VCU Spine Center, Virginia Commonwealth University Department of Physical Medicine and Rehabilitation, Richmond, VA 23235, USA.
PM R. 2009 Oct;1(10):908-15. doi: 10.1016/j.pmrj.2009.09.008.
To examine changes in pain, disability, and medication usage over time from baseline to up to 12 months after facet joint injection of hylan G-F 20.
Prospective, uncontrolled, pilot study.
University spine center.
Fifteen patients (12 females), mean age of 57 years (standard deviation = 12.5), with a median duration of low back pain of 24 months (interquartile range = 11-66).
Patients who fulfilled inclusion criteria underwent diagnostic blocks with local comparative anesthetics at one unilateral facet joint (FJ). Those with a true positive response underwent 2 1.0-mL intra-articular hylan G-F 20 injections, 10 days apart, into the painful FJ. A third hylan G-F 20 injection was offered to patients dissatisfied with the results obtained with the first 2 injections.
Visual analog scale (VAS) (average, standing, walking), Oswestry Disability Index (ODI), SF-36, finger to floor distance (FTF), tolerance (standing, sitting, walking), analgesic usage, and patient satisfaction collected at baseline, 7-10 days, and at 1-, 3-, 6-, and 12-months follow-up.
Repeated measures mixed-models indicated that VAS (average, standing, walking [P all < .005]), ODI (P = .029), SF-36 (P = .013), FTF (P = .032), and sitting tolerance (P = .020) all showed significant changes from baseline up to 6 months and were not sustained at 12 months; with the exception of the baseline to 12-month difference for FTF. There was not evidence of changes over time in standing (P = .085) or walking (P = .084) tolerance. Satisfaction initially increased from baseline (0%) to 7-10 days (64%) but declined over time (36% at 12 months). As compared with baseline (80%), analgesic usage decreased nominally over time showing significant decreases at 6 months (33%, P = .0253) and increased slightly at 12 months (45%).
Viscosupplementation for lumbar FJ arthropathy with hylan G-F 20 is associated with modest efficacy that predominately lasts up to 6 months. Limitations include a small sample size and lack of both a control and blinding. Larger, randomized, controlled studies are indicated to better clarify its clinical safety, efficacy, and utility.
从基线到 facet 关节注射透明质酸 G-F 20 后长达 12 个月，检查疼痛、残疾和药物使用的变化。
前瞻性、非对照、试点研究。
大学脊柱中心。
15 名患者（12 名女性），平均年龄 57 岁（标准差=12.5），腰痛中位数持续时间为 24 个月（四分位距=11-66）。
符合纳入标准的患者在单侧 facet 关节（FJ）处接受局部比较麻醉的诊断性阻滞。那些出现真正阳性反应的患者接受了 2 次 1.0 毫升关节内透明质酸 G-F 20 注射，间隔 10 天，进入疼痛的 FJ。对前 2 次注射结果不满意的患者，再给予第 3 次透明质酸 G-F 20 注射。
视觉模拟量表（VAS）（平均、站立、行走）、Oswestry 残疾指数（ODI）、SF-36、手指到地板距离（FTF）、站立、坐着、行走时的耐受性、镇痛药物使用情况和患者满意度，分别在基线、7-10 天以及 1、3、6 和 12 个月随访时收集。
重复测量混合模型表明，VAS（平均、站立、行走[P 均<.005]）、ODI（P=0.029）、SF-36（P=0.013）、FTF（P=0.032）和坐立耐受性（P=0.020）均显示出从基线到 6 个月的显著变化，并且在 12 个月时未持续；除了 FTF 的基线到 12 个月的差异。站立（P=0.085）或行走（P=0.084）耐受性没有随时间变化的证据。满意度最初从基线（0%）增加到 7-10 天（64%），但随时间下降（12 个月时为 36%）。与基线（80%）相比，镇痛药物的使用随着时间的推移呈名义下降，在 6 个月时显著下降（33%，P=0.0253），12 个月时略有增加（45%）。
透明质酸 G-F 20 治疗腰椎 facet 关节病的粘弹性补充治疗与适度疗效相关，主要持续时间长达 6 个月。局限性包括样本量小以及缺乏对照和盲法。需要更大规模的、随机、对照研究来更好地阐明其临床安全性、疗效和实用性。
