Trial Outcomes & Findings for Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis (NCT NCT04343716)

Investigating Racial Differences in Diet Benefits for Knee Osteoarthritis

The Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain score is a 0-20 score with higher scores reflecting more severe pain. Questions 1-5 are summed to provide a WOMAC pain score. Change scores will be calculated. The week 6 WOMAC pain subscale score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.

The Brief Pain Inventory (BPI) pain score is a 0-40 score with higher scores reflecting more pain. Questions 3-6 are scored on 0-10 and are summed to provide an overall pain score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.

The Western Ontario and McMaster Osteoarthritis Index (WOMAC) function score is a 0-68 score with higher scores reflecting greater impairment in function. The 17 items assess difficulty performing specific tasks and are scored 0-4. These scores are summed to provide a WOMAC function score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.

The Brief Pain Inventory (BPI) pain interference score is a 0-90 score with higher scores reflecting more pain. Question 9A-I are scored on 0-10 and are summed to provide an overall pain interference score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.

Before and after the Temporal Summation (TS) task, participants will be asked to rate the intensity of pain in their knee on a 0-100 scale, with "0" representing no pain and "100" representing the most pain imaginable. The difference in the ratings will be considered the evoked pain score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change. A positive number suggests improved pain, whereas a negative value would suggest worsening pain reports.

Before and after the Repeated Chair Stand (RCS) task, participants will be asked to rate the intensity of pain in their knee on a 0-100 scale, with "0" representing no pain and "100" representing the most pain imaginable. The difference in the ratings will be considered the evoked pain score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change. Positive values suggest improved pain, whereas negative values suggest worsening pain.

The Patient Health Questionnaire 9 (PHQ-9) depression score is a 0-27 score with higher scores reflecting more severe depression. The 9 items are scored on a 0-3 scale and are summed to provide an overall depression score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change.

The time to complete the Repeated Chair Stand (RCS) task will be measured with a stopwatch. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change. Positive scores reflect faster completion at the week 6 time point, whereas negative scores reflect slower completion at the last time point. The time to complete the chair stands is unlimited and represented in seconds.

Before and after the Timed Walk (TW) task, participants will be asked to rate the intensity of pain in their knee on a 0-100 scale with "0" representing no pain and "100" representing the most pain imaginable. The difference in the ratings will be considered the evoked pain score. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change. Positive values suggest improved pain, whereas negative values suggest worsening evoked pain.

The time to complete the Timed Walk (TW) task will be measured with a stopwatch. The week 6 score was subtracted from the baseline score to obtain a difference score. Numbers closer to zero indicate no change. The time allowed is unlimited and represented in seconds. Positive values suggest faster time to completion at the week 6 time point, whereas negative values suggest slower time to completion at the week 6 test.

The total composite score from the Short Form 36. The scale is scored from 0-100 with 100 representing high quality of life and 0 representing very low quality of life. This is completed by summing the 8 subscales and dividing by 8. The week 6 score is subtracted from the baseline score. Final scores close to 0 suggest no change. Positive scores suggest worsening quality of life, whereas negative scores suggest improved overall quality of life.

The change score on a 0-100 visual analogue scale following the timed up and go task. On the scale, "0" represents no pain and "100" represents the most pain imaginable. A difference score will be calculated by subtracting the score at week 6 from the baseline score. Positive values would suggest improved pain and negative values would suggest worsening pain, with values around zero representing no change.