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
Prognostic factors for perceived recovery or functional improvement in non-specific low back pain: secondary analyses of three randomized clinical trials.
The objective of this study was to report on secondary analyses of a merged trial dataset aimed at exploring the potential importance of patient factors associated with clinically relevant improvements in non-acute, non-specific low back pain (LBP). From 273 predominantly male army workers (mean age 39 +/- 10.5 years, range 20-56 years, 4 women) with LBP who were recruited in three randomized clinical trials, baseline individual patient factors, pain-related factors, work-related psychosocial factors, and psychological factors were evaluated as potential prognostic variables in a short-term (post-treatment) and a long-term logistic regression model (6 months after treatment). We found one dominant prognostic factor for improvement directly after treatment as well as 6 months later: baseline functional disability, expressed in Roland-Morris Disability Questionnaire scores. ⋯ Less strongly associated with the outcome, but also included in our final models, were supervisor social support and duration of complaints (short-term model), and co-worker social support and pain radiation (long-term model). Information about initial levels of functional disability and fear-avoidance behaviour can be of value in the treatment of patient populations with characteristics comparable to the current army study population (e.g., predominantly male, physically active, working, moderate but chronic back problems). Individuals at risk for poor long-term LBP recovery, i.e., individuals with high initial level of disability and prominent fear-avoidance behaviour, can be distinguished that may need additional cognitive-behavioural treatment.
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Randomized Controlled Trial
Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up.
A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. ⋯ In our study, Trabecular Metal showed a lower fusion rate than the Smith-Robinson technique with autograft after single-level anterior cervical fusion without plating. There was no difference in clinical outcomes between the groups. The operative time was shorter with Trabecular Metal implants.
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Randomized Controlled Trial
Higher risk of dural tears and recurrent herniation with lumbar micro-endoscopic discectomy.
Existing studies on micro-endoscopic lumbar discectomy report similar outcomes to those of open and microdiscectomy and conflicting results on complications. We designed a randomised controlled trial to investigate the hypothesis of different outcomes and complications obtainable with the three techniques. 240 patients aged 18-65 years affected by posterior lumbar disc herniation and symptoms lasting over 6 weeks of conservative management were randomised to micro-endoscopic (group 1), micro (group 2) or open (group 3) discectomy. Exclusion criteria were less than 6 weeks of pain duration, cauda equina compromise, foraminal or extra-foraminal herniations, spinal stenosis, malignancy, previous spinal surgery, spinal deformity, concurrent infection and rheumatic disease. ⋯ Wound infections were similar in group 2 and 3, but did not affect patients in group 1. Overall costs were significantly higher in group 1 and lower in group 3. In conclusion, outcome measures are equivalent 2 years following lumbar discectomy with micro-endoscopy, microscopy or open technique, but severe complications are more likely and costs higher with micro-endoscopy.
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Randomized Controlled Trial
Plasma disc decompression for contained cervical disc herniation: a randomized, controlled trial.
Prospective case series studies have shown that plasma disc decompression (PDD) using the COBLATION SpineWand device (ArthroCare Corporation, Austin, TX) is effective for decompressing the disc nucleus in symptomatic contained cervical disc herniations. This prospective, randomized controlled clinical trial was conducted to evaluate the clinical outcomes of percutaneous PDD as compared to conservative care (CC) through 1 year. Patients (n = 115) had neck/arm pain >50 on the visual analog scale (VAS) pain scale and had failed at least 30 days of failed CC. ⋯ CC: 8.86 + 8.04 vs. 4.24 +/- 3.79, P = 0.0004; 17.64 +/- 10.37 vs. 10.50 +/- 10.6, P = 0.0003, respectively). In patients who had neck/arm pain due to a contained cervical disc herniation, PDD was associated with significantly better clinical outcomes than a CC regimen. At 1 year, CC patients appeared to suffer a "relapse, showing signs of decline in most measurements, whereas PDD patients showed continued stable improvement.
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Randomized Controlled Trial Multicenter Study Comparative Study
Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone.
Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain. ⋯ There were significantly more number of patients with excellent to good response for the aceclofenac-tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study, aceclofenac-tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.