Knee osteoarthritis. Osteoarthritis of knee, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Cream containing Turmeric, Black Seeds, Flaxseed, and Medicago Sativa. Intervention 2: Control group: Vaseline cream.
Sponsors
Tabriz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: At least 6 months of diagnosis of knee osteoarthritis, and whose OA diagnosis meets the American College of Rheumatology criteria Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale baseline value of = 9 (0-20 scale) Functional Capacity Classification of I-III Radiograph evidence of OA in the target knee with a Kellgren-Lawrence score of 2 or 3 Morning stiffness of <30 min duration or crepitus on active motion, which is present upon examination
Exclusion criteria
Exclusion criteria: Evidence of other conditions or diseases of the skin or joints Evidence of partial or complete knee joint replacement or anticipated joint replacement in the target knee Contraindications to the use of non-steroidal anti-inflammatory drugs (NSAIDs) or who use anticoagulant therapy that prohibits them from using NSAIDs Pregnancy, planning to become pregnant or breastfeeding during the study period Ischemic heart disease, heart failure, end-stage cirrhosis, end-stage renal failure, or psychiatric conditions that prevent an adequate evaluation of the study outcomes Insufficient cognitive functioning to participate and complete the questionnaires Unable or unwilling to follow up and complete the study pathway, A history or diagnosis of other arthritic conditions, such as rheumatoid arthritis, joint and bone deformities, fibromyalgia and/or other inflammatory and immune system disorders Type I or II diabetes or obesity (body mass index = 39) Suffering from painful conditions or frequent headaches requiring the use of systemic opiates or derivatives, or the need for additional NSAID or COX-2 inhibitors Receiving systemic or intra-articular corticosteroid injections. Having active cancer undergoing treatment that prevents the evaluation of the outcome measures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint pain. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.;Joint stiffness. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.;Physical function. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index pain, joint stiffness and physical function subscales.;Overall Western Ontario and McMaster Universities Osteoarthritis score. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.;Subjective Global Evaluation (SGE). Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Subjective Global Evaluation forms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Evaluation of patient’s quality of life, which will be measured using the 36-Item Short Form Survey which produces Mental Component and Physical Component scores.;Quality of sleep. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: The quality of sleep, which will be measured using the Pittsburgh Sleep Quality Index.;Functional Capacity Classification. Timepoint: Day 0, 30, 60, 90 post intervention. Method of measurement: Functional Capacity Classification will be evaluated using a 4-point Likert scale and will be evaluated by the doctor and placed into 4 classes (Class I-IV), which range from full functional capacity to disabled. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaeid Safiri
Tabriz University of Medical Sciences
Outcome results
None listed