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A four arm multicentre trial recruited 259 people with subacute low back pain. The duration of symptoms at baseline was more than six weeks but less than three months. Patients were randomised to receive a combination of 12 real or sham exercise sessions with a physiotherapist and three real or sham advice sessions over six weeksweeks.
Compared with the sham interventions, real exercise and real advice separately reduced pain (advice: −7 points, 95% CI −1.2 to −0.2, P=0.011; exercise: −0.8 points, −1.3 to −0.3, P=0.004) and improved global perceived effect (advice: 0.8 points, 0.3 to 1.2, P<0.001; exercise: 0.5 points, 0.1 to 1.0; P=0.017) in people with subacute low back pain, but only at six weeks . Compared with sham exercise and sham advice, a combination of real exercise and real advice also improved these outcomes at six weeks (pain: −1.5 points, −2.2 to-0.7, P=0.001; global perceived effect: 1.3 points, 0.7 to 1.9, P<0.001), in addition to function (effect 1.1 points, 0.3 to 1.9, P=0.006).
However, all the effects were smaller at three months, and most were non-significant at 12 months of follow-up. At 12 months, however, the combination of real exercise and real advice significantly improved function (effect 1.1 points, 0.3 to 1.8, P=0.005) when compared with a combination of sham exercise and sham advice. Although both interventions are widely used for low back pain, this is the first trial to compare the effects of exercise and advice with placebo in people with strictly defined subacute low back pain.