The effect of exercise therapy on pain relief due to knee osteoarthritis
Design
Clinical efficiency with control group, parallel groups, without blindness, randomized, letters card was used for randomization .50 patients were included in the study and followed up for 3 months.
Settings and conduct
This study will be conducted in Yasa hand-held pain clinic in Fasa, patients less than 30 years and over 70 years old and patients who are not satisfied with participation in the study will be excluded from the results of unexplored outcomes and according to ODI patients will announce their pain improvement.
Participants/Inclusion and exclusion criteria
The criteria for entering the study are age 30 to 70 years with the severity of knee VAS pain above 3, lack of knee-related rheumatology disease such as gout, rheumatological orthotics, RA and lack of uncontrollable underlying disease
Intervention groups
In this study, the effect of exercise on the improvement of knee pain due to knee osteoarthritis will be determined. The first group will receive only medication and the second group will receive medication and exercise.
The effect of exercise therapy and drug in relieving pain and disability caused by osteoarthritis of the knee
Public title
The effect of exercise therapy and drug in relieving pain and disability caused by osteoarthritis of the knee
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 30 to 70 years
the severity of knee VAS pain above 3
Exclusion criteria:
Knee-related rheumatology such as gout, rheumatological arthritis, RA
No uncontrollable underlying disease
History of knee surgery
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will prepare a sample size of 50 cards, on 25 cards, we will write the letter a and 25 of the rest, and put them in the envelope in the package, and then we ask the patient to select one of the cards at the time of referral. If the patient has an a card, the intervention group and if the owner of the b card is placed in the control group.
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 Fasa University of Medical Sciences
Street address
Ibn Sina Square
City
Fasa
Province
Fars
Postal code
7461459331
Approval date
2022-08-30, 1401/06/08
Ethics committee reference number
IR.FUMS.REC.1401.075
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 score in oswestry Disability index
Timepoint
Evaluation of pain improvement 6 weeks after exercise
Method of measurement
Oswestry Disabylity Index Questionnaire
Secondary outcomes
1
Description
Patient satisfaction score from 0 to 10
Timepoint
Pain score after 6 weeks of exercise
Method of measurement
Patients were asked to tell their satisfaction score from exercises from 0 to 10.
Intervention groups
1
Description
Intervention group:The intervention group evaluated 25 patients with knee pain by giving me exercise strength, hydrotherapy, aerobic exercise and they are asked to do it 3 times a day for 6 weeks every 10 minutes.This group also use uniflex once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain uniflex uniflex tablets containing calcium carbonate, methylsulfonylmethane , vitamin D and K , magnesium and zinc . Methylsulfonylmethane is anti-inflammatory and antioxidant and has been shown to have cartilage and collagen-making effects, which is useful for our study due to wear, which is cartilage analysis.
Category
Rehabilitation
2
Description
Control group: The control group also use uniflex tablets once a day, wishca cream three times a day and meloxicam tablets 15 mg every 12 hours in case of pain, uniflex uniflex tablets containing calcium carbonate, methylsulfonylmethane, vitamin D and K, magnesium and zinc. Methylsulfonylmethane is anti-inflammatory and antioxidant and has been shown to have cartilage and collagen-making effects, which is useful for our study due to wear, which is cartilage analysis.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-Asr Fasa Hospital
Full name of responsible person
Fateme Zeinali
Street address
Fasa Phase 1 Golestan 9 and 19
City
Fasa
Province
Fars
Postal code
7461459331
Phone
+98 917 251 6706
Email
Zeynalif26@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Bordbar Zare
Street address
Fasa Field Avicenna University of Medical Sciences Fasa
City
Fasa
Province
Fars
Postal code
7461459331
Phone
+98 71 5331 6300
Email
Zeynalif26@gemail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Fateme Zeinali
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Fars Fasa Phase 1 England Alley I No. 19
City
Fasa
Province
Fars
Postal code
7461459331
Phone
+98 917 251 6706
Email
Zeynalif26@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Fateme Zeinali
Position
intern
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Fars Fasa Phase 1 England Alley I No. 19
City
FASa
Province
Fars
Postal code
7461459331
Phone
+98 917 251 6706
Email
Zeynalif26@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Fateme Zeinali
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Fars Fasa Phase 1 Golestan Alley I No. 19
City
fasa
Province
Fars
Postal code
7461459331
Phone
+98 917 251 6706
Email
Zeynalif26@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Only a portion of data, such as information about the original outcome or the like, can be shared
When the data will become available and for how long
Start access 6 months after printing the results
To whom data/document is available
Academic and Scientific Institutions
Under which criteria data/document could be used
Data usage can be used for complementary work and expanding research
From where data/document is obtainable
fateme zeinali 09172516706
What processes are involved for a request to access data/document
The applicant can access the information after contacting Fatemeh Zeinali