Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain

Quantitative urine biomarker levels after 1 and 3 months of supplementation.

Summary scores of quality-of-life measures, patient reported outcome measurement information system 29 (PROMIS-29); assesses pain intensity using a single 0-10 numeric rating item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. For overall scoring of the test (i.e., adding each response) a higher score equals more of the concept being measured (e.g., more Fatigue, more Physical Function), meaning a worse outcome.

Summary scores of quality-of-life measures, Short Form- 36 (SF-36); The RAND 36-Item Health Survey (Version 1.0) taps eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Coding of each item varies across the measure however all items are scored so that a high score defines a more favorable health state.

Visual Analog Scale (VAS) pain scores are asked with 4 questions, current pain, worst pain, least pain and average pain since the subjects last visit. The scale is 0 to 10 where 0 is "no pain" and 10 is "worst imaginable pain", 10 would indicate a worse outcome.

Percentage of subjects with a decrease in depression symptoms.

Percentage of subjects with a decrease in anxiety symptoms.

Sleep quality (Pittsburg Sleep Quality Index (PSQI)) score (and subscale scores). The PSQI is a 19-item, self-rated questionnaire designed to measure sleep quality and disturbance over the past month in clinical populations.17 The 19 items are grouped into 7 components, including (1) sleep duration, (2) sleep disturbance, (3) sleep latency, (4) daytime dysfunction due to sleepiness, (5) sleep efficiency, (6) overall sleep quality, and (7) sleep medication use. Each of the sleep components yields a score ranging from 0 to 3, with 3 indicating the greatest dysfunction. The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score (referred to as global score) indicating worse sleep quality.

Profile of Mood States (POMS) score (and subscale scores). The POMS is a 40 item questionnaire assessing mood. The scale is a 5 point scale ranging from "Not at All" (0), "A Little" (1), "Moderately" (2), or "Quite a Lot" (3) or "Extremely" (4). Scores for the seven subscales are calculated by summing the numerical ratings for items that contribute to each subscale. Two of the items on the Esteem-related Affect (ERA) subscale are reverse-scored prior to being combined with the other items. They are all added or subtracted based on the subscale (TMD = [TEN+DEP+ANG+FAT+CON] - [VIG+ERA]. ) to obtain total mood disturbance. A higher score would indicate a negative outcome.