BACKGROUND: Many treatments are recommended for chronic low back pain (cLBP), but comparative effectiveness and adaptive interventions have not been adequately studied.
OBJECTIVE: To compare the effectiveness of physical therapy (PT) and cognitive behavioral therapy (CBT) as first-stage treatment and switching treatments versus mindfulness as second-stage treatment.
DESIGN: Multisite sequential, multiple-assignment, randomized trial with 52-week follow-up. (ClinicalTrials.gov: NCT03859713).
SETTING: Three health care systems.
PARTICIPANTS: Adults with cLBP.
INTERVENTION: Eight weeks of PT or CBT in stage I. Nonresponders were randomly assigned again to 8 weeks of stage II treatment.
MEASUREMENTS: Co-primary outcomes were function measured with the Oswestry Disability Index (ODI; range, 0 to 100) and pain intensity (range, 0 to 10) at 10 (stage I), 26, and 52 (stage II) weeks.
RESULTS: The sample comprised 749 participants. After 10 weeks, there was greater improvement in function in the PT group (adjusted mean ODI difference, 2.8 [96% CI, 0.38 to 5.1]) and no difference in pain intensity (adjusted mean difference, 0.32 [99% CI, -0.07 to 0.71]). The mean difference in ODI was below the minimum important difference of 6. After 52 weeks, there were no differences in stage II treatments for nonresponders for either function (adjusted mean ODI difference, 0.43 [96% CI, -0.29 to 2.4]) or pain intensity (adjusted mean difference, -0.05 [96% CI, -0.58 to 0.48]).
LIMITATIONS: Treatment initiation was lower than expected, particularly for CBT and for nonresponders. Participants were not blinded. Sample size was reduced due to the COVID-19 pandemic.
CONCLUSION: Patients with cLBP may benefit from PT as first-line treatment. Among nonresponders, there were no differences in second-stage treatment with mindfulness or switching.
PRIMARY FUNDING SOURCE: Patient-Centered Outcomes Research Institute (PCORI).
| Discipline Area | Score |
|---|---|
| Physician |  |
Physician rater
An important study that suggests that PT is more effective than CBT as first-line therapy for chronic low back pain. However, the poor uptake of first-line therapy and second-line therapy precludes making any conclusions with even moderate certainty.
Physician rater
This trial supports using PT as an initial approach for cLBP, recognising that its effect is modest and that function tends to improve before pain. For those who do not respond, the trial provides no specific algorithm: shared decision-making, taking into account access and patient preferences, should be the default. Procedural and pharmacological choices remain the responsibility of physicians, but the data indicate that strong engagement in rehabilitation could slightly reduce the need for injections later.
Physician rater
PT modestly surpassed CBT in function at 10 weeks, with an ODI difference of 2.8 (below the MID of 6), showing consistent yet small benefits across PROMIS domains that lasted up to 52 weeks. Pain intensity was similar. Among nonresponders, mindfulness and switching modality performed equally. Adaptive sequences starting with PT outperformed those starting with CBT, regardless of stage II decision. A key finding is implementation failure: only 58–68% initiated stage I treatment and 45% moved to stage II, with wait times exceeding 30 days. While PT remains the preferred first option, barriers to access and engagement rather than modality choice limit progress. Integrated multidisciplinary care might be more effective than stepped algorithms.
, McMaster University