Evaluating the Benefits of a Second Pain Treatment Following a Clinical Trial

Objective: To examine the value of including an open label phase after a clinical trial of pain treatments by examining participant characteristics and potential benefits. Method: Secondary data analysis. Veterans with chronic pain who completed a randomized controlled trial (RCT) comparing hypnosis, mindfulness meditation, and pain education were invited to participate in an open label phase. Average and worst pain intensities, pain interference, and depression were assessed pre- and postopen label phase; global impressions of change and treatment satisfaction were assessed at postopen label phase only. Results: Of those who were offered the open label phase, 40% (n = 68) enrolled. Enrollees were likely to be older, to have attended more sessions in the RCT, to be satisfied with their first treatment, and to perceive improvement in their ability to manage pain after the RCT. In the open label phase, depression and worst pain decreased across all three treatment conditions. No other improvements were observed. However, most Veterans perceived improvements in pain intensity, ability to manage pain, and pain interference, and were satisfied with the second intervention. Conclusions: There appears to be some value to adding an open label phase to the end of a trial of pain treatments. A substantial portion of study participants elected to participate and reported it to be beneficial. Exploring data from an open label phase can illuminate important aspects of patient experience, barriers to and facilitators of care, as well as treatment preferences. Impact and Implications Effective pain management requires a biopsychosocial approach that includes engagement in multiple treatments including complementary and integrative health (CIH) approaches (e.g., mindfulness meditation). Little is known about who is likely to participate in multiple treatments and whether multiple treatments are beneficial. Following a study that compared the effectiveness of hypnosis, mindfulness meditation, and pain education in Veterans with chronic pain, participants were invited to enroll in a second intervention of their choosing (i.e., one of the study interventions to which they were not randomized). Almost half of the Veterans (40%) enrolled in a second treatment; these Veterans were more likely to be older and to perceive the first treatment as beneficial. Veterans reported less depression and lower worst pain intensity following the second treatment, and they thought that the se