This research is a clinical trial that will be done in order to analyze the analogous analgesic effects of rosemary ointment and placebo in patients with acute law back pain who will be hospitalized before surgery. Participants of the study will be whole patients with acute law back pain who come to the hospital. Sampling method includes patients who are not allergic to rosemary ointment and do not have any skin deficiency on their waist as well, twenty- four hours before the surgery.They also should be males and willing in order to participate in the study. The patients will be chosen randomly along with single blind method and then they will included in one of the experimental(48 people) and control(48) groups by chance respectively. In order to decrease the intervention factors the patients will be chosen homogeneously so that they will benefit all the cures evenly. At first the rate of the pain of the patients who are included in the experimental group will be measured by VAS and then they will be recorded. Next the rosemary ointment for the patients of this group is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total. In the control group the pain of the patients will be measured and recorded Simultaneously before intervention, then Vaseline (the placebo) is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total. At last, the rate of pain will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017060434328N1
Registration date:2017-09-14, 1396/06/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-14, 1396/06/23
Registrant information
Name
Ruhollah Mahdiun
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0320
Email address
r.mahdiun@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2017-08-28, 1396/06/06
Expected recruitment end date
2017-09-28, 1396/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical trial comparison effect of rosemary and placebo on decreasing pain of acute law back patients
Public title
The effect of Rosemary in decreasing of pain in patients with backache
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: patients who have acute backache and do not have any information about the effects of rosemary; become fully conscious and be able to analyze pain based on Visual Analog Scale(VAS) and do not have any skin deficiency in pain place as well; patients who are males. Exclusion criteria: patients who experience consciousness reduction during the research; disinclination of chosen patient about cooperation with the researcher; patient's allergy to rosemary ointment.
Age
No age limit
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences, across from Mellat park, after Pajohesh sq.
City
Hamedan
Postal code
6565165131
Approval date
2017-05-02, 1396/02/12
Ethics committee reference number
IR.UMSHA.REC.1396.85
Health conditions studied
1
Description of health condition studied
Back ache
ICD-10 code
M54.5 Low
ICD-10 code description
Acute low back pain diseases
Primary outcomes
1
Description
Low back pain patients
Timepoint
Before the intervention and after the intervention for 6 times at an interval of every half an hour
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Sampling method includes patients who are not allergic to rosemary ointment and do not have any skin deficiency on their waist as well, twenty- four hours before the surgery.They also should be males and willing in order to participate in the study. The patients will be chosen randomly along with single blind method and then they will included in the experimental group by chance respectively. In order to decrease the intervention factors the patients will be chosen homogeneously so that they will benefit all the cures evenly.At first the pain of the patients in the experimental group will be measured and recorded by VAS, then the rosemary ointment for the patients of this group is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total.
Category
Treatment - Drugs
2
Description
In the control group first the pain of the patients will be measured and recorded by VAS Simultaneously, then (Vaseline) the placebo is rubbed on their waist in the size of twenty centimeters to twenty centimeters with the thickness of one tenth in centimeter in a circular smooth massage for five minutes from center towards outside locally and then the rate of their pain will be measured and recorded every thirty minutes again for sixth times in total.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat technichal and super technichal training, treatment hospital