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CONSORT 清单评价RCT论文
论文
部分 条 目 内 容 评 价 VAS 文题
摘要 1a 文题能识别是随机临床试验 The long-term effect of posterolateral fusion in adult isthmic
spondylolisthesis: a randomized controlled study 是 1b 结构式摘要,包括试验设计、方法、结果、结论几个部分 BACKGROUND: Today there is some evidence-based medicine support for a positive short-term
treatment effect of fusion in chronic low back pain in spondylolisthesis and in nonspecific degenera-
tive lumbar spine disorders. The long-term effect is, however, unknown.
PURPOSE: To determine the long-term outcome of lumbar fusion in adult isthmic spondy-
lolisthesis.
STUDY DESIGN: Prospective, randomized controlled study comparing a 1-year exercise program
with instrumented and non-instrumented posterolateral fusion with average long-term follow-up of
9 years (range, 5–13).
PATIENT SAMPLE: 111 patients aged 18 to 55 years with adult lumbar isthmic spondylolisthesis
at L5 or L4 level of all degrees, and at least 1-year’s duration of severe lumbar pain with or
without sciatica.
OUTCOME MEASURES: Pain and functional disability was quantified by pain (VAS), the Disabil-
ity Rating Index (DRI), the Oswestry Disability Index (ODI) work status, and global assessment
of outcome by the patient into much better, better, unchanged or worse. Quality of life was assessed
by the SF-36.
METHODS: The patients were randomly allocated to treatment with 1) a 1-year exercise program
(n 34), 2) posterolateral fusion without pedicle screw instrumentation (n 37), or 3) posterolateral
fusion with pedicle screw instrumentation (n 40). Long-term follow-up was obtained in 101 (91%)
patients. Nine patients in the exercise group were eventually operated on.
RESULTS: Longitudinal analysis: At long-term follow-up pain and functional disability were
significantly better than before treatment in both surgical groups. No significant differences
were observed between instrumented and non-instrumented patients in any variable studied. In the
exercise group the pain was significantly reduced but not
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