Comparing the effect of Rosemary and Ginger ointment on pain and physical function of older people with Knee Osteoarthritis
Design
A Randomized, Open-Label, Controlled Clinical Trial with 111 patients
The studied groups are divided into three groups by random blocking method
Settings and conduct
Patients in both intervention groups will receive the desired ointment twice a day, from 8 to 10 in the morning and from 18 to 19 in the evening, for 14 days. Gently massage two fingers of ointment on the knee for a few minutes
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age over 60 years
Having first and second-degree osteoarthritis in one or both knees
The willingness of the patient to attend the study
BMI less than or equal to 30
Not using oral and topical steroids within 14 days before the study
No intra-articular steroid injection within 90 days before the study
Not taking antioxidant supplements and anti-anxiety and depression drugs at least one month before
Absence of balance disorders
Obtaining a score of 7 and above in the abbreviated cognitive test (AMT)
Exclusion criteria:
Stopping the intervention by the patient
Osteoarthritis secondary to rheumatological diseases such as rheumatoid arthritis, gout, infectious arthritis, metabolic arthritis, traumatic arthritis,
Knee joint replacement surgery during the intervention
Severe sensitivity and allergy to the drug
Patient participation in other motor rehabilitation programs
Suffering from acute inflammatory diseases and infectious diseases, and malignancies
Intervention groups
There are two intervention groups and one control group. One group receives ginger ointment, one rosemary ointment group, and the control group receives non-steroidal anti-inflammatory drugs.
Main outcome variables
The effect of the studied ointments on pain and physical function of the elderly with knee osteoarthritis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210521051354N1
Registration date:2022-08-16, 1401/05/25
Registration timing:prospective
Last update:2022-08-16, 1401/05/25
Update count:0
Registration date
2022-08-16, 1401/05/25
Registrant information
Name
Ehsan Asadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3332 9670
Email address
beyranvand.a@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-13, 1401/07/21
Expected recruitment end date
2023-02-10, 1401/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Rosemary and Ginger ointment on pain and physical function of older people with Knee Osteoarthritis
Public title
Comparing the effect of Rosemary and Ginger ointment on pain and physical function of older people with Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 60 years
Exclusion criteria:
Age
From 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
111
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
Lorestan University of Medical Sciences's ethics committee
Street address
Psychiatric Hospital Kamalvand-Kahriz-Mehr
City
Khorramabad
Province
Lorestan
Postal code
381251698
Approval date
2021-04-24, 1400/02/04
Ethics committee reference number
IR.LUMS.REC.1400.002
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
Pain rate score on The Visual Analogue Scale; the intensity of people whose pain scale score is above 3
Timepoint
Measurement of pain in the elderly with osteoarthritis of the knee before the intervention and fourteen days after the application of rosemary and ginger ointment
Method of measurement
Questionnaire of Visual Analog Scale for Pain
2
Description
WOMAC Physical function Score in People whose physical performance scale scores is between 0 and 96
Timepoint
Measurement of physical function in the elderly with osteoarthritis of the knee before the intervention and fourteen days after the application of rosemary and ginger ointment
Method of measurement
WOMAC Physical Performance Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: This group receives rosemary ointment made by Gol Daru company, so they receive it twice a day at 8-10 AM and in the evening at 6-7 PM for 14 days. It is explained to the patient first clean the target area and then massage two knuckles of ointment on the knee for a few minutes. Before and after the intervention, questionnaires, including a visual Analogue scale of pain, Abbreviated Mental test (AMT), and arthritis severity scale (WOMAC), are completed.
Category
Treatment - Drugs
2
Description
Intervention group: The second intervention group: This group receives ginger ointment made by knowtechphar company, so they receive the ointment twice a day at 8-10 AM and 6-7 PM for 14 days. It is explained to the patient first clean the target area and then massage two knuckles of ointment on the knee for a few minutes. Before and after the intervention, questionnaires including the visual Analogue scale of pain, Abbreviated Mental test (AMT), and arthritis severity scale (WOMAC) are completed.
Category
Treatment - Drugs
3
Description
Control group: This group receives non-steroidal anti-inflammatory drugs(NSAIDs). Before and 14 days after receiving the drugs, questionnaires including the visual Analogue scale of pain, Abbreviated Mental test (AMT), and arthritis severity scale (WOMAC) are completed.