Rheumatoid Arthritis
Conditions
Keywords
Fish Oil, Knee, Analgetics
Brief summary
This is a single-center, prospective, randomized, double blind, placebo control study. The aim of this study is to assess the effect of fish oil capsules on pain intensity and postoperative analgesics consumption in patients after knee replacement surgery. The study population will be adult are referred for knee replacement surgery due to osteoarthritis of the knee.
Detailed description
Primary outcome: Post surgical pain level and analgesics use Secondary outcomes: 1. Pain levels and analgesic use at six weeks and 3 months after surgery 2. ω3 incorporation into blood cell membranes(RBC) 3. Stress and inflammation markers 4. Rates of postoperative complications Study Procedure : Enrolled patient will be randomly divided into a control group and intеrvention group during preoperative clinic visit. Each patient will receive total 150 capsules (5 capsules per day) accordingly to randomized group. Patients in treatment group will receive Fish Oil capsules. Patients in control group will receive placebo capsules.
Interventions
DIETARY_SUPPLEMENTEPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
Patient will receive Fish Oil capsules (EPAX 6000 EE) . Treatment: 5 capsules per day
DIETARY_SUPPLEMENTCapsules (Placebo)
Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day
Sponsors
Rabin Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Patients are referred for knee replacement surgery due to osteoarthritis of the knee *
Exclusion criteria
* Use of steroids, NSAIDs two weeks before surgery, antidepression drugs, antiepileptic drugs, coumadin * Diabetic neuropathy * Herpes-zoster/ post-herpetic neuralgia * n-3 supplements use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Levels | 10 weeks | Pain assessment of patients will be measured using visual analog scale (VAS) score. |
| Analgetics use | 10 weeks | All analgetics drugs used by patient will be noted |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Markers | Day 1 | Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6). |
| Fatty Acids Composition | Day 1 | ω3 incorporation into blood cell membranes(RBC) |
| Cortisol | Day 1 | Cortisol levels in blood test. |
| ACTH | Day 1 | ACTH levels in blood test. |
Countries
Israel
Contacts
Primary ContactPierre Singer, Professor, MD
Backup ContactMilana Grinev, RN, Study Coordinator
Outcome results
None listed