Abstract
BACKGROUND: Pain is prevalent among adults with neurofibromatoses (NF) and hinders quality of life. Pain management for NF is predominantly pharmacological and often ineffective. Psychosocial treatments improve pain outcomes in other chronic illness populations but have not been developed and tested in fully powered efficacy trials among adults with NF. Using data from a fully powered randomized clinical trial of an 8-week mind-body program (Relaxation Response Resiliency Program for NF [3RP-NF]) versus a health education control (HEP-NF), we examined (1) improvements in pain intensity and pain interference, and (2) mechanisms underlying improvements. METHODS: Participants (N = 210, M (age) = 42.6, 73.4% female) were randomized to 3RP-NF versus HEP-NF. They completed measures of pain intensity, pain interference, and putative mechanisms (eg, mindfulness, coping, and social support) at baseline, post-intervention, 6-month, and 12-month follow-ups. RESULTS: There was a statistically significant change in pain interference over time F(3, 537.06) = 7.21, P < .001, but not pain intensity. Neither group (3RP-NF vs. HEP-NF) nor the group-by-time interaction predicted change in pain interference. While the group-by-time interaction was not statistically significant across all time points, planned post-hoc analyses probing the interaction at specific time points revealed a statistically significant decrease in pain interference from baseline to post-intervention (P < .001), which was sustained (ie, no subsequent change) from post-intervention through 6-month (P = 1.00) and 12-month follow-ups (P = 1.00) in the 3RP-NF group. The HEP-NF group had no significant changes in pain intensity or interference over time. The association between group (3RP-NF) and decreased pain interference from baseline to post-intervention was fully mediated by change in coping over the same period. CONCLUSIONS: Participation in the 3RP-NF is associated with sustained improvement in pain interference. Improvement occurred through increased coping. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03406208. TRIAL REGISTRATION URL: https://clinicaltrials.gov/study/NCT03406208.