Early osteoarthritis of the knee. Osteoarthritis of knee
Conditions
Interventions
Intervention group: After entering the study, patients will be randomly assigned to one of the drug groups (intervention with peppermint gel) or control (diclofenac gel). The intervention group will b
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1 - Age between 50 and 80 years. 2 - Osteophyte severity grade 1 to 3 according to the Kellgren-Allerance classification 3 - VAS score =4 & <8
Exclusion criteria
Exclusion criteria: 1 - Participation in another clinical study in the past 6 months 2 - Cognitive or psychiatric disorder 3 - Use of oral and intra-articular corticosteroids in the past two months 4 - People with a history of allergy to herbal medicines 5 - Skin disease at the joint site 6 - Patients with acute arthritis, osteoarthritis secondary to rheumatological diseases such as rheumatoid arthritis and gout, arthritisInfection, metabolic arthritis, traumatic arthritis, uncontrolled diabetes, known heart, liver, cancer 7 - Joint replacement surgery 8 - Fibromyalgia, radiculopathy and neuropathy 9 - Those who are unable to tolerate the study and complete the treatment and follow-up period 10 - Patients who are taking glucosamine, chondroitin sulfate and muscle relaxants at the same time
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of pain will be assessed using the VAS and KOOS questionnaires, and the secondary outcomes of joint symptoms, physical activity, exercise, and quality of life in patients will be measured using the KOOS questionnaire. Timepoint: Patients will be visited three times, at the beginning of treatment, 4 weeks after the start of treatment, and 4 weeks after stopping treatment. Method of measurement: KOOS: A valid, reliable, and responsive self-report instrument used for short-term and long-term follow-up of various knee injuries, including osteoarthritis, and was developed to expand the WOMAC index.[30] This relatively new, well-designed, and simple self-report instrument has good reliability, validity, and responsiveness in various populations with various knee problems [31].It can be used to assess the patient's opinion about knee problems in short-term and long-term follow-up periods ranging from one week to one decade, as well as in young and middle-aged people with osteoarthritis following trauma.The original version of the questionnaire has remained unchanged, although some small improvements have been made. The content of this questionnaire consists of 42 items, which are classified into 5 subgroups or arms:1. Pain intensity and frequency during physical activities [1]2. Symptoms such as knee stiffness or swelling and limited range of motion, clicking sound [2]3. Difficulty experiencing daily activities [3]4. Difficulty performing sports and recreational activities [4]5. Lifestyle changes and knee-related quality of life [5]Each question is scored between 0 and 4. The criterion for answering the questions is the patient's condition in the past week. After summing the items in each subgroup, the resulting number is obtained based on a specific formula in the form of scores between 0 and 100. Where 0 indicates a severe knee problem and 100 indicates a problem-free condition. Obtaining an overall score from the KOOS questionnaire is of no value and | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMaedeh Rezghi
Babol University of Medical Sciences
Outcome results
None listed