Chronic Pain Clinical Trial
Official title:
Influence of an Omega-3 SPM Supplement on Quality of Life
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.
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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