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 Clinical Trial
The General Function Score: a useful tool for measurement of physical disability. Validity and reliability.
The General Function Score (GFS) is a disease-specific instrument consisting of nine items focusing on strict physical activities of daily living. It is intended as an alternative to the more complex scores of disability (such as the Oswestry Disability Index), serving as a complement to the quality of life instruments in the study of low back pain (LBP). It was developed from an original 17-item questionnaire, of which 11 of the items were tested for criterion validity in an observer-supervised performance test. ⋯ The GFS showed a high responsiveness to difference and change. The effect size was 0.82-0.96 in surgically treated disc herniation and 0.55-0.85 in spondylolisthesis. The GFS is a highly valid and reliable instrument with good responsiveness and feasibility, useful for evaluation of physical disability.
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Randomized Controlled Trial Comparative Study Clinical Trial
Conservative treatment versus surgery in spondylotic cervical myelopathy: a prospective randomised study.
A prospective randomised 2-year study was performed to compare the conservative and operative treatment of mild and moderate forms of spondylotic cervical myelopathy (SCM). Forty-eight patients presenting with the clinical syndrome of SCM, with a modified Japanese Orthopaedic Association (mJOA) score of 12 points or more, were randomised into two groups. Group A, treated conservatively, consisted of 27 patients, mean age 55.6 +/- 8.6 years, while group B was treated surgically (21 patients, mean age 52.7 +/- 8.1 years). ⋯ A comparison of the two groups showed no significant differences in changes over time in mJOA score or quantified gait, but there were significant differences in the score of daily activities recorded by video at 24 months, which was a little lower in the surgical group, and also in RR and subjective evaluation, which were both worse in the surgical group at months 12 and 24. However, at month 6, this last parameter was significantly better in the surgical than in conservative group. Surgical treatment of mild and moderate forms of SCM in the present study design, comprising the patients with no or very slow, insidious progression and a relatively long duration of symptoms, did not show better results than conservative treatment over the 2-year follow-up.
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Randomized Controlled Trial Comparative Study Clinical Trial
Accuracy of pedicle screw insertion with and without computer assistance: a randomised controlled clinical study in 100 consecutive patients.
We performed a randomised controlled study to assess the accuracy of computer-assisted pedicle screw insertion versus conventional screw placement under clinical conditions. One hundred patients scheduled for posterior thoracolumbar or lumbosacral pedicle screw instrumentation were randomised into two groups, either for conventional pedicle screw placement or computer-assisted screw application using an optoelectronic navigation system. From the computer-assisted group, nine patients were excluded: one because of an inadequate preoperative computed tomography study, seven because of problems with the specific instruments or the computer system, and one because of an intraoperative anesthesiological complication. ⋯ Pedicle perforations of more than 4 mm were found in 1.4% (4/277) of the screw insertions in the conventional group, and none in the computer-assisted group. Complications not related to pedicle screws were two L5 nerve root lesions, one end plate fracture, one major intraoperative bleeding and one postoperative death in the conventional group, and one deep infection in the computer-assisted group. In conclusion, pedicular screws were inserted more accurately with image-guided computer navigation than with conventional methods.
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Randomized Controlled Trial Comparative Study Clinical Trial
Single-blind randomised controlled trial of chemonucleolysis and manipulation in the treatment of symptomatic lumbar disc herniation.
This single-blind randomised clinical trial compared osteopathic manipulative treatment with chemonucleolysis (used as a control of known efficacy) for symptomatic lumbar disc herniation. Forty patients with sciatica due to this diagnosis (confirmed by imaging) were treated either by chemonucleolysis or manipulation. Outcomes (leg pain, back pain and self-reported disability) were measured at 2 weeks, 6 weeks and 12 months. ⋯ Crude cost analysis suggested an overall financial advantage from manipulation. Because osteopathic manipulation produced a 12-month outcome that was equivalent to chemonucleolysis, it can be considered as an option for the treatment of symptomatic lumbar disc herniation, at least in the absence of clear indications for surgery. Further study into the value of manipulation at a more acute stage is warranted.
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Randomized Controlled Trial Clinical Trial
Expanded polytetrafluoroethylene membrane for the prevention of peridural fibrosis after spinal surgery: a clinical study.
Peridural fibrosis developing after laminectomy may cause pain that can necessitate reoperation. Many materials have been used as a barrier to invasion of fibrous tissue into the vertebral canal, but the ideal material has not been found. Various studies in animals have achieved favourable results with an expanded polytetrafluoroethylene (ePTFE) membrane. ⋯ Significantly more seromas occurred in the ePTFE group (P = 0.0002). There were no infections or other complications in either group. The results showed that placement of an ePTFE spinal membrane over the laminectomy defect produced by lumbar spine surgery provided a physical barrier to invasion of fibrous tissue into the vertebral canal, and patients with the membrane had less postoperative radicular pain.