The Pain Center of Arizona, Peoria, AZ, USA.
Spine (Phila Pa 1976). 2011 Mar 1;36(5):E293-300. doi: 10.1097/BRS.0b013e3181ddd597.
Randomized, double-blinded trial clinical trial.
To compare efficacies of 2 active therapies for chronic low back pain.
Radicular pain may result from intervertebral disk herniation (IDH). Clonidine has demonstrated analgesic and antiinflammatory activity in animal studies of nerve injury. Extensive clinical experience supports neuraxial clonidine's safety.
Patients with ˜3 months of low back and leg pain due to IDH were randomized to transforaminal epidural (TFE) injection(s) of 2% lidocaine and either clonidine (200 or 400mcg) or triamcinolone (40mg). Patients received 1- 3 injections administered about 2 weeks apart. Patients, investigators and study coordinators were blinded to treatment. Primary outcome was 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 1 month. Other outcomes included Patient Global Impression of Change (PGIC), and functional measures.
Thirty-three patients were screened and randomized. Twenty-six patients enrolled; 11 received clonidine and 15 triamcinolone. Both groups showed significant improvement in pain score at 2 weeks and 1 month compared to baseline (p< 0.05). The corticosteroid group showed additional functional improvement at 1 month relative to clonidine (p=0.022). There was no difference between groups for primary outcome. However, as target enrollment was not reached, we cannot say with confidence that the 2 treatments would be expected to result in similar short-term pain relief. Side-effects were common in both groups, but there were no serious complications.
Radicular pain due to IDH improved rapidly with TFE injection of either clonidine or triamcinolone. Corticosteroid resulted in greater functional improvement, with unclear differences in analgesia. Future studies will determine if clonidine is superior to placebo and of particular use in those at risk for corticosteroid complications.
随机、双盲临床试验。
比较两种慢性腰痛的有效治疗方法。
神经根痛可能由椎间盘突出症（IDH）引起。动物神经损伤研究表明，可乐定具有镇痛和抗炎作用。大量临床经验支持椎管内可乐定的安全性。
因 IDH 导致腰痛和腿痛约 3 个月的患者被随机分配到经椎间孔硬膜外（TFE）注射 2%利多卡因和可乐定（200 或 400μg）或曲安奈德（40mg）。患者接受 1-3 次注射，间隔约 2 周。患者、研究者和研究协调员对治疗方案均不知情。主要结局是治疗后 1 个月的 11 点疼痛强度数字评分量表（PI-NRS）。其他结局包括患者整体印象变化（PGIC）和功能测量。
共筛选 33 名患者，其中 26 名患者入组，11 名患者接受可乐定治疗，15 名患者接受曲安奈德治疗。两组患者的疼痛评分在治疗后 2 周和 1 个月均较基线显著改善（p<0.05）。与可乐定组相比，皮质类固醇组在治疗后 1 个月的功能改善更为明显（p=0.022）。由于目标入组人数未达到，我们不能确定这两种治疗方法在短期疼痛缓解方面是否会产生类似的效果。然而，两组之间的主要结局没有差异。两组患者均常见副作用，但无严重并发症。
TFE 注射可乐定或曲安奈德均可迅速缓解 IDH 引起的神经根痛。皮质类固醇可显著改善功能，且镇痛效果不明确。未来的研究将确定可乐定是否优于安慰剂，以及在有皮质类固醇并发症风险的患者中是否具有特殊的应用价值。
