David Judy A, Sankarapandian Venkatesan, Christopher Prince Rh, Chatterjee Ahana, Macaden Ashish S
Department of Physical Medicine and Rehabilitation, Christian Medical College, Ida Scudder Road, Vellore, Tamil Nadu, India, 632004.
Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD009348. doi: 10.1002/14651858.CD009348.pub2.
Plantar heel pain, commonly resulting from plantar fasciitis, often results in significant morbidity. Treatment options include nonsteroidal anti-inflammatory drugs (NSAIDs), orthoses, physical therapy, physical agents (e.g. extracorporeal shock wave therapy (ESWT), laser) and invasive procedures including steroid injections.
To assess the effects (benefits and harms) of injected corticosteroids for treating plantar heel pain in adults.
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials (the Cochrane Library), MEDLINE, Embase, CINAHL, clinical trials registries and conference proceedings. Latest search: 27 March 2017.
Randomised and quasi-randomised trials of corticosteroid injections in the treatment of plantar heel pain in adults were eligible for inclusion.
At least two review authors independently selected studies, assessed risk of bias and extracted data. We calculated risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcome measures. We used a fixed-effect model unless heterogeneity was significant, when a random-effects model was considered. We assessed the overall quality of evidence for individual outcomes using the GRADE approach.
We included a total of 39 studies (36 randomised controlled trials (RCTs) and 3 quasi-RCTs) that involved a total of 2492 adults. Most studies were small (median = 59 participants). Participants' mean ages ranged from 34 years to 59 years. When reported, most participants had heel pain for several months. The trials were usually conducted in outpatient specialty clinics of tertiary care hospitals in 17 countries. Steroid injection was given with a local anaesthetic agent in 34 trials. Follow-up was from one month to over two years. With one exception, trials were assessed at high risk of bias in one or more domains, mostly relating to lack of blinding, including lack of confirmation of allocation concealment. With two exceptions, we rated the available evidence as very low quality, implying in each case that we are 'very uncertain about the estimate'.The 39 trials covered 18 comparisons, with six of the seven trials with three or four groups providing evidence towards two comparisons.Eight trials (724 participants) compared steroid injection versus placebo or no treatment. Steroid injection may lead to lower heel pain visual analogue scores (VAS) (0 to 100; higher scores = worse pain) in the short-term (< 1 month) (MD -6.38, 95% CI -11.13 to -1.64; 350 participants; 5 studies; I² = 65%; low quality evidence). Based on a minimal clinically significant difference (MCID) of 8 for average heel pain, the 95% CI includes a marginal clinical benefit. This potential benefit was diminished when data were restricted to three placebo-controlled trials. Steroid injection made no difference to average heel pain in the medium-term (1 to 6 months follow-up) (MD -3.47, 95% CI -8.43 to 1.48; 382 participants; 6 studies; I² = 40%; low quality evidence). There was very low quality evidence for no effect on function in the medium-term and for an absence of serious adverse events (219 participants, 4 studies). No studies reported on other adverse events, such as post-injection pain, and on return to previous activity. There was very low quality evidence for fewer treatment failures (defined variously as persistent heel pain at 8 weeks, steroid injection at 12 weeks, and unrelieved pain at 6 months) after steroid injection.The available evidence for other comparisons was rated as very low quality. We are therefore very uncertain of the estimates for the relative effects on people with heel pain of steroids compared with other interventions in:1. Tibial nerve block with anaesthetic (2 trials); orthoses (4 trials); oral NSAIDs (2 trials); and intensive physiotherapy (1 trial).2. Physical modalities: ESWT (5 trials); laser (2 trials); and radiation therapy (1 trial).3. Other invasive procedures: locally injectable NSAID (1 trial); platelet-rich plasma injections (5 trials); autologous blood injections (2 trials); botulinum toxin injections (2 trials); cryopreserved human amniotic membrane injection (1 trial); localised peppering with a needle (1 trial); dry needling (1 trial); and mini scalpel needle release (1 trial).We are also uncertain about the estimates from trials testing different techniques of local steroid injection: ultrasonography-guided versus palpation-guided (5 trials); and scintigraphy-guided versus palpation-guided (1 trial).An exploratory analysis involving pooling data from 21 trials reporting on adverse events revealed two ruptures of plantar fascia (reported in 1 trial) and three injection site infections (reported in 2 trials) in 699 participants allocated to steroid injection study arms. Five trials reported a total of 27 participants with less serious short-term adverse events in the 699 participants allocated steroid injection study arms. Reported treatments were analgesia, ice or both. Given the high risk of selective reporting for these outcomes and imprecision, this evidence was rated at very low quality.
AUTHORS' CONCLUSIONS: We found low quality evidence that local steroid injections compared with placebo or no treatment may slightly reduce heel pain up to one month but not subsequently. The available evidence for other outcomes of this comparison was very low quality. Where available, the evidence from comparisons of steroid injections with other interventions used to treat heel pain and of different methods of guiding the injection was also very low quality. Although serious adverse events relating to steroid injection were rare, these were under-reported and a higher risk cannot be ruled out.Further research should focus on establishing the effects (benefits and harms) of injected steroids compared with placebo in typical clinical settings, subsequent to a course of unsuccessful conservative therapy. Ideally, this should be preceded by research, including patient involvement, aimed to obtain consensus on the priority questions for treating plantar heel pain.
足底足跟痛通常由足底筋膜炎引起，常导致显著的发病率。治疗选择包括非甾体抗炎药（NSAIDs）、矫形器、物理治疗、物理因子（如体外冲击波疗法（ESWT）、激光）以及包括类固醇注射在内的侵入性操作。
评估注射用皮质类固醇治疗成人足底足跟痛的效果（益处和危害）。
我们检索了Cochrane骨、关节和肌肉创伤组专业注册库、Cochrane对照试验中央注册库（Cochrane图书馆）、MEDLINE、Embase、CINAHL、临床试验注册库和会议论文集。最新检索时间：2017年3月27日。
皮质类固醇注射治疗成人足底足跟痛的随机和半随机试验符合纳入标准。
至少两名综述作者独立选择研究、评估偏倚风险并提取数据。我们计算了二分结局的风险比（RRs）和连续结局指标的平均差（MDs）。除非异质性显著，否则我们使用固定效应模型，此时考虑随机效应模型。我们使用GRADE方法评估个体结局的总体证据质量。
我们共纳入39项研究（36项随机对照试验（RCTs）和3项半RCTs），涉及2492名成人。大多数研究规模较小（中位数 = 59名参与者）。参与者的平均年龄在34岁至59岁之间。报告显示，大多数参与者足跟痛持续数月。试验通常在17个国家的三级护理医院的门诊专科诊所进行。34项试验中皮质类固醇注射与局部麻醉剂联合使用。随访时间从1个月到两年多不等。除一项研究外，试验在一个或多个领域被评估为高偏倚风险，主要与缺乏盲法有关，包括缺乏分配隐藏的确认。除两项研究外，我们将现有证据评为极低质量，这意味着在每种情况下我们“对估计值非常不确定”。这39项试验涵盖18种比较，七项有三组或四组的试验中有六项为两种比较提供了证据。八项试验（724名参与者）比较了类固醇注射与安慰剂或不治疗。在短期（<1个月），类固醇注射可能导致足跟痛视觉模拟评分（VAS）（0至1百；分数越高疼痛越严重）降低（MD -6.38，95%CI -11.13至 -1.64；350名参与者；5项研究；I² = 65%；低质量证据）。基于平均足跟痛最小临床重要差异（MCID）为8，95%CI包括边缘临床益处。当数据仅限于三项安慰剂对照试验时，这种潜在益处减弱。在中期（随访1至6个月），类固醇注射对平均足跟痛无差异（MD -3.47，95%CI -8.43至1.48；382名参与者；6项研究；I² = 40%；低质量证据）。关于中期对功能无影响以及无严重不良事件（219名参与者，4项研究）的证据质量极低。没有研究报告其他不良事件，如注射后疼痛以及恢复至先前活动情况。关于类固醇注射后治疗失败较少（定义各异，如8周时持续足跟痛、12周时类固醇注射、6个月时疼痛未缓解）的证据质量极低。其他比较的现有证据被评为极低质量。因此，我们非常不确定与其他干预措施相比，类固醇对足跟痛患者的相对影响估计值：1. 麻醉下胫神经阻滞（2项试验）；矫形器（4项试验）；口服NSAIDs（2项试验）；以及强化物理治疗（1项试验）。2. 物理方式：ESWT（5项试验）；激光（2项试验）；以及放射治疗（1项试验）。3. 其他侵入性操作：局部可注射NSAIDs（1项试验）；富血小板血浆注射（5项试验）；自体血注射（2项试验）；肉毒杆菌毒素注射（2项试验）；冷冻保存人羊膜注射（1项试验）；局部针刺（1项试验）；干针疗法（1项试验）；以及微型手术刀针松解术（1项试验）。我们也不确定比较局部类固醇注射不同技术（超声引导与触诊引导（5项试验）；以及闪烁扫描引导与触诊引导（1项试验））的试验估计值。一项涉及汇总2项报告不良事件的试验数据的探索性分析显示，在分配至类固醇注射研究组的699名参与者中，有2例足底筋膜破裂（1项试验报告）和3例注射部位感染（在2项试验中报告）。5项试验报告在分配至类固醇注射研究组的699名参与者中共有27名参与者出现不太严重的短期不良事件。报告的治疗方法为镇痛、冰敷或两者兼用。鉴于这些结局选择性报告的高风险和不精确性，该证据被评为极低质量。
我们发现低质量证据表明，与安慰剂或不治疗相比，局部类固醇注射可能在1个月内略微减轻足跟痛，但随后无效。该比较其他结局的现有证据质量极低。在可得的情况下，类固醇注射与用于治疗足跟痛的其他干预措施比较以及不同注射引导方法比较的证据质量也极低。尽管与类固醇注射相关的严重不良事件罕见，但报告不足且不能排除更高风险。进一步的研究应聚焦于确定在典型临床环境中，与安慰剂相比，注射类固醇在保守治疗失败后的效果（益处和危害）。理想情况下，在此之前应进行研究，包括患者参与，旨在就治疗足底足跟痛的优先问题达成共识。
