Chronic Pain
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTOmega-3 SPM™ softgel
This four week, prospective, non-randomized, open-label study is assessing the impact on quality of life from taking an Omega-3 SPM™ softgel supplement in adults with pain symptoms at screening of 4 or higher on the PROMIS-43 Profile - Pain Intensity subscale.
Sponsors
Metagenics, Inc.
National University of Natural Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life through PROMIS-43 | 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). |
| Quality of Life ACPA | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Depression and Anxiety GAD-7 | four weeks | To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the GAD-7 |
| Depression and Anxiety PROMIS-43 | four weeks | To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the PROMIS-43 Profile |
| Pain | four weeks | Changes in pain levels, pain symptoms, pain relief, physical function, pain interference, and pain intensity and pain quality determined using the Brief Pain Inventory |
| Patient Satisfaction PSS | four weeks | Patient satisfaction and impression of change determined using the PSS |
| ncidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | four weeks | To assess the effect of 4 weeks of treatment with a SPM supplement on safety and tolerability will be monitored by changes in multi-system symptoms using the NCNM Adverse Event Monitoring Form. |
| Pain medication usage | four weeks | Changes in the use of pain medications determined using the case report form |
| hs-CRP | four weeks | Changes in inflammatory biomarkers assessed by high-sensitivity C-reactive protein (hs-CRP) |
| ESR | four weeks | Changes in inflammatory biomarkers assessed by erythrocyte sedimentation rate (ESR) |
| Patient Satisfaction PGIC | four weeks | Patient satisfaction and impression of change determined using the PGIC |
| Depression and Anxiety PHQ-9 | four weeks | To assess the effect of 4 weeks of treatment with a SPM supplement on changes in depression and anxiety determined using the PHQ-9 |
Countries
United States
Outcome results
None listed