Osteoarthritis of the knee Musculoskeletal Diseases Arthropathies
Conditions
Interventions
Celadrin® (oral cetylated fatty acid) 1720 mg per day or placebo.
Sponsors
Imagenetix Inc. (USA)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of moderate to severe osteoarthritis of the knee by American College of Rheumatology (ACR) clinical criteria (95% sensitive and 69% specific) 2. Pain in the knee 3. At least three of the following: 3.1. Age greater than or equal to 40 (note - original ACR Criteria call for age greater than 50) 3.2. Morning stiffness lasting 30 minutes or less 3.3. Demonstration of crepitus during knee Range Of Motion (ROM) 3.4. Bony tenderness 3.5. Bony enlargement 3.6. No palpable warmth 4. Presence of knee pain greater than six months 5. Presence of knee pain for at least 10 days in the previous month 6. Subjects agree to stop all pain medications 7. Baby aspirin (81 mg) is allowed 8. Subject agrees to all study visits 9. Females of child bearing potential must agree to use appropriate birth control methods during the active study 10. Must agree not to initiate any new exercise or diet program during the study 11. Must agree not to change their current diet or exercise program
Exclusion criteria
Exclusion criteria: 1. Rheumatoid arthritis or other autoimmune arthritis 2. Receipt of glucocorticoid injection or hyaluronic acid injection in affected knee within the last three months 3. Use of cetylated fatty acid within the 45 days prior to screening 4. Serious active medical conditions 5. Corticosteroids or other immunosuppressants 6. Current use of insulin or use of insulin in the past three months 7. Non-compliance during the run-in phase of the study 8. Cannot perform all of the required functional assessments 9. Subjects unable to understand or follow the study protocol 10. Subjects with known sensitivities to the ingredients in the product 11. Subjects with any cancer in the last five years (except non-melanoma skin cancer) 12. Subjects on anticoagulation therapy 13. Subjects with brain and/or spinal cord injury 14. Bed or wheelchair bound
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Six-minute timed walk, assessed at baseline, 2, 4 and 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| The following were assessed at baseline, 2, 4 and 8 weeks: 1. Pain Visual Analogue Scale (VAS) 2. ?Timed up and go? test 3. Unilateral anterior reach 4. Western Ontario and McMasters Universities Osteoarthritic (WOMAC) index 5. Lequesne Algofunctional Index (LAI) 6. ROM | — |
Countries
United States of America
Outcome results
None listed