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
Randomised placebo-controlled trial on the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis.
This is a double blind randomised controlled trial to assess the effectiveness of nasal salmon calcitonin in the treatment of lumbar spinal stenosis. The trial compared the outcome of salmon calcitonin nasal spray to placebo nasal spray in patients with MRI confirmed lumbar spinal stenosis. Lumbar spinal stenosis is one of the commonest conditions encountered by spine surgeons. ⋯ There was no significant difference in walking distance between the two groups, with a mean improvement in walking distance of 21 m in the calcitonin group and 8 m in the placebo group (P = 0.78). At the end of the trial the ODI had improved by a mean of 3.7 points in the calcitonin group and 3.8 points in the placebo group (P = 0.44). This randomised placebo controlled trial has not shown any treatment effect in patients with lumbar spinal stenosis treated with nasal salmon calcitonin.
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Randomized Controlled Trial Comparative Study
Assessment of CAOS as a training model in spinal surgery: a randomised study.
The objectives of this study were (1) to quantify the benefit of computer assisted orthopaedic surgery (CAOS) pedicle screw insertion in a porcine cadaver model evaluated by dissection and computed tomography (CT); (2) to compare the effect on performance of four surgeons with no experience of CAOS, and varying experience of pedicle screw insertion; (3) to see if CT with extended windows was an acceptable method to evaluate the position of the pedicle screws in the porcine cadaver model, compared to dissection. This was a prospective, randomised, controlled and blinded porcine cadaver study. Twelve 6-month-old porcine (white skinned Landrace) lumbar spines were scanned pre-operatively by spiral CT, as required for the CAOS computer data set. ⋯ The experienced general orthopaedic surgeon did not benefit from CAOS (P = 0.5). CT compared to dissection showed an intra-observer reliability of 99.4% and inter-observer reliability of 92.6%. The conclusions of this study were as follows: (1) an increased number of pedicle screws were ideally placed using the CAOS electromagnetic guidance system compared to the conventional freehand technique; (2) junior surgeons benefited most from CAOS; (3) we believe CAOS (Navitrak) with porcine lumbar spines evaluated by post operative CT, represents a useful model for training junior surgeons in pedicle screw placement; (4) experienced spine surgeons, who have never used CAOS, may find CAOS less helpful than previously reported.
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Randomized Controlled Trial Clinical Trial
The value of nerve root infiltration for leg pain when used with a nerve stimulator.
Randomized comparative study of the efficacy of nerve root infiltration (NRI) guided by neurostimulator to find the value of nerve stimulators in nerve root infiltration was undertaken. The response to nerve root infiltration using local anaesthetics and steroid is unpredictable, partly because the exact nerve root giving rise to pain may not be truly infiltrated. The nerve stimulator is advocated to identify the nerve root of concern prior to infiltration. ⋯ When responded there was no significant statistical difference using the Oswestry disability score between both groups. After excluding disc bulge in patients who respond partially to NRI, it is worthwhile repeating the injection. There was a significant difference in response rate when NRI was done under guidance of a nerve stimulator, the stimulator is safe to use and increases the specificity of the block.
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Randomized Controlled Trial
Results of complete hemivertebra excision followed by circumferential fusion and anterior or posterior instrumentation in patients with type-IA formation defect.
To evaluate the results of surgical treatment in patients with unlocked full-segmented hemivertebra treated by excision. Twenty-six patients with a mean age of 12.4+/-1.7 years were included in the study. The mean duration of follow-up was 47.8+/-21.9 months. ⋯ Circumferential fusion could be achieved in all cases. No neurological complication developed, the only complication was delayed wound healing. In view of these data, it is concluded that these techniques can be safely used for this patient group at low thoracic, thoracolumbar, and lumbar levels of vertebral column with high correction rates.
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Randomized Controlled Trial Comparative Study
A randomized clinical trial and subgroup analysis to compare flexion-distraction with active exercise for chronic low back pain.
Many clinical trials on chiropractic management of low back pain have neglected to include specific forms of care. This study compared two well-defined treatment protocols. The objective was to compare the outcome of flexion-distraction (FD) procedures performed by chiropractors with an active trunk exercise protocol (ATEP) performed by physical therapists. ⋯ There were no significant differences between groups on the Roland Morris and SF-36 outcome measures. Overall, flexion-distraction provided more pain relief than active exercise; however, these results varied based on stratification of patients with and without radiculopathy and with and without recurrent symptoms. The subgroup analysis provides a possible explanation for contrasting results among randomized clinical trials of chronic low back pain treatments and these results also provide guidance for future work in the treatment of chronic low back pain.