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Clinical Trial 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.


Clinical Trial 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


NCT number NCT02683850
Study type Interventional
Source National College of Natural Medicine
Contact
Status Completed
Phase Phase 0
Start date January 2016
Completion date July 2016

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