Tag: pubmed

Pain Physician. 2024 Nov;27(8):E909-E917.

ABSTRACT

BACKGROUND: Since the initial introduction in 1967 of spinal cord stimulation (SCS) in the field of neuromodulation, SCS has been utilized to treat a multitude of chronic pain disorders refractory to both conservative and surgical management. Although efficacious when indicated, SCS has associated risks.

OBJECTIVES: The goals of this study are to explore the trend of rates of SCS complications in 2 approximately equally sized cohorts (1999-2015 and 2016-2021) within a single institution over a 22-year period.

STUDY DESIGN: A retrospective cohort study.

SETTING: A tertiary care academic hospital.

METHODS: A retrospective chart review with pre-existing institutional review board approval was performed on 2 cohorts, one comprising 257 patients between 2016 and 2021 and the other comprising 262 patients between 1999 and 2015, who underwent percutaneous SCS implantation provided by 2 experienced interventional chronic pain specialists. The patients’ demographics and complications were recorded in the REDCAP database. Data were collected on complications of both the biological (allergic/foreign-body reactions, dural puncture/leaks, infections, pain over implantation site, poor wound healing, skin erosions, neurological injuries, and subcutaneous/epidural hematomas) and device-related (electrical leaks, inadequate pain coverage, lead fractures, lead migrations, ligamentum flavum stimulation, recharging/battery failures, and unwanted stimulation) varieties. The chart review included records that started 6 months prior to SCS placement and ended at a period of at least one year of follow-up after placement.

RESULTS: Of the patients studied between 2016 and 2021, the mean age was 58.5 ± 13.0 years, with men representing 46.3% and women 53.7% of the patients studied. Of those studied between 1999 and 2015, the mean age was 50.6 +/- 12.3 years, with men representing 42.4% of the patients and women 57.6%. The overall complication rates were 14.0% (36/257) and 38.9% (102/262) for 2016-2021 and 1999-2015, respectively. The rate of biological complications was nearly 3 times lower in the 2016-2021 group than in the 1999-2015 group (4.3% [11/257] vs 12.2% [32/262], P < 0.001). In the 1999-2015 group, the leading biological complication was infection, the rate of which decreased in the 2016-2021 group (3.4% [9/262] vs 1.9% [5/257], P < 0.42). The rate of device complications was nearly 3 times lower in the 2016-2021 group than in the 1999-2015 group (9.7% [25/257] vs. 26.7% [70/262], P < 0.0001). The leading device complication was inadequate pain coverage (12.2% [32/262] vs 7.4% [19/257], P < 0.08). No serious neurological injury or death occurred in either cohort.

LIMITATIONS: Limitations were inherent to this study’s design, since it was a retrospective cohort study.

CONCLUSION: The rate of SCS-related complications decreased from one group to the next, with the most recent group demonstrating a statistically significant decrease in both device and biological complications. Our results are consistent with SCS literature trends that demonstrate decreasing complications, which may be due to technological advancements in SCS device technology and improved complication mitigation strategies. Further prospective research utilizing multicenter data is needed to better define the overall trend of SCS complications.

PMID:39621991

Pain Physician. 2024 Nov;27(8):E851-E863.

ABSTRACT

BACKGROUND: Exploring factors linked to the outcomes of certain interventional pain management techniques may optimize the selection of candidates for those procedures. Our hypothesis is that factors that influence responses to interventional therapies for chronic low back pain (CLBP) can be identified by analyzing a prospective cohort.

OBJECTIVES: Our main aim is to identify the factors that may be associated with adult patients’ responses to interventional therapies for the treatment of CLBP after 4 weeks of follow-up. Secondary objectives include the development of a predictive model and the establishment of a predictive score.

STUDY DESIGN: The PReTi-Back (Predicting REsponse to interventional Therapies In chronic BACK pain) study is an observational prospective single-center study, employing a nonprobability-sampling method.

SETTING: Our population consists of adult outpatients with CLBP in a chronic pain unit of a tertiary hospital. The procedures we evaluated included epidural steroid injections, medial branch blocks and denervations, dorsal root ganglion blocks, and pulsed radiofrequency.

METHODS: Ratings on the Numeric Pain Rating Scale (NPRS) and Oswestry Disability Index (ODI) were measured at the baseline and after 4 weeks of follow-up. The primary outcome of the study was composite and was evaluated at 4 weeks. A positive response to an intervention was defined as the simultaneous occurrence of a decrease of at least 2 points in the NPRS score and a decrease of at least 20% in the ODI score. A predictive model was constructed using logistic regression analysis, which incorporated 14 variables selected in advance. A predictive score was developed based on the odds ratios of the model variables.

RESULTS: Four hundred patients were recruited. Of these patients, 368 completed follow-up, 49 were excluded, and 319 were included in the analysis. The interventional therapies provided a positive response to 85 patients (26.6%) at 4 weeks. Listhesis, radicular compression, and satisfaction with previous interventional therapies were positively associated with the positive response, and their ORs were close to 2. Meanwhile, obesity and persistent spinal pain syndrome type 2 (PSPS-2) had negative associations with the outcome, presenting ORs close to 0.5. The models were statistically significant and exhibited satisfactory goodness of fit. The area under the curve was 0.67 (95% CI, 0.60-0.74). Both models exhibited low sensitivity but high specificity. The synthesis of the prediction score had little impact on its discriminatory capacity.

LIMITATIONS: The subgroup analysis revealed that both listhesis and radicular compression were associated with the response to epidural therapies but not with the response to medial branch therapies. The score was efficient in ruling out those who would not benefit from intervention (scores of 0 or one), but its main limitation was that it was less effective in identifying those who might respond favorably (scores ≥ 2).

CONCLUSIONS: Patients satisfied with previously performed interventional therapies or who exhibit findings of radicular compression or listhesis on imaging show approximately twice the likelihood of experiencing a positive response to short-term IMPT than do patients without those characteristics. Patients who are obese or have PSPS-2 exhibit approximately a 50% lower likelihood of short-term response than do patients without these conditions.

PMID:39621985

Pain Physician. 2024 Nov;27(8):E835-E842.

ABSTRACT

BACKGROUND: Ultrasound-guided 5% dextrose (D5W) hydrodissection provides favorable outcomes for treating peripheral entrapment neuropathies; its safety is well recognized. However, clinical evidence regarding the use of D5W hydrodissection for meralgia paresthetica (MP) is limited. Although corticosteroids are the most common injectates, the possible adverse effects are a big concern.

OBJECTIVE: To compare the efficacy and safety of ultrasound-guided D5W hydrodissection compared to corticosteroid hydrodissection in patients with MP during a 6-month follow-up period.

STUDY DESIGN: A prospective, randomized double-blind, controlled trial.

SETTING: Outpatient clinic at a university hospital.

METHODS: A total of 56 patients with MP were randomly allocated to either a D5W or steroid group in a 1:1 ratio. The patients received one session of ultrasound-guided perineural injection therapy of 10 mL D5W or a corticosteroid solution (1 mL compound betamethasone [1 mL: betamethasone sodium phosphate 5 mg and betamethasone dipropionate 2 mg] mixed with 5 mL 2% lidocaine and 4 mL 0.9% saline).The primary outcomes were Visual Analog Scale (VAS) scores for MP (pain and paresthesia) and global quality of life. The secondary outcomes included self-reported successful clinical response and injection adverse effects. Evaluations were conducted at pretreatment and at one, 3, 4 and 6 months posttreatment.

RESULTS: All patients completed the study. Compared with baseline, both groups exhibited reductions in VAS scores for MP and global quality of life at all follow-up time points, with statistical differences at 3, 4, and 6 months in the D5W group (P < 0.05), as well as those at one, 3, and 4 months in the steroid group (P < 0.05). The D5W group exhibited greater improvement than the steroid group in VAS scores for MP and global quality of life at 4 and 6 months (P < 0.05), and demostrated a more successful clinical response at 6 months (P < 0.05). No adverse effects were reported in the D5W group during the study period, while 6 patients in the steroid group reported an adverse effect.

LIMITATIONS: A longer follow-up period is necessary; the exact mechanism of D5W is not clear.

CONCLUSIONS: Ultrasound-guided perineural injection therapy of D5W is more beneficial than corticosteroid injection for MP at 4 to 6 months posttreatment. Additionally, D5W displays a better safety profile than corticosteroid. Thus, we suggest D5W as a more suitable injectate for patients with MP.

PMID:39621981

Pain Physician. 2024 Nov;27(8):529-535.

ABSTRACT

BACKGROUND: Informed consent is a crucial ethical and legal requirement in medical practice to ensure that patients understand the risks, benefits, and alternatives of medical procedures. Recent advances in multimedia technology have facilitated the exploration of multimedia consent, aiming to enhance patient understanding and satisfaction. Ascertaining that patients have full comprehension of the procedures before opting to undergo them is especially important now that instances of such procedures as lumbar transforaminal epidural steroid injections (TESIs) are increasing.

OBJECTIVES: To determine the effectiveness of multimedia consent forms for lumbar transforaminal steroid injections.

STUDY DESIGN: Randomized clinical trial.

SETTING: Outpatient multidisciplinary pain medicine center of a tertiary hospital.

METHODS: A randomized controlled trial was conducted with 30 patients who received lumbar TESIs for lumbar radiculopathy. Patients were randomly assigned to either the multimedia consent group (Group M) or the conventional paper consent group (Group C). This study evaluated patients’ comprehension of the procedure, their anxiety levels (using the State-Trait Anxiety Inventory short form), and the patients’ post-procedure satisfaction.

RESULTS: Group M showed significantly greater understanding of the procedure and reported lower levels of anxiety than did Group C (P = 0.041; P = 0.03). However, there were no statistically significant differences in post-procedure satisfaction between the groups (P = 0.25). These findings suggest that multimedia consent can effectively improve patient comprehension and reduce anxiety without significantly affecting patient satisfaction.

LIMITATIONS: First, the limited sample size of 30 patients restricts the applicability of our findings to a wider population, suggesting a need for larger studies to better assess the effects of multimedia consent. Second, conducting the study in a single hospital might have introduced bias. Multicenter research may provide a more diverse and accurate evaluation of the efficacy of multimedia consent.

CONCLUSION: This pilot study contributes to the growing evidence supporting the use of multimedia consent to enhance patient understanding and reduce anxiety, marking a promising direction for improving informed consent practices for less invasive procedures, such as lumbar TESIs. Further research is required to fully explore the benefits and limitations of multimedia consent forms in various medical settings.

PMID:39621978

Pain Physician. 2024 Nov;27(8):479-494.

ABSTRACT

BACKGROUND: The effectiveness of mindfulness meditation (MM) for the treatment of fibromyalgia syndrome (FMS) is unknown and needs to be updated.

OBJECTIVE: This study aimed at investigating the effectiveness of MM for the treatment of FMS.

STUDY DESIGN: A systematic review and meta-analysis.

METHODS: A comprehensive search of relevant studies published from the databases’ inception through April 12, 2023 was conducted within the following databases: Cochrane Library, Embase, MEDLINE, PubMed, Clinicaltrials.gov, and PsycINFO. We included randomized controlled trials that reported at least one of the following outcome indicators: the Fibromyalgia Impact Questionnaire (FIQ), the Pittsburg Sleep Quality Index (PSQI), the Beck Depression Inventory (BDI), and the Perceived Stress Scale (PSS). Results are presented in terms of mean difference (MD), supplemented by 95% CIs The I2 statistic assessed heterogeneity across 3 distinct observational time frames. We used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework to appraise the robustness of the evidence.

RESULTS: Ten randomized controlled trials were selected from 1,377 citations (n = 818). Various MM regimens were reported (type of mindfulness, duration, schemes, and ingredients). Among 818 patients, very low to moderate evidence indicated that MM could reduce FIQ in the short-term (MD = -6.20; 95% CI,-8.51 to -3.89; P < 0.05; GRADE: moderate); a lower PSQI score (MD = -1.84; 95% CI, -3.35 to -0.33; P < 0.05; GRADE: very low); a reduce BDI score (MD = -3.26; 95% CI, -5.77 to -0.76; P < 0.05; GRADE: moderate); and a decreased PSS score (MD = -4.85; 95% CI, -8.22 to -1.49; P < 0.05; GRADE: very low). At medium-term follow-up, MM consistently reduced the BDI score (MD = -2.88; 95% CI, -4.98 to -0.79; P < 0.05; GRADE: moderate) and decreased the PSS score (MD = -2.76; 95% CI, -4.82 to -0.70; P < 0.05; GRADE: moderate) but there was no significant difference in FIQ scores (MD = -2.78; 95% CI, -6.32 to 0.76; P > 0.05; GRADE: low) and PSQI scores (MD = -1.28; 95% CI, -3.35 to -0.80; P > 0.05; GRADE: very low). However, at long-term follow-up, MM still reduced FIQ scores (MD = -6.09; 95% CI, -9.01 to -3.16; P < 0.05; GRADE: moderate).

LIMITATIONS: The relatively small sample size and the average quality of the included studies may have introduced biases. The time and method of meditation in the included studies were not completely unified, and there were confounding factors. Additionally, the limited amount of available literature is a challenge. Despite focusing on randomized controlled trials, there is heterogeneity among these studies. Future research should aim for larger, higher-quality studies to address these limitations and provide a more comprehensive understanding of MM’s effectiveness in fibromyalgia management.

CONCLUSIONS: Very low to moderate evidence shows that MM improves quality of life, relieves stress, and relieves insomnia and depression in patients with FMS in the short-term. Notably, the improvement in depression and stress levels continued into the medium-term period. Furthermore, quality of life improvement was discernible at long-term follow-up. This suggests that MM can be used as an adjunct therapy for FMS.International Prospective Register of Systematic Reviews (PROSPERO) Registration Number: CRD42023442356.

PMID:39621973

Pain Physician. 2024 Nov;27(8):469-478.

ABSTRACT

BACKGROUND: Because of its side effects, a morphine replacement has been searched for in the field of postoperative analgesia. Hydromorphone is a derivative of morphine with no active metabolites.

OBJECTIVES: We conducted a meta-analysis of hydromorphone and morphine to compare their clinical effects in postoperative analgesia.

STUDY DESIGN: Systematic review and meta-analysis.

METHODS: The methodological quality of the studies included in this meta-analysis was assessed according to the Cochrane risk-of-bias tool. The Grading of Recommendations Assessment, Development and Evaluation (GRADE) criteria were used to evaluate the quality of evidence and recommendation grade for inclusion of randomized controlled trials. The primary outcome was postoperative pain score. Secondary outcomes were severe sedation, nausea, vomiting, and pruritus. The meta-analysis was performed using RevMan 5.4 (The Nordic Cochrane Centre for The Cochrane Collaboration).

RESULTS: Eight randomized controlled trials comprising 833 patients were found. There was no significant difference in pain scores between the hydromorphone and morphine groups at any measured postoperative time point: 8 hours (mean difference [MD] = -0.42; 95%CI, -2.08 to 1.24; P = 0.62); 12 hours (MD = -0.19; 95%CI, -0.62 to 0.24; P = 0.39); 24 hours (MD = -0.22; 95%CI, -0.54 to 0.09; P = 0.17); 36 hours (MD = 0.01; 95%CI, -0.67 to 0.69; P = 0.98) and 48 hours (MD = -0.14; 95%CI, -1.25 to 0.96; P = 0.80). There was no significant difference in the incidence of nausea and vomiting at 24 hours postoperative. The incidence of pruritus at 24 hours postoperative was lower in the hydromorphone group (relative risk = 0.24; 95%CI, 0.09 to 0.66; P = 0.005).

LIMITATIONS: The perioperative multimodal analgesia measures were varying in the included studies, such as different medication doses. The sample size was small for some outcomes and high heterogeneity was observed.

CONCLUSIONS: There was no significant statistical difference in postoperative analgesic effect between hydromorphone and morphine, as well as side effects, including severe sedation, nausea, and vomiting at 24 hours postoperative. However, the incidence of pruritus was lower in the hydromorphone group at 24 hours postoperative.

PMID:39621972

J Clin Oncol. 2024 Dec 2:JCO2401715. doi: 10.1200/JCO-24-01715. Online ahead of print.

ABSTRACT

PURPOSE: Several genomic subsets of NPM1 mutations with varying sequences (type A, B, D, etc) have been identified. Despite molecular heterogeneity, NPM1 mutations cumulatively portend a more favorable outcome, but biology and prognostic implications of different genomic subsets have not been extensively studied. In this multicentric study, we investigated the impact of NPM1 genotypes on patient’s outcomes and interrogated the underlying biology of the different subtypes.

MATERIALS AND METHODS: Of more than 4,000 patients enrolled in multiple pediatric cooperative (AIEOP, BFM, ELAM02, NOPHO, DCOG, and COG trials), or adult (SWOG) trials, 348 pediatric and 75 adult AML patients with known NPM1 genotype and available outcome were selected for this study. Diverse NPM1 variants were correlated with the probabilities of overall survival (OS) and event-free survival. Nuclear localization and translational efficiency of the NPM1 variants was studied.

RESULTS: Evaluation of clinical outcome on the basis of NPM1 genotypes showed that patients with type A, B, and other rare variants had similarly favorable outcomes, whereas those with type D had a significantly worse outcome (OS of 63% for type D v 86% for type non-D, P = .005). Multivariate analysis confirmed type D as an independent prognostic factor associated with inferior OS (hazard ratio, 3; P = .005). In vitro, we demonstrated that in type D versus type A synonymous variants, codon optimality plays major roles in determining gene expression levels, and translation efficiency, which resulted in a more expressed NPM1-D mRNA and protein, mediating peculiar mitochondrial gene expression.

CONCLUSION: The evaluation of specific NPM1 genotypes identified AML patients with type D mutations being significantly associated with inferior outcomes, suggesting a reclassification of D cases to higher-risk groups.

PMID:39621969 | DOI:10.1200/JCO-24-01715

J Clin Oncol. 2024 Dec 2:JCO2401507. doi: 10.1200/JCO-24-01507. Online ahead of print.

ABSTRACT

PURPOSE: Clinicopathological factors and the 21-gene Oncotype DX Breast Recurrence Score (RS) test both influence prognosis. Our goal was to develop a new tool, RSClinN+, to individualize recurrence risk and chemotherapy benefit predictions by menopausal status for patients with HR+/human epidermal growth factor receptor 2-negative, lymph node-positive breast cancer by integrating the RS result with clinicopathological factors (grade, tumor size, age).

METHODS: We used patient-level data from 5,283 patients treated with chemoendocrine therapy (CET) versus endocrine therapy alone (ET) in the S1007 (N = 4,916) and S8814 (N = 367) trials to develop the tool. Cox proportional hazards regression models stratified by trial were used to estimate 5-year invasive disease-free survival for pre- and postmenopausal woman, respectively. The integrated RSClinN+ model was compared with RS alone and clinicopathological models using likelihood ratio tests. Absolute CET benefit was estimated as the difference between ET and CET risk estimates. Validation of RSClinN+ was performed in 592 patients with node-positive disease in the Clalit Health Services registry.

RESULTS: RSClinN+ provides better prognostic information than RS model alone (premenopausal P = .034; postmenopausal P < .001) or clinicopathological model alone (premenopausal P = .002; postmenopausal, P < .001). In postmenopausal women, RS showed interaction with CET benefit (P = .016), with RSClinN+ absolute CET benefit ranging from <0.1% to 21.5% over RS ranges 0-50. In premenopausal patients with RS ≤25, there was no significant interaction between RS and CET benefit. In external validation, RSClinN+ risk estimates were prognostic (hazard ratio, 1.75 [95% CI, 1.38 to 2.20]) and concordant with observed risk (Lin’s concordance, 0.92).

CONCLUSION: RSClinN+ provides improved estimates of prognosis and absolute CET benefit for individual patients compared with RS or with clinical data alone and could be used in patient counseling.

PMID:39621968 | DOI:10.1200/JCO-24-01507

J Occup Environ Med. 2024 Dec 1;66(12):e646-e652. doi: 10.1097/JOM.0000000000003250.

ABSTRACT

OBJECTIVE: To assess the relationship between metabolic syndrome (MetS) and physical fitness in firefighters.

METHODS: Firefighters (n = 309) were systematically recruited to participate in this study. A questionnaire and physical measures were used to collect data on firefighters’ cardiometabolic health and physical fitness levels. Data were analyzed using binary and multinomial logistic regressions.

RESULTS: The prevalence of MetS was 23.0%, which was most prevalent in station and platoon commanders. Multivariable analysis showed that age (P < 0.001), lean body mass (P < 0.001), absolute aerobic capacity (P < 0.001), and leg strength (P < 0.001) was significantly associated with MetS. In addition, relative aerobic capacity (P < 0.001), push-ups (P = 0.016), and sit-ups (P < 0.001) were inversely associated with MetS.

CONCLUSIONS: Firefighters with MetS had a higher absolute aerobic capacity and strength, and healthier fighters had a higher relative aerobic capacity, muscular endurance capacity, and flexibility.

PMID:39621962 | DOI:10.1097/JOM.0000000000003250

J Occup Environ Med. 2024 Dec 1;66(12):e642-e645. doi: 10.1097/JOM.0000000000003249.

ABSTRACT

OBJECTIVE: The aim of the study is to measure cancer’s incidence in endemic fight agents in a Brazil’s Northeast state.

METHODS: This is a historical cohort with 1053 endemic fight agents. A survival analysis was performed using Kaplan-Meier method.

RESULTS: The overall neoplasm incidence rate has been 5508 cases per 105, and 4843 cases per 105 when nonmelanoma skin tumors were excluded. The increase in incidence of neoplasms occurred in 2019 and has conferred a risk of neoplasms 20 times higher than the national and state incidence.

CONCLUSIONS: We believe in an occupational factor for these results: the chronic exposure to insecticides used in public health campaigns. The peak incidence of neoplasms, in 2019, may corroborate with long induction period of these compounds, in addition to consistency with specialized literature.

PMID:39621961 | DOI:10.1097/JOM.0000000000003249