Rheumatoid ArthritisEFOPaKR-01NCT01274910
Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial
A study testing EPAX 6000 EE 1000mg (0.6 gr DHA+EPA) in people with Rheumatoid Arthritis, run by Rabin Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2011to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients are referred for knee replacement surgery due to osteoarthritis of the knee
Who cannot join
- Use of steroids, NSAIDs two weeks before surgery, antidepression drugs, antiepileptic drugs, coumadin
- Diabetic neuropathy
- Herpes-zoster/ post-herpetic neuralgia
- n-3 supplements use
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rabin Medical Center, Campus Beilinson
Petah Tikva, Petah Tikva, 49100
Pierre Singer, Professor,MD, 972-39376521, psinger@clalit.org.il
Milana Grinev, RN, Study Coordinator, 972-39376521, milang@clalit.org.il
About this study
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.
Read the detailed description
Primary outcome:
Post surgical pain level and analgesics use
Secondary outcomes:
- Pain levels and analgesic use at six weeks and 3 months after surgery
- ω3 incorporation into blood cell membranes(RBC)
- Stress and inflammation markers
- 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- EPAX 6000 EE 1000mg (0.6 gr DHA+EPA), Capsules (Placebo)
- Keywords
- Fish Oil, Knee, Analgetics
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)Dietary supplement
Also called Caps.Omeguard Triomar 1000 mg SGC
Patient will receive Fish Oil capsules (EPAX 6000 EE) .
Treatment: 5 capsules per day
Capsules (Placebo)Dietary supplement
Patient will receive capsules which not contain fish oil.
Treatment: 5 capsules per day
| Study group | Role | What they receive |
|---|---|---|
| Fish oil group | Active comparator | Treatment Group. Receives: Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA) |
| Control group | Placebo comparator | Placebo group Receives: Dietary Supplement: Capsules (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels
Pain assessment of patients will be measured using visual analog scale (VAS) score.
Measured: 10 weeks
Analgetics use
All analgetics drugs used by patient will be noted
Measured: 10 weeks
Secondary outcomes (4)
Inflammatory Markers
Blood test. Concentration of circulated inflammatory markers (TNF-α,IL-1,IL-6).
Measured: Day 1
Fatty Acids Composition
ω3 incorporation into blood cell membranes(RBC)
Measured: Day 1
Cortisol
Cortisol levels in blood test.
Measured: Day 1
ACTH
ACTH levels in blood test.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre singer, Rabin Medical Center
- Investigators
- Pierre Singer, Professor, MD, Principal investigator, ICU dep't, Rabin MC,Petah Tikva, IsraelMilana Grinev, RN, Study Coordinator, Study director, ICU dep't, Rabin MC, Petah Tikva, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01274910
- Sponsor's protocol ID
- 5961
- Acronym
- EFOPaKR-01
- Status last verified
- Feb 2013
- First submitted
- 4 Jan 2011
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fish Oil on Surgery Pain After Knee Replacement Patients: Randomized, Prospective, Double Blind, Placebo Control Trial
- ClinicalTrials.gov ID
- NCT01274910
- Acronym / sponsor ID
- EFOPaKR-01 / 5961
- Conditions
- Rheumatoid Arthritis
- Keywords
- Fish Oil, Knee, Analgetics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Jan 2014 (estimated)
- First posted
- 12 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Pain levels and analgesic use at six weeks and 3 months after surgery
- ω3 incorporation into blood cell membranes(RBC)
- Stress and inflammation markers
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil group | Active comparator | Dietary Supplement: EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)Treatment Group. |
| Control group | Placebo comparator | Dietary Supplement: Capsules (Placebo)Placebo group |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are referred for knee replacement surgery due to osteoarthritis of the knee
Key exclusion criteria (4 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)Also: Caps.Omeguard Triomar 1000 mg SGCPatient will receive Fish Oil capsules (EPAX 6000 EE) . Treatment: 5 capsules per day | Dietary supplement | Fish oil group |
| Capsules (Placebo)Patient will receive capsules which not contain fish oil. Treatment: 5 capsules per day | Dietary supplement | Control group |
Primary outcome
Pain Levels
Time frame: 10 weeks
Pain assessment of patients will be measured using visual analog scale (VAS) score.
Analgetics use
Time frame: 10 weeks
All analgetics drugs used by patient will be noted
4 secondary outcomes
Inflammatory Markers
Time frame: Day 1
Fatty Acids Composition
Time frame: Day 1
Cortisol
Time frame: Day 1
ACTH
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2013.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Singer, Professor, MD principal investigator
ICU dep't, Rabin MC,Petah Tikva, Israel
Milana Grinev, RN, Study Coordinator study director
ICU dep't, Rabin MC, Petah Tikva, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EPAX 6000 EE 1000mg (0.6 gr DHA+EPA) in people with Rheumatoid Arthritis, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Singer, Professor, MD (972-3-9376521, psinger@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Levels (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2013.