IMPORTANCE: Back pain is among the most common, disabling, and costly conditions managed in primary care in the US, but current treatment options often do not provide adequate relief. Mindfulness-based interventions have demonstrated effectiveness in individuals with chronic low back pain (CLBP); however, mindfulness remains underused in part because it is not integrated into most outpatient care models.
OBJECTIVE: To assess whether persons with CLBP participating in a mindfulness group medical visit intervention experience significantly improved pain intensity and interference compared with those receiving usual care.
DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial, Optimizing Pain Treatment in Medical Settings Using Mindfulness (OPTIMUM), using a pragmatic approach (designed to evaluate interventions under typical conditions of care) was conducted from May 7, 2021, to November 6, 2024. Adults with CLBP attending primary care clinics in Massachusetts, Pennsylvania, and North Carolina were included.
INTERVENTION: Participants were randomized 1:1 to the OPTIMUM intervention, an 8-week telehealth-delivered mindfulness group medical visit program delivered as part of primary care (intervention), or usual care (controls).
MAIN OUTCOMES AND MEASURES: The primary analysis assessed the between-group difference in the primary outcome of change from baseline to month 6 in the Pain, Enjoyment of Life and General Activity (PEG) scale score. A mean minimal clinically important difference (MCID) in PEG score of at least 1 was considered. Secondary analyses evaluated the between-group differences in change from baseline to week 8 and month 12 in PEG score.
RESULTS: Of 451 participants (mean [SD], 52.1 [14.7] years; 318 [70.5%] female), 224 were randomized to the intervention group and 227 to the control group. All reported moderate pain interference at baseline. In intention-to-treat analyses, the intervention participants had a statistically significant improvement in PEG score from baseline compared with controls at the 6-month primary time point (mean change, -1.21 [95% CI, -1.50 to -0.92] vs -0.59 [95% CI, -0.86 to -0.31]; between-group difference, -0.62 [95% CI, -1.02 to -0.23]; P = .002) and at 8 weeks (mean change, -1.16 [95% CI, -1.44 to -0.88] vs -0.27 [95% CI, -0.53 to -0.003]; between-group difference, -0.89 [95% CI, -1.27 to -0.51]; P < .001) and 12 months (mean change, -1.52 [95% CI, -1.81 to -1.23] vs -0.78 [95% CI, -1.05 to -0.50]; between-group difference, -0.74 [95% CI, -1.14 to -0.34]; P < .001). The MCID was not met at any time point.
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, a telehealth-delivered mindfulness group medical visit program for persons with CLBP resulted in significant improvements in pain intensity and interference compared with usual care; however, these changes did not meet the prespecified mean 1-point MCID between groups. The program incorporated primary care clinicians, was accessible, and is potentially scalable as a nonpharmacologic treatment for CLBP.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04129450.
| Discipline Area | Score |
|---|---|
| Physician |  |
| Psychologist | |
| Rehab Clinician (OT/PT) | |
Physician rater
Chronic back pain: mind-body connection. This interesting trial demonstrated that utilizing mindfulness to alter the perception of pain is a valuable tool. This may have been, in part, due to increased attention by the primary provider. Many providers are not comfortable managing and prescribing for pain. In any case, considering some type of mindfulness intervention looks to be of value.
Physician rater
Population here matches mine: safety-net, majority Black/low-income, long-standing pain. I was pleasantly surprised. Result is statistically significant, MCID not met. Responder analysis more useful than mean difference and should've been the prespecified outcome. The real barrier is visits weren't billed to insurance. FQHCs won't adopt non-billable models, regardless of effect size. Question worth studying: Does conducting these non-billable group visits reduce downstream utilization enough?
Psychologist rater
Well done study on the common and important problem of low back pain. This patient population is not usually seen by psychologists but by primary care. The effects of the treatment were statistically significant but quite modest.
Psychologist rater
This study shows that telehealth mindfulness group medical visits can be integrated into primary care, but the clinical benefit appears modest. The primary outcome was statistically significant, but the between-group improvement did not reach the prespecified threshold for clinical importance. The adapted format, telehealth delivery and limited adherence may have attenuated the effect. It is also plausible that outcomes might differ if the intervention were delivered by a clinical psychologist, but the study did not compare provider types, so this remains speculative. The large proportion of potentially eligible individuals who were not randomized may limit reach and generalizability, although it does not necessarily threaten internal validity. The accompanying editorial appropriately emphasizes feasibility, accessibility and scalability, but arguably gives greater weight to durability and secondary outcomes than to the failure to achieve a clinically meaningful primary effect.
Psychologist rater
The study showing generally modest gains raises more questions: What are the characteristics of the patients who benefitted and those who did not? What other factors could suggest more targeted application of this approach? Did the program need to be longer? Would some patients benefit more from individual treatment?
Rehab Clinician (OT/PT) rater
Several points arise: 1) a heterogeneous chronic low back pain cohort presents a multifactorial and compelling spectre of non-generalizability; 2) statistically significant improvement in Pain, Enjoyment of Life and General Activity (PEG) score does not necessarily project clinically meaningful change; and 3) authors identify that their stated mean clinical difference did not meet their pre-specified mean 1-point difference between groups.
, McMaster University