Objective؛ The aim of this study was to determine the effect of topical application of essential oils of ginger on pain of knee OA in older women. Design؛ A quasi-experimental clinical trial with a control group. Study population; elderly women with knee osteoarthritis, referring to the Rheumatology Clinic Hospital Prophet (PBUH) University of Medical Sciences. Sample size: 96 people. Main inclusion criteria; being older than 65 years of chronic diseases and cancer، history of eczema and skin allergies، no history of knee joint replacement surgery and intra-articular injection. the main criteria Exclusion: non-use of oil more than two days a week; except acetaminophen use of medicines during the study. Intervention methods؛ experimental group after the pre-test (completion of baseline characteristics and individual, McGill pain questionnaire and a scale to measure VAS) for one month and a half cc of ginger essential oils topically twice daily, morning and night before bed will. The control group did not receive any intervention and receive routine treatment recommended by your doctor, and the second and fourth weeks after the intervention of the questionnaire completed by the elderly and analysis of the will be
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016011726059N1
Registration date:2016-03-06, 1394/12/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-06, 1394/12/16
Registrant information
Name
ameneh pishghadam
Name of organization / entity
Iranian Univercity of Medical Scinces School of Nursing & Middwifery
Country
Iran (Islamic Republic of)
Phone
+98 77348023
Email address
pishghadam.a@tak.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-01-15, 1394/10/25
Expected recruitment end date
2016-03-15, 1394/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of topical application with aromatic ginger oil on pain of osteoarthritis among female older adult
Public title
The effect of ginger oil on pain in patients with knee osteoarthritis
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria؛ age over 65 years, the lack of chronic diseases and cancer, history of eczema and skin allergies, no history of knee joint replacement surgery and intra-articular injection
Main criteria Exclusion؛ non-use of oil more than two days a week, except acetaminophen use of medicines during the study
Age
From 65 years old to 100 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran,Tehran, Highway martyr Hemmat West, the intersection of Sheikh Fadlallah and Chamran, Iran University of Medical Sciences, the fifth floor of the headquarters building
City
Tehran
Postal code
Approval date
2015-11-22, 1394/09/01
Ethics committee reference number
IR.IUMS.REC.1394.9211580205
Health conditions studied
1
Description of health condition studied
Knee Oseoarthritis
ICD-10 code
M15-M19
ICD-10 code description
Arthrosis
Primary outcomes
1
Description
Pain
Timepoint
befor of intervention, 2 and 4 week for intervention
Method of measurement
VAS, Mac Gills Pain Qustionner
Secondary outcomes
empty
Intervention groups
1
Description
Control groups؛ the control group with no intervention and treatment is not routinely recommended by doctors receive. McGill pain questionnaire and VAS before and in the second and fourth weeks will be completed by the control group.
Category
Treatment - Other
2
Description
The intervention group؛ after the sample selection from among eligible elderly referred to the Rheumatology Clinic Hospital Prophet (PBUH), the individual questionnaire, McGill pain questionnaire and Visual Analogue Scale will be completed by elderly people, then how do intervention patients are taught individually. Ginger essential oils in the intervention group than half a cc twice daily, morning and night before bed on knees with, will be applied for four weeks, then in the second week and the fourth visit to the clinic completed questionnaires will in the intervening during the phone call, the oil will remind them. If you have pain, you can use one gram of acetaminophen maximum.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital Prophet (PBUH)
Full name of responsible person
Ameneh Pishghadam
Street address
Tehran, Two area, Satta Khan Street, worship, St. Mansouri, Hospital Prophet (PBUH)
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Doctor Syed Ali Javad Mousavi
Street address
Iran,Tehran, Highway martyr Hemmat West, the intersection of Sheikh Fadlallah and Chamran, Iran University of Medical Sciences, the fifth floor of the headquarters building
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Nursing,Iran University of Medical Sciences
Full name of responsible person
Ameneh Pishghadam
Position
Master, student
Other areas of specialty/work
Street address
Tehran, Vanak Square, St. Martyr Yassami, School of Nursing and Midwifery, Iran University of Medical Sciences