Abstract: We included a total of 24 randomised controlled trials (reported in 39 published research articles or abstracts) in this review. The trials included 2352 participants with lumbar spinal stenosis with symptoms of neurogenic claudication. None of the included trials compared surgery with no treatment, placebo or sham surgery. Therefore, all included studies compared two or more surgical techniques. We judged all trials to be at high risk of bias for the blinding of care provider domain, and most of the trials failed to adequately conceal the randomisation process, blind the participants or use intention-to-treat analysis. Five trials compared the effects of fusion in addition to decompression surgery. Our results showed no significant differences in pain relief at long-term (mean difference (MD) -0.29, 95% confidence interval (CI) -7.32 to 6.74). Similarly, we found no between-group differences in disability reduction in the long-term (MD 3.26, 95% CI -6.12 to 12.63). Participants who received decompression alone had significantly less perioperative blood loss (MD -0.52 L, 95% CI -0.70 L to -0.34 L) and required shorter operations (MD -107.94 minutes, 95% CI -161.65 minutes to -54.23 minutes) compared with those treated with decompression plus fusion, though we found no difference in the number of reoperations (risk ratio (RR) 1.25, 95% CI 0.81 to 1.92). Another three trials investigated the effects of interspinous process spacer devices compared with conventional bony decompression. These spacer devices resulted in similar reductions in pain (MD -0.55, 95% CI -8.08 to 6.99) and disability (MD 1.25, 95% CI -4.48 to 6.98). The spacer devices required longer operation time (MD 39.11 minutes, 95% CI 19.43 minutes to 58.78 minutes) and were associated with higher risk of reoperation (RR 3.95, 95% CI 2.12 to 7.37), but we found no difference in perioperative blood loss (MD 144.00 mL, 95% CI -209.74 mL to 497.74 mL). Two trials compared interspinous spacer devices with decompression plus fusion. Although we found no difference in pain relief (MD 5.35, 95% CI -1.18 to 11.88), the spacer devices revealed a small but significant effect in disability reduction (MD 5.72, 95% CI 1.28 to 10.15). They were also superior to decompression plus fusion in terms of operation time (MD 78.91 minutes, 95% CI 30.16 minutes to 127.65 minutes) and perioperative blood loss (MD 238.90 mL, 95% CI 182.66 mL to 295.14 mL), however, there was no difference in rate of reoperation (RR 0.70, 95% CI 0.32 to 1.51). Overall there were no differences for the primary or secondary outcomes when different types of surgical decompression techniques were compared among each other. The quality of evidence varied from 'very low quality' to 'high quality'. The results of this Cochrane review show a paucity of evidence on the efficacy of surgery for lumbar spinal stenosis, as to date no trials have compared surgery with no treatment, placebo or sham surgery. Placebo-controlled trials in surgery are feasible and needed in the field of lumbar spinal stenosis. Our results demonstrate that at present, decompression plus fusion and interspinous process spacers have not been shown to be superior to conventional decompression alone. More methodologically rigorous studies are needed in this field to confirm our results.

Plain-language summary: We included all trials that compared any surgical technique with no surgery or placebo surgery, and also trials comparing different surgical techniques with each other, including fusion and spinal implants. All the patients included in these studies were diagnosed with lumbar spinal stenosis and had symptoms in the leg or thigh that worsened by walking or standing and were generally relieved by a change in position, such as bending forward or sitting. The main measure we used to compare how well the different types of surgery worked was how much less pain people felt as they went about their daily lives. We also looked at whether their leg pain improved, how much blood they lost during surgery, how long the surgery took, how long they had to stay in hospital, how many patients had to have another operation for the problem and how much the treatment cost. Twenty-four randomised controlled trials were included with a total of 2352 people. We did not find trials that compared surgery with no treatment or placebo surgery, so all included trials compared different surgical techniques. The quality of the evidence from these studies varied from very low quality to high quality. This large variation was mainly due to different study protocols, surgical techniques and quality of reporting according to the 'Risk of bias' assessment. We found that patients who had decompression plus fusion fared no better than those who underwent decompression surgery alone. In fact, decompression plus fusion resulted in more blood loss during surgery than decompression alone. Although the spinal spacers were slightly better than decompression plus fusion in terms of improvements on daily activities, there were no differences when they were compared with decompression alone. Finally, we found no differences between different forms of decompression.