Optimizing Chronic Pain Management through Patient Engagement with Health-Related Quality-of-Life Measures: A Randomized Controlled Trial

Purpose Chronic low back pain (CLBP) is a common health issue that requires accessible and cost-effective methods of management. Relevant guidelines in the United States emphasize the use of non-pharmacological and non-opioid treatments as first-line interventions. Additionally, health-related quality of life (HRQOL) has been proposed as an emerging measure of CLBP outcomes that may provide important information not captured by conventional measures such as pain intensity or physical function. Recent studies suggest that eHealth interventions to promote patient self-management may improve health outcomes in patients with chronic pain, including low back pain. The primary aim of this randomized controlled trial was to measure the efficacy of an eHealth intervention for HRQOL outcomes in patients with CLBP. Methods Trial participants were recruited from the PRECISION Pain Research Registry from November 2019 through February 2021. These participants met the NIH definition of CLBP, were between 21-79 years of age, and had HRQOL deficits involving sleep disturbance, pain interference, anxiety, depression, and low energy or fatigue (SPADE cluster derived from the Patient-Reported Outcomes Measurement Information System) as evidenced by a baseline score ≥55. A total of 331 participants were randomized to treatment or wait-list control groups. The treatment group received an eHealth intervention, which consisted of an individualized HRQOL report based on the SPADE cluster and subscale scores and an interpretation guide. Outcomes were assessed 3 months after randomization. The primary outcomes were changes in the SPADE cluster and subscale scores. Secondary outcomes included low back pain intensity measured with a numerical rating scale, and back-related disability measured with the Roland-Morris Disability Questionnaire. Changes over time for each outcome measure reported by participants in each group were compared using the Student's t test for statistical significance and Cohen's d statistic for clinical importance. Positive change scores and d-statistics favored the eHealth intervention group. Results There were no significant differences between the eHealth intervention and wait-list control groups for changes over time in any primary or secondary outcome measure. The mean difference between groups in change scores on the SPADE cluster was 0.15 (95% CI, -0.73 to 1.03) (P=0.73). The d statistic for this difference was 0.04 (95% CI, -0.18 to 0.25). The corresponding d statistics for the SPADE subscales ranged from -0.06 (95% CI, -0.27 to 0.16) for anxiety to 0.11 (95% CI, -0.10 to 0.33) for sleep disturbance. Conclusions The eHealth intervention studied herein did not achieve statistically significant or clinically important improvements in any of the primary or secondary outcome measures. However, almost three-fourths of participants were enrolled after onset of the COVID-19 pandemic and may have had limited access to treatments for low back pain or to facilities or services needed to act on the information or recommendations derived from the HRQOL report. Thus, the validity and generalizability the findings may have been limited by the unforeseen onset and impact of the COVID-19 pandemic shortly after beginning the trial.