Effect of cannabis oil on clinical symptoms in patients with Knee osteoarthritis referred to the Rheumatology Clinic of Rafsanjan in 2022: A randomized, double-blind, control trial
Topical effect of cannabis oil on some clinical signs of knee osteoarthritis in patients referred to Rafsanjan Rheumatology Clinic in 2022: a double-blind clinical trial
Design
A clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 126 patients, stratified randomization was used for randomization.
Settings and conduct
clinical trial, will be performed on osteoarthritis patients referred to the Rheumatology Clinic in Rafsanjan in 2022, Patients will be evaluated at the beginning of the study and one to two months after the intervention using the Visual Analogue Scale (VAS) and the WOMAC index. In order to double-blind the study, Clinical symptoms are assessed by a Rheumatologist who is not aware of the type of medication used by each individual.
Participants/Inclusion and exclusion criteria
Iَnclusion: Age 45-70 years diagnosis of knee osteoarthritis according to American College of Rheumatology, approved by rheumatology specialist the average knee pain within 24 hours is based on the linear-visual pain scale (VAS) between 4 to 7.
Exclusion: Patients with inflammatory diseases, serious diseases, history of liver or kidney failure, oral corticosteroids, smoking and drug use, unwillingness to continue the study, non-compliance with the study protocol, Medical supplements use of analgesics, Skin or infectious disease at the site of pregnancy medication
Intervention groups
Participants will be divided into three groups: group 1 (42 people) using Cannabis oil, group 2 (42 people) placebo and group 3 (42 people) receiving diclofenac gel.
Main outcome variables
Pain and status of osteoarthritis in terms of morning stiffness, range of motion and function of patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180811040759N2
Registration date:2022-04-05, 1401/01/16
Registration timing:prospective
Last update:2022-04-05, 1401/01/16
Update count:1
Registration date
2022-04-05, 1401/01/16
Registrant information
Name
Mitra Abbasifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3428 0040
Email address
dr.mabbasifard@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-20, 1401/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of cannabis oil on clinical symptoms in patients with Knee osteoarthritis referred to the Rheumatology Clinic of Rafsanjan in 2022: A randomized, double-blind, control trial
Public title
Effect of cannabis oil on clinical symptoms in patients with Knee osteoarthritis referred to the Rheumatology Clinic of Rafsanjan in 2022: A randomized, double-blind, control trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 45-70 years
The diagnosis of osteoarthritis of the knee according to the criteria of the American College of Rheumatology, which is confirmed by a specialist in hematology
The presence of moderate knee pain within 24 hours based on linear-visual pain scale (VAS) between 4 7 cm
Completing the informed consent form
Exclusion criteria:
Patients with inflammatory diseases (such as lupus, rheumatoid arthritis, history of brucellosis, etc.)
Cancer or chronic diseases
Symptoms or history of liver or kidney failure
Oral corticosteroid consumption during the past 4 weeks
Corticosteroid injection in the last 6 months fever
Consumption of medical herbs continuously
Smoking and drug abuse
Allergy to cannabis
Observe any side effects that the patient thinks are caused by the oil
use of food and drug supplements
Oral use of other analgesics regularly and advanced disease
Use of other topical medications at the site of drug administration
Skin or infectious disease or ulcers at the site of pregnancy medication
Reluctance to continue participating in the study
Failure to comply with the study protocol
Age
From 45 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method. Unit: individual, simple random instrument: dice throwing one and two numbers for group 1 the numbers three and four for group 2 and the numbers five and six for group 3. Completion of groups with this sequence. Concealment is done using randomly coded boxes (allocation concealment).
Blinding (investigator's opinion)
Double blinded
Blinding description
The Physician and the patients will not be aware of the contents of the oil (double-blind). The duration of the massage is 3 to 5 minutes daily and the duration of taking the medicine is 2 months. The drugs are coded by someone other than the investigator and will be delivered to the Physician. Clinical examinations and confirmation of the disease are performed by a rheumatologist and subsequent evaluations are performed under the supervision of a rheumatologist and by an internal resident who will be unaware of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
Ali-Ibn Abi-Talib Square
City
Rafsanjan
Province
Kerman
Postal code
7737937555
Approval date
2022-01-23, 1400/11/03
Ethics committee reference number
IR.RUMS.REC.1400.234
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Knee pain intensity
Timepoint
At the beginning and the end of the study (two months after the beginning of the study)
Method of measurement
Visual Analogue Scale (VAS) And WOMAC index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group 1 (42 people) will use Cannabis oil. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
Category
Treatment - Drugs
2
Description
Control group: Group 2 (Placebo) (42 people). the form and type of the drug is the same. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
Category
Placebo
3
Description
Intervention group: Group 3 will receive Diclofenac gel. The treatment duration is 2 months, massage 3 to 5 minutes daily. During the study, patients are only allowed to use oral analgesics (7.5 mg of meloxicam) once daily in all groups if needed, and none of the common drugs will be used during this period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rheumatology Clinic of Rafsanjan University of Medical Sciences
Full name of responsible person
Mitra Abbasifard
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
dr.mabbasifard@rums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Bazmandegan
Street address
Imam Ali Street, Central Authority
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Fax
Email
gh.bazmandegan@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Mitra Abbasifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Rheumatology
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
dr.mabbasifard@rums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mitra Abbasifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
dr.mabbasifard@rums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Dr. Mitra Abbasifard
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Ali ibn Abi Talib Square, Ali ibn Abi Talib Hospital
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0185
Email
dr.mabbasifard@rums.ac.ir
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
Not applicable
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