Influence of an Omega-3 SPM Supplement on Quality of Life
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Quality of Life ACPA
研究概览
简要总结
This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft gel supplement for four weeks will increase the quality of life in adults with chronic pain.
详细描述
One third of the America population is affected by chronic pain. The societal costs associated with chronic pain is up to $635 billion dollars annually. Prescribed pain medications may have negative side effects, or cause addictions. Having alternative treatments that can reduce inflammation and the side effects associated with chronic pain may improve the quality of life for millions.
This prospective, non-randomized, open-label study will assess if taking an Omega-3 SPM™ soft gel supplement for four weeks will increase the quality of life in adults with chronic pain. SPM™ softgels are a dietary supplement intended to reduce pain and inflammation. Up to 40 men and women with chronic pain will be recruited. Outcome measures will be collected at baseline, 2 weeks, and 4 weeks with a primary endpoint of 4 weeks. The primary outcomes of this pilot study include questionnaires to assess quality of life. Exploratory outcomes assess safety and tolerability, changes in anxiety and depression as well as levels of pain, and blood markers associated with inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Quality of Life ACPA
时间窗: Four weeks
To assess the effect of 4 weeks of treatment with a SPM supplement on quality of life in a chronic pain population using American Chronic Pain Association's Quality of Life Scale.
Quality of Life through PROMIS-43
时间窗: Four weeks
To assess the effect of 4 weeks of treatment with a SPM supplement on quality of life in a chronic pain population using the PROMIS-43 Profile (including PROMIS-43 subscales addressing physical function, fatigue, and sleep disturbance, ability to participate in social roles and activities).
次要结局
未报告次要终点
研究者
Ryan Bradley
Assistant Director of Research
National University of Natural Medicine