Pain and Therapy最新文献

Introduction: Lumbar facet joint pain is a treatable condition often overlooked or misclassified as nonspecific low back pain. Although facet joint blocks are useful for diagnosis, they are unsuitable for early-stage screening. This study aimed to develop practical diagnostic criteria for lumbar facet joint pain that are easily applicable by general practitioners without invasive procedures to facilitate early identification and referral for appropriate treatment.

Methods: PubMed was searched for articles on facet joint pain. All diagnostic items described in the identified articles were comprehensively collected. A questionnaire survey was administered to orthopedic spine surgeons, who rated each item based on its diagnostic value; only those considered important were extracted. Next, using factor analysis, the items were grouped into a small number of factors. Diagnostic criteria were then established through multiple Delphi rounds.

Results: The query identified 2682 articles published between 2000 and 2023; eight articles were used to extract 77 diagnostic items. A survey collected responses from 39 orthopedic spine surgeons. The 25 most important items were selected from the survey results, and factor analysis was applied. Through multiple Delphi rounds, four diagnostic criteria were established: physical findings suggesting facet joint pain, neurological symptoms, imaging findings suggesting non-facet causes, and signs of discogenic low back pain. Diagnosis is confirmed if the first criterion is met and no more than one of the others is present.

Conclusion: Consensus-based diagnostic criteria for lumbar facet joint pain were developed, which offer a noninvasive, clinically practical approach to diagnosis, promoting early recognition and appropriate referral by general practitioners.

Introduction: Given the limitations of single-modality analgesia for rib fractures, this study aimed to determine whether combining systemic flurbiprofen axetil with a regional intercostal nerve block (ICNB) yields more effective and sustained preoperative pain relief than either technique used alone.

Methods: In this single-center, randomized, double-blind, controlled trial, 150 patients scheduled for surgery were allocated to one of three groups: Group F (flurbiprofen axetil + saline ICNB), Group FB (flurbiprofen axetil + ropivacaine ICNB), and Group B (saline + ropivacaine ICNB). The primary outcome was the Visual Analog Scale (VAS) score at quiet breathing 30 min post-intervention. Secondary outcomes included VAS scores at 6, 12, 18, and 24 h, rescue analgesia requirements, diaphragmatic excursion, arterial blood gas parameters, adverse events, and patient satisfaction.

Results: The FB group demonstrated significantly lower VAS scores at 30 min than the other groups (p < 0.001), along with significantly reduced rescue analgesia requirements across most time intervals (p < 0.05). No patients in the FB group required rescue thoracic paravertebral block versus eight in Group F (p < 0.001). The FB group also showed a significantly higher sum of pain intensity difference over 0-24 h (SPID_0-24h), improved diaphragmatic excursion, higher oxygenation index, and greater patient satisfaction (all p < 0.001). The overall incidence of adverse events was low, with no serious complications reported.

Conclusion: The combination of flurbiprofen axetil and ultrasound-guided ICNB provided superior preoperative analgesia than either agent alone, reduced rescue medication needs, improved respiratory function, and enhanced patient satisfaction, with a favorable safety profile in patients with traumatic multiple rib fractures.

Trial registration: The study protocol was registered at the Chinese Clinical Trial Registry with registration no. ChiCTR2500105786 ( https://www.chictr.org.cn ).

Introduction: Postoperative pain management poses unique challenges in older adult patients undergoing laparoscopic abdominal tumor surgery. While morphine remains a standard analgesic option, its use in this population is frequently complicated by adverse effects. Tegileridine represents a potential alternative with distinct pharmacological properties that warrant clinical evaluation.

Methods: This will be a single-center, randomized, assessor-blinded, active-controlled trial. A total of 66 older adult patients undergoing laparoscopic abdominal tumor surgery will be randomized in a 1:1 ratio to receive either tegileridine (0.1 mg bolus) or morphine (1 mg bolus) via patient-controlled intravenous analgesia.

Planned outcomes: The primary endpoint is the incidence of moderate-to-severe movement-related pain (NRS ≥ 4) at 24 h postoperatively. Secondary assessments include pain at rest, requirement for rescue analgesia, safety outcomes, and recovery parameters.

Trial registration: Registered at the Chinese Clinical Trial Registry on October 14, 2025.

Trial registration number: ChiCTR2500110485.

Introduction: Evoked compound action potentials (ECAPs) are neurophysiological biomarkers of neural activation during spinal cord stimulation (SCS). Clear distinction between ECAPs and nonphysiological signals is critical to the application of contemporary, ECAP-based closed-loop (CL) SCS therapies. Herein, we evaluated the performance and user acceptability of a novel programming software that automates generation of ECAP-based CL-SCS programs-the Assisted Programming Module (APM).

Methods: We report results from two prospective, multicenter, single-arm, feasibility studies: Freshwater (NCT04662905) and Rosella (NCT06057480). APM performance was compared with the previous generation programming software and other published methods. Performance was assessed by comparing signal-to-noise ratios, artifact rejection, and other objective parameters. User acceptability was assessed using questionnaires administered to SCS users.

Results: The APM successfully generated a CL program in 96% of initial programming sessions (n = 81/84; Freshwater, 31/34; Rosella, 50/50). In the Rosella study, median time to generate an automated CL program (n = 68) was 11.9 min [interquartile range (IQR) 9.9-14.0]. Median dose ratio was 1.31 (IQR 1.20-1.46) at end of trial (n = 24), 1.34 (IQR 1.13-1.51) at 1 month post implant (n = 16), and 1.32 (IQR 1.21-1.48) at 3 months post implant (n = 15). At least 90% of patients [trial, 90% (27/30); implant, 94% (17/18)] were satisfied with their programming experience, and ≥ 90% of patients [trial, 90% (26/29); implant, 94% (16/17)] felt in control of their therapy. The APM achieved a mean signal-to-noise ratio of 4.6 ± 1.2, a 35% improvement over the previous generation ECAP dose-controlled CL-SCS system. Detectable artifact leakage rates decreased by 75% when compared with other published methods without compromise to signal-to-noise performance.

Conclusions: Next-generation ECAP dose-controlled CL technology demonstrated strong feasibility, high patient satisfaction and therapy control, and superior ECAP signal fidelity compared with existing methods. By standardizing CL-SCS programming and enhancing signal fidelity, the APM may improve workflow efficiency and long-term therapy outcomes in chronic pain management.

Trial registration: ClinicalTrials.gov identifiers: NCT04662905, NCT06057480.

Introduction: Chronic low back pain (CLBP) affects over half a billion people worldwide. Current pharmacologic treatments, comprising mainly non-steroidal anti-inflammatory drugs and opioids, offer limited efficacy and pose significant risks, warranting the development of tolerable, safe and effective alternatives.

Methods: This randomized controlled trial on adults with CLBP was designed to confirm the superior efficacy and gastrointestinal tolerability of VER-01, a novel, standardized full-spectrum extract from Cannabis sativa DKJ127 L., over opioids. Subjects were randomized (1:1) to receive VER-01 or a range of commercially available opioids. After a 3-week titration, subjects underwent 24 weeks of treatment, followed by 2 weeks of wash-out. The primary endpoint was the relative risk of constipation occurrence after 27 weeks treatment. Secondary endpoints included changes in pain and sleep scores, determined using an 11-point numeric rating scale (NRS), with key secondary endpoints defined for week 27.

Results: A total of 384 individuals were randomized to receive VER-01 (n = 192) or opioids (n = 192). Subjects receiving VER-01 were fourfold less likely to develop constipation than those receiving opioids (relative risk [RR] VER-01/opioids 0.25; 95% confidence interval [CI] 0.09-0.69; p = 0.007) and threefold less likely to use laxatives (RR 0.34; 95% CI 0.18-0.65; p < 0.001). Longitudinal analysis revealed that VER-01 was superior to opioids in terms of pain reduction over 6 months of treatment, although differences in secondary endpoints limited to week 27 alone were not significant. Throughout the 6 months of treatment, mean pain reduction was 2.50 NRS points with VER-01 versus 2.16 with opioids (mean difference [MD] 0.34; 95% CI 0.00-0.67; p = 0.048), and sleep improved by 2.52 points with VER-01 versus 2.07 with opioids (MD 0.45; 95% CI 0.11-0.79; p = 0.009). These benefits were particularly pronounced in participants with severe pain, with greater pain reduction (MD 0.58; 95% CI 0.01-1.15) and sleep improvement (MD 0.66, 95% CI 0.05-1.27) compared to opioids.

Conclusions: VER-01 demonstrated superiority over opioids in treating CLBP, both in terms of efficacy and gastrointestinal tolerability.

Trial registration: ClinicalTrials.gov ID: NCT05610813; EudraCT ID: 2022-001358-41.

Introduction: Lumbar disc herniation (LDH) is characterized by the displacement of intervertebral disc material with compression of adjacent nerve roots, leading to nociceptive and neuropathic pain in the lower limbs and lower back. The Miro-Hers study explored the efficacy and safety of mirogabalin add-on treatment in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) compared with NSAIDs alone. We hypothesized that mirogabalin added on to NSAID therapy may reduce neuropathic pain due to LDH more than NSAIDs alone.

Methods: This was a multicenter, 8-week, randomized (1:1), open-label, parallel-group study conducted in Japan between March 2023 and September 2024. The study included participants with LDH diagnosed by magnetic resonance imaging who had inadequately controlled lower limb pain [numerical rating scale (NRS) score ≥ 4] despite NSAID treatment. The primary endpoint was the change in the NRS score for lower limb pain from baseline to Week 8. The secondary endpoints included quality of life, as assessed by the EuroQol 5 dimensions 5-level score (EQ-5D-5L), and NRS score for sleep disturbance. Safety endpoints included treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs).

Results: Of the 182 participants screened and randomized, 90 in the mirogabalin add-on group and 89 in the NSAIDs alone group were included in the efficacy analysis. The reduction in NRS score for lower limb pain from baseline to Week 8 was significantly greater in the mirogabalin add-on group than in the NSAIDs alone group, with least squares mean changes of - 3.8 [95% confidence interval (CI): - 4.4, - 3.3] and - 2.2 (- 2.8, - 1.7), respectively [intergroup difference - 1.6 (- 2.4, - 0.8); P < 0.001]. EQ-5D-5L and NRS score for sleep disturbance both significantly improved over the study period with mirogabalin add-on treatment compared with NSAIDs alone [intergroup difference: 0.0653 (95% CI 0.0235, 0.1071); P = 0.002 and - 1.3 (- 1.9, - 0.7); P < 0.001, respectively]. No severe or serious TEAEs were observed. In the mirogabalin add-on group, ADRs were observed in 48.9% of participants, with somnolence (31.1%) and dizziness (18.9%) being the most common.

Conclusion: The addition of mirogabalin to NSAIDs treatment significantly improved pain, quality of life, and sleep disturbance in patients with LDH, with no previously undocumented safety concerns identified.

Trial registration: Japan Registry of Clinical Trials (jRCTs061220102, registered 27/February/2023, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs061220102 ).

Introduction: Pain is a debilitating symptom of hidradenitis suppurativa (HS). Bimekizumab, a humanized IgG1 monoclonal antibody, selectively inhibits IL-17A and IL-17F. The impact of bimekizumab on pain outcomes in moderate to severe HS was assessed using pooled 48-week data from BE HEARD I&II (observed case and multiple imputation).

Methods: Patients were randomized 2:2:2:1 to receive one of bimekizumab 320 mg every 2 weeks (Q2W); bimekizumab Q2W to Week 16, then every 4 weeks (Q4W) to Week 48; bimekizumab Q4W; or placebo to Week 16, then bimekizumab Q2W to Week 48. HS Symptom Daily Diary (HSSDD; baseline-Week 16) and HS Symptom Questionnaire (HSSQ; baseline, Weeks 16-48) assessed patient-reported skin pain. Mean scores, change from baseline (CfB), responder rates, shifts across pain severity categories, and association of HS Clinical Response (HiSCR) with pain outcomes were assessed.

Results: A total of 1014 patients with moderate to severe HS were enrolled. Mean (standard deviation) age was 36.6 (12.2) years and 56.8% were women. Bimekizumab demonstrated rapid reductions in mean HSSDD worst and average skin pain scores after 2 weeks. Greater reductions from baseline in HSSDD worst (mean CfB ± standard error, bimekizumab Q2W: - 1.9 ± 0.1; bimekizumab Q4W: - 1.5 ± 0.2) and average skin pain scores (bimekizumab Q2W: - 1.8 ± 0.1; bimekizumab Q4W: - 1.4 ± 0.2) were observed at Week 16 versus placebo (worst: - 0.7 ± 0.2; average: - 0.8 ± 0.2). Mean HSSQ skin pain showed similar improvements to Week 16; further reductions were seen to Week 48 in those continually receiving bimekizumab. Week 16 placebo switchers saw rapid improvements in HSSQ skin pain scores from Week 16 to Week 18, comparable to those continually receiving bimekizumab. Responses were maintained to Week 48 (bimekizumab Q2W/Q2W: - 2.9 ± 0.2; bimekizumab Q2W/Q4W: - 2.5 ± 0.2; bimekizumab Q4W/Q4W: - 2.8 ± 0.2; placebo/bimekizumab Q2W: - 2.5 ± 0.3). Many patients shifted from severe/very severe to lower severity HSSQ skin pain categories (mild/no pain). Improvements corresponded with higher HiSCR scores at Week 48.

Conclusions: Treatment with bimekizumab leads to rapid, continuous, and clinically meaningful reductions in skin pain.

Trial registration: NCT04242446 ( https://clinicaltrials.gov/study/NCT04242446 ); NCT04242498 ( https://clinicaltrials.gov/study/NCT04242498 ). An Infographic is available for this article. Infographic.

Introduction: Epidural steroid injections (ESIs) are commonly used to manage chronic spinal pain. However, variations in ESI practices remain prevalent among interventional pain physicians. This study evaluates current practice patterns and perceptions of ESI efficacy to identify areas for potential standardization in clinical application.

Methods: A structured survey was distributed to interventional pain physicians via email and social media outlets, collecting data on several aspects of ESI practice: (1) the importance of precise injectate placement, (2) perceived effectiveness for axial versus limb pain, and (3) preference for fixed versus variable injectate volume based on contrast pattern spread. Responses were collected and analyzed to understand prevailing practice trends. The survey included a diverse group of pain management physicians representing different primary specialties and practice settings.

Results: Of the 94 respondents, 77.7% (73/94) selected that precise injectate placement is crucial for optimal outcomes, while 22.3% (21/94) did not view it as essential. Regarding pain type, 61.7% (58/94) selected that ESIs help with axial and limb pain, while 36.2% (34/94) found ESIs primarily effective for limb pain. Only 1.1% (1/94) selected that ESIs were beneficial solely for axial back pain, with one respondent selecting ineffectiveness for either pain type. For injectate volume, 69.2% (65/94) selected that they use a fixed volume for injection, while 30.9% (29/94) adjusted injectate volume based on contrast spread.

Conclusion: This survey highlights practice patterns among interventional pain physicians regarding ESIs, underscoring the value placed on targeted injectate placement and the perceived broad efficacy of ESIs for axial and limb pain. However, the variability in volume administration suggests a need for further research to explore the impact of fixed versus variable injectate volumes on clinical outcomes. These findings may influence future standardization efforts in ESI practice.

Introduction: Schroth therapy improves outcomes in mild degenerative scoliosis but may be insufficient for patients with vertebrogenic pain linked to vertebral endplate changes. Basivertebral nerve ablation (BVNA) is a novel intervention that may provide additional benefit in these cases.

Methods: This retrospective, propensity score-matched cohort study included adults aged ≥ 18 years with idiopathic or degenerative scoliosis (Cobb angle ≥ 20°) and vertebrogenic pain, treated between January 1, 2020 and January 31, 2024, across two major healthcare systems. A subset received BVNA between December 5, 2022 and December 5, 2024. Propensity score matching was performed 1:1 for age, sex, body mass index, baseline disability and pain scores, and prior therapy sessions, yielding 44 matched patients (22 per group). The primary outcome was ≥ 15-point improvement in Oswestry Disability Index (ODI) at 12 months. Secondary outcomes included ≥ 3-point pain reduction, opioid and health-resource utilization, and complications.

Results: Among 76 patients (mean [standard deviation] age 68.8 [14.8] years; 82.9% female), 44 were included in the matched analysis. At 12 months, patients receiving Schroth therapy plus BVNA achieved greater ODI improvement (mean change - 22.3 vs - 15.1; P = 0.03) and were more likely to reach ≥ 15-point ODI improvement (81.8% vs 59.1%; OR 2.58 [95% CI 1.01-6.60]; P = 0.048). Opioid use declined more in the BVNA group (- 37% vs - 14%, P = 0.037), with progressive MEDD reduction (19 → 10 mg) compared with stable use in the Schroth-only group (17 → 17 mg; group × time P = 0.003). Rates of subsequent pain procedures (81.8% vs 13.6%, P < .001) and ER visits for chronic back pain (63.6% vs 9.1%, P = 0.0004) were higher for Schroth-only patients. No complications were reported.

Conclusion: In adults with scoliosis and vertebrogenic pain, combining BVNA with Schroth therapy was associated with superior outcomes at 12 months compared with Schroth therapy alone.