Influence of an Omega-3 SPM Supplement on Quality of Life

• ClinicalTrials.gov Identifier: NCT02683850
• Recruitment Status: Completed
• First Posted: February 17, 2016
• Last Update Posted: September 2, 2016
• Sponsor: National University of Natural Medicine
• Collaborator: Metagenics, Inc.
• Information provided by (Responsible Party): Ryan Bradley, National University of Natural Medicine

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Pain	Dietary Supplement: Omega-3 SPM™ softgel	Early Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Influence of an Omega-3 SPM Supplement on Quality of Life
• Study Start Date: January 2016
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2016

Arms and Interventions

Arm

Intervention/treatment

Experimental: Omega-3 SPM; Intervention: Study participants will be instructed to take 3 Omega-3 SPM™ softgel supplements in the morning and 3 Omega-3 SPM™ soft gel supplements in the evening for two weeks. At weeks two participants whose PROMIS-43 Pain Intensity score indicates a reduction in pain levels weeks, will take 2 Omega-3 SPM™ soft gel supplements in the morning and 2 in the evening for the remaining 2 weeks of the study. Participants whose PROMIS-43 Pain Intensity score remained the same after two weeks, or increased will take 4 Omega-3 SPM™ soft gel supplements in the morning and 4 SPM™ softgels in the evening for the remaining two weeks of the study.

Dietary Supplement: Omega-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.

Outcome Measures

Primary Outcome Measures :

1. Quality of Life through PROMIS-43 [ Time Frame: 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).
2. Quality of Life ACPA [ Time Frame: 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 Outcome Measures:

1. ncidence of Treatment-Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 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.
2. Depression and Anxiety PHQ-9 [ Time Frame: 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
3. Depression and Anxiety GAD-7 [ Time Frame: 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
4. Depression and Anxiety PROMIS-43 [ Time Frame: 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
5. Pain [ Time Frame: 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
6. Pain [ Time Frame: Four weeks ]
   Changes in physical function, pain interference, and pain intensity the PROMIS-43 Profile subscales
7. Patient Satisfaction PSS [ Time Frame: four weeks ]
   Patient satisfaction and impression of change determined using the PSS
8. Patient Satisfaction PGIC [ Time Frame: four weeks ]
   Patient satisfaction and impression of change determined using the PGIC
9. Pain medication usage [ Time Frame: four weeks ]
   Changes in the use of pain medications determined using the case report form
10. hs-CRP [ Time Frame: four weeks ]
    Changes in inflammatory biomarkers assessed by high-sensitivity C-reactive protein (hs-CRP)
11. ESR [ Time Frame: four weeks ]
    Changes in inflammatory biomarkers assessed by erythrocyte sedimentation rate (ESR)

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Oregon

National University of Natural Medicine

Portland, Oregon, United States, 97201

Sponsors and Collaborators

National University of Natural Medicine

Metagenics, Inc.

Investigators

• Principal Investigator: Ryan Bradley, ND, MPH; National University of Natural Medicine

More Information

Publications:

Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146.

Ussai S, Miceli L, Pisa FE, Bednarova R, Giordano A, Della Rocca G, Petelin R. Impact of potential inappropriate NSAIDs use in chronic pain. Drug Des Devel Ther. 2015 Apr 9;9:2073-7. doi: 10.2147/DDDT.S80686. eCollection 2015.

Reuben DB, Alvanzo AA, Ashikaga T, Bogat GA, Callahan CM, Ruffing V, Steffens DC. National Institutes of Health Pathways to Prevention Workshop: the role of opioids in the treatment of chronic pain. Ann Intern Med. 2015 Feb 17;162(4):295-300. doi: 10.7326/M14-2775.

Chou R, Turner JA, Devine EB, Hansen RN, Sullivan SD, Blazina I, Dana T, Bougatsos C, Deyo RA. The effectiveness and risks of long-term opioid therapy for chronic pain: a systematic review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Feb 17;162(4):276-86. doi: 10.7326/M14-2559. Review.

Maroon JC, Bost JW. Omega-3 fatty acids (fish oil) as an anti-inflammatory: an alternative to nonsteroidal anti-inflammatory drugs for discogenic pain. Surg Neurol. 2006 Apr;65(4):326-31.

Serhan CN. Pro-resolving lipid mediators are leads for resolution physiology. Nature. 2014 Jun 5;510(7503):92-101. doi: 10.1038/nature13479. Review.

Serhan CN, Chiang N, Van Dyke TE. Resolving inflammation: dual anti-inflammatory and pro-resolution lipid mediators. Nat Rev Immunol. 2008 May;8(5):349-61. doi: 10.1038/nri2294. Review.

Colas RA, Shinohara M, Dalli J, Chiang N, Serhan CN. Identification and signature profiles for pro-resolving and inflammatory lipid mediators in human tissue. Am J Physiol Cell Physiol. 2014 Jul 1;307(1):C39-54. doi: 10.1152/ajpcell.00024.2014. Epub 2014 Apr 2.

Dworkin RH, Turk DC, Wyrwich KW, Beaton D, Cleeland CS, Farrar JT, Haythornthwaite JA, Jensen MP, Kerns RD, Ader DN, Brandenburg N, Burke LB, Cella D, Chandler J, Cowan P, Dimitrova R, Dionne R, Hertz S, Jadad AR, Katz NP, Kehlet H, Kramer LD, Manning DC, McCormick C, McDermott MP, McQuay HJ, Patel S, Porter L, Quessy S, Rappaport BA, Rauschkolb C, Revicki DA, Rothman M, Schmader KE, Stacey BR, Stauffer JW, von Stein T, White RE, Witter J, Zavisic S. Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. J Pain. 2008 Feb;9(2):105-21. Epub 2007 Dec 11.

Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, Carr DB, Chandler J, Cowan P, Dionne R, Galer BS, Hertz S, Jadad AR, Kramer LD, Manning DC, Martin S, McCormick CG, McDermott MP, McGrath P, Quessy S, Rappaport BA, Robbins W, Robinson JP, Rothman M, Royal MA, Simon L, Stauffer JW, Stein W, Tollett J, Wernicke J, Witter J; IMMPACT. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005 Jan;113(1-2):9-19. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Callan N, Hanes D, Bradley R. Early evidence of efficacy for orally administered SPM-enriched marine lipid fraction on quality of life and pain in a sample of adults with chronic pain. J Transl Med. 2020 Oct 21;18(1):401. doi: 10.1186/s12967-020-02569-5.

• Responsible Party: Ryan Bradley, Assistant Director of Research, National University of Natural Medicine
• ClinicalTrials.gov Identifier: NCT02683850
• Other Study ID Numbers: 091515-B
• First Posted: February 17, 2016
• Last Update Posted: September 2, 2016
• Last Verified: August 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Additional relevant MeSH terms:

Chronic Pain; Pain; Neurologic Manifestations