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Study aim
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Investigating the topical effect of Joint cream (A production of Traditional Iranian Medicine) on the Outcome of Pain and Function in Patients with Knee Osteoarthritis
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Design
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The first group runs the usual program for the treatment of osteoarthritis (including patient education, exercise, weight loss, Using insoles, physiotherapy, and medication use).
The second group, in addition to the usual program of treatment for osteoarthritis (described above), also uses topical arthritis cream (Persian medicine product).
The study is a clinical trial with a controlled and randomized control group. Meanwhile, the study is not blind and is done in Phase 3. The sample size is defined as 40 pathent (20 pathent per group).
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Settings and conduct
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Individuals after obtaining consent to participate in this study are divided into two groups of 20 A and B by stratified balanced block randomization.Then, in both groups, two questionnaires including visual analog scale and KOOS were used to assess pain and function before and after the intervention. Also, 6MWT, Timed up and go test and 30 second chair stand tests were evaluated for performance evaluation in these patients.
The patient in A group runs the usual program for the treatment of osteoarthritis (including patient education, exercise, weight loss, Using insoles, physiotherapy, and medication use).The patient in B group, in addition to the usual program of treatment for osteoarthritis (described above), also uses topical arthritis cream (Persian medicine product).The method of using the product (daily at two times in the morning and night) is merely rubbing the cream on the knee joint without massage.
Both groups were reassessed 2 times, 4 and 8 weeks after the onset of the course, and both groups completed again the visual analog score and KOOs questionnaires.
Both groups A and B are evaluated based on the comparison of two questionnaires before and after the intervention in terms of pain relief and increased performance.
This study was carried out in Sport Medicine Clinic of Tehran University of Medical Sciences in Imam Khomeini Hospital.
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Participants/Inclusion and exclusion criteria
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Entry requirements:
Age over 40 years
Having diagnostic criteria for knee osteoarthritis (defined by the American College of Rheumatology)
Having grade 2 or 3 osteoarthritis according to radiological criteria
Having a BMI of 20-35
Non-arrival conditions:
History of rheumatoid arthritis
History of knee or hip replacement surgery in the affected joint
History of any lower limb surgery over the past 6 months
History of intra-articular corticosteroid injection in the last 6 months
History of intra-articular injection of gel and PRP in the last year
The onset of opioid analgesics or oral corticosteroids over the past four weeks
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Intervention groups
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The first group runs the usual program for the treatment of osteoarthritis (including patient education, exercise, weight loss, Using insoles, physiotherapy, and medication use).
The second group, in addition to the usual program of treatment for osteoarthritis (described above), also uses topical arthritis cream (Persian medicine product).
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Main outcome variables
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The Effect of Local use of Joints cream (Persian medicine product) on pain and function in patients with knee osteoarthritis.