Determination and comparison of the efficacy of topical heat therapy and kldrab gel on the symptoms and joint function of patients with knee erosion
Design
The controlled clinical trials, community-based and action-oriented, parallel group, randomized
Settings and conduct
An interventional study with three groups including two groups of control group and control group from patients with osteoarthritis in Imam Sajjad Dehdasat and Mofattah Yasouj clinics
Participants/Inclusion and exclusion criteria
The willingness of the patient to participate in the study, aged between 45 and 60 years, approved by the orthopedic surgeon,There is crepitus in knee active movement , morning stiffness less than 30 minutes, restriction of movement, knee pain on most days last month
Exclusion criteria:withdrawal patient of continue cooperation,Migration of patients from the study, the patient's death
Intervention groups
gel kldrab and heat therapy
Main outcome variables
Pain and swelling and stinginess in patients with knee erosion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180802040671N1
Registration date:2018-08-28, 1397/06/06
Registration timing:registered_while_recruiting
Last update:2018-08-28, 1397/06/06
Update count:0
Registration date
2018-08-28, 1397/06/06
Registrant information
Name
Moslem Aryana
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3226 8646
Email address
moslem.ariana@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-22, 1397/05/31
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of two methods localized heat therapy and kldrab gel on symptoms and joint function in patients with knee erosion
Public title
Comparison the effectiveness of two methods localized heat therapy and kldrab gel on symptoms and joint function in patients with knee erosion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient's willingness to participate in the study
Age range from 45 to 60 years
Certified orthopedic practitioner
Creatine keratinization in knee joint active movement, morning dryness less than 30 minutes, movement constraints, knee pain in most days of the last month
Exclusion criteria:
Patient's refusal to continue cooperation, immigration of the patient from the study site
Patient death
Immigration of the patient from the study site
Age
From 45 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
114
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be simple random and will continue until reaching the sample size. The samples will be assigned to two experimental groups (the Kelderab gel intervention group, the Therapy group) and a control group (three groups) based on randomized block assignment.
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
Ethics committee of yasuj University of Medical Sciences
Street address
Yasuj motahari blvd
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
IR.YUMS.REC.1397.039
Health conditions studied
1
Description of health condition studied
KNEE EROSION
ICD-10 code
M19.9
ICD-10 code description
Osteoarthritis, unspecified site
Primary outcomes
1
Description
KNEE EROSION
Timepoint
1MONTHS
Method of measurement
QUESTIONNAIRE
Secondary outcomes
1
Description
STINGINESS
Timepoint
1MONTHS
Method of measurement
QUESTIONAIRE
2
Description
PAIN
Timepoint
1 MONTH
Method of measurement
QUESTIONAIRE
3
Description
SWELLING
Timepoint
1MONTHS
Method of measurement
QUESTIONAIRE
Intervention groups
1
Description
The protocol of using Kelderab gel: In case group 1, a combination topical gel in the knee area is used before the application of topical gel in case group 1, symptoms and performance status are assessed by the researcher using the wear and tear injuries inventory questionnaire. In the case group 1, the ointment containing eucalyptus, menthol and camphor (clodrub ointment, manufactured by Gol Dara Company, Iran) is supplied to the patients. Each patient should use it daily twice a day. Treatment lasts for 4 weeks. Patients undergo weekly evaluations using wear and tear injuries questionnaire.
Category
Treatment - Drugs
2
Description
Prototype of hot water bag: In group 2, a hot water bag is used in the knee area at 55 ° C. Before the intervention, symptoms and functional status of the patients are examined using a questionnaire together with the researcher. Subsequently, the intervention group Treatment with a warm water bag daily is treated twice daily for up to 20 minutes each time for 4 weeks. Patients are evaluated weekly by using a questionnaire.
Category
Treatment - Devices
3
Description
Control group: no interventionControl group:There will be no intervention in the control group. Patients in this group received routine care and only the research tools will be completed.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Imam Sajad of Dehdasht
Full name of responsible person
Moslem Ariana
Street address
Dehdasht .Golzar Street
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75711845449
Phone
+98 74 3226 5903
Email
Moslem.Ariana@Yums.Ac.Ir
2
Recruitment center
Name of recruitment center
Clinic Shahid Mofateh of Yasuj City
Full name of responsible person
Moslem Ariana
Street address
Yasuj Side Shahid Behshte Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3336 4721
Email
Moslem.Ariana@Yums.Ac.Ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Hossein Marioryad
Street address
Martyr Motahhari
City
yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571845449
Phone
+98 74 1223 1556
Email
Moslem.ariana@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Ariana
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golzar Street
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571845449
Phone
+98 74 3226 8646
Email
MOSKEM.ARIANA@YUMS.AC.IR
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Shahla Najafi
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Martyr Motahhari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571845449
Phone
+98 74 1223 1556
Email
MOSLEM.ARIANA@YUMS.AC.IR
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Moslem Ariana
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golzar Street
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
٧٥٧١٨٤٥٤٤٩
Phone
+98 987432268646
Email
Moslem.Ariana@Yums.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data is analyzed and the results are published as a paper
When the data will become available and for how long
one year
To whom data/document is available
For scholars working in academia and academia
Under which criteria data/document could be used
For use in other studies
From where data/document is obtainable
By email and with the researcher
What processes are involved for a request to access data/document