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脊柱手法治疗对机械性胸椎疼痛的疗效:一项初步随机临床试验。

Effectiveness of spinal manipulative therapy in the treatment of mechanical thoracic spine pain: a pilot randomized clinical trial.

作者信息

Schiller L

出版信息

J Manipulative Physiol Ther. 2001 Jul-Aug;24(6):394-401. doi: 10.1067/mmt.2001.116420.

Abstract

BACKGROUND

To date, no substantiated studies have been performed to investigate the efficacy of spinal manipulative therapy on thoracic spinal syndromes.

OBJECTIVE

To investigate the effectiveness of spinal manipulative therapy in the treatment of mechanical thoracic spine pain.

STUDY DESIGN

A single-blind, randomized, comparative, controlled pilot study.

SETTING

Technikon Natal Chiropractic Clinic in Durban, South Africa.

PARTICIPANTS

Thirty subjects selected from the general population (from 16 to 60 years old) were randomly divided into two different treatment groups of 15 each.

METHODS

The objective measurements collected were the thoracic spine ranges of motion with the BROM II goniometer and pain threshold with an algometer. The subjective information required completion of the Oswestry Back Pain Disability Index, short-form McGill Pain Questionnaire, and Numerical Pain Rating Scale-101 Questionnaire by the patient. These 3 forms and objective measurements were collected before the first and final treatment and again at the 1-month follow-up consultation. The data gathered were then statistically analyzed with use of a 95% confidence level. The nonparametric Mann-Whitney U test and the Wilcoxon signed-rank test were used to compare intergroup and intragroup data, respectively. This was conducted at the alpha =.05 level of confidence. Further assessment of the data was conducted by use of power analysis.

INTERVENTIONS

The treatment group received thoracic spinal manipulation. The placebo group received nonfunctional ultrasound application only. The research project was carried out so that both groups received 6 treatments over a period of 2 to 3 weeks. A 1-month follow-up appointment was scheduled after the final treatment to assess the relative long-term benefits of the two different treatments.

RESULTS

Statistically significant results (P < or = .025) were noted for the percentage of pain experienced (Numerical Pain Rating Scale) and for right and left lateral flexion during intergroup comparison after the final treatment. The final treatment results were maintained at the 1-month follow-up consultation; however, there were no further statistically significant results. It was noted that the power was weak, so the probability of committing type II error (falsely accepting the null hypothesis) for the other measurements was high. The intragroup analysis showed statistically significant improvements in the group that received spinal manipulative therapy in both subjective and objective measurements between the first to final treatment and the first treatment to the 1-month follow-up consultation. The placebo group analysis showed a statistically significant improvement in sensory pain only (subjective measurement) between the first treatment and the final treatment.

CONCLUSIONS

This pilot study suggests that spinal manipulative therapy has greater benefits than placebo treatment. The sample size was small, therefore the findings of this trial study should not be considered conclusive but rather should be used as a foundation for planning future studies. In further studies a larger sample size will be necessary to identify subtle changes in measurement parameters and to add to the validity of the results.

摘要

背景

迄今为止,尚未进行有充分证据的研究来调查脊柱手法治疗对胸椎综合征的疗效。

目的

研究脊柱手法治疗在治疗机械性胸椎疼痛中的有效性。

研究设计

一项单盲、随机、对比、对照的试点研究。

地点

南非德班的纳塔尔理工学院整脊诊所。

参与者

从普通人群中选取的30名受试者(年龄在16至60岁之间)被随机分为两个不同的治疗组,每组15人。

方法

收集的客观测量指标是使用BROM II角度计测量的胸椎活动范围以及使用痛觉计测量的疼痛阈值。主观信息要求患者完成Oswestry背痛残疾指数、简化麦吉尔疼痛问卷和数字疼痛评分量表 - 101问卷。这3种表格和客观测量指标在首次和最后一次治疗前以及1个月随访咨询时再次收集。然后使用95%的置信水平对收集到的数据进行统计分析。分别使用非参数曼 - 惠特尼U检验和威尔科克森符号秩检验来比较组间和组内数据。这是在α = 0.05的置信水平下进行的。通过功效分析对数据进行进一步评估。

干预措施

治疗组接受胸椎手法治疗。安慰剂组仅接受无功能超声应用。研究项目进行时,两组在2至3周的时间内均接受6次治疗。在最后一次治疗后安排了1个月的随访预约,以评估两种不同治疗的相对长期益处。

结果

在最后一次治疗后的组间比较中,疼痛发生率(数字疼痛评分量表)以及左右侧屈方面观察到具有统计学意义的结果(P≤0.025)。最后一次治疗的结果在1个月随访咨询时得以维持;然而,没有进一步的统计学显著结果。注意到功效较弱,因此其他测量指标出现II类错误(错误地接受原假设)的概率较高。组内分析显示,接受脊柱手法治疗的组在首次治疗至最后一次治疗以及首次治疗至1个月随访咨询期间,主观和客观测量指标均有统计学显著改善。安慰剂组分析显示,在首次治疗和最后一次治疗之间仅在感觉疼痛方面(主观测量)有统计学显著改善。

结论

这项试点研究表明脊柱手法治疗比安慰剂治疗具有更大的益处。样本量较小,因此本试验研究的结果不应被视为结论性的,而应作为规划未来研究的基础。在进一步的研究中,需要更大的样本量来识别测量参数的细微变化并增加结果的有效性。

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