Ultrasound-guided lumbar medial branch blocks and intra-articular facet joint injections: a systematic review and meta-analysis.

There is great interest in expanding the use of ultrasound (US), but new challenges exist with its application to lumbar facet-targeted procedures. The primary aim of this systematic review and meta-analysis was to determine the risk of incorrect needle placement associated with US-guided lumbar medial branch blocks (MBB) and facet joint injections (FJI) as confirmed by fluoroscopy or computerized tomography (CT). An a priori protocol was registered, and a database search was conducted. Inclusion criteria included all study types. Risk of bias was assessed using the Cochrane risk of bias tool for randomized controlled trials and the National Heart, Lung, and Blood tool for assessing risk bias for observational cohort studies. Pooled analysis of the risk difference (RD) of incorrect needle placement was calculated. Pooled analysis of 7 studies demonstrated an 11% RD (P < 0.0009) of incorrect needle placement for US-guided MBB confirmed using fluoroscopy with and without contrast. Pooled analysis of 3 studies demonstrated a 13% RD (P < 0.0001) of incorrect needle placement for US-guided FJI confirmed using CT. The time to complete a single-level MBB ranged from 2.6 to 5.0 minutes. The certainty of evidence was low to very low. Ultrasound-guided lumbar MBB and FJI are associated with a significant risk of incorrect needle placement when confirmed by fluoroscopy or CT. The technical limitations of US and individual patient factors could contribute to the risk of incorrect needle placement.

Injectable Biologics for Neuropathic Pain: A Systematic Review.

BACKGROUND: Neuropathic pain is a complex condition that can be refractory to conventional management and can cause persistent suffering in patients. Current pharmacologic treatments can provide temporary symptomatic relief; however, the mechanism of these therapies does not address the underlying cause of neuropathic pain. The use of injectable biologics for neuropathic pain has multiple proposed mechanisms for analgesia including attenuation of inflammatory mediated processes, arrest or delay of the degenerative process, inhibition of apoptotic pathways, and augmentation of the survival and recovery of injured and uninjured nerves. STUDY DESIGN: A systematic review of human studies involving the use of injectable biologics for neuropathic pain. METHODS: A comprehensive search of several data bases including Ovid MEDLINE ® and Epub Ahead of Print, In Process & Other Non-Indexed Citations and Daily, and Ovid Embase from inception to November 24, 2020. RESULTS: The initial search yielded 3,450 studies with an additional 6 studies identified through other resources. Twenty-seven studies were included after independent review by two of the investigators. The included studies assessed the efficacy of injectable biologics for the treatment of neuropathic pain defined as pain reduction. Secondary outcome measures included functional improvement as well as safety of the procedures. A qualitative assessment of the literature without meta-analysis was performed due to the heterogeneity of the data. CONCLUSION: According to the GRADE criteria, there is very low certainty of evidence in support of the efficacy of injectable biologics for treatment of neuropathic pain. Future efforts should focus on creating a standardized methodology and study design with respect to preparation, dosage and route of administration of biologics. This will serve as a catalyst for higher quality randomized trials with generation of more useful data to help drive informed clinical decision making.

Adverse Events Associated With 10-kHz Dorsal Column Spinal Cord Stimulation: A 5-Year Analysis of the Manufacturer and User Facility Device Experience (MAUDE) Database.

BACKGROUND: High-frequency (10-kHz) spinal cord stimulation (SCS) continues to be an emerging therapy in chronic pain management. The same complications that plagued earlier SCS systems may affect newer stimulation technologies, although there is limited data on the type of complications and surgical management of these complications. OBJECTIVE: The aim of this study was to systematically examine real-world complications associated with 10-kHz SCS reported on the Manufacturer and User Facility Device Experience (MAUDE) database. MATERIALS AND METHODS: The MAUDE database was queried for entries reported between January 1, 2016 and December 31, 2020. Entries were classified into procedural complications, device-related complications, patient complaints, surgically managed complications, serious adverse events, and/or other complications. Primary outcomes included type and frequency of complications, and surgical management of complications. RESULTS: A total of 1651 entries were analyzed. Most entries were categorized as procedural complications (72.6%), followed by serious adverse events (10.5%), device-related complications (10.5%), and patient complaints (9.9%). Most complications were managed surgically with explant (50.9%) rather than revision (5.0%) or incision/drainage (6.6%). Of procedural complications, the most common entries included non-neuraxial infection (52.9%), new neurological symptoms (14.7%), and dural puncture (9.5%). Of device-related complications, the most common entries included lead damage (41.6%), erosion (18.5%), and difficult insertion (11.5%). CONCLUSION: This retrospective 5-year analysis of complications from10-kHz SCS provides a real-world assessment of safety data unique for this stimulation modality. This analysis may help inform future clinical decisions, lead to device enhancement and optimization, and improve mitigation of risks to provide safe and efficacious use of 10-kHz SCS.

Prevalence of postamputation pain and its subtypes: a meta-analysis with meta-regression.

INTRODUCTION: The inconsistent use of standardized approaches for classifying postamputation pain (PAP) has been a barrier to establishing its prevalence. OBJECTIVES: The primary objective of this systematic review and meta-analysis is to determine the prevalence of nontraumatic lower-extremity PAP using an established taxonomy. The secondary objective is to determine the prevalence of PAP subtypes, including phantom limb pain and residual limb pain (RLP). METHODS: An a priori protocol was registered, and a database search was conducted by a reference librarian. Randomized trials and uncontrolled studies were eligible for inclusion. The risk of bias was assessed using a tool developed for uncontrolled studies. A total of 2679 studies were screened, and 13 studies met inclusion criteria (n = 1063). RESULTS: The sources of risk of bias included selection bias and, to a lesser extent, whether the outcome was adequately ascertained. Two studies reported the prevalence of PAP and the pooled prevalence was 61% (95% confidence interval [CI], 33%-86%) with high heterogeneity (I2 = 93%). Thirteen studies reported the prevalence of phantom limb pain and the pooled prevalence was 53% (95% CI, 40%-66%) with high heterogeneity (I2 = 93%). Eight studies reported the prevalence of RLP and the pooled prevalence was 32% (95% CI 24%-41%) with high heterogeneity (I2 = 76%). Clinical subtypes of RLP were not reported. CONCLUSIONS: The prevalence of PAP is high in patients with nontraumatic lower-extremity amputations. Ongoing research that uses a taxonomy for PAP is needed to fully delineate the prevalence of PAP subtypes.

Sex-Related Differences in Symptoms and Psychosocial Outcomes in Patients With Fibromyalgia: A Prospective Questionnaire Study.

OBJECTIVE: To investigate sex-related differences in patients with fibromyalgia (FM) in terms of demographic characteristics and clinical features, including tender point count (TPC), mood disorders, sleep problems, FM symptom severity, fatigue, cognitive dysfunction, and quality of life (QOL). PATIENTS AND METHODS: We studied 668 consecutive patients with FM (606 women) from May 1, 2012, to November 30, 2013. Validated questionnaires assessed outcomes of depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), sleep problems (Medical Outcomes Study Sleep Scale), FM symptom severity (Revised Fibromyalgia Impact Questionnaire), fatigue (Multidimensional Fatigue Inventory), cognitive dysfunction (Multiple Ability Self-report Questionnaire), and QOL (36-Item Short Form Health Survey). Nonparametric Mann-Whitney U and Pearson χ2 tests were used to compare continuous and categorical outcome measures, respectively, between men and women. Linear regression models were performed for all continuous dependent variables, adjusting for age, body mass index, ethnicity, marital status, and highest education level completed. P<.05 was considered statistically significant. The Benjamini-Hochberg procedure was used to adjust for multiple comparisons. RESULTS: Multiple linear regression analysis revealed a significant association of female sex and greater TPC (P<.001), lower overall FM symptom severity (lower overall Revised Fibromyalgia Impact Questionnaire score; P=.03), and higher QOL subscale score for vitality (36-Item Short Form Health Survey vitality subscale score; P=.02). After adjustment for multiple comparisons, only the association between female sex and greater TPC remained significant. There were no sex-related differences in demographic characteristics, depression, anxiety, sleep problems, FM symptom severity, cognitive dysfunction, and QOL. CONCLUSION: A higher TPC may be associated with female sex in patients with FM. The assumption of other sex-based differences in the clinical presentation of FM was not supported in our study.

The Relative Risk of Achilles Tendon Injury in Patients Taking Quinolones.

OBJECTIVE: To examine the association between quinolone use and Achilles tendon injury, comparing well-matched cohorts of users of quinolone and nonquinolone antibiotics, and well-matched cohorts of quinolone users and patients not using any nonquinolone antibiotics. PATIENTS AND METHODS: This retrospective cohort study used Clinformatics data from 2008-2014. Using the propensity score, we matched quinolone users with other antibiotic users and quinolone users with nonusers. The primary outcome was Achilles tendon injury within 6 months. Bivariate analyses determined risk factors for Achilles tendon injury, and conditional logistic regression assessed the impact of quinolone use on these injuries. RESULTS: A total of 716,522 fluoroquinolone users were matched with other antibiotic users, and 645,034 fluoroquinolone users were matched with nonusers. Rates of Achilles tendon injury were less than 0.5% in all groups. Quinolone use increased the risk of Achilles tendon injury compared with other antibiotic users (odds ratio [OR] 1.24, 95% confidence interval [CI] 1.17-1.31) and nonusers (OR 1.54, 95% CI 1.44-1.64). Interaction with age did not significantly impact the relationship between quinolone use and Achilles injury; however, older quinolone users had a slightly higher relative risk of injury than nonusers versus younger patients. Furthermore, the youngest group of patients had similarly elevated relative risk for injury with quinolone use as did the elderly. CONCLUSION: Although quinolone use increases the risk of Achilles tendon injury, the absolute risk increase is minimal, especially when compared with similar morbidity patients taking other nonquinolone antibiotics. In relatively healthy populations, such as the one studied here, quinolone use may not make a clinically significant contribution to risk of Achilles tendon injury, at any age range, among those in need of such drugs.

Patient Impressions of Possible Catastrophic Outcomes after Diabetic Foot Ulceration.

BACKGROUND: Diabetes Mellitus (DM) and its complications are well studied; patients with diabetes may suffer from neuropathy and vascular issues, and associated with these, lower extremity ulceration. Ulcers are often refractory to treatment, and can be difficult for both patients and clinicians to manage. Such complications may lead to amputations, which in turn are a risk factor for death. However, in certain situations amputation may be the only option available, and may be used as reconstructive surgery, restoring function. The impacts of ulceration, amputation, use of prostheses, and other complications of diabetes on Quality of Life (QOL) are well studied. Similarly, the impact of QOL on overall health has been studied in some detail. OBJECTIVE: Not as well understood are patient expectations regarding amputation and ulceration, and patient knowledge of these outcomes. Specifically, it is not fully understood how patients view these complications prior to their occurrence. In this review we survey the literature for studies discussing these attitudes. Our objective was to perform a systematic review of the medical literature to understand how patients understand and anticipate the potential negative outcomes of ulceration and amputation. We also aimed to identify areas where there are gaps in patient knowledge, which could be addressed by clinicians. RESULTS: Our study yielded articles regarding impressions of patients with diabetes about their general health and outcomes. However, we did not discover much literature directly concerning attitudes toward catastrophic lower extremity outcomes before they occurred. We also identified that patients lack knowledge of management and complications of diabetes; both of these gaps provide an opportunity to better direct care for such patients.