The aim of the study was to assess the effectiveness of surgical treatment for degenerative lumbar spinal stenosis (LSS) as compared with non-operative measures. Four university hospitals contributed, after agreement on study protocol, surgical rationale and non-operative procedures (For details, see Spine2007;32:1–8). Ninety-four patients were randomized into a surgical or nonoperative treatment group, 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments, in 10 patients augmented with transpedicular instrumented fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (ODI, scale 0–100). Intensity of leg and back pain (scales 0–10), as well as self-reported walking ability, were recorded at randomization and at follow-ups at 6, 12, 24 months and on average 6 years after the randomization. At the 2-year follow-up, back and leg pain scales and ODI had improved more in the surgical than the nonoperative group (p-values for global difference < 0,01). At the 6-year follow-up the mean difference in ODI in favor of surgery was 9.5 (95% confidence interval 0.9–18.1). However, the intensity of pains did not any-more differ between the two treatment groups at the 6-year follow-up. Walking ability did not differ between the treatment groups at any time point. Of the 44 patients in the nonoperative group, 4 had been subjected to surgery within two years after randomization because of persistent symptoms.

We conclude that surgical treatment improves functional ability in lumbar spinal stenosis. We emphasize that improvement also occurs after nonoperative measures. We recommend starting treatment with non-operative measures during a 2-year surveillance period, as during this period only 10 per cent of the patients will need surgical intervention.

Since neurological claudication is a major symptom in lumbar spinal stenosis (LSS), walking distance is commonly used as a measure of the severity and surgical outcome in LSS. The aim of this study was to compare self-reported and treadmill-measured walking distances in a trial, in which 94 patients with moderate LSS had been randomized into conservative and surgical treatment. Among the 44 patients in conservative treatment, the treadmill-measured walking distance was more reproducible after 6 months than the self-reported distance; the intraclass correlation coefficients were 0.75 and 0.41, respectively. Among all the patients at baseline, the agreement between self-reported and measured walking distance was satisfactory (intraclass correlation 0.57), although male patients overwhelmed their performance by 200 meters. Such a shift was not found in women. For walking distance categorized as < 400, 400–1249 and ≥ 1250 meters, there was a fair agreement between self-report and treadmill (weighed kappa 0.42). However, when the analysis was restricted to those whose walking distance was restricted to < 1250 meters, the corresponding agreement was poor (intraclass correlation 0.26). The self-reported walking distance was closely correlated with Oswestry index at baseline (r = 0.26), and changes in these outcomes from randomization to the follow-up of 6 months showed a strong correlation with each other (r = 0.37). We conclude that walking distance is a fundamental element of disability in LSS. Self-reported walking distance seems to be an appropriate clinical tool, but its limited precision in relation to treadmill-measured distance must be considered, when walking ability is severely restricted.

Aims: To evaluate the efþcacy and safety of inßiximab, a monoclonal chimeric antibody against TNFα, for the treatment of severe sciatica. Background: Evidence from animal studies indicates that tumour necrosis factor (TNF)α plays a role in the pathophysiology of sciatica. Anti-TNFα therapy has not been previously evaluated in sciatic patients. Methods: 10 patients with disc herniation-induced severe sciatica received inßiximab (Remi-cade¨; 3mg/weight-kg) intravenously over 2 hours. The outcome was assessed at 1 hour, 1 week, 2 weeks, 1 month and 3 months after the infusion, and was compared to historical controls consisting of 62 patients who received saline in a trial of periradicular inþltration for sciatica. Leg pain was the primary outcome, with over 75% decrease from baseline score constituting a painless state. Fisherñs exact test and repeated measures analysis of variance were used for statistical analysis. Results: One hour after the infusion, leg pain had decreased by 50%. At 2 weeks, 60% of patients in the inßiximab group were painless vs. 16% of control patients (P = 0.006). The difference was sustained at 3-months (90% vs. 46%; P = 0.014). Inßiximab was superior over the whole follow-up period in leg pain (P=0.003) and back-related disability (P=0.004). At 1 month, every patient in the inßiximab group had returned to work whereas 38% of controls were still on sick leave (P=0.02). None of the patients treated with inßiximab underwent surgery during the follow-up. No immediate or delayed adverse drug reactions, or any adverse effects due to medication were observed. Conclusions: Anti-TNFα therapy is a promising treatment option for sciatica. There is an urgent need for a ran-domised controlled trial to evaluate if these promising early results can be conþrmed.

Aims: Hallux valgus operations cannot always be carried out immediately due to long waiting lists. Effect of waiting for hallux valgus surgery has not been under investigation in a randomized controlled study. Methods: 209 consecutive patients (mean age 48 years, 93% female) with a painful hallux valgus were randomized in three groups: immediate operation or one year waiting time with or without foot orthoses. The follow-up period was 2 years. Main outcome measure was pain intensity during walking (VAS 0 to 100). Results: During the þrst year 64/71, 0/69 and 4/69 patients were operated in surgery, orthosis and no-orthosis groups, respectively, and during the two-year follow-up 66, 43 and 48, respectively. At one-year follow-up the pain was least intensive in surgery group. At two year follow-up the pain intensity was similar in all groups. The satisfaction with treatment was the best in the surgery group and orthosis group as was the fact also with the cosmetic disturbances. The total costs of care were similar in all groups. Conclusion: Immediate operation is superior to delayed operation or foot orthoses, as the beneþt from surgery is obtained already during the þrst follow-up year. If this, however, because of limited operative capacity is not possible, one year waiting, with or without orthois, does not jeopardize the results.

Aims: To clarify the effectiveness of surgical intervention (S) as compared to non-operative measures (NO) in the treatment of patients with moderate lumbar spinal stenosis. Patients and methods. Four university hospitals agreed upon classiþcation of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles and follow up protocols. Moderate stenosis was deþned as a longstanding (> 6 months) low back disorder with pain radiating to the lower limbs and buttocks, aggravated by walking. Narrowing of the dural sac was sagittally < 10 mm or the cross-sectional area < 75 mm2. 94 patients were randomized in the two groups. Results. Sex-adjusted average score of pain in the lower limbs (VAS scale, 0–10) before treatment was 6.5, and 6.3 in the S and NO groups, respectively. Between group difference favoured S group in the follow-up: at six month 2,4 (95% CI 0,9 to 3,8), and at 12 month 1,4 (95% CI 0,1 to 2,8). Sex-adjusted Oswestry score before treatment was 33,0, and 35,8 in the S and NO groups, respectively. Again, between group difference favoured S group: at six months follow-up 9.8 (95% CI 3,2 to 16,4) and at 12 months 12,3 (95% CI 5,2 to 19,5). Walking ability did not differ between the two groups: before treatment 32% of the patients in S group and 30% in NO group walked less than 400, at six month follow-up 23% in both groups, and at one year 18%, and 20% in the S and NO groups, respectively. Conclusions: The results indicate a favorable early effect on perceived outcomes after operative treatment, whereas measured walking ability remained largely unaffected.

Introduction: Infliximab, a monoclonal antibody against tumour necrosis factor alfa (TNFα) has been used succesfully in the treatment of rheumatoid arthritis and Crohn’s disease. Recent animal studies suggest that TNFα also has an important role in the pathogenesis of sciatica. The purpose of this study was to evaluate the efficacy and safety of infliximab in the treatment of sciatic patients.

Methods: 10 patients with acute or subacute severe sciatica (duration of symptoms from 2 to 12 weeks) were included. A disc herniation corresponding to symptoms was confirmed by MRI in each case. Patients with previous back operation or with contraindications for infliximab were excluded. A dose of 3 mg/kg body weight of infliximab in saline was infused intravenously over 2 hours. Leg pain (100-mm Visual Analog Scale) was recorded before and one hour after the infusion, and later at 1 week, 2 weeks, 1 month, 3 months and 6 months. Changes in leg pain were compared statistically with 62 historical controls (saline group in a study of periradicular infiltration) using repeated measures analysis of variance. Changes in back pain, back-related disability on Oswestry Index and clinical status were also assessed.

Results: Mean (SD) leg pain before the infusion was 80 (18) mm in the infliximab group. One hour after the infusion, there was a decrease of 49% in leg pain. At 1 week mean leg pain was 26 (21), at 2 weeks 19 (20), at 1 month 18 (19), at 3 months 10 (16) and at 6 months 13 (8). When compared with the historical controls, the difference was in favour of infliximab for leg pain (19 mm; 95% CI, 6 to 32, P=0.005) and for back-related disability on Oswestry (12%; 95%CI, 4 to 20, P=0.003) over the 6 month follow-up period. At the one-month follow-up every patient in the infliximab group had returned to work compared to 38% of control patients (P=0.02). None of the patients treated with infliximab underwent surgery during the follow-up compared to 14 (23%) in the control group (P=0.09). No immediate or delayed adverse drug reactions were observed.

Conclusions: According to this study, a single infusion of infliximab seems to provide immediate, highly effective and safe treatment of sciatica through 6 months. Rapid return to work appears to be fascilitated, and surgery may possibly be avoided in some patients. There is an urgent need for a randomized trial to verify these results.