Feeling reassured after a consultation does not reduce disability or healthcare use in people with acute low back pain: a mediation analysis of a randomised trial.

QUESTION:Does feeling reassured after a consultation reduce future disability or healthcare use in people with acute low back pain (LBP)? DESIGN:Mediation analysis of a randomised, sham-controlled trial. PARTICIPANTS:Two hundred and two people with acute LBP at above average risk (high risk) of developing chronic LBP. INTERVENTION:All participants received guideline-based care from their usual clinician. Participants received two additional 1-hour sessions of patient education focused on emphasising the benign nature of LBP or sham patient education that included active listening only. OUTCOME MEASURES:The two primary outcomes for this study were self-reported disability and healthcare use. The mediator was feeling reassured that LBP was not caused by serious illness. RESULTS:Data from 194 (96%) participants and 178 (88%) participants were included in the analysis for disability and healthcare use outcome models, respectively. Feeling reassured did not mediate the effect of the intervention on disability (indirect effect -0.23, 95% CI -0.71 to 0.18) or healthcare use (indirect effect 0.00, 95% CI -0.04 to 0.04). Patient education intervention increased feeling reassured (1.14 points, 95% CI 0.43 to 1.85) compared with sham patient education. However, the mediator (ie, feeling reassured) did not reduce disability (-0.20 points, 95% CI -0.58 to 0.19) or healthcare use (OR 1.09, 95% CI 0.98 to 1.21). CONCLUSION:Feeling reassured after a consultation did not lead to improvements in disability and healthcare use for people with acute LBP. Clinicians should reflect on the time that they allocate to reassuring their patients and consider reallocating time to other aspects of the consultation that could reduce disability and future healthcare use. TRIAL REGISTRATION:ACTRN12612001180808, study protocol https://osf.io/4tfaz/.