ntradiscalinjection therapy for degenerative chronic discogenic low.doc

CONSORT 清单评价RCT论文 论文 部分 条 目 内 容 评价 文题 摘要 1a 文题能识别是随机临床试验 Intradiscal injection therapy for degenerative chronic discogenic low back pain with endplate Modic changes 否 1b 结构式摘要，包括试验设计、方法、结果、结论几个部分 BACKGROUND CONTEXT: The effect of intradiscal steroid therapy for patients with degener- ative chronic discogenic low back pain remains an issue of debate. PURPOSE: To evaluate the effect of various intradiscal injection regimens for patients with degenerative chronic discogenic low back pain and endplate Modic changes. STUDY DESIGN: Double-blind, randomized, controlled, prospective clinical study. PATIENT SAMPLE: One hundred and twenty patients with discogenic low back pain and endplate Modic changes on magnetic resonance imaging (MRI) who received discography but were unwilling to accept surgical operation. OUTCOME MEASURES: Pain and function were determined by the visual analog scale (VAS) and the Oswestry Disability Index (ODI) assessment. METHODS: Patients who received diagnostic discography for suspected degenerative discogenic low back pain were recruited. A total of 120 patients with positive discography and endplate Modic changes at a single level were enrolled in the study and allocated into Groups A and B according to the type of Modic changes on MRI. Then, the patients in Groups A and B were randomized into three subgroups, respectively. Intradiscal injection of normal saline was performed in Subgroups A1 and B1, intradiscal injection of diprospan was performed in Subgroups A2 and B2, and intra- discal injection of a mixed solution of diprospantsongmeile (cervus and cucumis polypeptide) was performed in Subgroups A3 and B3. The clinical outcome of each patient was evaluated and recorded by using the VAS and ODI at 3 and 6 months after the procedure. RESULTS: The subgroups were comparable with respect to gender, age, pain, and percentage dis- ability. Neither VAS pain scores nor Oswestry function scores of the patients within Group A had any improvement at