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Rates of positive vs negative studies in the spine literature 脊柱文献中阳性研究与阴性研究的比率
Pub Date : 2024-07-17 DOI: 10.1016/j.inpm.2024.100423
Samantha Levin , Joshua Levin

Background

Accuracy in the interpretation of data, and publication of studies regardless of outcomes are vital to the development of the scientific literature.

Objective

To determine the proportion of studies in the spine literature that report positive results.

Study design

Review article of studies published in nine major spine, pain, and physical medicine and rehabilitation (PM&R) journals from January 1, 2018–December 31, 2022.

Patient sample

Not applicable.

Methods

Articles that reported on pain and/or function from 2018 to 2022 in nine major journals were reviewed by two independent evaluators. The articles were graded as either positive or negative based on the authors’ own conclusions about their work.

Results

Overall, 91 % [95 % CI 88–94 %] of all articles were reported to have positive results. No significant differences were found between the broad categories of spine, pain, and PM&R journals. When comparing different categories of treatments, there were lower rates of positive results from medication/supplement studies (54 % [95 % CI 27–81 %]) compared to studies of spine injections/interventions (95 % [95 % CI 91–99 %]) and those of surgery (100 % [95 % CI 96–100 %]), and a lower rate of positive results from studies on physical treatments (85 % [95 % CI 75–95 %]) compared to those of surgery (100 % [95 % CI 96–100 %]). Studies with placebo controls were less likely to report positive results (60 % [95 % CI 44–76 %]) compared to those that did not use placebo controls (96 % [95 % CI 94–98 %]).

Conclusions

Despite the vast majority of studies in the spine literature concluding positive results, the high disease prevalence of spine conditions and the enormous burden on the healthcare system remain.

背景数据解读的准确性以及无论结果如何都发表研究报告对科学文献的发展至关重要。目的确定脊柱文献中报告阳性结果的研究比例。研究设计对2018年1月1日至2022年12月31日期间在九种主要脊柱、疼痛、物理医学和康复(PM&R)期刊上发表的研究文章进行回顾性研究。患者样本不适用。方法由两名独立评估员对2018年至2022年期间九种主要期刊上报告疼痛和/或功能的文章进行回顾性研究。根据作者自己对其工作的结论,文章被评为阳性或阴性。结果总体而言,所有文章中有 91% [95 % CI 88-94%]报告了阳性结果。脊柱、疼痛和 PM&R 期刊大类之间没有发现明显差异。在比较不同类别的治疗方法时,药物/补充剂研究的阳性结果率(54 % [95 % CI 27-81%])低于脊柱注射/干预研究(95 % [95 % CI 91-99%])和手术研究(100 % [95 % CI 96-100%]),物理治疗研究的阳性结果率(85 % [95 % CI 75-95%])低于手术研究(100 % [95 % CI 96-100%])。与不使用安慰剂对照的研究(96 % [95 % CI 94-98%])相比,使用安慰剂对照的研究报告阳性结果的可能性较低(60 % [95 % CI 44-76%])。结论尽管脊柱文献中的绝大多数研究都得出了阳性结果,但脊柱疾病的高发病率和对医疗系统造成的巨大负担依然存在。
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引用次数: 0
Early epidural lead migration in spinal cord stimulator trials: A case series 脊髓刺激器试验中的早期硬膜外导线移位:病例系列
Pub Date : 2024-07-16 DOI: 10.1016/j.inpm.2024.100426
Wendy Han Cong Song , Tim Ting Han Jen , Jill Alison Osborn , Vishal Varshney

Background

Spinal cord stimulation (SCS) devices are routinely trialed to assess pain and functional improvement before permanent lead implantation. Lead migration is a common complication that may cause a loss of therapeutic effect in patients who may otherwise benefit from SCS. The timing of lead migration during the trial period is currently unknown.

Objectives

We hypothesize that significant lead migration may occur early in the SCS trial period, such as postoperative day 1 or 2, which may allow for contact stimulation adjustment to prevent false negative trial results. As such, in this study, we aim to evaluate the incidence and distance of lead migration in early thoracic SCS trial period.

Methods

We performed a case series of 27 patients ≥19 years of age who received differential target multiplexed thoracic SCS trials for chronic neuropathic pain from July 1, 2020 to July 1, 2023. Patients with a neuropathic pain diagnosis failing medical treatment, without structural pathology limiting epidural access, and with psychiatric clearance for suitability are eligible for SCS trials at our center. Pre- and post-flexion radiographs taken immediately after implantation and on postoperative day 1 or 2 were examined to assess the distance of lead migration. Clinically significant lead migration was pre-defined as ≥ 10 mm.

Results

The mean (SD) distances of epidural lead migration on postoperative day 1 or 2 were 18.2 (12.9) mm and 19.1 (13.3) mm for the cephalic and caudal leads, respectively. All migrations were caudad except for one trial. Clinically significant lead migration occurred in 20/27 (74 %) patients.

Conclusion

Clinically significant epidural lead migration occurs in the early SCS trial period.

背景脊髓刺激(SCS)装置在永久性导线植入前会进行常规试用,以评估疼痛和功能改善情况。导线移位是一种常见的并发症,可能会导致原本可从 SCS 中获益的患者失去治疗效果。我们假设,在 SCS 试验早期(如术后第 1 或第 2 天)可能会出现明显的导线移位,这样就可以对接触刺激进行调整,避免出现假阴性试验结果。因此,在本研究中,我们旨在评估胸椎 SCS 试验早期导联迁移的发生率和距离。方法我们对 2020 年 7 月 1 日至 2023 年 7 月 1 日期间因慢性神经病理性疼痛而接受不同靶点多路胸椎 SCS 试验的 27 名年龄≥19 岁的患者进行了病例系列研究。经诊断为神经病理性疼痛且无法接受药物治疗的患者、无限制硬膜外通路的结构性病变的患者,以及经精神科检查适合接受 SCS 试验的患者,均可在本中心接受 SCS 试验。在植入后立即和术后第 1 或第 2 天拍摄的屈曲前和屈曲后 X 光片用于评估导线移位的距离。结果术后第1天或第2天硬膜外导线移位的平均距离(标度)分别为18.2 (12.9)毫米和19.1 (13.3)毫米,头侧和尾侧导线移位的平均距离(标度)分别为18.2 (12.9)毫米和19.1 (13.3)毫米。除一次试验外,所有移位均发生在尾部。20/27(74%)例患者发生了有临床意义的导联移位。
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引用次数: 0
Sustained pain relief from radiofrequency ablation of the superior cluneal nerves using a bipolar palisade technique: A case report 使用双极帕利塞德技术对上锁骨神经进行射频消融可持续缓解疼痛:病例报告
Pub Date : 2024-07-16 DOI: 10.1016/j.inpm.2024.100425
Theodore Cohen

Previous authors have described the anatomy of the superior cluneal nerves with medial, intermediate, and lateral branches as they pass over the iliac crest. Prior authors describe a technique for radiofrequency of the superior cluneal nerves with needle placement walking off of the superior border of the iliac crest with needle redirection by sensory testing and a monopolar radiofrequency lesion. This is a case report of a patient with sustained pain relief after performing a radiofrequency ablation of the superior cluneal nerves utilizing a bipolar palisade technique.

之前的作者描述了楔上神经的解剖结构,包括穿过髂嵴的内侧、中间和外侧分支。之前的作者描述了一种对楔上神经进行射频治疗的技术,将针头放置在髂嵴上缘,通过感觉测试和单极射频病变对针头进行重新定向。这是一份利用双极帕利塞德技术对楔上神经进行射频消融后患者疼痛持续缓解的病例报告。
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引用次数: 0
A single-center retrospective chart review of percutaneous PNS for treatment of chronic shoulder pain 经皮 PNS 治疗慢性肩痛的单中心回顾性病历审查
Pub Date : 2024-07-11 DOI: 10.1016/j.inpm.2024.100419
Genaro J. Gutierrez , Pankaj Mehta , Trey Mouch , Shawn Puri , Jacob R. Caylor , William J. Huffman , Nathan D. Crosby , Joseph W. Boggs

Objective

The present IRB-approved retrospective chart review describes the use of a 60-day PNS treatment for shoulder pain at a single center in 60 total consecutive patients.

Background

Chronic shoulder pain affects an increasing number of patients per year and is especially prevalent in elderly populations. Percutaneous peripheral nerve stimulation (PNS) treatment targeting the nerves of the shoulder has been shown to reduce pain in prospective clinical studies and in analysis of real-world data.

Methods

Data were extracted from the electronic medical records of patients who had previously undergone percutaneous PNS treatment for chronic shoulder pain. Demographic data and treatment characteristics were summarized alongside treatment outcomes.

Results

Overall, 84 % (49/58) of patients reported substantial (≥50 %) pain relief at the end-of-treatment. The records for 2 patients did not include patient-reported percent pain relief. The average indwelling period for leads (i.e., treatment period) was 57 days. Findings on treatment effectiveness were consistent when the patient population was stratified by cause of pain, duration living with pain, and presence of pain-modifying comorbidities. Stimulation paradigms were identified and categorized by the nerve target and stimulation frequency (e.g., motor stimulation, sensory stimulation, or bimodal stimulation).

Conclusions

These results indicate percutaneous PNS is an effective treatment for patients with various shoulder pain histories, and while all stimulation paradigms were effective at reducing pain, patients who received bimodal PNS reported the greatest pain relief. Key limitations of the study included heterogeneous shoulder pain etiologies among patients and sparse availability of long-term follow-up data. These data support existing real-world and prospective clinical evidence on the efficacy of 60-day PNS treatment at treating chronic pain and provide valuable insights into its use in clinical practice.

背景慢性肩痛每年影响着越来越多的患者,在老年人群中尤为普遍。在前瞻性临床研究和实际数据分析中,针对肩部神经的经皮外周神经刺激(PNS)治疗已被证明可以减轻疼痛。方法从曾接受过经皮外周神经刺激治疗的慢性肩痛患者的电子病历中提取数据。结果总体而言,84%(49/58)的患者在治疗结束时疼痛得到了明显缓解(≥50%)。2 名患者的记录不包括患者报告的疼痛缓解百分比。导联的平均留置期(即治疗期)为 57 天。根据疼痛原因、疼痛持续时间和是否存在可改变疼痛的合并症对患者进行分层后,治疗效果的研究结果是一致的。结论:这些结果表明,经皮 PNS 对不同肩痛病史的患者都是一种有效的治疗方法,虽然所有刺激模式都能有效减轻疼痛,但接受双模式 PNS 治疗的患者疼痛缓解程度最高。该研究的主要局限性包括:患者肩痛病因各异,长期随访数据稀少。这些数据支持现有的关于 60 天 PNS 治疗慢性疼痛疗效的真实世界和前瞻性临床证据,并为其在临床实践中的应用提供了宝贵的见解。
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引用次数: 0
Erratum regarding previously published articles 关于以前发表的文章的勘误
Pub Date : 2024-06-29 DOI: 10.1016/j.inpm.2024.100424
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引用次数: 0
Suprascapular nerve peripheral nerve stimulation for malignancy-related pain: A case series 肩胛上神经周围神经刺激治疗恶性肿瘤相关疼痛:病例系列
Pub Date : 2024-06-01 DOI: 10.1016/j.inpm.2024.100421
Cole Cheney, Jason Dauffenbach

Background

Blockade of the suprascapular nerve is an effective diagnostic tool in the workup and potential treatment of shoulder pain. For chronic shoulder pain, peripheral nerve stimulation has been shown to provide significant, sustained pain relief. However, no literature to date has described peripheral nerve stimulation for the treatment of oncologic shoulder pain.

Objectives

We describe two cases of chronic oncologic-related shoulder pain that responded to posterior suprascapular peripheral nerve stimulator placement to facilitate future progress and discussion in the fields of peripheral nerve stimulation and oncology pain.

Methods

Two subjects with chronic shoulder pain underwent ultrasound-guided peripheral nerve stimulation therapy at the suprascapular nerve.

Results

At follow-up visits (30 and 98 days after procedure), both subjects reported greater than 50% pain relief as measured by the numerical rating scale (NRS).

Conclusions

Peripheral nerve stimulator placement at the suprascapular nerve is a feasible procedure to treat oncologic shoulder pain via the described technique. Both subjects experienced clinically significant pain relief and decreased oral analgesic medication intake, and decreased medication-related side effects. This warrants further investigation including large comparative, prospective studies to better assess efficacy and safety of this approach.

背景肩胛上神经阻断是肩痛检查和潜在治疗的有效诊断工具。对于慢性肩痛,外周神经刺激已被证明能显著、持续地缓解疼痛。目的我们描述了两例慢性肩部肿瘤相关疼痛病例,这两例病例对后肩胛上外周神经刺激器置入术有反应,以促进外周神经刺激和肿瘤疼痛领域的未来进展和讨论。方法两名患有慢性肩痛的受试者在超声引导下接受了肩胛上神经外周神经刺激治疗。结果在随访时(术后 30 天和 98 天),两名受试者的疼痛缓解率均超过了数字评分量表(NRS)的 50%。两名受试者的疼痛都得到了明显的缓解,口服镇痛药物的摄入量也有所减少,与药物相关的副作用也有所降低。这值得进一步研究,包括大型前瞻性对比研究,以更好地评估这种方法的有效性和安全性。
{"title":"Suprascapular nerve peripheral nerve stimulation for malignancy-related pain: A case series","authors":"Cole Cheney,&nbsp;Jason Dauffenbach","doi":"10.1016/j.inpm.2024.100421","DOIUrl":"https://doi.org/10.1016/j.inpm.2024.100421","url":null,"abstract":"<div><h3>Background</h3><p>Blockade of the suprascapular nerve is an effective diagnostic tool in the workup and potential treatment of shoulder pain. For chronic shoulder pain, peripheral nerve stimulation has been shown to provide significant, sustained pain relief. However, no literature to date has described peripheral nerve stimulation for the treatment of oncologic shoulder pain.</p></div><div><h3>Objectives</h3><p>We describe two cases of chronic oncologic-related shoulder pain that responded to posterior suprascapular peripheral nerve stimulator placement to facilitate future progress and discussion in the fields of peripheral nerve stimulation and oncology pain.</p></div><div><h3>Methods</h3><p>Two subjects with chronic shoulder pain underwent ultrasound-guided peripheral nerve stimulation therapy at the suprascapular nerve.</p></div><div><h3>Results</h3><p>At follow-up visits (30 and 98 days after procedure), both subjects reported greater than 50% pain relief as measured by the numerical rating scale (NRS).</p></div><div><h3>Conclusions</h3><p>Peripheral nerve stimulator placement at the suprascapular nerve is a feasible procedure to treat oncologic shoulder pain via the described technique. Both subjects experienced clinically significant pain relief and decreased oral analgesic medication intake, and decreased medication-related side effects. This warrants further investigation including large comparative, prospective studies to better assess efficacy and safety of this approach.</p></div>","PeriodicalId":100727,"journal":{"name":"Interventional Pain Medicine","volume":"3 2","pages":"Article 100421"},"PeriodicalIF":0.0,"publicationDate":"2024-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2772594424000414/pdfft?md5=3a5749a52eeca516ac4f6f04628d8e22&pid=1-s2.0-S2772594424000414-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141332956","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Peripheral nerve stimulation on trial: A novel, cost-effective approach to determine patient candidacy prior to implantation 外周神经刺激试验:在植入手术前确定患者是否适合接受手术的经济有效的新方法
Pub Date : 2024-06-01 DOI: 10.1016/j.inpm.2024.100418
Bhavana Yalamuru, Sam Nia
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引用次数: 0
Safety of cervical transforaminal epidural steroid injections 颈椎经椎间孔硬膜外类固醇注射的安全性
Pub Date : 2024-06-01 DOI: 10.1016/j.inpm.2024.100420
William J. Beckworth , Gilad M. Ghanbari , Eduardo Lamas-Basulto , Benjamin Taylor

Background

In 2014 the FDA issued a drug safety warning that steroids in the epidural space may result in rare but serious neurological adverse events. The FDA identified 131 cases of neurological adverse events and most complications were related to cervical transforaminal epidural injections (TFESIs). These complications occurred before the standard use of non-particulate steroids. Many still consider cervical TFSEIs to be unsafe.

Objectives

The objective of this study was to evaluate the safety of cervical TFESIs with non-particulate steroids.

Methods

A review was done of all cervical TFESIs from 2004 to 2021 at an academic institution when non-particulate steroids became more commonly used by reviewing CPT code 64479 linked to the performing physician. All treating physicians and department directors were queried about catastrophic complications (stroke, spinal cord injury, death or other). A secondary analysis was done on 200 consecutive cervical TFESIs looking at immediate and delayed side-effects documented by the nurse in recovery, day-after phone calls and clinic follow-up notes.

Results

From 2004 to 2021 the CPT code 64479 was used 6967 times, with 6241 cervical TFESIs and 726 thoracic TFESIs. No catastrophic complications occurred. In the subset analysis of 200 consecutive cervical TFESIs, 7 patients (3.5 %, 95 % CI 1.0–6.0) had a transient increase in pain, 18 (9 %, 95 % CI 5.0–13.0) had no change in pain and 171 (85.5 %, 95 % CI 80.6–90.4) had a decrease in pain. The average pain score among all participants dropped 3.7 (95 % 3.0–4.4) points. A 2-point drop was seen in 75.5 % (95 % CI 69.5–81.5) and a 3-point drop was seen in 62.5 % (95 % CI 59.1–65.9). Five of the seven patients with transient increased pain had an increase of 3 points on numerical rating scale. There was one of each of the following reported: insomnia, glucose >500, transient thumb numbness with pain, and hypertension. Two cases of headaches were reported.

Conclusion

This study supports the safety of cervical TFESIs with non-particulate steroids as recommended by consensus opinions from medical societies.

背景2014年,美国食品和药物管理局(FDA)发布了一项药物安全警告,称硬膜外腔注射类固醇可能导致罕见但严重的神经系统不良事件。FDA 发现了 131 例神经系统不良事件,其中大多数并发症与颈椎经椎间孔硬膜外注射 (TFESI) 有关。这些并发症发生在标准使用非颗粒类固醇之前。本研究的目的是评估使用非颗粒类固醇进行颈椎经椎硬膜外注射的安全性。方法在非颗粒类固醇开始普遍使用后,对一家学术机构 2004 年至 2021 年的所有颈椎经椎硬膜外注射进行了回顾,回顾的方法是查看与实施医师相关的 CPT 代码 64479。对所有主治医生和科室主任进行了有关灾难性并发症(中风、脊髓损伤、死亡或其他)的询问。我们还对 200 例连续的颈椎 TFESI 进行了二次分析,观察恢复期护士记录的即时和延迟副作用、术后第二天的电话和门诊随访记录。结果从 2004 年到 2021 年,CPT 编码 64479 共使用了 6967 次,其中颈椎 TFESI 6241 次,胸椎 TFESI 726 次。没有发生灾难性并发症。在对 200 例连续颈椎 TFESI 进行的子集分析中,7 例患者(3.5%,95 % CI 1.0-6.0)的疼痛短暂加剧,18 例患者(9%,95 % CI 5.0-13.0)的疼痛无变化,171 例患者(85.5%,95 % CI 80.6-90.4)的疼痛有所减轻。所有参与者的平均疼痛评分下降了 3.7(95 % CI 3.0-4.4)分。75.5%(95 % CI 69.5-81.5)的患者疼痛评分下降了 2 分,62.5%(95 % CI 59.1-65.9)的患者疼痛评分下降了 3 分。在 7 名出现一过性疼痛加剧的患者中,有 5 名患者的数字评分增加了≥3 分。据报告,失眠、血糖 500、一过性拇指麻木伴疼痛和高血压患者各占 1 例。结论这项研究支持医学会共识建议的使用非颗粒类固醇的颈椎 TFESIs 的安全性。
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引用次数: 0
Reclaiming confidence in cervical transforaminal epidurals: Dispelling myths and ensuring safety 重拾对颈椎经椎间孔硬膜外麻醉的信心:消除误解,确保安全
Pub Date : 2024-06-01 DOI: 10.1016/j.inpm.2024.100417
Samer Narouze MD, PhD, MMM
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引用次数: 0
Minimally invasive spine surgical procedures and interventional pain medicine: Need for standardization of training 微创脊柱外科手术和疼痛介入治疗:培训标准化的必要性
Pub Date : 2024-05-27 DOI: 10.1016/j.inpm.2024.100416
Eldhose Abrahams
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引用次数: 0
期刊
Interventional Pain Medicine
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