Monticone Marco, Cedraschi Christine, Ambrosini Emilia, Rocca Barbara, Fiorentini Roberta, Restelli Maddalena, Gianola Silvia, Ferrante Simona, Zanoli Gustavo, Moja Lorenzo
Physical Medicine and Rehabilitation Unit, Scientific Institute of Lissone (Milan), Institute of Care and Research, Salvatore Maugeri Foundation, IRCCS, Milan, Italy.
Cochrane Database Syst Rev. 2015 May 26;2015(5):CD010664. doi: 10.1002/14651858.CD010664.pub2.
EXPRESSION OF CONCERN - Professor Marco Monticone has acted as the first author of this Cochrane review. Readers should be informed that multiple randomized controlled trials authored by Professor Monticone have been scrutinized because of potential research integrity issues, including irregularities in the data (doi:10.1097/j.pain.0000000000002659). One of the trials suspected of research integrity issues is included in this Cochrane review (doi:10.1007/s00586-012-2287-y). The Cochrane editorial team has concerns about the trustworthiness of the trial data and is applying Cochrane's policy on managing potentially problematic studies (https://www.cochranelibrary.com/cdsr/editorial-policies#problematic-studies). No major differences to the conclusions of this review were found after performing a sensitivity analysis on the main outcomes, whether the potentially problematic trial was included or excluded. Cochrane will take further action as needed on this review once additional investigations into the potentially problematic trial are concluded. In the meantime, a new version of this review topic is underway with a new author team. The new review will supersede this review.
Although research on non-surgical treatments for neck pain (NP) is progressing, there remains uncertainty about the efficacy of cognitive-behavioural therapy (CBT) for this population. Addressing cognitive and behavioural factors might reduce the clinical burden and the costs of NP in society.
To assess the effects of CBT among individuals with subacute and chronic NP. Specifically, the following comparisons were investigated: (1) cognitive-behavioural therapy versus placebo, no treatment, or waiting list controls; (2) cognitive-behavioural therapy versus other types of interventions; (3) cognitive-behavioural therapy in addition to another intervention (e.g. physiotherapy) versus the other intervention alone.
We searched CENTRAL, MEDLINE, EMBASE, CINAHL, PsycINFO, SCOPUS, Web of Science, and PubMed, as well as ClinicalTrials.gov and the World Health Organization International Clinical Trials Registry Platform up to November 2014. Reference lists and citations of identified trials and relevant systematic reviews were screened.
We included randomised controlled trials that assessed the use of CBT in adults with subacute and chronic NP.
Two review authors independently assessed the risk of bias in each study and extracted the data. If sufficient homogeneity existed among studies in the pre-defined comparisons, a meta-analysis was performed. We determined the quality of the evidence for each comparison with the GRADE approach.
We included 10 randomised trials (836 participants) in this review. Four trials (40%) had low risk of bias, the remaining 60% of trials had a high risk of bias.The quality of the evidence for the effects of CBT on patients with chronic NP was from very low to moderate. There was low quality evidence that CBT was better than no treatment for improving pain (standard mean difference (SMD) -0.58, 95% confidence interval (CI) -1.01 to -0.16), disability (SMD -0.61, 95% CI -1.21 to -0.01), and quality of life (SMD -0.93, 95% CI -1.54 to -0.31) at short-term follow-up, while there was from very low to low quality evidence of no effect on various psychological indicators at short-term follow-up. Both at short- and intermediate-term follow-up, CBT did not affect pain (SMD -0.06, 95% CI -0.33 to 0.21, low quality, at short-term follow-up; MD -0.89, 95% CI -2.73 to 0.94, low quality, at intermediate-term follow-up) or disability (SMD -0.10, 95% CI -0.40 to 0.20, moderate quality, at short-term follow-up; SMD -0.24, 95% CI-0.54 to 0.07, moderate quality, at intermediate-term follow-up) compared to other types of interventions. There was moderate quality evidence that CBT was better than other interventions for improving kinesiophobia at intermediate-term follow-up (SMD -0.39, 95% CI -0.69 to -0.08, I(2) = 0%). Finally, there was very low quality evidence that CBT in addition to another intervention did not differ from the other intervention alone in terms of effect on pain (SMD -0.36, 95% CI -0.73 to 0.02) and disability (SMD -0.10, 95% CI -0.56 to 0.36) at short-term follow-up.For patients with subacute NP, there was low quality evidence that CBT was better than other interventions at reducing pain at short-term follow-up (SMD -0.24, 95% CI -0.48 to 0.00), while no difference was found in terms of effect on disability (SMD -0.12, 95% CI -0.36 to 0.12) and kinesiophobia.None of the included studies reported on adverse effects.
AUTHORS' CONCLUSIONS: With regard to chronic neck pain, CBT was found to be statistically significantly more effective for short-term pain reduction only when compared to no treatment, but these effects could not be considered clinically meaningful. When comparing both CBT to other types of interventions and CBT in addition to another intervention to the other intervention alone, no differences were found. For patients with subacute NP, CBT was significantly better than other types of interventions at reducing pain at short-term follow-up, while no difference was found for disability and kinesiophobia. Further research is recommended to investigate the long-term benefits and risks of CBT including for the different subgroups of subjects with NP.
关注声明——马尔科·蒙蒂科内教授担任了本Cochrane系统评价的第一作者。应告知读者,蒙蒂科内教授撰写的多项随机对照试验因潜在的研究诚信问题受到审查,包括数据异常(doi:10.1097/j.pain.0000000000002659)。本Cochrane系统评价纳入了一项涉嫌存在研究诚信问题的试验(doi:10.1007/s00586-012-2287-y)。Cochrane编辑团队对该试验数据的可信度表示担忧,并正在应用Cochrane关于管理潜在问题研究的政策(https://www.cochranelibrary.com/cdsr/editorial-policies#problematic-studies)。在对主要结局进行敏感性分析时,无论是否纳入该潜在问题试验,均未发现本系统评价结论有重大差异。一旦对该潜在问题试验的进一步调查结束,Cochrane将根据需要对本系统评价采取进一步行动。与此同时,一个新的作者团队正在对本系统评价主题进行新版本的研究。新的系统评价将取代本系统评价。
尽管针对颈部疼痛(NP)的非手术治疗研究正在取得进展,但认知行为疗法(CBT)对该人群的疗效仍存在不确定性。解决认知和行为因素可能会减轻NP的临床负担和社会成本。
评估CBT对亚急性和慢性NP患者的影响。具体而言,研究了以下比较:(1)认知行为疗法与安慰剂、无治疗或等待名单对照;(2)认知行为疗法与其他类型的干预措施;(3)CBT联合另一种干预措施(如物理治疗)与单独使用另一种干预措施。
我们检索了截至2014年11月的Cochrane系统评价数据库、MEDLINE、EMBASE、CINAHL、PsycINFO、SCOPUS、科学引文索引、PubMed,以及ClinicalTrials.gov和世界卫生组织国际临床试验注册平台。对已识别试验的参考文献列表和引文以及相关的系统评价进行了筛选。
我们纳入了评估CBT在亚急性和慢性NP成人患者中应用的随机对照试验。
两位系统评价作者独立评估每项研究的偏倚风险并提取数据。如果在预定义的比较中各研究之间存在足够的同质性,则进行荟萃分析。我们使用GRADE方法确定每项比较的证据质量。
本系统评价纳入了10项随机试验(836名参与者)。4项试验(40%)偏倚风险低,其余60%的试验偏倚风险高。CBT对慢性NP患者疗效的证据质量从极低到中等。有低质量证据表明,在短期随访中,CBT在改善疼痛(标准化均数差(SMD)-0.58,95%置信区间(CI)-1.01至-0.16)、残疾(SMD -0.61,95%CI -1.21至-0.01)和生活质量(SMD -0.93,95%CI -1.54至-0.31)方面优于无治疗,而在短期随访中对各种心理指标无影响的证据质量从极低到低。在短期和中期随访中,与其他类型的干预措施相比,CBT对疼痛(短期随访时SMD -0.06,95%CI -0.33至0.21,低质量;中期随访时MD -0.89,95%CI -2.73至0.94,低质量)或残疾(短期随访时SMD -0.10,95%CI -0.40至0.20,中等质量;中期随访时SMD -0.24,95%CI -0.54至0.07,中等质量)均无影响。有中等质量证据表明,在中期随访中,CBT在改善运动恐惧方面优于其他干预措施(SMD -0.39,95%CI -0.69至-0.08,I² = 0%)。最后,有极低质量证据表明,在短期随访中,CBT联合另一种干预措施与单独使用另一种干预措施在对疼痛(SMD -0.36,95%CI -0.73至0.02)和残疾(SMD -0.10,95%CI -0.56至0.36)的影响方面无差异。对于亚急性NP患者,有低质量证据表明,在短期随访中CBT在减轻疼痛方面优于其他干预措施(SMD -0.24,95%CI -0.48至0.00),而在对残疾(SMD -0.12,95%CI -0.36至0.12)和运动恐惧的影响方面未发现差异。纳入的研究均未报告不良反应。
对于慢性颈部疼痛,仅与无治疗相比时,CBT在短期减轻疼痛方面有统计学显著效果,但这些效果在临床上无意义。当将CBT与其他类型的干预措施以及CBT联合另一种干预措施与单独使用另一种干预措施进行比较时,未发现差异。对于亚急性NP患者,在短期随访中CBT在减轻疼痛方面显著优于其他类型的干预措施,而在残疾和运动恐惧方面未发现差异。建议进一步研究CBT的长期益处和风险,包括对NP不同亚组受试者的研究。