Abstract
OBJECTIVE: Trials testing promising interventions in knee osteoarthritis (OA) often fail to show pain reductions. This may be due to change in activity whereby a person's pain decreases, leading them to increase their activity levels, in turn increasing pain back to baseline levels. Using data from a trial of a beneficial treatment for knee pain, we explored whether activity changes might mask a treatment's effect on pain, by looking at whether activity levels increased with effective treatment and whether change in activity level related to change in pain. DESIGN: During the InRespond trial (ISRCTN55059760) participants wore an accelerometer for 7 days before and during treatments. We assessed change in pain on treatment using scores for overall knee pain and pain in a nominated pain-aggravating activity both in the last week and evaluated change in different types of activity using accelerometer data. Principal components analysis tested whether change in activity and pain outcomes were correlated and created composites combining them. We then tested whether activity, pain or the composites showed a treatment effect, and examined their responsiveness. RESULTS: In the 61 participants (mean age 64.5 years, 38% women, mean overall knee pain score 5.08 (0-10)), activity levels mostly decreased during the trial. Principal component analyses suggested that pain and activity did not correlate highly, loading on different components. Treatment that showed significant effects on pain did not show similar effects on either activity (e.g. the active treatment had a slightly greater reduction in total steps taken than the control treatment (difference 1942.6 steps/week, p = 0.42) nor on composites combining activity and pain. Pain outcomes were the most responsive; static loading (standing) outcomes were the most responsive activity outcome. CONCLUSION: We found no evidence to support the hypothesis that activity levels increase during effective OA treatment and might account for the negligible pain effects of OA treatments.