Pain Medicine最新文献

Objective: This manuscript describes the uptake of the AIM-Back Pain Navigator Pathway (PNP) designed to encourage use of non-pharmacologic care options within the Veterans Health Administration (VHA).

Design: This manuscript describes the implementation of a telehealth intervention from one arm of a multisite, embedded, cluster-randomized pragmatic trial comparing the effectiveness of two novel clinical care pathways that provide access to non-pharmacologic care for Veterans with low back pain (LBP).

Setting: Ten VHA clinics.

Subjects: 19 pain navigators, >200 primary care physicians, and over 1000 Veterans were involved in the PNP implementation.

Methods: Data were generated within the VHA electronic health record (EHR) for the ongoing AIM-Back trial to describe PNP implementation for system-level findings in terms of number of visits, and type of care received.

Results: Over a 3-year period, 9 of 10 clinics implemented the PNP within the context of the AIM-Back trial. The most frequent care recommended in the PNP included physical therapy, chiropractic, acupuncture, and yoga/tai chi. During follow-up at six-weeks, ∼50% of Veterans elected to receive a different care choice than what was initially prescribed. Notable variation across clinics was documented for PNP based on time to initiation of care and follow-up rates.

Conclusions: Implementation of the telehealth delivered PNP provides a nuanced understanding of the introduction of novel care programs within diverse clinical settings. These findings are most applicable to care programs that are delivered remotely and involve facilitation of existing care options.

Objective: To evaluate the efficacy and safety of fremanezumab for migraine prevention.

Design: Retrospective, single-center, real-world study.

Setting: Regional tertiary headache center in Japan.

Subjects: Adult individuals with migraine (n = 165, male = 17, female = 148; average age = 45.5 ± 16.0 years) who received fremanezumab between September 2021 and August 2022.

Methods: Fremanezumab was administered subcutaneously at a monthly dose of 225 mg or quarterly dose of 675 mg based on patient preferences. Patients received fremanezumab treatment for up to 1 year unless it was discontinued. Monthly data were collected on migraine days, headache days, and days requiring acute medication.

Results: Of the 165 patients, 125 (75.7%) received fremanezumab as their first anti-calcitonin gene-related peptide-related antibody drug. Significant reductions in monthly migraine days, headache days, and days requiring acute medication were observed in those with episodic and chronic migraines. The baseline monthly headache days was 8.1 ± 4.0 in the episodic migraine group, which reduced to 6.1 ± 4.8, 5.8 ± 4.4, 4.7 ± 3.6, and 4.6 ± 3.3 days at 1, 3, 6, and 12 months, respectively; in the chronic migraine group, the baseline monthly headache days was 20.9 ± 6.1, which reduced to 17.0 ± 8.9, 15.0 ± 9.2, 13.0 ± 7.7, and 12.0 ± 9.1 days at 1, 3, 6, and 12 months, respectively. Treatment benefits were enhanced after 6 months of administering fremanezumab in the chronic migraine group.

Conclusions: In this real-world study of patients with migraine, fremanezumab appears to be effective and safe. Further studies are required to identify additional predictors of treatment success and failure with fremanezumab.

Background: Best practices for clinical trials stipulate that statistical analysis plans (SAPs) need to be finalized before initiation of any analysis. However, there is limited guidance about when changes to SAPs are acceptable and how these changes should be incorporated into the research plan with appropriate documentation.

Methods: We conducted a survey of 12 pragmatic clinical trials (PCTs) in the Pain Management Collaboratory that evaluated nonpharmacological interventions for pain to assess the following SAP information: (1) location of statistical analysis details, (2) types of statistical analyses planned, (3) sponsor requirements, (4) templates used for development, (5) publication plan, (6) changes since trial launch, (7) process of documenting changes, and (8) process of updating the trial registry.

Results: All 12 PCTs provided details of their SAPs for the primary outcomes in the institutional review board-approved trial protocol; 8 included plans for secondary outcomes, and 6 included plans for tertiary/exploratory outcomes. Most PCTs made SAP changes after trial initiation, many as a result of COVID-19-related issues. Eleven of the PCTs were actively recruiting participants. Changes were made to sample size, study design, study arms, and analytical methods, all before the data lock/unblinding. In all cases, justification for the changes was documented in the trial protocol or SAP, signed off by the trial biostatistician and principal investigator, and reviewed/approved by an institutional review board, data and safety monitoring board, or sponsor.

Conclusions: We recommend that SAP changes can be acceptable up to the time of data lock/unblinding. To maintain full transparency and necessary rigor, clear documentation of such changes should include details, rationale, date(s) such changes were implemented, and evidence of approval by relevant oversight bodies.

Background: Neck pain and headaches can arise from the lateral atlanto-axial (LAA) joint. This pain can be diagnosed with intra-articular injections of local anesthetic. A widely used technique for access to the lateral atlanto-axial joint uses a posterior approach, but this approach can be hazardous because of the proximity of the vertebral artery, the dural sac, and the C2 spinal nerve and dorsal root ganglion.

Objective: The objective was to describe and test a new technique for accessing the LAA joint that avoids structures that lie behind the joint.

Interventions: The new technique was described and tested for tolerance in 10 patients with unilateral suboccipital pain and tenderness over the LAA joint, along with evidence of LAA joint arthropathy on SPECT CT. The technique requires inserting a needle along a trajectory tangential to the dorsal surface of the C2 lamina. It involves obtaining a declined view of the C2 lamina and C2 pedicle.

Conclusions: In all cases, the C2 pedicle was easily identified and allowed the needle to pass asymptomatically underneath the neurovascular structures behind the joint. The tactile response of the lamina of C2 provided important feedback regarding needle depth caudal to the LAA joint.

Background: Although mindfulness-based interventions (MBIs) are widely used in clinical and nonclinical settings, there has been little systematic study of their potential risks. To address this gap, we examined differences in psychological and physical worsening among participants in the usual care and intervention conditions of a 3-group, randomized pragmatic trial (Learning to Apply Mindfulness to Pain [LAMP]) that tested the effectiveness of 2 approaches to delivering MBIs to patients with chronic pain.

Methods: The sample consisted of 374 male and 334 female patients with chronic pain enrolled in the LAMP trial who completed a 10-week follow-up survey, 61% of whom had a mental health diagnosis. Psychological and physical worsening was assessed by a checklist asking whether participants experienced specific symptoms since beginning the study. We used multivariable logistic regression models with imputed data to determine whether predicted probabilities of increased symptoms differed between usual care and the 2 MBIs.

Results: Participants in usual care were more likely to report experiencing increased psychological and physical worsening than were those in the MBIs, including an increase in disturbing memories; sadness, anxiousness, and fatigue; isolation and loneliness; and feeling more upset than usual when something reminded them of the past.

Conclusions: MBIs do not appear to cause harm, in terms of increased symptoms, for this population of patients with chronic pain and high levels of mental health comorbidities.

Clinical trial registration: Preregistration with an analysis plan at www.ClinicalTrials.gov: NCT04526158. Patient enrollment began December 4, 2020.

Objective: Chemical neurolysis of the genicular nerves is a treatment option for intractable non-cancer knee pain. This scoping review synthesizes the available literature on the effectiveness, adverse effects and procedural techniques of chemical neurolysis of genicular nerves for the management of knee pain.

Design: Scoping review.

Setting: All clinical and research settings.

Subjects: Adult participants with chronic non-cancer knee pain undergoing chemical neurolysis of genicular nerves.

Methods: A literature search in MEDLINE, EMBASE and Cochrane Library was conducted up to 4 September 2023. Articles were searched via terms and keywords relating to "knee", "pain", "knee osteoarthritis", "ablation", "alcohol", "phenol" and "chemical neurolysis". Included articles were full text primary studies and in English. Data was extracted using an electronic database by 2 independent reviewers.

Results: There were 8 studies included in this review (including 1 randomized controlled trial), comprising 192 patients. There were 4 studies that used phenol, 3 studies that used alcohol, and 1 study that used either alcohol or phenol for chemical neurolysis. Both fluoroscopy and/or ultrasound guidance were utilized for nerve target identification. All studies demonstrated that chemical neurolysis resulted in improved pain and/or functional outcomes, with no serious adverse events reported.

Conclusions: Chemical neurolysis of the genicular nerves is a promising treatment strategy for chronic knee pain. Interpretation of the available studies are limited by study heterogeneity and small sample sizes. High-quality randomized controlled trials are required to clarify the selection of appropriate nerve targets, choice of image guidance, and to compare with other ablative modalities.