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BACKGROUND: Non-contiguous two-level Anterior Cervical Discectomy and Fusion (ACDF) may be a viable option for patients with degenerative cervical myelopathy and imaging-evident spine and radicular compression at two non-contiguous cervical levels. The risk of hastening degeneration and triggering Adjacent Segment Disease at the spine levels located between the fused levels is a putative adverse event, which was assessed in a few studies. The aim of this study is to investigate the clinical outcomes of patients undergoing non-contiguous two levels ACDF and to assess biomechanical modifications at non-fused segments.
METHODS: We retrospectively reviewed all patients with noncontiguous two-level spine and radicular compression, who underwent simultaneous noncontiguous two-level ACDF at our center. We analyzed clinical and radiological outcomes and investigated the rate of adjacent segment disease. Radiographic parameters were calculated on pre- and postoperative images.
RESULTS: Thirty-two patients underwent simultaneous noncontiguous two-level ACDF for cervical myelo-radiculopathy between 2015 and 2021 and were followed up for a mean period of 43.3 months. For all patients, the mJOA score significantly improved from 14.57 ± 2.3 to 16.5 ± 2.1 (p<0.01) and the NDI score significantly decreased from 21.45 ± 4.3 to 12.8 ± 2.3 (p<0.01) postoperatively. Cervical lordosis increased after surgery (from 9.65° ±9.47 to 15.12° ± 6.09); intermediate disc height decreased (5.68 mm ± 0.57 to 5.27 mm ±0.98); the ROMs of intermediate (from 12.45 ± 2.33 to 14.77 ± 1.98), cranial (from 14.63 ± 1.59 to 15.71 ± 1.02), and caudal (from 11.58 ± 2.32 to 13.33 ± 2.67) segments slightly increased. During follow-up assessment, in one patient the myelopathy worsened due to spine compression at the intermediate level.
CONCLUSIONS: Simultaneous and non-contiguous two-level ACDF is a safe and effective procedure. The occurrence of postoperative adjacent and intermediate segment disease is rare.

BACKGROUND: Patients surgically treated for lumbar spinal stenosis or cervical radiculopathy report improvement in approximately two out of three cases. Advancements in Machine Learning and the utility of large datasets have enabled the development of prognostic prediction models within spine surgery. This trial investigates if the use of the postoperative outcome prediction model, the Dialogue Support, can alter patient-reported outcome and satisfaction compared to current practice.
METHODS: This is a prospective, multicenter clinical trial. Patients referred to a spine clinic with cervical radiculopathy or lumbar spinal stenosis will be screened for eligibility. Participants will be assessed at baseline upon recruitment and at 12 months follow-up. The Dialogue Support will be used on all participants, and they will thereafter be placed into either a surgical or a non-surgical treatment arm, depending on the decision made between patient and surgeon. The surgical treatment group will be studied separately based on diagnosis of either cervical radiculopathy or lumbar spinal stenosis. Both the surgical and the non-surgical group will be compared to a retrospective matched control group retrieved from the Swespine register, on which the Dialogue Support has not been used. The primary outcome measure is global assessment regarding leg/arm pain in the surgical treatment group. Secondary outcome measures include patient satisfaction, Oswestry Disability Index (ODI), EQ-5D, and Numeric Rating Scales (NRS) for pain. In the non-surgical treatment group primary outcome measures are EQ-5D and mortality, as part of a selection bias analysis.
CONCLUSIONS: The findings of this study may provide evidence on whether the use of an advanced digital decision tool can alter patient-reported outcomes after surgery.
BACKGROUND: The trial was retrospectively registered at ClinicalTrials.gov on April 17th, 2023, NCT05817747.
METHODS: 1.
METHODS: Clinical multicenter trial.

BACKGROUND: SI-6603 (condoliase) is a chemonucleolytic agent approved in Japan in 2018 for the treatment of lumbar disc herniation (LDH) associated with radicular leg pain. Condoliase, a mucopolysaccharidase with high substrate specificity for glycosaminoglycans (GAGs), offers a unique mechanism of action through the degradation of GAGs in the nucleus pulposus. As LDH management is currently limited to conservative approaches and surgical intervention, condoliase could offer a less invasive treatment option than surgery for patients with LDH.
OBJECTIVE: The Discover 6603 study (NCT03607838) evaluated the efficacy and safety of a single-dose injection of SI-6603 (condoliase) vs sham for the treatment of radicular leg pain associated with LDH.
METHODS: A randomized, double-blind, sham-controlled, phase 3 study conducted across 41 sites in the United States.
METHODS: Male and female participants (N=352; aged 30-70 years) with contained posterolateral LDH and unilateral radiculopathy/radicular leg pain for greater than 6 weeks.
METHODS: The primary endpoint was the change from baseline (CFB) in average worst leg pain score at 13 weeks, assessed using the 100-mm visual analogue scale. Key secondary endpoints were CFB in average worst leg pain score at 52 weeks, herniation volume at 13 weeks, and Oswestry Disability Index (ODI) score at 13 weeks. Safety evaluations included adverse events (AEs) and imaging findings.
METHODS: Participants were randomized 1:1 to receive a single intradiscal injection of condoliase (1.25 units) or sham injection followed by 52 weeks of observation. The primary and key secondary endpoints were assessed using a mixed model for repeated measures (MMRM) analysis and a protocol-specified multiple imputation (MI) sensitivity analysis on the modified intention-to-treat (mITT) population. A prespecified serial gatekeeping algorithm was used for multiple comparisons. Safety endpoints included AEs, laboratory tests, vital signs, imaging (by X-ray and magnetic resonance imaging [MRI]), and occurrence of posttreatment lumbar surgery.
RESULTS: Of the 352 randomized participants, 341 constituted the mITT population (condoliase n=169; sham n=172) and the safety population (condoliase n=167; sham n=174). For the primary endpoint, the condoliase group showed significantly greater improvement in CFB in worst leg pain at Week 13 (least squares mean [LSM] CFB: -41.7) compared with sham injection (-34.2; LSM difference: -7.5; 95% confidence interval [CI]: -14.1, -0.9; p=.0263) based on the MMRM analysis. CFB in worst leg pain at Week 52 favored condoliase vs sham, but the difference was not statistically significant (p=.0558), which halted the serial gatekeeping testing algorithm and dictated that the CFB in herniation volume and ODI scores at Week 13 would be considered nonsignificant, regardless of their p-values. Treatment group differences in CFB in herniation volume and ODI score favored the condoliase group vs sham at all timepoints. The MI sensitivity analysis showed differences in CFB in worst leg pain at Week 13 (p=.0223) and Week 52 (p=.0433) in favor of the condoliase group. Treatment-emergent AEs (TEAEs) were more common in the condoliase group (≥1 TEAE: 71.9%; ≥1 treatment-related TEAE: 28.1%) compared with the sham group (≥1 TEAE: 60.3%; ≥1 treatment-related TEAE: 10.3%). Of the TEAEs, spinal MRI abnormalities and back pain occurred most frequently. No treatment-related serious AEs occurred.
CONCLUSIONS: Condoliase met its primary endpoint of significantly improving radicular leg pain at Week 13 and was generally well tolerated in patients with LDH. Chemonucleolysis with condoliase has the potential to provide a less invasive treatment option than surgery for those unresponsive to conservative treatment strategies.

BACKGROUND: Most patients with cervical radiculopathy improve within the first months without treatment or with non-surgical treatment. A systematic review concluded that these patients improve, regardless of their intervention. Still, many patients are offered surgery, despite limited evidence regarding the indications for surgical treatments. The aim of this article is to describe the intervention that is going to be followed in the non-surgical treatment arm of a randomised controlled trial (RCT) comparing the effectiveness of surgical and non-surgical treatment for patients with cervical radiculopathy.
METHODS: The non-surgical intervention is a functional intervention within a cognitive approach founded on previous experiences, and current recommendations for best practice care of musculoskeletal pain and cervical radiculopathy. It is based on the biopsychosocial rather than a biomedical perspective, comprises an interdisciplinary approach (physicians, physiotherapy specialists), and includes brief intervention and graded activities. The intervention consists of 6 sessions over 12 weeks. The primary goals are first, to validate the patients´ symptoms and build a therapeutic alliance, second, to explore the understanding and promote alternatives, and third, to explore problems and opportunities based on patients´ symptoms and function. Motivational factors toward self-management are challenging. We will attempt shared decision-making in planning progress for the individual patient and emphasise learning of practical self-help strategies and encouragement to stay active (reinforcing the positive natural course). General physical activities such as walking will be promoted along with simple functional exercises for the neck- and shoulder region. We will also explore social activity, comorbidities, pain location, sleep, and work-related factors. The health providers will set individualised goals together with each patient.
CONCLUSIONS: The aim of the intervention is to describe a functional intervention within a cognitive approach for patients with chronic cervical radiculopathy. The effectiveness of the present program will be compared to surgery in a randomised controlled trial.

BACKGROUND: Cervical spondylosis (CS), including myelopathy and radiculopathy, is the most common degenerative cervical spine disease. This study aims to evaluate the clinical outcomes of unilateral biportal endoscopy (UBE) compared to those of conventional anterior cervical decompression and fusion (ACDF) for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs.
METHODS: A prospective, randomized, controlled, noninferiority trial was conducted. The sample consisted of 131 patients who underwent UBE or ACDF was conducted between September 2021 and September 2022. Patients with cervical nerve roots or coexisting spinal cord compression symptoms and imaging-defined unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs were randomized into two groups: a UBE group (n = 63) and an ACDF group (n = 68). The operative time, blood loss, length of hospital stay after surgery, and perioperative complications were recorded. Preoperative and postoperative modified Japanese Orthopaedic Association (mJOA) scale scores, visual analog scale (VAS) scores, neck disability index (NDI) scores, and recovery rate (RR) of the mJOA were utilized to evaluate clinical outcomes.
RESULTS: The hospital stay after surgery was significantly shorter in patients treated with UBE than in those treated with ACDF (p < 0.05). There were no significant differences in the neck or arm VAS score, NDI score, mJOA score, or mean RR of the mJOA between the two groups (p < 0.05). Only mild complications were observed in both groups, with no significant difference (p = 0.30).
CONCLUSIONS: UBE can significantly relieve pain and disability without severe complications, and most patients are satisfied with this technique. Consequently, this procedure can be used safely and effectively as an alternative to ACDF for treating unilateral cervical radiculopathy or coexisting cervical myelopathy induced by unilateral cervical herniated discs.
BACKGROUND: This study was registered in the Chinese Clinical Trial Registry on 02/08/2023 ( http://www.chictr.org.cn , #ChiCTR2300074273).

OBJECTIVE: Selective nerve root blocks (SNRB) are used both as a therapeutic and diagnostic tool for lumbar radicular pain. Most studies evaluate the effect of SNRB simply by its relation to pain reduction. It is well known that pain is associated with other factors such as depression, anxiety, inactivity and sleeping disorders, but these patient-related outcomes are seldom evaluated. This study evaluated the influence of SNRB on pain-related outcomes including depression, anxiety, fatigue, pain interference, activity and sleep.
METHODS: One hundred three patients with lumbar radicular pain were treated with a SNRB. Patient-reported outcome measures (PROMs) were assessed with the PROMIS-29 for 12 weeks (84 days) following the SNRB. Patients were stratified based on their pain reduction at the 14-day follow up as responders (≥ 30% pain reduction) and non-responders (< 30% pain reduction). Post-treatment duration was estimated with the Kaplan-Meier analysis with return to baseline as an event. A paired t-test was used to compare pre- and post-treatment responses at specific time intervals.
RESULTS: Forty-four percent (n = 45) of the patients were responders and showed significant improvement in all parameters throughout the 84-days follow-up, the exception was sleep that lost significance at day 70. The mean post-treatment duration among responders was 59 (52-67) days. Non-responders showed significant improvements in pain interference and pain intensity until day 35 and in ability for social participation until 21-day.
CONCLUSIONS: SNRB can improve pain intensity, pain interference, physical function, fatigue, anxiety, depression, sleep disturbance and the ability to participate in social roles.

UNASSIGNED: The use of sedation during interventional procedures has continued to rise resulting in increased costs, complications and reduced validity during diagnostic injections, prompting a search for alternatives. Virtual reality (VR) has been shown to reduce pain and anxiety during painful procedures, but no studies have compared it to a control and active comparator for a pain-alleviating procedure. The main objective of this study was to determine whether VR reduces procedure-related pain and other outcomes for epidural steroid injections (ESI).
UNASSIGNED: A randomized controlled trial was conducted in 146 patients undergoing an ESI at 6 hospitals in Thailand and the United States. Patients were allocated to receive immersive VR with local anesthetic, sedation with midazolam and fentanyl plus local anesthetic, or local anesthetic alone. The primary outcome was procedure-related pain recorded on a 0-10 scale. Other immediate-term outcome measures were pain from a standardized subcutaneous skin wheal, procedure-related anxiety, ability to communicate, satisfaction, and time to discharge. Intermediate-term outcome measures at 4 weeks included back and leg pain scores, function, and success defined as a ≥2-point decrease in average leg pain coupled with a score ≥5/7 on a Patient Global Impression of Change scale.
UNASSIGNED: Procedure-related pain scores with both VR (mean 3.7 (SD 2.5)) and sedation (mean 3.2 (SD 3.0)) were lower compared to control (mean 5.2 (SD 3.1); mean differences -1.5 (-2.7, -0.4) and -2.1 (-3.3, -0.9), respectively), but VR and sedation scores did not significantly differ (mean difference 0.5 (-0.6, 1.7)). Among secondary outcomes, communication was decreased in the sedation group (mean 3.7 (SD 0.9)) compared to the VR group (mean 4.1 (SD 0.5); mean difference 0.4 (0.1, 0.6)), but neither VR nor sedation was different than control. The trends favoring sedation and VR over control for procedure-related anxiety and satisfaction were not statistically significant. Post-procedural recovery time was longer for the sedation group compared to both VR and control groups. There were no meaningful intermediate-term differences between groups except that medication reduction was lowest in the control group.
UNASSIGNED: VR provides comparable benefit to sedation for procedure-related pain, anxiety and satisfaction, but with fewer side effects, superior communication and a shorter recovery period.
UNASSIGNED: Funded in part by grants from MIRROR, Uniformed Services University of the Health Sciences, U.S. Dept. of Defense, grant # HU00011920011. Equipment was provided by Harvard MedTech, Las Vegas, NV.

BACKGROUND: Double crush syndrome (DCS) is characterized by multiple compression sites along a single peripheral nerve. It commonly presents with persistent distal symptoms despite surgical treatment for cervical radiculopathy. Management typically involves nerve release of the most symptomatic site. However, due to overlapping symptoms with cervical radiculopathy, patients may undergo cervical surgery prior to DCS diagnosis. Due to its rarity and frequent misdiagnosis, the authors aim to utilize a large national database to investigate the incidence and associations of DCS.
METHODS: The Pearldiver database was utilized to identify patients undergoing cervical surgery for the management of cervical radiculopathy. Patients were stratified into three cohorts based on their clinical course before and after cervical surgery. The primary outcome was the prevalence of DCS, and secondary outcomes included an evaluation of predictive factors for each Group, using a significance level of P < 0.05.
RESULTS: Among 195,271 patients undergoing cervical surgery for cervical radiculomyelopathy, 97.95% were appropriately managed, 1.42% had potentially mids-diagnosed DCS, and 0.63% were treatment-resistant. Diabetes and obesity were significant predictors of potentially misdiagnosed DCS (P < 0.05).
CONCLUSIONS: This study presents data indicating that 1.42% of patients who receive cervical surgery may have underlying DCS and potentially benefit from nerve release prior to undergoing surgery. A concurrent diagnosis of diabetes and obesity may predict an underlying DCS.

BACKGROUND: To identify the sensitivity, specificity, and overall diagnostic accuracy of infrared thermography in diagnosing lumbosacral radicular pain.
METHODS: Patients sequentially presenting with lower extremity pain were enrolled. A clinical certainty score ranging from 0 to 10 was used to assess the likelihood of lumbosacral radicular pain, with higher scores indicating higher likelihood. Infrared Thermography scans were performed and the temperature difference (ΔT) was calculated as ΔT = T1 - T2, where T2 represents the skin temperature of the most painful area on the affected limb and T1 represents the skin temperature of the same area on the unaffected limb. Upon discharge from the hospital, two independent doctors diagnosed lumbosacral radicular pain based on intraoperative findings, surgical effectiveness, and medical records.
RESULTS: A total of 162 patients were included in the study, with the adjudicated golden standard diagnosis revealing that 101 (62%) patients had lumbosacral radicular pain, while the lower extremity pain in 61 patients was attributed to other diseases. The optimal diagnostic value for ΔT was identified to fall between 0.8℃ and 2.2℃, with a corresponding diagnostic accuracy, sensitivity, and specificity of 80%, 89%, and 66% respectively. The diagnostic accuracy, sensitivity, and specificity for the clinical certainty score were reported as 69%, 62%, and 79% respectively. Combining the clinical certainty score with ΔT yielded a diagnostic accuracy, sensitivity, and specificity of 84%, 77%, and 88% respectively.
CONCLUSIONS: Infrared thermography proves to be a highly sensitive tool for diagnosing lumbosacral radicular pain. It offers additional diagnostic value in cases where general clinical evaluation may not provide conclusive results.
BACKGROUND: ChiCTR2300078786, 19/22/2023.