Percutaneous image-guided lumbar decompression and interspinous spacers for the treatment of lumbar spinal stenosis: A 2-year Medicare Claims Benchmark Study.

OBJECTIVE: This prospective longitudinal study compares outcomes between Medicare beneficiaries receiving percutaneous image-guided lumbar decompression (PILD) using the mild® procedure and a control group of patients receiving interspinous spacers for the treatment of lumbar spinal stenosis (LSS) with neurogenic claudication (NC). METHODS: Patients diagnosed with LSS with NC and treated with either the mild procedure or a spacer were identified in the Medicare claims database. The incidence of harms, the rate of subsequent interventions, and the overall combined rate of harms and subsequent interventions during 2-year follow-up after the index procedure were compared between the two groups and assessed for statistical significance with p = 0.05. RESULTS: The study included 2229 patients in the mild group and 3401 patients who were implanted with interspinous spacers. The rate of harms for those treated with the mild procedure was less than half that of patients implanted with a spacer (5.6% vs. 12.1%, respectively; p < 0.0001) during 2-year follow-up. The rate of subsequent interventions was not significantly different between the two groups (24.9% and 26.1% for the mild and spacer groups, respectively; p = 0.7679). The total rate of harms and subsequent interventions for mild was found to be noninferior to spacers (p < 0.0001). CONCLUSIONS: This comprehensive study of real-world Medicare claims data demonstrated a significantly lower rate of harms for the mild procedure compared to interspinous spacers for patients diagnosed with LSS with NC, and a similar rate of subsequent interventions during 2-year follow-up.

Nonorganic (Behavioral) Signs and Their Association With Epidural Corticosteroid Injection Treatment Outcomes and Psychiatric Comorbidity in Cervical Radiculopathy: A Multicenter Study.

OBJECTIVE: To determine the association between cervical nonorganic pain signs and epidural corticosteroid injection outcomes and coexisting pain and psychiatric conditions. PATIENTS AND METHODS: Seventy-eight patients with cervical radiculopathy who received epidural corticosteroid injection were observed to determine the effects that nonorganic signs have on treatment outcome. A positive outcome was a decrease of 2 or more points in average arm pain, coupled with a score of 5 on a 7-point Patient Global Impression of Change scale 4 weeks after treatment. Nine tests in 5 categories (abnormal tenderness, regional disturbances deviating from normal anatomy, overreaction, discrepancies in examination findings with distraction, and pain during sham stimulation) were modified from previous studies and standardized. Other variables examined for their association with nonorganic signs and outcomes included disease burden, psychopathology, coexisting pain conditions, and somatization. RESULTS: Of the 78 patients, 29% (n=23) had no nonorganic signs, 21% (n=16) had signs in 1 category, 10% (n=8) had signs in 2 categories, 21% (n=16) had signs in 3 categories, 10% (n=8) had signs in 4 categories, and 9% (n=7) had signs in 5 categories. The most common nonorganic sign was superficial tenderness (44%; n=34). Mean number of positive nonorganic categories was higher in individuals with negative treatment outcomes (2.5±1.8; 95% CI, 2.0 to 3.1) compared with those with positive outcomes (1.1±1.3; 95% CI, 0.7 to 1.5; P=.0002). Negative treatment outcomes were most strongly associated with regional disturbances and overreaction. Positive associations were noted between nonorganic signs and multiple pain (P=.011) and multiple psychiatric (P=.028) conditions. CONCLUSION: Cervical nonorganic signs correlate with treatment outcome, pain, and psychiatric comorbidities. Screening for these signs and psychiatric symptoms may improve treatment outcomes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04320836.

Managing Complex Peripheral Nerve Injuries Within the Military Health System: A Multidisciplinary Approach to Treatment, Education, and Research at Walter Reed National Military Medical Center.

INTRODUCTION: Peripheral nerve injuries are a leading cause of disability within the Military Health System (MHS) patient population. Many peripheral nerve injuries (PNIs) are amenable to therapeutic intervention but require a timely diagnosis and prompt referral to a specialty center capable of intervention, as functional outcomes are directly related to the duration between injury and intervention. Even when appropriately identified, PNI management in the MHS is often challenged by the lack of an established pathway for care coordination and a limited awareness of available diagnostic and therapeutic resources. To address these potential shortcomings, the Walter Reed National Military Medical Center Peripheral Nerve Program (WRNMMC PNP) in Bethesda, MD, has been established to provide comprehensive, multidisciplinary care to peripheral nerve-injured patients across the MHS. Additionally, the WRNMMC PNP provides graduate medical education training in PNI management for multiple residency and fellowship programs, and it facilitates critical peripheral nerve research to advance knowledge within the field. MATERIALS AND METHODS: A retrospective review of all patients evaluated by the WRNMMC PNP between December 2015 and April 2019 was conducted in order to identify pertinent patient demographic information, referral patterns, and PNI etiology data. RESULTS: The WRNMMC PNP evaluated 356 patients consisting of active duty, dependents, retirees, and Veterans Affairs patients during the designated study period. These patients were referred by providers from more than nine different specialties from 78 commands across eight countries. The majority of these patients (222 patients) were referred for traumatic PNI. The WRNMMC PNP has also evaluated and treated patients with PNIs stemming from congenital and compressive etiologies. One hundred and one patients referred during this period were treated with surgery, while the remainder were managed through nonoperative means. CONCLUSIONS: The WRNMMC PNP facilitates comprehensive, patient-centered care for PNI patients within the MHS. Moreover, the program helps to prepare the next generation of providers for evaluating and treating PNI patients through its involvement with graduate medical education training. It also conducts critical peripheral nerve research and lays the foundation for collaborations with other institutions involved with peripheral nerve research. In the years ahead, the WRNMMC PNP aims to expand its outreach and capabilities within the MHS through more expansive use of telemedicine consultation and the establishment of satellite peripheral nerve clinic sites.

Compounded Topical Pain Creams to Treat Localized Chronic Pain: A Randomized Controlled Trial.

Background: The use of compounded topical pain creams has increased dramatically, yet their effectiveness has not been well evaluated. Objective: To determine the efficacy of compounded creams for chronic pain. Design: Randomized controlled trials of 3 interventions. (ClinicalTrials.gov: NCT02497066). Setting: Military treatment facility. Participants: 399 patients with localized pain classified by each patient's treating physician as neuropathic (n = 133), nociceptive (n = 133), or mixed (n = 133). Intervention: Pain creams compounded for neuropathic pain (ketamine, gabapentin, clonidine, and lidocaine), nociceptive pain (ketoprofen, baclofen, cyclobenzaprine, and lidocaine), or mixed pain (ketamine, gabapentin, diclofenac, baclofen, cyclobenzaprine, and lidocaine), or placebo. Measurements: The primary outcome measure was average pain score 1 month after treatment. A positive categorical response was a reduction in pain score of 2 or more points coupled with a score above 3 on a 5-point satisfaction scale. Secondary outcomes included Short Form-36 Health Survey scores, satisfaction, and categorical response. Participants with a positive outcome were followed through 3 months. Results: For the primary outcome, no differences were found in the mean reduction in average pain scores between the treatment and control groups for patients with neuropathic pain (-0.1 points [95% CI, -0.8 to 0.5 points]), nociceptive pain (-0.3 points [CI, -0.9 to 0.2 points]), or mixed pain (-0.3 points [CI, -0.9 to 0.2 points]), or for all patients (-0.3 points [CI, -0.6 to 0.1 points]). At 1 month, 72 participants (36%) in the treatment groups and 54 (28%) in the control group had a positive outcome (risk difference, 8% [CI, -1% to 17%]). Limitations: Generalizability is limited by heterogeneity among pain conditions and formulations of the study interventions. Randomized follow-up was only 1 month. Conclusion: Compounded pain creams were not better than placebo creams, and their higher costs compared with approved compounds should curtail routine use. Primary Funding Source: Centers for Rehabilitation Sciences Research, Defense Health Agency, U.S. Department of Defense.