Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT02683850
Eligibility Criteria:
Inclusion Criteria:
* Age 20-70
* Body mass index 19 kg/m2 - 40 kg/m2
* Have had chronic pain lasting 3 months or longer
* Have moderate to severe pain as define by an average level of pain score of greater than or equal to a 4 on the PROMIS-43 Profile - Pain Intensity subscale
* Willing to have blood drawn three times
* Maintained stable medications, dietary supplements and therapies for pain for at least 30 days and willing to continue the same therapies and not add new therapies for the duration of the study unless medically advised to do so
* Able to follow study protocol and attend visits at the clinical practices associated with Clinical Investigator
* Able to speak, read and understand English
Exclusion Criteria:
* Initiation of or changes in use of fish oil supplements, krill oil supplements, omega 3 supplements, or omega 3-based drugs (Lovaza®, etc.) within the past 3 months
* Initiation of new pain medications and non-steroidal anti-inflammatory drugs NSAIDS within the past month such as \[aspirin, ibuprofen (Advil®, Motrin®, Nuprin®), acetaminophen (Tylenol®), naproxen (Aleve®, Naprosyn®), codeine (Vicodin®), morphine (Dilaudid®), oxycodone (OxyContin®, Percocet®) fentanyl (Duragesic®) and COX-2 inhibitors, Celebrex®)
* Currently taking:
* Medication to reduce the tendency to form blood clots such as \[warfarin, jantoven (Coumadin®); dabigatran (Pradaxa®); rivaroxaban, (Xarelto®); apixaban (Eliquis®)\]
* Statin use for cholesterol reduction such as \[atorvastatin (Lipitor®), fluvastatin (Lescol®), lovastatin (Mevacor®, Altocor®), pitavastatin (Livalo®), pravastatin (Pravachol®), rosuvastatin (Crestor®) or simvastatin (Zocor®)\] (not including Red Yeast Rice if also supplementing with CoQ10)
* Corticosteroids such as \[prednisone, dexamethasone, prednisolone (Orapred®, Prelone®, Pediapred®), methylprednisolone (Medrol®)\] (not including topical corticosteroids for dermatological conditions or nasally inhaled for asthma, rhinitis or sinusitis)
* Daily aspirin \>325 mg per day (not including low dose aspirin therapy of 81 mg - 325 mg per day)
* Other medications and supplements to be evaluated by the investigators on a case-by-case basis
* Steroid injections, Prolotherapy, or other injections into a ligament, tendon, joint or muscle during the past month or initiation or continuation of therapy injections during the course of the study.
* Present or past history of any of the following:
* Inflammatory disease (e.g. rheumatoid arthritis, autoimmune disease, Crohn's disease, diverticulitis, viral hepatitis, ulcerative colitis, systemic lupus, Parkinson's disease, Alzheimer's, ankylosing spondylitis)
* Blood clot disorder (e.g., phlebitis)
* Diabetes (self-report; includes Type I and Type II Diabetes but does not include a history of Gestational Diabetes during pregnancy)
* Cancer within the last 5 years (with the exception of basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ of the cervix)
* Cardiovascular disease within the last year, including but not limited to: myocardial infarction, stroke, congestive heart failure (CHF)
* Kidney failure or liver failure
* Current active pelvic inflammatory disease, urinary tract infection or a kidney infection
* Women who are lactating, pregnant or planning pregnancy within the next six months
* Difficulty or aversion to swallowing soft gels, capsules, tablets or pills
* Known intolerance or allergy to fish oils
* Upon administering the NCNM Adverse Event Monitoring form at screening, a sign or symptom of Grade 3 (severe or medically significant but not immediately life-threatening) or higher is reported
* Currently participating in another research study or participated in another study within the last month
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT02683850
Study Brief:
Protocol Section:
NCT02683850