Optimizing Chronic Pain Management through Patient Engagement with Quality of Life Measures: A Randomized Controlled Trial | John C. Licciardone, DO, MS, MBA, holds the Osteopathic Heritage Foundation Richards-Cohen Distinguished Chair in Clinical Research at the University of North Texas Health Science Center. He directs the Osteopathic Research Center and its PRECISION Pain Research Registry, which studies precision medicine and biopsychosocial aspects of pain.
Executive summary: Health-related quality of life (HRQOL) represents a new paradigm for guiding chronic pain management. This study aimed to assess the value and utility of an eHealth intervention for patients with chronic low back pain (CLBP) that was based on HRQOL measures and to assess clinical outcomes associated with its use. Subgroup analyses according to the type of physician (i.e., osteopathic vs. allopathic physician) who provided medical care for CLBP were also conducted to identify and further explore any significant interaction effects.
The Optimizing Chronic Pain Management through Patient Engagement with Quality of Life Measures Trial (OPTIQUAL) was conducted by the Osteopathic Research Center using its Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation. Registry participants with CLBP were screened for eligibility from Nov. 2019 through Feb. 2021. Trial participants were randomized to the experimental treatment group that received an eHealth intervention consisting of a HRQOL report and interpretation guide, or to the control treatment group that was placed on a wait list to receive the eHealth intervention after completing the trial. The eHealth intervention on HRQOL involved the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, low energy/fatigue).
The eHealth intervention was assessed by surveying the experimental treatment group about the value and utility of the HRQOL report. The overall value of the report was rated from 0 (worst score) to 100 (best score). The clinical outcome measures in the trial were recommended by the National Institutes of Health Task Force on Research Standards for Chronic Low Back Pain. The primary outcomes involving HRQOL were derived from the SPADE cluster of the Patient-Reported Outcomes Measurement Information System. The two secondary outcome measures involved low back pain intensity and back-related functioning. A numerical rating scale was used to measure low back pain intensity. The Roland-Morris Disability Questionnaire was used to measure back-related disability.
A total of 331 participants were randomized, including 166 and 165 in the experimental and control treatment groups, respectively. The survey for value and utility of the eHealth intervention was completed by 158 (95.2%) of participants randomized to the experimental treatment group. The mean overall value of the report was 63.7 (SD, 26.7). A total of 36 (23%) participants shared the report with the physician who treated their CLBP.
The primary and secondary outcome measures were available for 326 (98.5%) trial completers, including 164 (98.8%) and 162 (98.2%) completers in the experimental and control treatment groups, respectively. There were no significant differences between the experimental and control treatment groups for changes over time in any primary or secondary outcome measure. Correspondingly, there were no clinically important differences between treatment groups on any measure. No serious adverse events were reported during the trial. An intention-to-treat analysis was not performed because there were virtually no missing data attributable to attrition during the trial.
There are at least two possible explanations for the negative findings of the study. The prior feasibility trial recruited participants from August 2019 through January 2020, when all registry participants resided in Texas. However, the OPTIQUAL participants were recruited from the 48 contiguous states and District of Columbia. Nevertheless, it is seems unlikely that clinical outcomes of CLBP would have been substantially affected by this research design enhancement. More likely, the clinical outcomes were impacted by onset of the COVID-19 pandemic on March 13, 2020. Because almost three-fourths of participants in the trial were enrolled during the pandemic, they may have had limited access to CLBP treatments. This may have attenuated differences in outcomes between the experimental and control treatment groups that would otherwise have been observed if the pandemic had not occurred.
There were no significant subgroup differences observed in the reported value and utility of the eHealth intervention, or in the primary or secondary outcome measures, based on the type of physician provider for CLBP. Again, it is possible that decreased access to health care (including osteopathic manipulative treatment) during the COVID-19 pandemic may have attenuated any osteopathic vs. allopathic physician interaction effects relating to the association between treatment group assignment and outcomes for HRQOL, low back pain intensity and back-related functioning.
Despite several strengths attributable to using the registry to conduct this randomized controlled trial, the validity and generalizability of its findings may have been limited by the unforeseen onset and impact of the COVID-19 pandemic shortly after beginning the trial.