Evaluation the safety and effectiveness of Oxiplex Gel for reduction of pain and associated symptoms following single level lumbar discectomy
Design
This study is clinical trials and double blind. 60 patients candidate discectomy in valiasr hospital will inter in this study. We will divide the patients to 2 groups.
Settings and conduct
This study is clinical trials and double blind. 60 patients candidate discectomy in valiasr hospital will inter in this study. This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer not aware from grouping.The person evaluating the outcome is unaware of the grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:18-70 years, Lumbar disc disease
Exclusion criteria:Dissatisfaction
Intervention groups
Patients in the two groups randomly receive Oxiplex gel and the placebo receptor are placed right in the site before closure of the surgical site.
Main outcome variables
Disability- pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141209020258N106
Registration date:2019-04-23, 1398/02/03
Registration timing:registered_while_recruiting
Last update:2019-04-23, 1398/02/03
Update count:0
Registration date
2019-04-23, 1398/02/03
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-22, 1397/04/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the safety and effectiveness of Oxiplex Gel for reduction of pain and associated symptoms followingsingle level lumbar discectomy
Public title
Evaluation the safety and effectiveness of Oxiplex Gel for reduction of pain and associated symptoms followingsingle level lumbar discectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-70 years
Lumbar disc disease
Exclusion criteria:
Dissatisfaction
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B.
Randomization method: Simple randomization.
Random unit: Individual.
How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group.
Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences