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脊柱推拿治疗慢性颈源性头痛的剂量反应和疗效:一项先导随机对照试验。

Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial.

机构信息

Center for Outcomes Studies, Western States Chiropractic College, 2900 NE 132nd Ave., Portland, OR 97230, USA.

出版信息

Spine J. 2010 Feb;10(2):117-28. doi: 10.1016/j.spinee.2009.09.002.

DOI:10.1016/j.spinee.2009.09.002
PMID:19837005
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2819630/
Abstract

BACKGROUND CONTEXT

Systematic reviews of randomized controlled trials suggest that spinal manipulative therapy (SMT) is efficacious for care of cervicogenic headache (CGH). The effect of SMT dose on outcomes has not been studied.

PURPOSE

To compare the efficacy of two doses of SMT and two doses of light massage (LM) for CGH.

PATIENT SAMPLE

Eighty patients with chronic CGH.

MAIN OUTCOME MEASURES

Modified Von Korff pain and disability scales for CGH and neck pain (minimum clinically important difference=10 on 100-point scale), number of headaches in the last 4 weeks, and medication use. Data were collected every 4 weeks for 24 weeks. The primary outcome was the CGH pain scale.

METHODS

Participants were randomized to either 8 or 16 treatment sessions with either SMT or a minimal LM control. Patients were treated once or twice per week for 8 weeks. Adjusted mean differences (AMD) between groups were computed using generalized estimating equations for the longitudinal outcomes over all follow-up time points (profile) and using regression modeling for individual time points with baseline characteristics as covariates and with imputed missing data.

RESULTS

For the CGH pain scale, comparisons of 8 and 16 treatment sessions yielded small dose effects: |AMD|</=5.6. There was an advantage for SMT over the control: AMD=-8.1 (95% confidence interval=-13.3 to -2.8) for the profile, -10.3 (-18.5 to -2.1) at 12 weeks, and -9.8 (-18.7 to -1.0) at 24 weeks. For the higher dose patients, the advantage was greater: AMD=-11.9 (-19.3 to -4.6) for the profile, -14.2 (-25.8 to -2.6) at 12 weeks, and -14.4 (-26.9 to -2.0) at 24 weeks. Patients receiving SMT were also more likely to achieve a 50% improvement in pain scale: adjusted odds ratio=3.6 (1.6 to 8.1) for the profile, 3.1 (0.9 to 9.8) at 12 weeks, and 3.1 (0.9 to 10.3) at 24 weeks. Secondary outcomes showed similar trends favoring SMT. For SMT patients, the mean number of CGH was reduced by half.

CONCLUSIONS

Clinically important differences between SMT and a control intervention were observed favoring SMT. Dose effects tended to be small.

摘要

背景

系统评价随机对照试验表明,脊柱手法治疗(SMT)对颈源性头痛(CGH)的治疗有效。SMT 剂量对结果的影响尚未研究。

目的

比较两种 SMT 剂量和两种轻按摩(LM)剂量治疗 CGH 的效果。

患者样本

80 例慢性 CGH 患者。

主要观察指标

CGH 和颈部疼痛的改良 Von Korff 疼痛和残疾量表(最小临床重要差异=100 分制上的 10 分)、过去 4 周头痛次数和药物使用情况。每 4 周收集一次数据,共 24 周。主要结局是 CGH 疼痛量表。

方法

参与者随机分为 8 或 16 次治疗,分别接受 SMT 或最小 LM 对照治疗。患者每周接受 1 或 2 次治疗,持续 8 周。使用广义估计方程(GEE)计算所有随访时间点(概况)的组间调整均数差异(AMD),并使用回归模型在基线特征作为协变量的情况下对个别时间点进行建模,并进行缺失数据的插补。

结果

对于 CGH 疼痛量表,8 次和 16 次治疗的比较产生了较小的剂量效应:|AMD|≤5.6。SMT 优于对照组:AMD=-8.1(95%置信区间=-13.3 至-2.8),AMD=-10.3(-18.5 至-2.1),在 12 周,AMD=-9.8(-18.7 至-1.0)在 24 周。对于高剂量患者,优势更大:AMD=-11.9(-19.3 至-4.6),AMD=-14.2(-25.8 至-2.6)在 12 周,AMD=-14.4(-26.9 至-2.0)在 24 周。接受 SMT 的患者在疼痛量表上达到 50%改善的可能性也更高:调整后的优势比=3.6(1.6 至 8.1),AMD=3.1(0.9 至 9.8)在 12 周,AMD=3.1(0.9 至 10.3)在 24 周。次要结局显示有利于 SMT 的类似趋势。对于 SMT 患者,CGH 的平均次数减少了一半。

结论

观察到 SMT 与对照干预之间存在有临床意义的差异,有利于 SMT。剂量效应倾向于较小。

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