20 km khazar abad Road
City
Sari
Postal code
Phone
+98 11 3354 3814
Fax
Email
mahilamonajati@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)