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
No effect of traction in patients with low back pain: a single centre, single blind, randomized controlled trial of Intervertebral Differential Dynamics Therapy.
Low back pain (LBP) poses a significant problem to society. Although initial conservative therapy may be beneficial, persisting chronic LBP still frequently leads to expensive invasive intervention. A novel non-invasive therapy that focuses on discogenic LBP is Intervertebral Differential Dynamics Therapy (IDD Therapy, North American Medical Corp. ⋯ None of the parameters showed a difference between both protocols. Both treatment regimes had a significant beneficial effect on LBP, leg pain, functional status and quality of life after 14 weeks. The added axial, intermittent, mechanical traction of IDD Therapy to a standard graded activity program has been shown not to be effective.
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Randomized Controlled Trial Comparative Study
Total disc replacement compared to lumbar fusion: a randomised controlled trial with 2-year follow-up.
The study design includes a prospective, randomised controlled study comparing total disc replacement (TDR) with posterior fusion. The main objective of this study is to compare TDR with lumbar spinal fusion, in terms of clinical outcome, in patients referred to a spine clinic for surgical evaluation. Fusion is effective for treating chronic low back pain (LBP), but has drawbacks, such as stiffness and possibly adjacent level degradation. ⋯ Complications and reoperations were similar in both groups, but pedicle screw removal as additive surgery, was frequent in the fusion group. One year after surgery, TDR was superior to spinal fusion in clinical outcome, but this difference had diminished by 2 years, apart from (VAS for back pain and) numbers of pain-free. The long-term benefits have yet to be examined.
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Randomized Controlled Trial
Perioperative and short-term advantages of mini-open approach for lumbar spinal fusion.
It has been widely reported a vascular and neurologic damage of the lumbar muscles produced in the classic posterior approach for lumbar spinal fusions. The purpose of this study is to demonstrate a better clinical and functional outcome in the postoperative and short term in patients undergoing minimal invasive surgery ("mini-open") for this lumbar spinal arthrodesis. We designed a prospective study with a 30 individuals cohort randomized in two groups, depending on the approach performed to get a instrumented lumbar circumferential arthrodesis: "classic posterior" (CL group) or "mini-open" approach (MO group). ⋯ No significant differences were found between two groups in surgery timing, X-rays exposure or sciatic postoperative pain. This study, inline with previous investigations, reinforces the concept of minimizing the muscular lumbar damage with a mini-open approach for a faster and better recovery of patients' disability in the short term. Further investigations are necessary to confirm these findings in the long term, and to verify the achievement of a stable lumbar spinal fusion.
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Randomized Controlled Trial
Corticosteroids in peri-radicular infiltration for radicular pain: a randomised double blind controlled trial. One year results and subgroup analysis.
The objective of this study is to evaluate the efficacy of corticosteroids in patients with radicular pain due to lumbar disc herniation or lumbar spinal stenosis through a prospective randomised, double blind controlled trial, and whether there was an effect on subsequent interventions such as additional root blocks or surgery. Peri-radicular infiltration of corticosteroids has previously been shown to offer no additional benefit in patients with sciatica compared to local anaesthetic alone. It is not known if the response to peri-radicular infiltration is less marked in certain subgroups of patients such as those with radicular pain due to lumbar spinal stenosis. ⋯ Patients with lumbar spinal stenosis had a less marked reduction in the ODI at 3 months with a mean change of 3.3 points when compared with 15 points for patients with lumbar disc herniation. In conclusion, peri-radicular infiltration of corticosteroids for sciatica does not provide any additional benefit when compared to local anaesthetic injection alone. Corticosteroids do not obviate the need for subsequent interventions such as additional root blocks or surgery.
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Randomized Controlled Trial
A prospective randomised study on the long-term effect of lumbar fusion on adjacent disc degeneration.
The existence and importance of an accelerated adjacent segment disc degeneration (ASD) after lumbar fusion have previously not been demonstrated by RCTs. The objectives of this study were, to determine whether lumbar fusion in the long term accelerates degenerative changes in the adjacent disc and whether this affects the outcome, by using a prospective randomised design. A total of 111 patients, aged 18-55, with isthmic spondylolisthesis were randomised to exercise (EX, n = 34) or posterolateral fusion (PLF, n = 77), with (n = 37) or without pedicle screw instrumentation (n = 40). ⋯ In conclusion, the long-term RCT shows that fusion accelerates degenerative changes at the adjacent level compared with natural history. The study suggests that not only fusion, but also laminectomy may be of pathogenetic importance. The clinical importance of ASD seems limited, with only the more severe forms affecting the outcome.