Determining the effect of topical use of frankincense oil on the pain intensity of patients with lumbar disc herniation referred to neurologists' office in Rafsanjan
Design
The study used accessible random sampling, grouping based on pain scores and gender. Group sizes were equalized with random minimization. Sampling continued until reaching the desired size. Sample size in each group was determined to be 27.67, considering potential losses.
Settings and conduct
The research population was all patients with lumbar disc herniation who referred to the office of neurologists in Rafsanjan city.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age between 20 and 60 years
2- Not suffering from nervous and mental diseases
3- Lumbar disc herniation based on neurologist and MRI diagnosis
..
Exclusion criteria:
1- Desire to quit studying
2- The need for surgery during the study
3- The need to inject coronet during the study
..
Intervention groups
In the intervention group, the patients were taught to use 10 drops of frankincense oil topically twice a day for 6 weeks. In the control group, olive oil was used as a placebo in the pain area. 30 ml droppers containing olive oil, in the same packaging, for local use, were provided to patients in the placebo group.
Main outcome variables
Evaluation of the effect of frankincense oil on pain, level of effectiveness of frankincense oil, tolerability and side effects, relationship with images of treatment exacerbation, suggestions for prescribing the best treatment, economic effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230919059473N1
Registration date:2023-10-09, 1402/07/17
Registration timing:prospective
Last update:2023-10-09, 1402/07/17
Update count:0
Registration date
2023-10-09, 1402/07/17
Registrant information
Name
Fatemeh Tavakoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3251 8458
Email address
fatemetavakoli1998@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-17, 1402/07/25
Expected recruitment end date
2024-01-15, 1402/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of topical Boswellia oil on pain severity in patients with lumbar disc herniation
Public title
effect of topical Boswellia oil on pain severity in patients with lumbar disc herniation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20 and 60 years
Not suffering from nervous and mental diseases
Lumbar disc herniation based on neurologist and MRI diagnosis
Lack of sensitivity to frankincense oil
Not having wounds and lesions at the place of use
Absence of diabetes mellitus
Absence of absolute rest
Absence of immune system problems in a person such as lupus erythematosus, multiple sclerosis (MS)
Not having a history of surgery in the back area
Absence of alcohol and drug addiction
Not using other complementary methods for pain relief
Not taking anticoagulants
Absence of pregnancy and breastfeeding
The amount of pain is more than 3 on the numerical-visual scale of VAS
Exclusion criteria:
Desire to quit studying
The need for surgery during the study
The need to inject coronet during the study
Not performing intervention for more than two consecutive days or one alternate week
Change or exacerbation of back pain
Incidence of sensitivity and allergy during the implementation of the study, which is characterized by symptoms such as skin rashes.
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The sampling method was accessible and randomly assigned to groups, classified based on important intervening variables, including pain score at the time of entering the study and gender. The number of samples in the groups was equal. In order to control the confounding factors and ensure the same number of samples in the groups, the random minimization method was used (table below). The first and second samples were randomly entered into the groups, and in the rest of the cases, attention was paid to the sum of the indicators in the groups. Sampling continued until the desired sample volume was reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients were completely unaware of which intervention group they were in. But they were aware of participating in the intervention.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Rafsanjan University of Medical Sciences
Street address
Rafsanjan University of Medical Sciences - Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2023-05-03, 1402/02/13
Ethics committee reference number
IR.RUMS.REC.1402.018
Health conditions studied
1
Description of health condition studied
Patients with lumbar disc herniation
ICD-10 code
M51.86
ICD-10 code description
Other intervertebral disc disorders, lumbar region
Primary outcomes
1
Description
Evaluation of the effect of frankincense oil on pain: This study can show whether the local consumption of frankincense oil makes a significant change in the pain intensity of lumbar disc herniation patients.
Timepoint
Immediately after the end of the intervention
Method of measurement
Visual Pain Scale Questionnaire (VAS)
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, 30 ml droppers containing 10% frankincense oil (prepared in the laboratory of the Faculty of Iranian Medicine, Kerman University of Medical Sciences) for topical use were provided to the patients. The patients were taught to use 10 drops (Razavi et al., 2019) of frankincense oil topically, twice a day for 6 weeks. It was explained to the patients that they should first massage the pain area a little and when they feel heat, put the oil on the massage area for a maximum of one minute. If the patient himself is not able to use the oil in the pain area, the second person should do it for him.
Category
Treatment - Other
2
Description
In the control group, olive oil was used as a placebo in the pain area. 30 ml droppers containing olive oil, in the same packaging, (prepared in the laboratory of the Faculty of Iranian Medicine, Kerman University of Medical Sciences) for topical use, were provided to patients in the placebo group. The method of use is similar to the conditions of using frankincense oil. It was emphasized to the patient to use the drops without interruption and at specified intervals. To reduce the possibility of forgetting, the patients were asked to use the oil at the same times and set a reminder on their mobile phones to remind them when to use the drops. The number of times and how the oil was consumed was tracked by the researcher once a week by phone and recorded in the relevant form.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rafsanjan Health Clinic
Full name of responsible person
Dr. Karmi
Street address
Pistachio Boulevard in front of Tare Bar Square - Fars Gulf Boulevard - Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
0000000000
Phone
+98 34 3434 2215
Email
not_have_an_email@email.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Vahid Mohammadi Shahrokhi
Street address
Research and Technology Vice-Chancellor - Building No. 3 - Central Organization - Imam Ali Blvd. - Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan University of Medical Sciences
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
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Tavakoli
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Central organization - Imam Ali Boulevard - Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
fatemetavakoli1998@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Shahin Heidari
Position
Department of Medical Surgical Nursing, School of Nursing and Midwifery, Rafsanjan University of Med
Latest degree
Ph.D.
Other areas of specialty/work
Geriatrics
Street address
Central organization - Imam Ali Boulevard - Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
kermanshah3252@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Fatemeh Tavakoli
Position
Nursing master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Central organization - Imam Ali Boulevard - Rafsanjan University of Medical Sciences
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
fatemetavakoli1998@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
In the analysis section, only output data and main results can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only for researchers working in academic and scientific institutions, or people who are also working in industry can apply to receive them.
Under which criteria data/document could be used
The data is available only to clarify the methodology of the present study
From where data/document is obtainable
Dr. Shahin Heydari - Rafsanjan University of Medical Sciences
What processes are involved for a request to access data/document
An email should be sent to Dr. Shahin Heydari, and as soon as the email is seen, and at her discretion, it will be sent within 10 working days.