Determination of local effect of tarragon oil extract on pain intensity, dryness and physical function of knee joint in patients with chronic osteoarthritis
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 3 on 90 patients. To randomize the draw was done with 3 cards
Settings and conduct
Clinical trial with control group, with parallel groups, one-way blind (participant), randomized, phase 3 on 90 patients. To randomize the draw was done with 3 cards.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1. Confirmation of knee osteoarthritis by an orthopedic specialist
2. Written and informed consent of the person
3- Age 30-70 years
Exclusion criteria
History of allergic reaction to sweet almond oil or tarragon-derived products
2. Hospitalization
3. Reluctance to continue participating in the study
4. Travel and leave treatment
Intervention groups
Tarragon oil extract
Main outcome variables
Pain intensity; Dryness and physical function of the knee joint
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211203053264N1
Registration date:2021-12-11, 1400/09/20
Registration timing:prospective
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Soheila Abedpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3238 1400
Email address
shoaybmohammadi1371@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-18, 1400/09/27
Expected recruitment end date
2022-01-07, 1400/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Topical effect of tarragon oil extract on pain intensity, dryness and physical function of knee joint in patients with chronic osteoarthritis
Public title
Topical effect of tarragon oil extract on pain intensity, dryness and physical function of knee joint in patients with chronic osteoarthritis referred to Taleghani Gonbad Kavous Hospital in 1399
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of osteoarthritis of the knee by an orthopedic specialist
Pain score ≥ 4 at least in the last 3 months based on the VAS scale
People who are able to understand the description and complete the interview
Written and informed consent of the person
Age 30-70 years
No cancer, pregnancy and blood coagulation diseases such as hemophilia
No wound above the knee joint
No signs of acute infection at the knee joint
No serious diseases such as liver disease and kidney failure
No history of gastric ulcer disease, and skin lesions in the knee area
No surgery to replace the knee joint or inject intra-articular steroids 90 days before the study.
Do not suffer from abnormalities related to the lower limbs
Exclusion criteria:
1- Taking oral and topical steroids for 14 days, alcoholism and drug addiction
Patients with radiculopathy and neuropathy, patients with musculoskeletal diseases (including rheumatoid arthritis, septic arthritis, metabolic arthritis, gout and fibromyalgia)
History of allergic reaction to sweet almond oil or tarragon-derived productsUse more than 2 grams per day of acetaminophen or other analgesics such as injectable drugs or other drugs such as glucosamine and chondroitin sulfate.
Hospitalization
Not wanting to continue participating in the study
Travel and leave treatment
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients were randomly divided into three intervention groups (topical application of 3% tarragon oil extract), sweet almond oil group, and control group. For this purpose, a lottery was conducted with three cards. Treatment methods were marked with three ABC marks on cards and placed in a box. Then, at the time of referral, the participants with the inclusion criteria were asked to remove one card from the box, and the next person removed the remaining two cards and the third person removed the remaining card from the box, and as a result, the type of treatment for each participant was determined. .
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients were randomly divided into three intervention groups (topical application of 3% tarragon oil extract), sweet almond oil group, and control group. For this purpose, a lottery was conducted with three cards. Treatment methods were marked with three ABC marks on cards and placed in a box. Then, at the time of referral, the participants with the inclusion criteria were asked to remove one card from the box, and the next person removed the remaining two cards and the third person removed the remaining card from the box, and as a result, the type of treatment for each participant was determined. . The researcher then explains to the patients how to study and the details of the intervention, and explains the method of topical use of the oil to each of them. 3% tarragon oil extract with the basis of sweet almond oil and also sweet almond oil was prepared from Barij Essential Oil Company of Kashan.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Birjand School of Medical Sciences and Health Services
Street address
South Khorasan, Birjand, Ghaffari St., Central Organization of Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.BUMS.REC.1399.164
Health conditions studied
1
Description of health condition studied
Chronic osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Intensity of pain
Timepoint
One week and three weeks after the intervention
Method of measurement
WOMAC questionnaire and VAS questionnaire
2
Description
Joint dryness
Timepoint
One week and three weeks after the intervention
Method of measurement
WOMAC Questionnaire
3
Description
Joint physical function
Timepoint
WOMAC Questionnaire
Method of measurement
One week and three weeks after the intervention
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients were randomly divided into three intervention groups (topical application of 3% tarragon oil extract), sweet almond oil group, and control group. For this purpose, a lottery was conducted with three cards. Treatment methods were marked with three ABC marks on cards and placed in a box. Then, at the time of referral, the participants with the inclusion criteria were asked to remove one card from the box, and the next person removed the remaining two cards and the third person removed the remaining card from the box, and as a result, the type of treatment for each participant was determined. . The researcher then explains to the patients how to study and the details of the intervention, and explains the method of topical use of the oil to each of them. 3% tarragon oil extract with the basis of sweet almond oil and also sweet almond oil was prepared from Barij Essential Oil Company of Kashan. The concentration of tarragon oil extract was determined based on literature review. Tarragon oil and sweet almond oil are poured into similar containers of dark opacity. The researcher then gave each participant in the group a bottle containing 40.5 cc of 3% tarragon oil and a weekly schedule. The sweet almond oil group also received a similar bottle containing 40.5 cc of sweet almonds with a weekly schedule. The intervention group applied 1.5 cc of tarragon oil extract and the sweet almond oil group applied 1.5 cc of oil (using a similar syringe or dropper) to the affected knee three times a day, daily for three weeks. In each direction, apply the inside, outside, front and back of the affected knee so that the oil covers the entire skin of the area. The control group did not receive any topical oil during the intervention. Before use, patients of almond oil and intervention groups are asked to test these oils to ensure skin sensitivity on the inside of the forearm. The researcher's contact number was also provided to the participants to contact the researcher in case of any allergies or side effects. The study was conducted in a specific chapter. In addition, in order to remind the participants how and when to perform the intervention, he reminded the participants by phone that all the participants had similar conventional drugs, including NSAIDs, acetaminophen, etc., which were prescribed by an orthopedic specialist. During the study, patients are allowed to use acetaminophen tablets at a rate of less than 2 grams per day, and patients are asked to record their daily acetaminophen use and the number of tablets to be taken at the end of the first and fourth week visits. Was recorded by the researcher. Evaluation of research and information variables was collected using WOMAC questionnaire and visual scale of VAS pain in 4 time points. The first point is the time of collection before the intervention that the questionnaire is presented to the participants. The next time points for data collection were immediately, 1 week after the intervention and 3 weeks after the intervention, which was completed by the researcher's telephone calls with the participants.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani Hospital Gonbad Kavous Clinic
Full name of responsible person
Zahra Younesi
Street address
South Khorasan, Birjand, Ghaffari St., Birjand University of Medical Sciences - School of Nursing and Midwifery
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Fax
+98 56 3238 1400
Email
abedpur.512@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Zahra Younesi
Street address
South Khorasan, Birjand, Ghaffari St., Birjand University of Medical Sciences - School of Nursing and Midwifery
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Fax
Email
z-unesi@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Birjand University of Medical Sciences
Full name of responsible person
Soheila Abedpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
South Khorasan, Birjand, Ghaffari St., Birjand University of Medical Sciences - School of Nursing and Midwifery
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 17 3322 6053
Fax
+98 56 3238 1400
Email
abedpur.0512@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zahra Younesi
Position
استادیار
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
South Khorasan, Birjand, Ghaffari St., Birjand University of Medical Sciences - School of Nursing and Midwifery
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1400
Fax
+98 56 3238 1400
Email
z-unesi@bums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Soheila Abedpour
Position
Nurse
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
South Khorasan, Birjand, Ghaffari St., Birjand University of Medical Sciences - School of Nursing and Midwifery
City
birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 17 3322 6053
Fax
+98 56 3238 1400
Email
abedpur.0512@gmail.com
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