knee osteoarthritis. Gonarthrosis
Conditions
Interventions
Intervention 1: Intervention group: Linum usitatissimum seed topical oil 20 drops every 8 hours without massage for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted. Interve
paraffin oil with the same method and order of intervention groups and for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted.
Treatment - Drugs
Placebo
Intervention group: Linum usitatissimum seed topical oil 20 drops every 8 hours without massage for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted
Control group: placebo
paraffin oil with the same method and order of intervention groups and for 6 weeks, in case of pain, up to 3 tablets of diclofenac 50 mg is permitted
Sponsors
Vice chancellor for research,Traditional Medicine College of Shahid Beheshti University of Medical S
Eligibility
Sex/Gender
All
Age
40 Years to 70 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Patient between 40 to 70 yaers age with BMI less than 35 that fill clinical and radiologic criteria of ACR and have Kellgren-Lawrence Grading Scale III / II / I, with VAS over than 4 cm; Clinical and radiological criteria of ACR include: knee pain, osteophyte in radiography, plus at least 1 of 3 below criteria: age more than 50 years old; morning stiffness less than 30 minutes; crepitation of knee. Exclusion criteria: Acute arthritis, osteoarthritis due to rheumatologic disease such as RA and gout, infective arthritis, metabolic arthritis, traumatic, uncontrolled diabetes, known case of cardiac or hepatic disease, cancer; History of knee replacement surgery; Fibromyalgia, radiculopathy and neuropathy; Those who are unable to tolerate and complete the study or treatment and follow-up; As well as those who use more than 3 tablets Diclofenac 50mg daily or need other oral or injection form of pain control, are excluded; At the same time, patients with Glucosamine, Chondroitin sulfate, and muscle relaxants use; sensitivity to medicinal plants; History of receiving oral or topical steroids during the 14 days prior to the study; Corticosteroids injection in the period of 30 days before study; pregnancy, hepatorenal active disease, gastritis, addiction to alcohol and narcotic drugs, skin disease of knee, those receiving antidepressant for chronic pain, Also, people who have mild and intermittent pain that only require non-pharmacological recommendations; New forms of therapies such as hydrotherapy, physiotherapy, start to interfere with the study.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Pain and VAS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Knee discomfort. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring.;Stiffness. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring.;Activities and daily living. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring.;Sport and recreation function. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring.;Quality of life. Timepoint: At the beginning of intervention and 6 weeks after the beginning of intervention. Method of measurement: KOOS Scoring and SF26 WHO. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNematollah Masoudi
College of Traditional Medicine, Shahid Beheshti University of Medical Sciences
Outcome results
None listed