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The Pain Course: a randomised controlled trial and economic evaluation of an internet-delivered pain management program.疼痛课程:一项互联网疼痛管理方案的随机对照试验和经济评价。
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远程管理成人慢性疼痛(不包括头痛)的心理治疗。

Psychological therapies delivered remotely for the management of chronic pain (excluding headache) in adults.

机构信息

Liverpool John Moores University, Liverpool, UK.

Cochrane Pain, Palliative and Supportive Care Group, Pain Research Unit, Churchill Hospital, Oxford, UK.

出版信息

Cochrane Database Syst Rev. 2023 Aug 29;8(8):CD013863. doi: 10.1002/14651858.CD013863.pub2.

DOI:10.1002/14651858.CD013863.pub2
PMID:37643992
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10476013/
Abstract

BACKGROUND

Chronic pain (pain lasting three months or more) is an unpleasant sensory and emotional experience associated with actual or potential tissue damage. Common types (excluding headache) include back pain, fibromyalgia, and neuropathic pain. Access to traditional face-to-face therapies can be restricted by healthcare resources, geography, and cost. Remote technology-based delivery of psychological therapies has the potential to overcome treatment barriers. However, their therapeutic effectiveness compared to traditional delivery methods requires further investigation.

OBJECTIVES

To determine the benefits and harms of remotely-delivered psychological therapies compared to active control, waiting list, or treatment as usual for the management of chronic pain in adults.

SEARCH METHODS

We searched for randomised controlled trials (RCTs) in CENTRAL, MEDLINE, Embase, and PsycINFO to 29 June 2022. We also searched clinical trials registers and reference lists. We conducted a citation search of included trials to identify any further eligible trials.

SELECTION CRITERIA

We included RCTs in adults (≥ 18 years old) with chronic pain. Interventions included psychological therapies with recognisable psychotherapeutic content or based on psychological theory. Trials had to have delivered therapy remote from the therapist (e.g. Internet, smartphone application) and involve no more than 30% contact time with a clinician. Comparators included treatment as usual (including waiting-list controls) and active controls (e.g. education).

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methodological procedures.

MAIN RESULTS

We included 32 trials (4924 participants) in the analyses. Twenty-five studies delivered cognitive behavioural therapy (CBT) to participants, and seven delivered acceptance and commitment therapy (ACT). Participants had back pain, musculoskeletal pain, opioid-treated chronic pain, mixed chronic pain, hip or knee osteoarthritis, spinal cord injury, fibromyalgia, provoked vestibulodynia, or rheumatoid arthritis. We assessed 25 studies as having an unclear or high risk of bias for selective reporting. However, across studies overall, risk of bias was generally low. We downgraded evidence certainty for primary outcomes for inconsistency, imprecision, and study limitations. Certainty of evidence ranged from moderate to very low. Adverse events were inadequately reported or recorded across studies. We report results only for studies in CBT here. Cognitive behavioural therapy (CBT) versus treatment as usual (TAU) Pain intensity Immediately after treatment, CBT likely demonstrates a small beneficial effect compared to TAU (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.39 to -0.16; 20 studies, 3206 participants; moderate-certainty evidence). Participants receiving CBT are probably more likely to achieve a 30% improvement in pain intensity compared to TAU (23% versus 11%; risk ratio (RR) 2.15, 95% CI 1.62 to 2.85; 5 studies, 1347 participants; moderate-certainty evidence). They may also be more likely to achieve a 50% improvement in pain intensity (6% versus 2%; RR 2.31, 95% CI 1.14 to 4.66; 4 studies, 1229 participants), but the evidence is of low certainty. At follow-up, there is likely little to no difference in pain intensity between CBT and TAU (SMD -0.04, 95% CI -0.17 to 0.09; 8 studies, 959 participants; moderate-certainty evidence). The evidence comparing CBT to TAU on achieving a 30% improvement in pain is very uncertain (40% versus 24%; RR 1.70, 95% CI 0.82 to 3.53; 1 study, 69 participants). No evidence was available regarding a 50% improvement in pain. Functional disability Immediately after treatment, CBT may demonstrate a small beneficial improvement compared to TAU (SMD -0.38, 95% CI -0.53 to -0.22; 14 studies, 2672 participants; low-certainty evidence). At follow-up, there is likely little to no difference between treatments (SMD -0.05, 95% CI -0.23 to 0.14; 3 studies, 461 participants; moderate-certainty evidence). Quality of life Immediately after treatment, CBT may not have resulted in a beneficial effect on quality of life compared to TAU, but the evidence is very uncertain (SMD -0.16, 95% CI -0.43 to 0.11; 7 studies, 1423 participants). There is likely little to no difference between CBT and TAU on quality of life at follow-up (SMD -0.16, 95% CI -0.37 to 0.05; 3 studies, 352 participants; moderate-certainty evidence). Adverse events Immediately after treatment, evidence about the number of people experiencing adverse events is very uncertain (34% in TAU versus 6% in CBT; RR 6.00, 95% CI 2.2 to 16.40; 1 study, 140 participants). No evidence was available at follow-up. Cognitive behavioural therapy (CBT) versus active control Pain intensity Immediately after treatment, CBT likely demonstrates a small beneficial effect compared to active control (SMD -0.28, 95% CI -0.52 to -0.04; 3 studies, 261 participants; moderate-certainty evidence). The evidence at follow-up is very uncertain (mean difference (MD) 0.50, 95% CI -0.30 to 1.30; 1 study, 127 participants). No evidence was available for a 30% or 50% pain intensity improvement. Functional disability Immediately after treatment, there may be little to no difference between CBT and active control on functional disability (SMD -0.26, 95% CI -0.55 to 0.02; 2 studies, 189 participants; low-certainty evidence). The evidence at follow-up is very uncertain (MD 3.40, 95% CI -1.15 to 7.95; 1 study, 127 participants). Quality of life Immediately after treatment, there is likely little to no difference in CBT and active control (SMD -0.22, 95% CI -1.11 to 0.66; 3 studies, 261 participants; moderate-certainty evidence). The evidence at follow-up is very uncertain (MD 0.00, 95% CI -0.06 to 0.06; 1 study, 127 participants). Adverse events Immediately after treatment, the evidence comparing CBT to active control is very uncertain (2% versus 0%; RR 3.23, 95% CI 0.13 to 77.84; 1 study, 135 participants). No evidence was available at follow-up.

AUTHORS' CONCLUSIONS: Currently, evidence about remotely-delivered psychological therapies is largely limited to Internet-based delivery of CBT. We found evidence that remotely-delivered CBT has small benefits for pain intensity (moderate certainty) and functional disability (moderate to low certainty) in adults experiencing chronic pain. Benefits were not maintained at follow-up. Our appraisal of quality of life and adverse events outcomes post-treatment were limited by study numbers, evidence certainty, or both. We found limited research (mostly low to very low certainty) exploring other psychological therapies (i.e. ACT). More high-quality studies are needed to assess the broad translatability of psychological therapies to remote delivery, the different delivery technologies, treatment longevity, comparison with active control, and adverse events.

摘要

背景

慢性疼痛(疼痛持续三个月或以上)是一种不愉快的感觉和情绪体验,与实际或潜在的组织损伤有关。常见的类型(不包括头痛)包括背痛、纤维肌痛和神经性疼痛。传统的面对面治疗可能受到医疗资源、地理位置和成本的限制。远程技术为基础的心理治疗有克服治疗障碍的潜力。然而,与传统的传递方法相比,它们的治疗效果需要进一步的调查。

目的

确定远程提供的心理疗法与成人慢性疼痛管理中的积极对照、等待名单或常规治疗相比的获益和危害。

检索方法

我们检索了 CENTRAL、MEDLINE、Embase 和 PsycINFO,以获取 2022 年 6 月 29 日之前的随机对照试验(RCTs)。我们还检索了临床试验登记册和参考文献列表。我们对纳入的试验进行了引文搜索,以确定任何其他符合条件的试验。

选择标准

我们纳入了成年人(≥ 18 岁)慢性疼痛的 RCTs。干预措施包括具有可识别的心理治疗内容或基于心理理论的心理疗法。试验必须远程提供治疗(如互联网、智能手机应用),且临床医生的接触时间不超过 30%。对照包括常规治疗(包括等待名单对照)和积极对照(如教育)。

数据收集和分析

我们使用了标准的 Cochrane 方法学程序。

主要结果

我们纳入了 32 项试验(4924 名参与者)进行分析。25 项研究对参与者提供认知行为疗法(CBT),7 项研究提供接受和承诺疗法(ACT)。参与者患有背痛、肌肉骨骼疼痛、阿片类药物治疗的慢性疼痛、混合性慢性疼痛、髋或膝关节骨关节炎、脊髓损伤、纤维肌痛、诱发的前庭性疼痛或类风湿关节炎。我们评估了 25 项研究,认为它们在选择性报告方面存在不确定或高偏倚的风险。然而,总体而言,研究的偏倚风险较低。我们将主要结局的证据确定性降低为不一致性、不精确性和研究局限性。证据确定性范围从中等到非常低。不良事件在研究中报告或记录不足。我们在这里仅报告 CBT 研究的结果。

认知行为疗法(CBT)与常规治疗(TAU)疼痛强度:立即治疗后,CBT 可能与 TAU 相比具有较小的有益效果(标准化均数差(SMD)-0.28,95%置信区间(CI)-0.39 至-0.16;20 项研究,3206 名参与者;中等确定性证据)。接受 CBT 的参与者可能更有可能在疼痛强度上实现 30%的改善,而不是 TAU(23%比 11%;风险比(RR)2.15,95%CI 1.62 至 2.85;5 项研究,1347 名参与者;中等确定性证据)。他们也可能更有可能在疼痛强度上实现 50%的改善(6%比 2%;RR 2.31,95%CI 1.14 至 4.66;4 项研究,1229 名参与者),但证据的确定性较低。在随访时,CBT 与 TAU 之间在疼痛强度上可能没有差异(SMD-0.04,95%CI-0.17 至 0.09;8 项研究,959 名参与者;中等确定性证据)。比较 CBT 与 TAU 在疼痛改善 30%的证据非常不确定(40%比 24%;RR 1.70,95%CI 0.82 至 3.53;1 项研究,69 名参与者)。没有证据表明疼痛改善 50%。

功能障碍

立即治疗后,CBT 可能与 TAU 相比具有较小的有益效果(SMD-0.38,95%CI-0.53 至-0.22;14 项研究,2672 名参与者;低确定性证据)。在随访时,治疗之间可能没有差异(SMD-0.05,95%CI-0.23 至 0.14;3 项研究,461 名参与者;中等确定性证据)。

生活质量

立即治疗后,CBT 可能没有改善生活质量的有益效果,而证据是非常不确定的(SMD-0.16,95%CI-0.43 至 0.11;7 项研究,1423 名参与者)。在随访时,CBT 与 TAU 在生活质量上可能没有差异(SMD-0.16,95%CI-0.37 至 0.05;3 项研究,352 名参与者;中等确定性证据)。

不良事件

立即治疗后,关于不良事件数量的证据非常不确定(34%在 TAU 中,6%在 CBT 中;RR 6.00,95%CI 2.2 至 16.40;1 项研究,140 名参与者)。在随访时没有证据。

认知行为疗法(CBT)与积极对照疼痛强度:立即治疗后,CBT 可能与积极对照相比具有较小的有益效果(SMD-0.28,95%CI-0.52 至-0.04;3 项研究,261 名参与者;中等确定性证据)。随访时的证据非常不确定(平均差异(MD)0.50,95%CI-0.30 至 1.30;1 项研究,127 名参与者)。没有证据表明疼痛改善 30%或 50%。

功能障碍

立即治疗后,CBT 与积极对照在功能障碍上可能没有差异(SMD-0.26,95%CI-0.55 至 0.02;2 项研究,189 名参与者;低确定性证据)。随访时的证据非常不确定(MD 3.40,95%CI-1.15 至 7.95;1 项研究,127 名参与者)。

生活质量

立即治疗后,CBT 与积极对照可能没有差异(SMD-0.22,95%CI-1.11 至 0.66;3 项研究,261 名参与者;中等确定性证据)。随访时的证据非常不确定(MD 0.00,95%CI-0.06 至 0.06;1 项研究,127 名参与者)。

不良事件

立即治疗后,比较 CBT 与积极对照的证据非常不确定(2%比 0%;RR 3.23,95%CI 0.13 至 77.84;1 项研究,135 名参与者)。在随访时没有证据。

作者结论

目前,关于远程提供的心理疗法的证据主要限于基于互联网的 CBT 提供。我们发现,远程提供的 CBT 对成人慢性疼痛有较小的益处,可改善疼痛强度(中等确定性)和功能障碍(中等至低确定性)。益处不能维持到随访时。我们对生活质量和不良事件结局的评估在治疗后受到研究数量、证据确定性或两者的限制。我们发现,关于其他心理疗法(即接受和承诺疗法)的研究很少(大多为低到非常低的确定性)。需要更多高质量的研究来评估心理疗法向远程传递的广泛可转移性、不同的传递技术、治疗的持久性、与积极对照的比较,以及不良事件。