Investigating and comparing the effect of subcutaneous and intradermal mesotherapy on improving pain and function in patients with osteoarthritis of the knee: a randomized clinical trial study
Investigating and comparing the effect of mesotherapy by two subcutaneous and intradermal methods on improving pain and function of patients with knee osteoarthritis
Design
A parallel randomized single blind clinical trial study in 2023-2024 on 50 patients diagnosed with knee osteoarthritis who were randomly assigned to one of 2 intervention groups.
Settings and conduct
In this single blind study, patients with knee osteoarthritis who referred to physical medicine clinics of Isfahan University of Medical Sciences in 2023-2024 will randomly subjected to intradermal or subcutaneous mesotherapy. After sampling and follow-ups, the analyzer who is unaware of the data, will analyze the data.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with mild to moderate osteoarthritis of the knee based on the Kellgren Lawrence criteria, aged between 40 and 70 years with clinical symptoms at least in the last month; Exclusion criteria: history of knee surgery. Rehabilitation treatments in the last 3 months, presence of any neurological, infectious, cognitive impairment, malignancy, cardiac and renal diseases, pregnancy
Intervention groups
In the first intervention group, 6 sessions of subcutaneous injection of 20 mg of piroxicam with a volume of 1 ml along with 2 ml of lidocaine 2%, 2 sessions per week and for 3 weeks will be performed in 6 aqua puncture points around the knee.
In the second intervention group, intradermal injection with drugs, the number of sessions and injection points similar to the first intervention group will be done.
The recommendation to follow the correct lifestyle and perform exercises related to strengthening the quadriceps muscle and then stretching the cuff muscles (each time for 20-30 seconds and for 10-20 times a day, depending on the individual's tolerance) will be done in both groups.
Main outcome variables
pain and function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231003059603N1
Registration date:2023-10-10, 1402/07/18
Registration timing:prospective
Last update:2023-10-10, 1402/07/18
Update count:0
Registration date
2023-10-10, 1402/07/18
Registrant information
Name
Maryam Behroozinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3668 0048
Email address
maryambehroozynia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-22, 1402/07/30
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating and comparing the effect of subcutaneous and intradermal mesotherapy on improving pain and function in patients with osteoarthritis of the knee: a randomized clinical trial study
Public title
Investigating and comparing the effect of subcutaneous and intradermal mesotherapy on improving pain and function in patients with osteoarthritis of the knee: a randomized clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with mild to moderate osteoarthritis of the knee based on the Kellgren Lawrence criteria
aged between 40 and 70 years
clinical symptoms for at least one month.
Exclusion criteria:
Patients who have a history of knee surgery.
Patients who have undergone rehabilitation treatments in the last 3 months due to knee pain.
Existence of neurological disease, infectious disease, cognitive disorder, malignancy, cardiac and nephrology disease
pregnancy
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
More than 1 sample in each individual
Number of samples in each individual:
2
If both knees of the patient have osteoarthritis, each knee will be considered as a sample.
Randomization (investigator's opinion)
Randomized
Randomization description
People are placed in 2 groups by random block method.
In this way, the first 2 eligible people are selected and after obtaining their consent, they enter to participate in the study. These 2 people are considered as a double block and are sorted according to the last digit of the national code. Treatment methods are Forms A and B are specified and all combinations of 2 are specified
Blinding (investigator's opinion)
Single blinded
Blinding description
The data analyst is unaware of which group each patient was placed in.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Science
Street address
Hezarjerib ave, Isfahan University of Medical Science
City
Isfahan
Province
Isfehan
Postal code
7346181746
Approval date
2023-09-27, 1402/07/05
Ethics committee reference number
IR.ARI.MUI.REC.1402.163
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
Timepoint
before treatment, immediately after last session, one month after treatment
Method of measurement
Visual Analogue Scale questionnaire
2
Description
The degree of knee disability
Timepoint
before treatment, immediately after last session, one month after treatment
Method of measurement
Western Ontario and McMaster Universities Arthritis Index questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 2 sessions per week for 3 weeks, subcutaneous mesotherapy with 1 ml of piroxicam and 2 ml of lidocaine2% in 6 acupuncture points around the knee along with exercise and advice related to lifestyle modification
Category
Treatment - Other
2
Description
Intervention group: 2 sessions per week for 3 weeks, intradermal mesotherapy with 1 ml of piroxicam and 2 ml of 2% lidocaine in 6 acupuncture points around the knee along with exercise and advice related to lifestyle modification
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amin hospital
Full name of responsible person
Parisa Taheri
Street address
Sonbulestan Alley, Ibn Sina Street, Shohada Square
City
Isfahan
Province
Isfehan
Postal code
8148653141
Phone
+98 31 3112 2020
Email
Prs_taheri@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Building 4, Hezar Jarib Street, Isfahan University of Medical science
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Hezar jarib Street, Isfahan University of Medical Science and health services
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
Prs_taheri@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Behroozinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan university of medical science, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
maryambehroozynia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Behroozinia
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Isfahan university of medical science, Hezarjarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
Email
maryambehroozynia@yahoo.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