European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society
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Randomized Controlled Trial Multicenter Study Comparative Study
Comparison of a minimally invasive procedure versus standard microscopic discotomy: a prospective randomised controlled clinical trial.
A Prospective randomised controlled study was done to determine statistical difference between the standard microsurgical discotomy (MC) and a minimally invasive microscopic procedure for disc prolapse surgery by comparing operation duration and clinical outcome. Additionally, the transferability of the results was determined by a bicentric design. The microscopic assisted percutaneous nucleotomy (MAPN) has been advocated as a minimally invasive tubular technique. ⋯ The results demonstrate that a shorter operation duration and concomitant quicker recovery is comprehensible at an experienced minimally invasively operating centre. These advantages could not be found at the transfer centre within 25 minimally invasive procedures. In conclusion both procedures show equal mid term clinical results and the same complication rate even if the suggested advantages for the minimally invasive procedure could not be confirmed for the transfer centre within the framework of this study.
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Randomized Controlled Trial
Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting.
The general population has a pessimistic view of low back pain (LBP), and evidence-based information has been used to positively influence LBP beliefs in previously reported mass media studies. However, there is a lack of randomized trials investigating whether LBP beliefs can be modified in primary prevention settings. This cluster randomized clinical trial investigated the effect of an evidence-based psychosocial educational program (PSEP) on LBP beliefs for soldiers completing military training. ⋯ Sensitivity analyses suggested minimal influence of drop out. In conclusion, soldiers that received the PSEP had an improvement in their beliefs related to the inevitable consequences of and ability to cope with LBP. This is the first randomized trial to show positive influence on LBP beliefs in a primary prevention setting, and these findings have potentially important public health implications for prevention of LBP.
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Randomized Controlled Trial Comparative Study
Does Wallis implant reduce adjacent segment degeneration above lumbosacral instrumented fusion?
Delayed complications following lumbar spine fusion may occur amongst which is adjacent segment degeneration (ASD). Although interspinous implants have been successfully used in spinal stenosis to authors' knowledge such implants have not been previously used to reduce ASD in instrumented lumbar fusion. This prospective controlled study was designed to investigate if the implantation of an interspinous implant cephalad to short lumbar and lumbosacral instrumented fusion could eliminate the incidence of ASD and subsequently the related re-operation rate. ⋯ In this series, the Wallis interspinous implant changed the natural history of ASD and saved the two cephalad adjacent unfused vertebra from fusion, while it lowered the radiographic ASD incidence until to 5 years postoperatively. Longer prospective randomized studies are necessary to prove the beneficial effect of the interspinous implant cephalad and caudal to instrumented fusion. We recommend Wallis device for UCLA degeneration I and II.
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Randomized Controlled Trial Multicenter Study
Timing of surgery for sciatica: subgroup analysis alongside a randomized trial.
Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. ⋯ In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7-3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8-2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.
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Randomized Controlled Trial
Clinic-based training in comparison to home-based training after first-time lumbar disc surgery: a randomised controlled trial.
The effectiveness of physiotherapy after first-time lumbar disc surgery is still largely unknown. Studies in this field are heterogeneous and behavioural treatment principles have only been evaluated in one earlier study. The aim of this randomised study was to compare clinic-based physiotherapy with a behavioural approach to a home-based training programme regarding back disability, activity level, behavioural aspects, pain and global health measures. ⋯ The patients in the clinic-based training group had significantly higher activity levels 12 months after surgery and were significantly more satisfied with physiotherapy care 3 months after surgery compared to the home-based training group. Rehabilitation after first-time lumbar disc surgery can be based on home training as long as the patients receive both careful instructions from a physiotherapist and strategies for active pain coping, and have access to the physiotherapist if questions regarding training arise. This might be a convenient treatment arrangement for most patients.