Evaluation the effect of a topical product prepared from mustard seed oil in controlling pain and improving the performance of patients with knee osteoarthritis, a double-blind randomized controlled clinical trial
Determining the effectiveness of topical cream from mustard seed oil in controlling pain and improving the performance of patients with knee OA.
Design
The number of 30 patients will be divided into two groups of 15 people according to the randomization table, and the intervention group will receive medicine for 1 month and the control group will receive placebo. This study is a double-blind randomized controlled clinical trial.
Settings and conduct
The location of the study is the Pain Clinic of Imam Reza Clinic affiliated to Shiraz University of Medical Sciences. After examining the patient and confirming the conditions for entering the study and obtaining informed consent, the doctor provides the drug or placebo to the patient. The doctor and the patient are not informed about the type of cream (with or without medicine).
Participants/Inclusion and exclusion criteria
The study is conducted on patients referred to the pain clinic of Imam Reza infirmary.
The age range of patients is between 40 and 80 years.
With the initial complaint of "knee pain" which was confirmed as "osteoarthritis of the knee joint" in the radiological examination and imaging.
Patients with the following underlying diseases are excluded from the study:
diabetes
Connective tissue diseases
Peripheral vascular diseases
Alzheimer
All kinds of diseases and movement disorders of the lower limbs
Psychiatric diseases
Intervention groups
15 patients in the intervention group use mustard oil topical cream on their knees twice a day for 1 month. 15 patients in the control group use a topical cream twice a day containing all the components of the original cream except the active ingredient as a placebo for 1 month.
Main outcome variables
Knee pain, joint stiffness, patient performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220812055668N1
Registration date:2022-11-16, 1401/08/25
Registration timing:registered_while_recruiting
Last update:2022-11-16, 1401/08/25
Update count:0
Registration date
2022-11-16, 1401/08/25
Registrant information
Name
Kimiya Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3630 3337
Email address
kimia.jafari098@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-02, 1401/07/10
Expected recruitment end date
2023-03-30, 1402/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of a topical product prepared from mustard seed oil in controlling pain and improving the performance of patients with knee osteoarthritis, a double-blind randomized controlled clinical trial
Public title
The effect of a topical product prepared from mustard seed oil in patients with knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The study is conducted on patients referred to the pain clinic of Imam Reza (AS) Shiraz
With the initial complaint of "knee pain" which has been confirmed as "osteoarthritis of the knee joint" in radiological examination and imaging
The age range of patients is between 40 and 80 years
Patients with ASA class I, II are included in the study
The grade of knee abrasion should be grade II-III based on radiological imaging
Exclusion criteria:
Patients with the following underlying diseases are excluded from the study
diabetes
Connective tissue diseases
Peripheral vascular diseases
Alzheimer
All kinds of diseases and movement disorders of the lower limbs
Psychiatric diseases
Age
From 40 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 30 patients are randomly divided between two groups of 15 people in a double-blind clinical trial using the block randomization method .This study is a double blind randomized controlled clinical trial. Patients in both the control group and the drug group are entered based on a random number table. For the control group, a topical cream without medicine (cold cream) is used. The doctor and the patient are not informed about the type of cream (containing medicine or without medicine). Determining the sample size and randomization was done with a computer statistical program. The minimum sample size in each group is 15 people.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be conducted in a double-blind manner and only the evaluator will know the results and code of the drug or placebo group. Creams of drug and drug group are completely similar in appearance. The drug and placebo groups will be separated from each other by receiving the code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
University Research Ethics Committee, 7th Floor, Shiraz University of Medical Sciences, Central Building, Zand ST
City
Shiraz
Province
Fars
Postal code
713451978
Approval date
2022-07-17, 1401/04/26
Ethics committee reference number
IR.SUMS.REC.1401.255
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
knee pain
Timepoint
Before the intervention, 4 weeks and 12 weeks after starting to use the topical product of mustard seed oil
Method of measurement
Changes in scores of VAS and WOMAC questionnaires
2
Description
Joint dryness
Timepoint
Before the intervention, 4 weeks and 12 weeks after starting to use the topical product of mustard seed oil
Method of measurement
Changes in WOMAC questionnaire scores
3
Description
Patient functionality
Timepoint
Before the intervention, 4 weeks and 12 weeks after starting to use the topical product of mustard seed oil
Method of measurement
Changes in WOMAC questionnaire scores
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients who underwent intra-articular injection of Hyaluronic Acid (Hyaluronic Acid Sodium salt 2%) called vijoint one (in the form of a ready-to-inject 60mg/3ml sodium hyaluronate cross-link syringe, manufactured by Apharm, Italy) were included in the study. One week after intra-articular injection of hyaluronic acid, topical medicine (cream prepared from mustard oil) is started to be used for patients. The studied topical product is used twice a day for 1 month. Patients are evaluated at intervals of 4 weeks and 3 months. During the period of examination of the patients, the painkillers are completely identical, including acetaminophen 500 mg, 2 times a day at the time of pain. Patients whose pain does not improve with this amount of medicine, use diclofenac 100 mg tablets.
Category
Treatment - Drugs
2
Description
Control group: In this group, 15 patients use placebo, which is the same cold cream, for 1 month and twice a day in the place of pain (knee). It should be noted that the placebo contains all the components of the original cream except the active ingredient (mustard seed oil)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Pain Clinic of Imam Reza (AS) Shiraz Clinic
Full name of responsible person
Mohammad Mehdi Zarshanas
Street address
Imam Reza Clinic, Namazi Sq
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
Fax
+98 71 3647 4673
Email
motahari@sums.ac.ir
Web page address
https://emamreza.sums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahtab Memarpour
Street address
Central Organization of Shiraz University of Medical Sciences, Zand ST
City
Shiraz
Province
Fars
Postal code
713451978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?