Posterior Cervical Foraminotomy Compared with Anterior Cervical Discectomy with Fusion for Cervical Radiculopathy: Two-Year Results of the FACET Randomized Noninferiority Study.

BACKGROUND: Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery. METHODS: This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536). RESULTS: From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, -0.06 [1-sided 95% confidence interval (CI), -0.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was -2.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, -0.02 [2-sided 95% CI, -0.09 to 0.05]). CONCLUSIONS: This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Heart Rate Variability in Surgical Patients Experiencing Live Bedside Music; An Explorative Study.

It's known that surgery elicits a stress response involving the autonomic nervous system (ANS) which is important in general recovery but can also have detrimental effects in older patients. Music seems to positively effect postoperative recovery, although the mechanism requires further unravelling. Our objective was to explore the response of the ANS to live bedside music in older surgical patients, by using heart rate variability (HRV) as a proxy. This explorative prospective non-randomized controlled cohort study included 101 older non-cardiac surgical patients, with a median age of 70 (range 60-88 years). HRV was measured in a cohort receiving live bedside music provided by professional musicians and in a control group that did not receive music. HRV was measured pre-intervention, during the intervention, 30 min after the intervention, and again after three hours. Mixed linear modelling was used to assess the effect of the intervention compared to the control group over time. A significant change in both the low and high frequency bands (p = 0.041) and (p = 0.041) respectively, was found over time in the music group compared to the control group indicating relaxation and increased parasympathetic activity in the music group. Other measures revealed a trend but no significant effect was shown. These results provide a first glance and contribute to a better understanding of the effect of music on the recovery of older surgical patients.

Role of non-invasive objective markers for the rehabilitative diagnosis of central sensitization in patients with fibromyalgia: A systematic review.

BACKGROUND: Central sensitization cannot be demonstrated directly in humans. Therefore, studies used different proxy markers (signs, symptoms and tools) to identify factors assumed to relate to central sensitization in humans, that is, Human Assumed Central Sensitization (HACS). The aims of this systematic review were to identify non-invasive objective markers of HACS and the instruments to assess these markers in patients with fibromyalgia (FM). METHODS: A systematic review was conducted with the following inclusion criteria: (1) adults, (2) diagnosed with FM, and (3) markers and instruments for HACS had to be non-invasive. Data were subsequently extracted, and studies were assessed for risk of bias using the quality assessment tools developed by the National Institute of Health. RESULTS: 78 studies (n= 5234 participants) were included and the findings were categorized in markers identified to assess peripheral and central manifestations of HACS. The identified markers for peripheral manifestations of HACS, with at least moderate evidence, were pain after-sensation decline rates, mechanical pain thresholds, pressure pain threshold, sound 'pressure' pain threshold, cutaneous silent period, slowly repeated evoked pain sensitization and nociceptive flexion reflex threshold. The identified markers for central manifestations of HACS were efficacy of conditioned pain modulation with pressure pain conditioning and brain perfusion analysis. Instruments to assess these markers are: pin-prick stimulators, cuff-algometry, repetitive pressure stimulation using a pressure algometer, sound, electrodes and neuroimaging techniques. CONCLUSIONS: This review provides an overview of non-invasive markers and instruments for the assessment of HACS in patients with FM. Implementing these findings into clinical settings may help to identify HACS in patients with FM.

Short-Term Neck Pain After Posterior Foraminotomy Compared with Anterior Discectomy with Fusion for Cervical Foraminal Radiculopathy: A Secondary Analysis of the FACET Randomized Controlled Trial.

BACKGROUND: Short-term neck pain after posterior cervical foraminotomy (posterior surgery) compared with anterior cervical discectomy with fusion (anterior surgery) treating cervical radiculopathy has only been assessed once, retrospectively, to our knowledge. The aim of this study was to prospectively evaluate the course of neck pain for 6 weeks after both treatments. METHODS: This is a secondary analysis of the multicenter Foraminotomy ACDF Cost-Effectiveness Trial (FACET), conducted from January 2016 to May 2020. Of 389 patients who had single-level, 1-sided cervical radiculopathy and were screened for eligibility, 265 were randomly assigned to undergo posterior surgery (n = 132) or anterior surgery (n = 133). The primary outcome of the present analysis was neck pain, assessed weekly for 6 weeks using the visual analog scale (VAS), on a scale of 0 to 100. The secondary outcomes were arm pain, neck disability, work ability, quality of life, treatment satisfaction, motor and sensory changes, and hospital length of stay. Data were analyzed with mixed model analysis in intention-to-treat samples using 2-sided 95% confidence intervals (CIs). RESULTS: In the first postoperative week, the mean VAS for neck pain was 56.2 mm (95% CI, 51.7 to 60.8 mm) after posterior surgery and 46.7 mm (95% CI, 42.2 to 51.2 mm) after anterior surgery. The mean between-group difference was 9.5 mm (95% CI, 3.3 to 15.7 mm), which gradually decreased to 2.3 mm (95% CI, -3.6 to 8.1 mm) at postoperative week 6. As of postoperative week 5, there was no significant difference between groups. Responder analyses confirmed this result. Secondary outcomes showed small differences between groups. CONCLUSIONS: Insight into the course of neck pain during the first 6 weeks after posterior compared with anterior surgery is provided. Despite initially more neck pain after posterior surgery, patients swiftly improved and, as of postoperative week 5, results similar to those after anterior surgery were observed. Our findings should enable improved patient counseling and enhanced shared decision-making between physicians and patients with cervical radiculopathy, where more neck pain in the first postoperative weeks should be balanced against the benefits of posterior surgery. LEVEL OF EVIDENCE: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year: The FACET Randomized Clinical Trial.

Importance: The choice between posterior cervical foraminotomy (posterior surgery) and anterior cervical discectomy with fusion (anterior surgery) for cervical foraminal radiculopathy remains controversial. Objective: To investigate the noninferiority of posterior vs anterior surgery in patients with cervical foraminal radiculopathy with regard to clinical outcomes after 1 year. Design, Setting, and Participants: This multicenter investigator-blinded noninferiority randomized clinical trial was conducted from January 2016 to May 2020 with a total follow-up of 2 years. Patients were included from 9 hospitals in the Netherlands. Of 389 adult patients with 1-sided single-level cervical foraminal radiculopathy screened for eligibility, 124 declined to participate or did not meet eligibility criteria. Patients with pure axial neck pain without radicular pain were not eligible. Of 265 patients randomized (132 to posterior and 133 to anterior), 15 were lost to follow-up and 228 were included in the 1-year analysis (110 in posterior and 118 in anterior). Interventions: Patients were randomly assigned 1:1 to posterior foraminotomy or anterior cervical discectomy with fusion. Main Outcomes and Measures: Primary outcomes were proportion of success using Odom criteria and decrease in arm pain using a visual analogue scale from 0 to 100 with a noninferiority margin of 10% (assuming advantages with posterior surgery over anterior surgery that would justify a tolerable loss of efficacy of 10%). Secondary outcomes were neck pain, disability, quality of life, work status, treatment satisfaction, reoperations, and complications. Analyses were performed with 2-proportion z tests at 1-sided .05 significance levels with Bonferroni corrections. Results: Among 265 included patients, the mean (SD) age was 51.2 (8.3) years; 133 patients (50%) were female and 132 (50%) were male. Patients were randomly assigned to posterior (132) or anterior (133) surgery. The proportion of success was 0.88 (86 of 98) in the posterior surgery group and 0.76 (81 of 106) in the anterior surgery group (difference, -0.11 percentage points; 1-sided 95% CI, -0.01) and the between-group difference in arm pain was -2.8 (1-sided 95% CI, -9.4) at 1-year follow-up, indicating noninferiority of posterior surgery. Decrease in arm pain had a between-group difference of 3.4 (1-sided 95% CI, 11.8), crossing the noninferiority margin with 1.8 points. All secondary outcomes had 2-sided 95% CIs clustered around 0 with small between-group differences. Conclusions and Relevance: In this randomized clinical trial, posterior surgery was noninferior to anterior surgery for patients with cervical radiculopathy regarding success rate and arm pain at 1 year. Decrease in arm pain and secondary outcomes had small between-group differences. These results may be used to enhance shared decision-making. Trial Registration: Netherlands Trial Register Identifier: NTR5536.

Surgical Interventions for Cervical Radiculopathy without Myelopathy: A Systematic Review and Meta-Analysis.

BACKGROUND: The effectiveness of surgical interventions for cervical degenerative disorders has been investigated in multiple systematic reviews. Differences in study population (e.g., patients with myelopathy and/or radiculopathy) were often neglected. Therefore, the objective of this study was to investigate the effectiveness of surgical interventions for patients with symptoms of cervical radiculopathy without myelopathy by conducting a systematic review and meta-analysis based on randomized controlled trials (RCTs). METHODS: A comprehensive systematic search was conducted in MEDLINE, Embase, and CENTRAL (Cochrane Central Register of Controlled Trials) to identify RCTs that investigated the effectiveness of surgical interventions using an anterior or posterior approach compared with other interventions for patients with pure cervical radiculopathy. Outcomes were success rates (Odom criteria, similar rating scales, or percentage of patients who improved), complication and reoperation rates, work status, disability (Neck Disability Index), and pain (arm and neck). The Cochrane risk-of-bias tool was used to assess the likelihood of the risk of bias. A random-effects model was used. Heterogeneity among study results (I2 ≥ 50% or p < 0.05) was explored by conducting subgroup analyses. Funnel plots were used to assess the likelihood of publication bias. RESULTS: A total of 21 RCTs were included, comprising 1,567 patients. For all outcomes, among all surgical techniques, only 1 pooled estimate showed a significant effect on success rate, which was in favor of anterior cervical discectomy with fusion compared with anterior cervical discectomy without an intervertebral spacer (p = 0.02; risk ratio [RR] = 0.87; 95% confidence interval [CI] = 0.77 to 0.98). Complication rates were higher when autologous bone graft from the iliac crest was used as an intervertebral spacer (p < 0.01; RR = 3.40; 95% CI = 1.56 to 7.43), related to donor-site morbidity. CONCLUSIONS: This meta-analysis demonstrated consistent results regarding clinical outcome for pure cervical radiculopathy among all studied interventions. Complication and reoperation rates were also similar, with the exception of higher complication rates in patients in whom autologous bone grafts were used. On the basis of clinical outcome and safety, there is no superior surgical intervention for pure cervical radiculopathy. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

The Odom Criteria: Validated at Last: A Clinimetric Evaluation in Cervical Spine Surgery.

BACKGROUND: The Odom criteria, established in 1958, are a widely used, 4-point rating scale for assessing the clinical outcome after cervical spine surgery. Surprisingly, the Odom criteria have never been validated, to our knowledge. The aim of this study was to investigate the reliability and validity of the Odom criteria for the evaluation of surgical procedures of the cervical spine. METHODS: Patients with degenerative cervical spine disease were included in the study and divided into 2 subgroups on the basis of their most predominant symptom: myelopathy or radiculopathy. Reliability was assessed with interrater and test-retest design using quadratic weighted kappa coefficients. Construct validity was assessed by means of hypotheses testing. To evaluate whether the Odom criteria could act as a global perceived effect (GPE) scale, we assessed concurrent validity by comparing area under the curve (AUC) values of receiver operating characteristic (ROC) curves for the set of questionnaires. RESULTS: A total of 110 patients were included in the study; 19 were excluded, leaving 91 in our analysis. Reliability assessments showed κ = 0.77 for overall interrater reliability and κ = 0.93 for overall test-retest reliability. Interrater reliability was κ = 0.81 for the radiculopathy subgroup and κ = 0.68 for the myelopathy subgroup. At least 75% of the hypotheses were met. The AUCs showed similar characteristics between the Odom criteria and GPE scale. CONCLUSIONS: The Odom criteria met the predefined criteria for reliability and validity. Therefore, the Odom criteria may be used to assess surgical outcome after a cervical spine procedure, specifically for patients presenting with radicular symptoms. The results of previous studies that have been deemed less trustworthy because of the use of the Odom criteria should be reconsidered.

Reference Values of the Pain Disability Index in Patients With Painful Musculoskeletal and Spinal Disorders: A Cross-national Study.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: To examine reference data for the Pain Disability Index (PDI) in Dutch and Canadian patient samples with a variety of musculoskeletal pain disorders and to test which potential factors are independently associated with the PDI score. SUMMARY OF BACKGROUND DATA: The PDI is a widely used generic instrument for measuring disability related to pain. It is unknown whether patients with spinal and other musculoskeletal diagnoses have different levels of disability when scored on the PDI. METHODS: Patients were referred to secondary and tertiary care centers in the Netherlands and Alberta, Canada, between 2009 and 2013. All patients filled out a baseline questionnaire including demographics and the PDI. After first consultation with a medical doctor, diagnoses were set by the medical specialist. Univariate general linear models were used to examine correlations between PDI scores and age, sex, country of residence, diagnosis, and work status. RESULTS: In total 6997 patients were included in this study: 1302 Canadian and 5695 Dutch patients. Mean PDI score of the total group was 37.8 ± 14.2. Reference values are presented and clustered into the following diagnostic groups: spinal nerve and intervertebral disc disorders; nonspecific back pain; rheumatic soft-tissue pain (widespread pain or fibromyalgia); spinal stenosis; and whiplash-associated disorder. The PDI score was significantly and relevantly associated with pain intensity (η explained variance from 20% to 25%), but not relevantly associated with age, sex, country of residence, and diagnostic group (η<3%). In the working subgroup, adding "current sick leave" as covariate increased the explained variance to 34%. CONCLUSION: Reference values of the PDI are presented. Patient ratings of disability on the PDI are relevantly associated with pain intensity and work status, but not with nationality or diagnostic group. Only minimal differences were identified between the various musculoskeletal diagnoses included. LEVEL OF EVIDENCE: N/A.