This pragmatic, patient-blinded randomized controlled trial evaluated whether beginning care for severely disabling chronic low back pain (cLBP) with cognitive functional therapy plus psychologist support (CFT+), with optional access to an interdisciplinary pain management program (IPMP) thereafter, produced superior clinical outcomes and cost-effectiveness at 12 months compared with offering IPMP alone.
The primary aim was to determine differences in disability at 12 months, using a predefined clinically important threshold on the Oswestry Disability Index (ODI). Secondary aims included assessment of pain intensity, pain catastrophizing, patient enablement, global impression of change, and an economic evaluation using quality-adjusted life years (QALYs) from the EQ-5D-3L and health care contacts.
The trial (registered as NCT04399772) randomized 133 adults referred to an interdisciplinary pain center for severely disabling cLBP. The design included concealed allocation, patient blinding, and an intention-to-treat analytic approach. Demographic and baseline details are reported in the full article; the abstract reports overall sample size and follow-up completeness for the primary outcome at 12 months.
Participants were randomized to one of two strategies:
CFT+ for 3 months, which combined cognitive functional therapy with psychologist support. After the 3-month CFT+ period, participants could access IPMP if clinically indicated or desired.
IPMP alone, the standard interdisciplinary pain management program available through the pain center.
Details of the content, intensity, or exact components of CFT+ and IPMP (session counts, provider mix, or specific psychological techniques) are provided in the full text and are not fully detailed in the abstract.
The primary outcome was the proportion of patients achieving a ≥8-point improvement on the Oswestry Disability Index (ODI) at 12 months. Secondary outcomes included pain intensity, pain catastrophizing, patient enablement, global impression of change, and cost-effectiveness analyses using QALYs derived from the EQ-5D-3L and health care contact data.
Follow-up ODI data at 12 months were available for 46 patients (70%) in the CFT+ group and 45 patients (67%) in the IPMP group.
The trial used intention-to-treat analysis with between-group comparisons for the primary binary outcome (≥8-point ODI improvement) and for mean ODI change. Confidence intervals and P values are reported for primary outcomes. Secondary outcomes were compared between groups; the economic analysis reported an incremental cost-effectiveness ratio (ICER) for CFT+ versus IPMP.
At 12 months, a clinically meaningful improvement in disability (≥8-point ODI improvement) was observed in 22% of participants randomized to CFT+ and in 18% randomized to IPMP. The absolute difference was 3.9% (95% CI: -12.4% to 20.3%), with a P value of .64, indicating no statistically significant difference. Mean change in ODI also did not differ between arms (difference 0.2 points; 95% CI: -3.8 to 4.2; P = .92).
Follow-up completeness for the ODI at 12 months was reported as 70% in the CFT+ group and 67% in the IPMP group; the abstract does not provide details about reasons for loss to follow-up or methods used to handle missing data beyond intention-to-treat principles.
The trial found no significant between-group differences across the reported secondary outcomes, which included measures of pain intensity, pain catastrophizing, patient enablement, and global impression of change. The abstract does not provide numeric results for these secondary measures; readers should consult the full article for detailed estimates and confidence intervals.
An economic evaluation compared costs and QALYs between the randomized strategies. The reported incremental cost-effectiveness ratio (ICER) for CFT+ versus IPMP was €53,075 per QALY. The abstract indicates QALYs were derived from the EQ-5D-3L and that health care contact data were used for the cost component. The abstract does not report uncertainty intervals around the ICER or specify the perspective (health care, societal) used for costing; these details are available in the full article.
The authors conclude that CFT+ was not superior to IPMP for people with severely disabling cLBP at 12 months. Given similar clinical outcomes and the ICER of €53,075 per QALY for CFT+ versus IPMP, the trial suggests no clear advantage of initiating treatment with CFT+ followed by optional IPMP over offering IPMP alone for this patient population. Clinicians and services should consider these findings in context of local resource constraints, patient preferences, and the full economic evaluation presented in the main paper.
This randomized controlled trial is registered at ClinicalTrials.gov as NCT04399772. The full trial report is published in J Orthop Sports Phys Ther, 2026 Sep;56(9):596-610, doi:10.2519/jospt.2026.14238. The abstract presents primary outcome data, select secondary outcomes, and the headline cost-effectiveness result; consult the full article for complete methods, baseline characteristics, intervention descriptions, sensitivity analyses, and detailed economic results.