The spine journal : official journal of the North American Spine Society
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Evidence-based clinical practice guidelines (CPGs) for the management of patients with acute mechanical low back pain (AM-LBP) have been defined on an international scale. Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments. To date, the value of implementing full and exclusively CPG-based treatment remains unclear. ⋯ This is the first reported randomized controlled trial comparing full CPG-based treatment, including spinal manipulative therapy administered by chiropractors, to family physician-directed UC in the treatment of patients with AM-LBP. Compared to family physician-directed UC, full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning.
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Randomized Controlled Trial
One-year prognosis in sick-listed low back pain patients with and without radiculopathy. Prognostic factors influencing pain and disability.
Previous research has documented various psychosocial risk factors with influence on outcome in low back pain (LBP) patients, but the value of clinical predictors has been less well documented. ⋯ Disability and pain at 1 year were associated with baseline disability and pain, diffuse tenderness, worrying and health anxiety, compensation claim, fear avoidance, and baseline exercise habits. Only in patients with verified nerve root affection, older age, and restrained alcohol seemed to play a role. The multivariate models were insufficient in predicting disability and pain, partly because disability and pain were also strongly associated with return to work.
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Randomized Controlled Trial
Sex life and sexual function in men and women before and after total disc replacement compared with posterior lumbar fusion.
Sex life and sexual function may be affected by low back pain (LBP). Sexual dysfunction after anterior lumbar fusion is reported in both men and women, but focus is mainly on impaired male biological function (retrograde ejaculation) as this may cause infertility. This has led to concern as to whether anterior surgery should be employed in men, at least in younger age groups. ⋯ Impairment of sex life appears to be related to CLBP. An improvement in sex life after TDR or lumbar fusion was positively correlated to a reduction in LBP. Total disc replacement in this study, performed through an anterior retroperitoneal approach, was not associated with greater sexual dysfunction compared with instrumented lumbar fusion performed either as a PLF or as a PLIF. Sexual function, expressed as orgasm, deteriorated in men in the Fusion group postoperatively, in spite of this group reporting less LBP after 2 years.
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Randomized Controlled Trial Multicenter Study
Effect of intervertebral disc height on postoperative motion and clinical outcomes after Prodisc-C cervical disc replacement.
Cervical total disc replacement (TDR) is an emerging technology. However, the factors that influence postoperative range of motion (ROM) and patient satisfaction are not fully understood. ⋯ Patients with greater disc collapse of less than 4mm preoperative disc height benefit more in ROM after TDR. The optimal postoperative disc height range to maximize ROM is between 5 and 7mm. This optimal range did not translate into better clinical outcome at 2-year follow-up.
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Randomized Controlled Trial Multicenter Study
Prospective, randomized, multicenter Food and Drug Administration investigational device exemption study of lumbar total disc replacement with the CHARITE artificial disc versus lumbar fusion: five-year follow-up.
The CHARITE artificial disc, a lumbar spinal arthroplasty device, was approved by the United States Food and Drug Administration in 2004 based on two-year safety and effectiveness data from a multicenter, prospective, randomized investigational device exemption (IDE) study. No long-term, randomized, prospective study on the CHARITE disc or any other artificial disc has been published to date. ⋯ The results of this five-year, prospective, randomized multicenter study are consistent with the two-year reports of noninferiority of CHARITE artificial disc vs. ALIF with BAK and iliac crest autograft. No statistical differences were found in clinical outcomes between groups. In addition, CHARITE patients reached a statistically greater rate of part- and full-time employment and a statistically lower rate of long-term disability, compared with BAK patients. Radiographically, the ROMs at index- and adjacent levels were not statistically different from those observed at two-years postsurgery.