The effect of Linum usitatissimum L. (flax seed) oil along with a calorie restricted diet in patients with knee osteoarthritis

Phase 3

Conditions: Knee osteoarthritis.
Osteoarthritis of knee

Registration Number: IRCT20161022030424N10

Lead Sponsor: Tabriz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 88

Inclusion Criteria

Diagnosis of knee osteoarthritis by a physical medicine specialist (mild, moderate) based on the diagnostic criteria of the American College of Rheumatology and the radiological evaluation of knee osteoarthritis by Clairgen Lawrence
Overweight and obese people based on body mass index of 25-40 weight per square meter
Not taking anticoagulants
Absence of knee joint replacement surgery
Absence of fractures involving the surface of the knee joint
Absence of skin diseases in the knee area
Absence of other systemic rheumatic diseases or RA, neuropathy, sensory disturbances due to drug, sedative or tobacco use

Exclusion Criteria

Treatment with oral or intra articular corticosteroids in the past 3 months

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical performance. Timepoint: Evaluation of physical performance at baseline (before intervention) and 8 weeks after starting the oral and topical supplement of flaxseed oil. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index questionnaire.

Secondary Outcome Measures

Name	Time	Method
Pain intensity. Timepoint: Measurement of the pain intensity at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil. Method of measurement: Visual Analogue Scale.;Anthropometric indices. Timepoint: Measurement of the anthropometric indices at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil. Method of measurement: Seca digital scale.;Serum concentration of oxidative stress indices (MDA and TAC). Timepoint: Measurement of the serum levels of inflammatory markers at baseline (before intervention) and 8 weeks after oral and topical supplement of flaxseed oil. Method of measurement: Biochemical analysis.