Protocol summary

Study aim
Lilium candidum oil effect on pain and disability of people with back pain
Design
Randomized, double blinded, clinical trial with parallel groups
Settings and conduct
The study will carried out at Imam reza hospital in Tehran. all groups receive medicines in the same container and they do not know about contents. After confirm non-specific back pain by physician which does not know the type of medication; randomly select a coded container for treatment. The questionnaires will be analyzed after receiving and converting into numbers, by someone who does not know the title of study.
Participants/Inclusion and exclusion criteria
All male and female 20 to 55 aged patients who they are willing to be cooperate and they have symptoms of back pain for more than 3 months and they have pain at the time of entering to the study will be included. Patients are excluded from project by reporting the following:previous history of cancer, history of chronic infection, history of trauma, urinary incontinence, history of corticosteroid use, progressive neurological history, fever without justification, weight loss without justification, pain in the spine, abdominal mass, rectum, pelvis, patricide or heel foot, test for direct and retrograde stretch marks, sign Progressive focal neurons. Patients who have been treated with other drugs or who are present in other research projects will be excluded from the study.
Intervention groups
In group 1, 120cc of lilium oil in the similar cans as the other groups used for four weeks with daily intake at bedtime in the pain spot. In group 2, 120cc of sesame oil in the similar cans as the other groups used for four weeks with daily intake at bedtime in the pain spot. In group 3, 120cc of diclofenac gel in the similar cans as the other groups used for four weeks with daily intake at bedtime in the pain spot.
Main outcome variables
Pain; Satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171010036691N2
Registration date: 2018-04-04, 1397/01/15
Registration timing: registered_while_recruiting

Last update: 2018-04-04, 1397/01/15
Update count: 0
Registration date
2018-04-04, 1397/01/15
Registrant information
Name
saeed Rasoulinezhad
Name of organization / entity
Aja medical university
Country
Iran (Islamic Republic of)
Phone
+98 21 4382 2051
Email address
saeed.rasoulinezhad@gmail.com
Recruitment status
Recruitment complete
Funding source
Aja university of medical science
Expected recruitment start date
2018-03-16, 1396/12/25
Expected recruitment end date
2018-04-14, 1397/01/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
ُStudy of Lilium candidum oil effect on pain and disability of people with back pain.
Public title
The effect of lily oil on pain and disability
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female Patients Patients aged 20 to 55 years Having symptoms of back pain for more than 3 months Having back ache at the time of entering to the study
Exclusion criteria:
Previous history of cancer History of chronic infection History of trauma Urinary incontinence History of corticosteroid usage Progressive neurological history Pain in the spine Abdominal, rectum and pelvis mass Patricide or heel foot Sign Progressive focal neurons Patients treated with other medications Patients that present in other research projects
Age
From 20 years old to 55 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method, individual randomization unit, randomization tool: random number table
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the use of medication is topically. All groups receive medicines in the same container and they do not know about contents. After confirm non-specific back pain by physician which does not know the type of medication; randomly select a coded container. The questionnaires are analyzed after receiving and converting into numbers, by someone who does not know the type of test.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Aja University Of Medical sciences
Street address
Shahid etemad zade Ave., Fatemi Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2017-10-02, 1396/07/10
Ethics committee reference number
IR.AJAUMS.REC.1396.65

Health conditions studied

1

Description of health condition studied
Back pain
ICD-10 code
M54.9
ICD-10 code description
Dorsalgia, unspecified

Primary outcomes

1

Description
Pain
Timepoint
At the Beginning Of The Study, The Second, Fourth And Eighth Weeks
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Satisfaction
Timepoint
At the Beginning Of The Study, The Second, Fourth And Eighth Weeks
Method of measurement
Qestionnaire

Intervention groups

1

Description
In group 1, 120cc of lilium oil in the similar cans as the other groups used for four weeks with daily intake at bedtime in the pain spot.
Category
Treatment - Drugs

2

Description
In group 2, 120cc of sesame oil in the similar cans as the other groups used for four weeks with daily intake at bedtime in the pain spot.
Category
Treatment - Drugs

3

Description
In group 3, 120cc of diclofenac gel in the similar cans as the other groups used for four weeks with daily intake at bedtime in the pain spot.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Nafiseh hosseini yekta
Street address
Etemadzadeh Ave., Fatemi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2051
Fax
+98 21 4382 2051
Email
nhyekta@yahoo.com
Web page address
http://imamreza.ajaums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Aja Medical University
Full name of responsible person
Armin zareiyan
Street address
Etemad zade Ave, Fatemi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 7765 4000
Email
a.zareian@ajaums.ac.ir
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, Aja Medical University
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
Artesh University of Medical Sciences
Full name of responsible person
Saeed rasoulinezhad
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Etemad zade Avr, Fatemi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2051
Fax
Email
saeed.rasoulinezhad@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Nafise Hosseiniyekta
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Etemad zadeh Ave, Fatemi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2051
Fax
Email
nhyekta@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
saeed rasoulinezhad
Position
Student
Latest degree
Specialist
Other areas of specialty/work
Traditional Medicine
Street address
Aja medical university, Etemad zadeh st., fatemi st.
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 4382 2051
Fax
Email
Saeed.rasoulinezhad@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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