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跖间神经瘤的治疗方法。

Treatments for Morton's neuroma.

作者信息

Matthews Barry G, Thomson Colin E, Harding Michael P, McKinley John C, Ware Robert S

机构信息

Faculty of Health, School of Clinical Sciences, Queensland University of Technology (QUT), Brisbane, Australia.

Department of Trauma & Orthopaedics, The Royal Infirmary of Edinburgh and St John's Hospital Livingston, Edinburgh, UK.

出版信息

Cochrane Database Syst Rev. 2024 Feb 9;2(2):CD014687. doi: 10.1002/14651858.CD014687.pub2.

Abstract

BACKGROUND

Morton's neuroma (MN) is a painful neuropathy resulting from a benign enlargement of the common plantar digital nerve that occurs commonly in the third webspace and, less often, in the second webspace of the foot. Symptoms include burning or shooting pain in the webspace that extends to the toes, or the sensation of walking on a pebble. These impact on weight-bearing activities and quality of life.

OBJECTIVES

To assess the benefits and harms of interventions for MN.

SEARCH METHODS

On 11 July 2022, we searched CENTRAL, CINAHL Plus EBSCOhost, ClinicalTrials.gov, Cochrane Neuromuscular Specialised Register, Embase Ovid, MEDLINE Ovid, and WHO ICTRP. We checked the bibliographies of identified randomised trials and systematic reviews and contacted trial authors as needed.

SELECTION CRITERIA

We included all randomised, parallel-group trials (RCTs) of any intervention compared with placebo, control, or another intervention for MN. We included trials where allocation occurred at the level of the individual or the foot (clustered data). We included trials that confirmed MN through symptoms, a clinical test, and an ultrasound scan (USS) or magnetic resonance imaging (MRI).

DATA COLLECTION AND ANALYSIS

We used standard Cochrane methodological procedures. We assessed bias using Cochrane's risk of bias 2 tool (RoB 2) and assessed the certainty of the evidence using the GRADE framework.

MAIN RESULTS

We included six RCTs involving 373 participants with MN. We judged risk of bias as having 'some concerns' across most outcomes. No studies had a low risk of bias across all domains. Post-intervention time points reported were: three months to less than 12 months from baseline (nonsurgical outcomes), and 12 months or longer from baseline (surgical outcomes). The primary outcome was pain, and secondary outcomes were function, satisfaction or health-related quality of life (HRQoL), and adverse events (AE). Nonsurgical treatments Corticosteroid and local anaesthetic injection (CS+LA) versus local anaesthetic injection (LA) Two RCTs compared CS+LA versus LA. At three to six months: • CS+LA may result in little to no difference in pain (mean difference (MD) -6.31 mm, 95% confidence interval (CI) -14.23 to 1.61; P = 0.12, I = 0%; 2 studies, 157 participants; low-certainty evidence). (Assessed via a pain visual analogue scale (VAS; 0 to 100 mm); a lower score indicated less pain.) • CS+LA may result in little to no difference in function when compared with LA (standardised mean difference (SMD) -0.30, 95% CI -0.61 to 0.02; P = 0.06, I = 0%; 2 studies, 157 participants; low-certainty evidence). (Function was measured using: the American Orthopaedic Foot and Ankle Society Lesser Toe Metatarsophalangeal-lnterphalangeal Scale (AOFAS; 0 to 100 points) - we transformed the scale so that a lower score indicated improved function - and the Manchester Foot Pain and Disability Schedule (MFPDS; 0 to 100 points), where a lower score indicated improved function.) • CS+LA probably results in little to no difference in HRQoL when compared to LA (MD 0.07, 95% CI -0.03 to 0.17; P = 0.19; 1 study, 122 participants; moderate-certainty evidence), and CS+LA may not increase satisfaction (risk ratio (RR) 1.08, 95% CI 0.63 to 1.85; P = 0.78; 1 study, 35 participants; low-certainty evidence). (Assessed using the EuroQol five dimension instrument (EQ-5D; 0-1 point); a higher score indicated improved HRQoL.) • The evidence is very uncertain about the effects of CS+LA on AE when compared with LA (RR 9.84, 95% CI 1.28 to 75.56; P = 0.03, I = 0%; 2 studies, 157 participants; very low-certainty evidence). Adverse events for CS+LA included mild skin atrophy (3.9%), hypopigmentation of the skin (3.9%) and plantar fat pad atrophy (2.6%); no adverse events were observed with LA. Ultrasound-guided (UG) CS+LA versus non-ultrasound-guided (NUG) CS+LA Two RCTs compared UG CS+LA versus NUG CS+LA. At six months: • UG CS+LA probably reduces pain when compared with NUG CS+LA (MD -15.01 mm, 95% CI -27.88 to -2.14; P = 0.02, I = 0%; 2 studies, 116 feet; moderate-certainty evidence). (Assessed with a pain VAS.) • UG CS+LA probably increases function when compared with NUG CS+LA (SMD -0.47, 95% CI -0.84 to -0.10; P = 0.01, I = 0%; 2 studies, 116 feet; moderate-certainty evidence). We do not know of any established minimum clinical important difference (MCID) for the scales that assessed function, specifically, the MFPDS and the Manchester-Oxford Foot Questionnaire (MOXFQ; 0 to 100 points; a lower score indicated improved function.) • UG CS+LA may increase satisfaction compared with NUG CS+LA (risk ratio (RR) 1.71, 95% CI 1.19 to 2.44; P = 0.003, I = 15%; 2 studies, 114 feet; low-certainty evidence). • HRQoL was not measured. • UG CS+LA may result in little to no difference in AE when compared with NUG CS+LA (RR 0.42, 95% CI 0.12 to 1.39; P = 0.15, I = 0%; 2 studies, 116 feet; low-certainty evidence). AE included depigmentation or fat atrophy for UG CS+LA (4.9%) and NUG CS+LA (12.7%). Surgical treatments Plantar incision neurectomy (PN) versus dorsal incision neurectomy (DN) One study compared PN versus DN. At 34 months (mean; range 28 to 42 months), PN may result in little to no difference for satisfaction (RR 1.06, 95% CI 0.87 to 1.28; P = 0.58; 1 study, 73 participants; low-certainty evidence), or for AE (RR 0.95, 95% CI 0.32 to 2.85; P = 0.93; 1 study, 75 participants; low-certainty evidence) compared with DN. AE for PN included hypertrophic scaring (11.4%), foreign body reaction (2.9%); AE for DN included missed nerve (2.5%), artery resected (2.5%), wound infection (2.5%), postoperative dehiscence (2.5%), deep vein thrombosis (2.5%) and reoperation with plantar incision due to intolerable pain (5%). The data reported for pain and function were not suitable for analysis. HRQoL was not measured.

AUTHORS' CONCLUSIONS: Although there are many interventions for MN, few have been assessed in RCTs. There is low-certainty evidence that CS+LA may result in little to no difference in pain or function, and moderate-certainty evidence that UG CS+LA probably reduces pain and increases function for people with MN. Future trials should improve methodology to increase certainty of the evidence, and use optimal sample sizes to decrease imprecision.

摘要

背景

Morton 神经瘤(MN)是一种疼痛性神经病变,由足底总趾神经良性肿大引起,常见于足部第三趾蹼间隙,较少见于第二趾蹼间隙。症状包括趾蹼间隙灼痛或刺痛并延伸至脚趾,或有踩在鹅卵石上的感觉。这些症状会影响负重活动和生活质量。

目的

评估MN干预措施的益处和危害。

检索方法

2022年7月11日,我们检索了Cochrane系统评价数据库、CINAHL Plus EBSCOhost数据库、ClinicalTrials.gov、Cochrane神经肌肉专业注册库、Embase Ovid、MEDLINE Ovid和世界卫生组织国际临床试验注册平台。我们检查了已识别的随机试验和系统评价的参考文献,并在需要时联系试验作者。

选择标准

我们纳入了所有将任何干预措施与安慰剂、对照或另一种针对MN的干预措施进行比较的随机平行组试验(RCT)。我们纳入了个体或足部层面进行分配的试验(聚类数据)。我们纳入了通过症状、临床检查以及超声扫描(USS)或磁共振成像(MRI)确诊为MN的试验。

数据收集与分析

我们采用标准的Cochrane方法学程序。我们使用Cochrane偏倚风险2工具(RoB 2)评估偏倚,并使用GRADE框架评估证据的确定性。

主要结果

我们纳入了6项RCT,涉及373例MN患者。我们判断大多数结局的偏倚风险为“有些担忧”。没有研究在所有领域均具有低偏倚风险。干预后报告的时间点为:距基线3个月至不到12个月(非手术结局),以及距基线12个月或更长时间(手术结局)。主要结局为疼痛,次要结局为功能、满意度或健康相关生活质量(HRQoL)以及不良事件(AE)。非手术治疗 皮质类固醇和局部麻醉剂注射(CS+LA)与局部麻醉剂注射(LA) 两项RCT比较了CS+LA与LA。在3至6个月时: • CS+LA可能导致疼痛几乎无差异(平均差(MD)-6.31 mm,95%置信区间(CI)-14.23至1.61;P = 0.12,I² = 0%;2项研究,157例参与者;低确定性证据)。(通过疼痛视觉模拟量表(VAS;0至100 mm)评估;分数越低表明疼痛越轻。) • CS+LA与LA相比,功能可能几乎无差异(标准化平均差(SMD)-0.30,95% CI -0.61至0.02;P = 0.06,I² = 0%;2项研究,157例参与者;低确定性证据)。(功能使用以下量表测量:美国矫形足踝协会小趾跖趾关节-趾间关节量表(AOFAS;0至100分)-我们对该量表进行了转换,使得分数越低表明功能改善-以及曼彻斯特足部疼痛与残疾量表(MFPDS;0至100分),分数越低表明功能改善。) • 与LA相比,CS+LA可能导致HRQoL几乎无差异(MD 0.0,95% CI -0.03至0.17;P = 0.19;1项研究,122例参与者;中等确定性证据),且CS+LA可能不会提高满意度(风险比(RR)1.08,95% CI 0.63至1.85;P = 0.78;1项研究,35例参与者;低确定性证据)。(使用欧洲五维健康量表(EQ-5D;0 - 1分)评估;分数越高表明HRQoL改善。) • 与LA相比,关于CS+LA对AE影响的证据非常不确定(RR 9.84,95% CI 1.28至75.56;P = 0.03,I² = 0%;2项研究,157例参与者;极低确定性证据)。CS+LA的不良事件包括轻度皮肤萎缩(3.9%)、皮肤色素减退(3.9%)和足底脂肪垫萎缩(2.6%);LA未观察到不良事件。超声引导(UG)CS+LA与非超声引导(NUG)CS+LA 两项RCT比较了UG CS+LA与NUG CS+LA。在6个月时: • 与NUG CS+LA相比,UG CS+LA可能减轻疼痛(MD -15.01 mm,95% CI -27.88至-2.14;P = 0.02,I² = 0%;2项研究,116只脚;中等确定性证据)。(通过疼痛VAS评估。) • 与NUG CS+LA相比,UG CS+LA可能改善功能(SMD -0.47,95% CI -0.84至-0.10;P = 0.01,I² = 0%;2项研究,116只脚;中等确定性证据)。我们不知道评估功能的量表,特别是MFPDS和曼彻斯特-牛津足部问卷(MOXFQ;0至100分;分数越低表明功能改善)的任何既定最小临床重要差异(MCID)。 • 与NUG CS+LA相比,UG CS+LA可能提高满意度(风险比(RR)1.71;95% CI 1.19至2.44;P = 0.003,I² = 15%;2项研究,114只脚;低确定性证据)。 • 未测量HRQoL。 • 与NUG CS+LA相比,UG CS+LA可能导致AE几乎无差异(RR 0.42,95% CI 0.12至1.39;P = 0.15,I² = 0%;2项研究,116只脚;低确定性证据)。AE包括UG CS+LA的色素脱失或脂肪萎缩(4.9%)和NUG CS+LA的(12.7%)。手术治疗 足底切口神经切除术(PN)与背侧切口神经切除术(DN) 一项研究比较了PN与DN。在34个月(平均;范围28至42个月)时,与DN相比,PN在满意度(RR 1.06,95% CI 0.87至1.28;P = 0.58;1项研究,73例参与者;低确定性证据)或AE(RR 0.95,95% CI 0.32至2.85;P = 0.93;1项研究,75例参与者;低确定性证据)方面可能几乎无差异。PN的AE包括肥厚性瘢痕(11.4%)、异物反应(2.9%);DN的AE包括神经遗漏(2.5%)、动脉切除(2.5%)、伤口感染(2.5%)、术后裂开(2.5%)、深静脉血栓形成(2.5%)以及因无法忍受的疼痛而进行足底切口再次手术(5%)。报告的疼痛和功能数据不适合分析。未测量HRQoL。

作者结论

尽管有许多针对MN的干预措施,但很少在RCT中进行评估。有低确定性证据表明CS+LA可能在疼痛或功能方面几乎无差异,有中等确定性证据表明UG CS+LA可能减轻MN患者的疼痛并改善功能。未来的试验应改进方法以提高证据的确定性,并使用最佳样本量以减少不精确性。

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Acta Biomed. 2022 Mar 10;92(S3):e2021556. doi: 10.23750/abm.v92iS3.12545.
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