This blind clinical trial aimed to determine the effect of capsicum ointment on chronic low back pain of patient with lumbar disc herniation. A total of 43 patients with low back pain were randomly assigned into Pepper or placebo group. The patients were instructed to apply the cream on the painful area thrice daily for 3 weeks. Pain and satisfaction of patients in both groups were measured and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107207073N1
Registration date:2011-08-15, 1390/05/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-15, 1390/05/24
Registrant information
Name
Somaye Talali
Name of organization / entity
School of Nursing and Midwifery, Jondi Shapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1377 7216
Email address
talali.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Jondi Shapur University of Medical Sciences
Expected recruitment start date
2011-04-04, 1390/01/15
Expected recruitment end date
2011-06-05, 1390/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of capsicum ointment on chronic low back pain of patient with lumbar disc herniation
Public title
Effect of capsicum ointment on chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Inter-vertebral disc disease, Lack of sensitivity to red pepper cream, No skin disease, no skin infection in the lumbar, Having a BMI less than 30, Willingness to participate in the intervention
Exclusion criteria: Unwillingness, candidate for Inter-vertebral disc surgery, pregnancy, no breast feeding
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
43
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Jondi Shapur University of Medical Sciences-School of Nursing and Midwifery
Street address
Jundishapur University of Medical Sciences, School of Nursing and Midwifery, Golestan Highway, Ahvaz
City
Ahvaz
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
ETH193
Health conditions studied
1
Description of health condition studied
Disc herniation
ICD-10 code
M51.1
ICD-10 code description
Lumbar and other intervertebral disc disorder
Primary outcomes
1
Description
pain
Timepoint
Baseline, the first week, second week and third week
Method of measurement
visual analog scale
Secondary outcomes
1
Description
Patient's satisfaction
Timepoint
The end of the third week
Method of measurement
Question of the patient
Intervention groups
1
Description
Intervention group: Red pepper cream %0/35-%0/65, made in Iran by Goldaroo Company, a thin layer on painful area, three times a day, for three weeks
Category
Treatment - Drugs
2
Description
Control group: A cream without the active ingredient Similar to the active drug, a thin layer on painful area, three times a day, for three weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Mahmood Pamorghy' Office
Full name of responsible person
Dr Mahmood Pamorghy
Street address
Aryan Complex, next to Blood Transfusion Organization, Nadery Crossroad, Ahvaz
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jondi Shapur University of Medical Sciences
Full name of responsible person
Dr. Mostafa Feghhi, Vice-Chancellor for Research
Street address
Jondi Shapur University of Medical Sciences, School of Nursing and Midwifery
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jondi Shapur 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
School of Nursing and Midwifery, Jondi Shapur University of Medical Sciences
Full name of responsible person
Somaye Talali
Position
Master of Science in Nursing
Other areas of specialty/work
Street address
Jondi Shapur University of Medical Sciences, School of Nursing and Midwifery, Golestan Highway ,Ahwaz
City
Ahvaz
Postal code
Phone
+98 61 1377 7216
Fax
Email
talali.s@ajums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Jondi Shapur University of Medical Sciences,
Full name of responsible person
Sedighe Faiazy
Position
Master of Science in Nursing and a faculty member
Other areas of specialty/work
Street address
Jondi Shapur University of Medical Sciences, School of Nursing and Midwifery, Golestan Highway ,Ahwaz
City
Ahvaz
Postal code
Phone
+98 61 1377 7216
Fax
Email
sadighe.fa@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)