Determination of the effect of the topical application of chamomile oil on rheumatoid arthritis knee pain in older women
Design
The present study is a non-randomized clinical trial with placebo group (semi-experimental) with parallel and one-way blind groups.
Settings and conduct
The two educational centers of Firouzgar and Hazrat-e Rasool, affiliated to Iran University of Medical Sciences, are considered as research environments. All elderly women (aged 60-75) with knee rheumatoid arthritis constitute the community of research.
Participants/Inclusion and exclusion criteria
Older women aged 60-75; having rheumatoid arthritis knee disease; not having concurrent (non-pharmacological) treatment for pain associated with rheumatoid arthritis; lack of cognitive impairment of the elderly by the AMT scale; absence of brittleness of the skin; having a high VAS score.
Intervention groups
The present study is a clinical trial (quasi-experimental) with two experimental and placebo groups. For the test group, oil is treated by a researcher and a sample. As much as 1.5 cc of chamomile oil is used twice a day and 6 hours apart, the first time is used by the researcher and secondly by the specimen. The same amount of liquid paraffin is used in the placebo group.
Main outcome variables
Regarding the multiplicity of drugs in the elderly and its complications, the use of complementary and alternative therapies for the improvement of pain in elderly patients with rheumatoid arthritis can be considered as valuable and it is possible to use this low cost and uncomplicated method in this group of elderly people.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180809040749N1
Registration date:2018-09-08, 1397/06/17
Registration timing:registered_while_recruiting
Last update:2018-09-08, 1397/06/17
Update count:0
Registration date
2018-09-08, 1397/06/17
Registrant information
Name
Mina Janalizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6663 9900
Email address
janalizadeh.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-18, 1397/05/27
Expected recruitment end date
2018-09-19, 1397/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the topical application of chamomile oil on rheumatoid arthritis knee pain in older women
Public title
The effect of the topical application of chamomile oil on pain
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Older women aged 60-75
Having a knee rheumatoid arthritis disease (according to medical records)
Having a VAS score above 3
Exclusion criteria:
Elderly cognitive disorder by AMT scale
Concomitant (non-pharmacological) treatment for pain associated with rheumatoid arthritis, such as massage therapy, acupuncture, kaeropraktika, yoga, ayurveda, traditional Chinese medicine
Skin brittleness due to diseases such as liver dysfunctions, etc. (based on records of medical records).
Age
From 60 years old to 75 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the test and placebo groups are selected from two separate hospitals, plus they receive oils in similar cans.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Unit 6, No 9, Salabat 8th Alley, Salabat Street, Velayat Ave, Farzan Town, Kalhor Blvd, Shahre ghods, Tehran
City
Tehran
Province
Tehran
Postal code
3751374827
Approval date
2017-06-12, 1396/03/22
Ethics committee reference number
IR.IUMS.REC.1396.9411580002.
Health conditions studied
1
Description of health condition studied
Rheumatoid Arthritis
ICD-10 code
M00-M99
ICD-10 code description
XIII Diseases of the musculoskeletal system and connective tissue
Primary outcomes
1
Description
Intensity of pain
Timepoint
Before intervention, immediately after intervention, 2 hours after intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the test group, oil is treated by a researcher and a sample. As soon as 1.5 cc of chamomile oil is applied twice a day for 6 hours, first by the researcher and secondly by the specimen and with the help of a dropper on the affected joint skin and around it, and slowly spread over until oil is on The skin will disappear so that the friction between the hands and skin of the patient is minimized to prevent heat generation. Non-fat chamomile oil has been produced by Shafa Kordestan Company under the supervision of Iran's Herbal Medicine Company under license No. 10335/41 of the Ministry of Health and Medical Education. Specified amount of oil is provided in small plastic cans that can be easily opened and closed.
Category
Treatment - Drugs
2
Description
Control group: In the placebo group, a similar amount of 1.5 cc of liquid sanitary paraffin is used.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul-e-Akram Medical Education Complex
Full name of responsible person
Hassan Amiri
Street address
Rasoul-e-Akram Medical Education Complex, Mansouri St, Niayesh St, Sattarkhan, Tehran