A pragmatic randomized prospective trial of cooled radiofrequency ablation of the medial branch nerves versus facet joint injection of corticosteroid for the treatment of lumbar facet syndrome: 12 month outcomes.

BACKGROUND: Lumbar medial branch radiofrequency ablation (LRFA) and intraarticular facet steroid injections (FJI) are commonly performed for recalcitrant facet joint-mediated pain. However, no study has compared clinical outcomes of the two treatments in patients selected using dual medial branch blocks (MBBs) with an 80% relief threshold. OBJECTIVE: Compare the effectiveness of cooled LRFA (C-LRFA) to FIJ as assessed by pain and functional improvements. DESIGN: Prospective randomized comparative trial. METHODS: Patients with dual MBB-confirmed facet joint-mediated pain were randomized to receive C-LRFA or FIJ. Outcomes were assessed at 1, 3, 6, and 12 months. The primary outcome was ≥50% improvement in numerical pain rating scale (NPRS) score at 3 months. Secondary outcomes included ≥30% Oswestry Disability Index (ODI) improvement and Patient Global Impression of Chance (PGIC) ≥6 points, among others. Data were analyzed using contingency tables and mixed-effects logistic regression models. RESULTS: Of 1128 patients screened, 32 met eligibility criteria, were randomized, and received their allocated study treatment. In total, 20 (62.5%) and 12 (37.5%) participants received C-LRFA and FIJ, respectively. In the C-LRFA group, 70% (95% CI 48-85), 55% (95% CI 34-74), and 45% (95% CI 26-66) of participants met the NPRS responder definition, compared to 25% (95%CI 9-53), 25% (95% CI 9-53), and 17% (95% CI 5-45) in the FJI group at 3, 6, and 12 months, respectively (P = .014 at 3 months). The PGIC responder proportion was higher in the C-LRFA compared to FJI group at 3 and 6 months (P < .05). CONCLUSIONS: C-LRFA demonstrated superior success rates compared to FJI across pain and functional outcome domains. TRIAL REGISTRATION DETAILS: ClinicalTrials.gov (NCT03614793); August 3, 2018.

The Relationship Between Patient Demographic and Clinical Characteristics and Successful Treatment Outcomes After Basivertebral Nerve Radiofrequency Ablation: A Pooled Cohort Study of Three Prospective Clinical Trials.

OBJECTIVE: Multiple studies have demonstrated the safety and effectiveness of basivertebral nerve radiofrequency ablation (BVN RFA) for improving low back pain related to the vertebral endplate. However, the influence of patient demographic and clinical characteristics on treatment outcome is unknown. DESIGN: Pooled cohort study of three clinical trials of patients with vertebral endplate pain identified by Type 1 and/or Type 2 Modic changes and a correlating presentation of anterior spinal element pain. SETTING: Thirty-three global study centers. SUBJECTS: Patients (n = 296) successfully treated with BVN RFA. METHODS: Participant demographic and clinical characteristics were analyzed with stepwise logistic regression to identify predictors of treatment success. Three definitions of treatment success were defined: 1) ≥50% visual analog scale pain improvement, 2) ≥15-point Oswestry Disability Index (ODI) improvement, and 3) ≥50% visual analog scale or ≥15-point ODI improvement from baseline. RESULTS: Low back pain of ≥5 years' duration and higher ODI scores at baseline increased the odds of treatment success, whereas baseline opioid use and higher Beck Depression Inventory scores reduced these odds. However, the three regression models demonstrated receiver-operating characteristics of 62-70% areas under the curve, and thus, limited predictive capacity. CONCLUSIONS: This analysis identified no demographic or clinical characteristic that meaningfully increased or reduced the odds of treatment success from BVN RFA. On the basis of these findings and the high response rates from the three analyzed trials, we recommend the use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain to determine optimal candidacy for BVN RFA.

Pain Location and Exacerbating Activities Associated with Treatment Success Following Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trial Data.

OBJECTIVE: Develop pain location "maps" and investigate the relationship between low back pain (LBP)-exacerbating activities and treatment response to basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically suspected vertebral endplate pain (VEP). DESIGN: Aggregated cohort study of 296 patients treated with BVN RFA at 33 centers in three prospective trials. METHODS: Participant demographics, pain diagrams, and LBP-exacerbating activities were analyzed for predictors using stepwise logistic regression. Treatment success definitions were: (1) ≥50% LBP visual analog scale (VAS), (2) ≥15-point Oswestry Disability Index (ODI), and (3) ≥50% VAS or ≥15-point ODI improvements at 3 months post-BVN RFA. RESULTS: Midline LBP correlated with BVN RFA treatment success in individuals with clinically-suspected VEP. Duration of pain ≥5 years (OR 2.366), lack of epidural steroid injection within 6 months before BVN RFA (OR 1.800), lack of baseline opioid use (OR 1.965), LBP exacerbation with activity (OR 2.099), and a lack of LBP with spinal extension (OR 1.845) were factors associated with increased odds of treatment success. Regressions areas under the curve (AUCs) were under 70%, indicative of low predictive value. CONCLUSIONS: This study demonstrates that midline LBP correlates with BVN RFA treatment success in individuals with VEP. While none of the regression models demonstrated strong predictive value, the pain location and exacerbating factors identified in this analysis may aid clinicians in identifying patients where VEP should be more strongly suspected. The use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain remain the most useful patient selection factors for BVN RFA.

The Effectiveness of Intraosseous Basivertebral Nerve Radiofrequency Neurotomy for the Treatment of Chronic Low Back Pain in Patients with Modic Changes: A Systematic Review.

OBJECTIVE: Determine the effectiveness of intraosseous basivertebral nerve radiofrequency neurotomy for the treatment of chronic low back pain with type 1 or 2 Modic changes. DESIGN: Systematic review. POPULATION: Persons aged ≥18 years with chronic low back pain with type 1 or 2 Modic changes. INTERVENTION: Intraosseous basivertebral nerve radiofrequency neurotomy. COMPARISON: Sham, placebo procedure, active standard care treatment, or none. OUTCOMES: The primary outcome of interest was the proportion of individuals with ≥50% pain reduction. Secondary outcomes included ≥10-point improvement in function as measured by Oswestry Disability Index as well as ≥2-point reduction in pain score on the Visual Analog Scale or Numeric Rating Scale, and decreased use of pain medication. METHODS: Three reviewers independently assessed publications before May 15, 2020, in MEDLINE and Embase and the quality of evidence was evaluated using the Grades of Recommendation, Assessment, Development, and Evaluation framework. RESULTS: Of the 725 publications screened, seven publications with 321 participants were ultimately included. The reported 3-month success rate for ≥50% pain reduction ranged from 45% to 63%. Rates of functional improvement (≥10-point Oswestry Disability Index improvement threshold) ranged from 75% to 93%. For comparison to sham treatment, the relative risk of treatment success defined by ≥50% pain reduction and ≥10-point Oswestry Disability Index improvement was 1.25 (95% confidence interval [CI]: .88-1.77) and 1.38 (95% CI: 1.10-1.73), respectively. For comparison to continued standard care treatment the relative risk of treatment success defined by ≥50% pain reduction and ≥10-point Oswestry Disability Index improvement was 4.16 (95% CI: 2.12-8.14) and 2.32 (95% CI: 1.52-3.55), respectively. CONCLUSIONS: There is moderate-quality evidence that suggests this procedure is effective in reducing pain and disability in patients with chronic low back pain who are selected based on type 1 or 2 Modic changes, among other inclusion and exclusion criteria used in the published literature to date. Success of the procedure appears to be dependent on effective targeting of the BVN. Non-industry funded high-quality, large prospective studies are needed to confirm these findings.

Genicular Nerve Radiofrequency Ablation for Chronic Knee Pain Using a Three-Tined Electrode: A Technical Description and Case Series.

BACKGROUND: Genicular nerve radiofrequency ablation (RFA) for the treatment of chronic knee pain has traditionally targeted the superomedial, superolateral, and inferomedial genicular nerves. However, recent cadaveric studies of knee neuroanatomy demonstrate varied locations of these specific nerves as well as additional articular nerves. This work suggests that traditional genicular nerve RFA lesion locations may be inadequate. OBJECTIVE: 1) To describe a novel protocol utilizing a three-tined RFA electrode to target the superomedial (SMGN), superolateral (SLGN), and inferomedial genicular nerves (IMGN), as well as the terminal articular branches of the nerves to the vastus medialis (NVM), intermedius (NVI), and lateralis (NVL). 2) To assess the ability of this technique to reduce chronic knee pain. METHODS: Case series of consecutive patients with six or more months of refractory knee pain who underwent genicular nerve RFA according to the novel protocol described. Seven discrete RFA lesions were placed to target the SMGN, NVM, NVI, NVL, SLGN, and IGMN. RESULTS: Eleven patients underwent RFA, nine with knee osteoarthritis and two postarthroplasty. At one month, 91% (95% CI = 59-100%), 82% (95% CI = 48-98%), and 9% (95% CI = 2-41%), of patients reported ≥50%, ≥80%, and 100% improvement in knee pain on the numeric rating scale, respectively. These results were sustained at six months. There were no complications. DISCUSSION/CONCLUSIONS: These preliminary data suggest the feasibility and possible effectiveness of genicular nerve RFA using the described novel protocol including a three-tined electrode. Larger-scale studies with comparative groups are warranted.

Prevalence and Discordance of the "Startle Response" with True Discogenic Pain According to Spine Intervention Society Guidelines for Provocation Discography: A Cohort Study.

SUMMARY OF BACKGROUND DATA: The literature on cervical provocation discography (C-PD) is sparse. A "Startle Response" during C-PD is a known phenomenon that might be mistaken as an indicator of discogenic pain at the provoked disc level, but this has not been quantitatively described. OBJECTIVES: To determine the incidence of the Startle Response and its concordance/discordance with true-positive C-PD in patients referred for surgical planning or evaluation after ruling out other axial pain generators. METHODS: Retrospective cohort study of consecutive patients who received C-PD at an outpatient spine center. The primary outcome was the rate of discordance of the Startle Response with true-positive C-PD according to the operational criteria of the Spine Intervention Society (SIS) guidelines. RESULTS: One hundred five discs were provoked in 36 individuals (19 female, mean age [SD] = 45.7 [10.9] years). C-PD was performed at a median of three levels (range = 1-5) with C4/5 (N = 30), C5/6 (N = 30), and C6/7 (N = 31) the most commonly evaluated. Twenty-six of 36 patients reported responses consistent with true-positive C-PD. A Startle Response was observed in 14 patients (39%, 95% confidence interval [CI] = 23-57%), and 22 of 105 (21%, 95% CI = 14-30%) provoked discs. Of the 14 patients who exhibited a Startle Response, four had negative C-PD results (29%, 95% CI = 8-58%). As assessed per disc, C-PD results were positive in 12 of the 22 (55%, 95% CI = 32-76%) provoked discs that generated a Startle Response. CONCLUSIONS: The present data demonstrate high discordance, 45% (95% CI = 24-68%), between the Startle Response and true-positive C-PD. Clinicians should be aware of this phenomenon and take care to distinguish it from a true-positive response during C-PD, as defined by the SIS guidelines. Misinterpretation of the Startle Response as a positive C-PD result may lead to inappropriate future care decisions in a substantial proportion of patients.

Does the Contrast Dispersion Pattern During Fluoroscopically Guided Cervical Transforaminal Epidural Steroid Injection Predict Short-Term Pain and Functional Outcomes? An Exploratory Analysis of Prospective Cohort Data.

SUMMARY OF BACKGROUND DATA: No study has evaluated the relationship between contrast dispersion patterns and outcomes after fluoroscopically guided cervical transforaminal epidural steroid injection (CTFESI). OBJECTIVES: Determine whether contrast dispersion patterns predict pain and functional outcomes after CTFESI. METHODS: Secondary analysis of data collected during two prospective studies of CTFESI for the treatment of refractory radicular pain. Contrast dispersion patterns visualized by true anteroposterior (AP) projections during CTFESIs were categorized by flow: 1) completely external to the lateral border of the neuroforamen (zone 1); 2) within the neuroforamen but without entry into the lateral epidural space (zone 2); and 3) with extension into the lateral epidural space (zone 3). At baseline and at 1 month post-CTFESI, neck pain, arm pain, and "dominant index pain" (the greater of arm or neck pain) were evaluated using a numeric rating scale (NRS); physical function was assessed using the Five-Item Version of the Neck Disability Index (NDI-5). RESULTS: One-month post-CTFESI, neck pain, arm pain, and "dominant index pain" reductions of ≥50% were observed in 39.4% (95% confidence interval [CI], 28.2-51.8), 55.6% (95% CI, 43.0-67.5), and 44.1% (95% CI, 32.7-56.2) of participants, respectively. Regarding "dominant index pain," 72.7% (95% CI, 40.8-91.2), 39.4% (95% CI, 24.2-57.0), and 37.5% (95% CI, 20.5-58.2) of participants reported ≥50% pain reduction when zone 1, zone 2, and zone 3 contrast flow patterns were observed. Contrast dispersion zone was not significantly associated with subgroup differences in neck pain, arm pain, or NDI-5 scores (P>0.05). CONCLUSION: Improvements in pain and function 1 month after treatment with CTFESI did not differ significantly based on the contrast dispersion pattern. Future study is needed to confirm or refute these findings in other procedural settings, in broader patient populations, and with longer-term outcome assessment.

A Randomized Comparative Trial of Targeted Steroid Injection via Epidural Catheter vs Standard Transforaminal Epidural Injection for the Treatment of Unilateral Cervical Radicular Pain: Six-Month Results.

OBJECTIVES: Compare the effectiveness of catheter-directed cervical interlaminar epidural steroid injection (C-CIESI) with triamcinolone to cervical transforaminal steroid injection (CTFESI) with dexamethasone for the treatment of refractory unilateral radicular pain. DESIGN: Prospective, randomized, comparative trial. METHODS: Primary outcome: proportion of participants with ≥50% numeric rating scale pain score reduction from baseline "dominant pain" (the greater of arm vs neck) at one month postinjection. Secondary outcomes: ≥30% Neck Disability Index (NDI-5) reduction and Patient Global Impression of Change (PGIC) response indicating "much improved" or "very much improved." RESULTS: One hundred twenty participants (55.6% females, 52.3 ± 12.5 years of age, BMI 28.2 ± 6.5 kg/m2), were enrolled. The proportions of participants who experienced ≥50% pain reduction at one, three, and six months were 68.5% (95% CI = 54.9-79.5%), 59.3% (95% CI = 45.7-71.6%), and 60.8% (95% CI = 46.7-73.2%), respectively, in the C-CIESI group compared with 49.1% (95% CI = 36.4-62.0%), 46.4% (95% CI = 33.8-59.6%), and 51.9% (95% CI = 38.4-65.2%), respectively, in the CTFESI group. The between-group difference at one month was significant (P = 0.038). The proportions of participants who experienced a ≥30% NDI-5 score improvement were 64.0% (95% CI = 49.8-76.1%) and 54.9% (95% CI = 41.1-68.0%) in the C-CIESI and CTFESI groups (P = 0.352). Participants reported similar PGIC improvement in both groups: At six months, 53.2% (95% CI 38.9-67.1%) and 54.5% (95% CI = 39.7-68.7%) of the C-CIESI and CTFESI groups reported being "much improved" or "very much improved," respectively (P = 0.897). CONCLUSIONS: Both C-CIESI with triamcinolone and CTFESI with dexamethasone are effective in reducing pain and disability associated with refractory unilateral cervical radiculopathy in a substantial proportion of participants for at least six months.

The Effectiveness of Spinal Cord Stimulation for the Treatment of Axial Low Back Pain: A Systematic Review with Narrative Synthesis.

OBJECTIVE: Determine the effectiveness of spinal cord stimulation (SCS) for the treatment of axial low back pain (LBP) with or without leg pain. DESIGN: Systematic review. SUBJECTS: Persons aged ≥18 with axial LBP with or without accompanying leg pain. INTERVENTION: Traditional low-frequency, burst, or high-frequency SCS. COMPARISON: Sham, active standard of care treatment, or none. OUTCOMES: The primary outcome was ≥50% pain improvement, and the secondary outcome was functional improvement measured six or more months after treatment intervention. METHODS: Publications in PubMed, MEDLINE, and Cochrane databases were reviewed through September 19, 2019. Randomized or nonrandomized comparative studies and nonrandomized studies without internal controls were included. The Cochrane Risk of Bias Tool and GRADE system were used to assess individual study characteristics and overall quality. RESULTS: Query identified 262 publications; 17 were suitable for inclusion. For high-frequency SCS, the only level 1 study showed that 79% (95% confidence interval = 70-87%) of patients reported ≥50% pain improvement. For low-frequency SCS, the only level 1 study reported no categorical data for axial LBP-specific outcomes; axial LBP improved by a mean 14 mm on the visual analog scale at six months. Meta-analysis was not performed due to study heterogeneity. CONCLUSIONS: According to GRADE, there is low-quality evidence that high-frequency SCS compared with low-frequency SCS is effective in patients with axial LBP with concomitant leg pain. There is very low-quality evidence for low-frequency SCS for the treatment of axial LBP in patients with concomitant leg pain. There is insufficient evidence addressing the effectiveness of burst SCS to apply a GRADE rating.

Assessing optimism and pessimism about genomic medicine: Development of a genomic orientation scale.

Efforts to characterize stakeholder attitudes about the implementation of genomic medicine would benefit from a validated instrument for measuring public views of the potential benefits and harms of genomic technologies, which would facilitate comparison across populations and clinical settings. We sought to develop a scale to evaluate attitudes about the future of genomic medicine. We developed a 21-item scale that examined the likelihood of various outcomes of genomic medicine. The scale was administered to participants in a genomic sequencing study. Exploratory factor analysis was conducted and bivariate correlations were calculated. The genomic orientation (GO) scale was completed by 2895 participants. A two-factor structure was identified, corresponding to an optimism subscale (16 items, α = 0.89) and a pessimism subscale (5 items, α = 0.63). Genomic optimism was positively associated with a perceived value of genetic test results, higher health literacy, and decreased decisional conflict about participation in a genomic research study. Genomic pessimism was associated with concerns about genetic testing, lower health literacy, and increased decisional conflict about the decision to participate in the study. The GO scale is a promising tool for measuring both positive and negative views regarding the future of genomic medicine and deserves further validation.

Percutaneous treatments for residual and/or phantom limb pain in adults with lower-extremity amputations: A narrative review.

Residual limb pain (RLP) and phantom limb pain (PLP) profoundly affect the lives of many individuals who have undergone lower- or upper-extremity amputation. Despite the considerable impact of RLP/PLP on quality of life in persons with amputation, there have been few attempts to evaluate the efficacy of percutaneous interventions in the treatment of RLP and/or PLP. This narrative review evaluates the effectiveness of percutaneous treatments for RLP and/or PLP in patients after lower-extremity amputation. Peripheral nerve stimulation, alcohol neurolysis, conventional thermal radiofrequency ablation, perineural corticosteroid injection, botulinum toxin injection, and etanercept injection were associated with varying success rates. Wide confidence intervals and small treatment cohorts impede assessments of overall success. High-quality studies of nonsurgical, percutaneous treatments for RLP and/or PLP are lacking. Well-designed randomized controlled trials and large cohort studies with comparison groups using validated outcomes are needed to determine the effectiveness of nonsurgical interventions for the treatment of RLP and PLP.

The Effectiveness of Fluoroscopically Guided Genicular Nerve Radiofrequency Ablation for the Treatment of Chronic Knee Pain Due to Osteoarthritis: A Systematic Review.

ABSTRACT: The objective was to determine the effectiveness of fluoroscopically guided genicular nerve radiofrequency ablation for painful knee osteoarthritis. Primary outcome measure was improvement in pain after 6 mos. Secondary outcomes included the Oxford Knee Score and Western Ontario and McMaster Universities Osteoarthritis Index. Two reviewers independently assessed publications before October 10, 2020. The Cochrane Risk of Bias Tool and Grades of Recommendation, Assessment, Development, and Evaluation system were used. One hundred ninety-nine publications were screened, and nine were included. Six-month success rates for 50% or greater pain relief after radiofrequency ablation ranged from 49% to 74%. When compared with intra-articular steroid injection, the probability of success was 4.5 times higher for radiofrequency ablation (relative risk = 4.58 [95% confidence interval = 2.61-8.04]). When radiofrequency ablation was compared with hyaluronic acid injection, the probability of treatment success was 1.8 times higher (relative risk = 1.88, 95% confidence interval = 1.38-2.57). The group mean Oxford Knee Score and Western Ontario and McMaster Universities Osteoarthritis Index scores improved in participants receiving genicular radiofrequency ablation compared with intra-articular steroid injection and hyaluronic acid injection. According to Grades of Recommendation, Assessment, Development, and Evaluation, there is moderate-quality evidence that fluoroscopically guided genicular radiofrequency ablation is effective for reducing pain associated with knee osteoarthritis at minimum of 6 mos. Further research is likely to have an important impact on the current understanding of the long-term effectiveness of this treatment.