Design: Pragmatic randomised clinical trial
Population: 451 adults with chronic low back pain in US primary care
Primary outcome: Change in PEG score at 6 months
Effect: Between-group difference -0.62 (95% CI -1.02 to -0.23); MCID of 1 not met

OPTIMUM was a pragmatic randomised trial in primary care clinics in three US states. It assigned 451 adults with chronic low back pain to an eight-week telehealth mindfulness group programme, run within primary care, or usual care.

The primary outcome was change in the PEG score (pain, enjoyment of life, general activity) at six months. It fell by 1.21 points with the programme and 0.59 with usual care, a difference of 0.62 (95% CI 0.23 to 1.02). The advantage was present at eight weeks and at 12 months, but at no point reached the one-point difference the investigators had set as clinically important.

The result is modest. Mindfulness is a low-risk option to offer alongside exercise, not a replacement for it, and the group format may make it easier to provide.

Offer mindfulness as one non-drug option for chronic low back pain, alongside exercise and education.
Set expectations: the average extra benefit was small.
Consider group telehealth formats where individual sessions are not available.
Keep opioids out of first-line treatment for chronic low back pain.

Why it matters

It shows mindfulness can be delivered at scale within primary care, but tempers expectations about how much it adds.

The statistics, in plain English

The difference was statistically significant, meaning unlikely to be chance, but smaller than the one-point change the investigators judged patients would notice. Some individuals may gain more than the average; the trial does not identify who.