Study Design. Prospective study of assessment of surgical results using a new outcome measure for cervical myelopathy, the Japanese Orthopedic Association cervical myelopathy evaluation questionnaire (JOACMEQ). Objective. To clarify correlations between pre- and postoperative JOACMEQ severity scores for cervical spine operations and grip strength and grip-and-release test, as objective evaluations, as well as correlations with the 8 subscales of the short form-36 (SF-36). Methods. For pre- and postoperative evaluations, we examined 87 subjects who had undergone cervical spine operations and could be followed up for ≥6 months. JOACMEQ and the Japanese version of SF-36 were administered along with grip strength and grip-and-release tests, immediately preoperatively and 6 months postoperatively. Based on JOACMEQ severity scores pre- and postoperatively, treatment effectiveness was determined for cervical spine function, upper extremity function, lower extremity function, bladder function, and quality of life (QOL). We also clarified correlations between JOACMEQ scores and upper extremity function using grip strength and the grip-and-release test. In addition, correlations between the 5 JOACMEQ severity scores and the 8 subscales of SF-36 were analyzed. Results. Effective rate of treatment was lower for upper extremity function than for other items (i.e., lower extremity function, bladder function, and QOL), and upper extremity function showed a different tendency for subjective improvement of symptoms following surgery compared to other items. JOACMEQ scores for upper extremity function, as subjective evaluations, may not necessarily improve even though improvements are seen in objective indicators such as grip strength and grip-and-release tests. Conclusion. JOACMEQ offers an effective method of evaluation from the perspective of patient evaluations of QOL.

To develop screening tools for neuropathic pain caused by spinal disorders, the Spine painDETECT questionnaire (SPDQ) and its short-form version (SF-SPDQ), by modifying the Japanese version of the painDETECT questionnaire (PDQ-J), and to validate these tools. Using data from patients with neuropathic pain caused by spinal disorders (NeP-SD) and patients with nociceptive pain caused by joint disorders (NocP) as controls, we devised a scoring system for the SPDQ by calculating weighting coefficients for nine PDQ-J items. Simultaneously, we selected some items for the SF-SPDQ. Next, we conducted the validation study primarily using patients with a confirmed diagnosis (a multicenter study) and general patients (a web-based survey). Sensitivity, specificity, and the area under the receiver-operating characteristic curve (AUC), along with additional positive/negative predictive values and positive/negative likelihood ratios, were calculated to assess the diagnostic utility of these tools in each population. Data for 85 patients with NeP-SD and 45 patients with NocP were analyzed to develop the SPDQ/SF-SPDQ. The SPDQ had sensitivity of 78.8% and specificity of 75.6% (AUC = 0.77). The SF-SPDQ had 82.4% sensitivity and 66.7% specificity (AUC = 0.75). In the multicenter study (n = 45), both tools had diagnostic utility almost comparable with that demonstrated at development: the SPDQ had sensitivity of 83.3% and specificity of 69.2%, with the SF-SPDQ having 86.2% sensitivity and 68.8% specificity. In the web-based survey (n = 500), while the SPDQ had slightly low sensitivity (74.0%), the SF-SPDQ maintained high sensitivity (84.4%), although specificity was relatively low (61.2%). We developed the SPDQ and SF-SPDQ as valid screening tools for neuropathic pain caused by spinal disorders. Both have moderate utility as screening tools, with the SF-SPDQ perhaps being preferable for clinical use. However, physicians should be vigilant about possible false-positive diagnoses.

Purpose: Decreased physical function with increasing life expectancy is a public health concern worldwide. Knee osteoarthritis (KOA) is considered one of the primary illnesses causing decreased physical function. Depression affects decreased physical function and is closely related to knee pain in KOA. However, the effect of these interacting factors on physical function is not clear. Patients and Methods: We conducted a cross-sectional analysis of the baseline data of 1106 subjects of the 2009 Locomotive Syndrome and Health Outcome in Aizu Cohort Study (LOHAS). We determined the association between their Timed Up and Go test (TUG) scores and radiographic KOA, knee pain, and depression in a multivariate analysis. Results: Severe knee pain was significantly associated with decreased physical function (the odds ratio [OR] was 2.13, 95% confidence interval [CI]: 1.32– 4.89), as was depression (OR 2.64, 95% CI 1.61– 4.33). Only Kellgren-Lawrence (KL) grade 4 was significantly associated with decreased physical function in the radiographic KOA severity (OR 6.58, 95% CI 1.75– 24.68). Conclusion: Severe knee pain and depression were significantly associated with decreased physical function, but not radiographic KOA severity except for KL grade 4. The limitations of using radiographic KOA severity alone as the indicator of assessment for physical function were suggested. When assessing decreased physical function, the clinical focus tends to be on radiographic KOA severity, but it is important to consider the patient’s knee pain and psychological factors.

Introduction In Japan, conservative therapy for patients with lumbar spinal stenosis (LSS) includes non-steroidal anti-inflammatory drugs (NSAIDs), prostaglandin E1, tramadol, physical/exercise therapy, and nerve blocks. Mirogabalin, a selective oral α2δ ligand, is approved for treating peripheral neuropathic pain, though data regarding visual analog scores (VAS) for pain in patients with LSS are limited. We investigated the efficacy and safety of mirogabalin as an add-on treatment in patients with LSS taking NSAIDs compared with patients taking NSAIDs only. Methods This multicenter, randomized, open-label study (MiroTAS) was conducted at 32 centers in Japan between June 2020 and October 2021. Patients were randomly assigned to mirogabalin and NSAIDs or NSAIDs alone in a 1:1 ratio. NSAIDs were administered according to their Japanese package inserts; mirogabalin was administered based on renal function [creatinine clearance (CrCL) ≥ 60 mL/min, 5 mg twice daily (BID) in Weeks 1–2, 10 mg BID in Weeks 3–4, and 15 or 10 mg BID after Week 5; CrCL 30 to < 60 mL/min, 2.5 mg BID Weeks 1–2, 5 mg BID Weeks 3–4, and 7.5 or 5 mg BID after Week 5]. The primary endpoint was the change in VAS score for leg pain from baseline to Week 12. Secondary endpoints were quality of life, evaluated using the EuroQol five-dimensional descriptive system (EQ-5D-5L) (at baseline and Week 12) and Patient Global Impression of Change (PGIC) (at Week 12), and safety. Change in VAS score at Week 12 was calculated using a linear mixed model for repeated measures. The safety endpoints were treatment-emergent adverse events (TEAEs) and adverse drug reactions. Results In total, 220 patients who met the eligibility criteria were enrolled. In the mirogabalin and NSAIDs and NSAIDs groups, mean ages (67.8 vs. 70.9 years), proportions of female patients (54.5% vs. 49.0%), mean body weights (63.9 vs. 62.0 kg), mean CrCL values (81.5 vs. 70.7 mL/min), proportions of patients with CrCL 30 to < 60 mL/min (27.3% vs. 33.7%), mean VAS scores (63.8 vs. 62.8 mm), and proportions of patients with VAS score ≥ 60 (53.6% vs. 52.9%) at enrollment were similar. The median durations of LSS were 9.0 and 11.0 months and the spine pain DETECT questionnaire (SPDQ) scores were 6.8 and 7.8, respectively. The least square (LS) mean change in VAS score from baseline to Week 12 was − 24.1 mm in the mirogabalin and NSAIDs group and − 14.2 mm in the NSAIDs group (both P < 0.0001 vs. baseline). The difference in LS mean was − 9.9 [95% confidence interval (CI), − 18.0, − 1.8] (P = 0.0174). The improvement in EQ-5D-5L score at Week 12 was significantly greater in the mirogabalin and NSAIDs group versus the NSAIDs group [mean difference, 0.0529 (95% CI, 0.0036, 0.1022), P = 0.0357]. At Week 12, the proportions of patients with PGIC scores ≤ 3 and ≤ 2 were higher in the mirogabalin and NSAIDs group vs. the NSAIDs group (76.2% vs. 50.0%, P = 0.0006, and 47.6% vs. 32.4%, P = 0.0523). In the mirogabalin and NSAIDs group, the incidences of TEAEs and adverse drug reactions were 60.9% and 57.3%, respectively, and the most common TEAEs were somnolence (30.0%) and dizziness (25.5%). Conclusions The addition of mirogabalin to NSAIDs improved VAS, EQ-5D-5L, and PGIC. The main TEAEs were somnolence and dizziness. The addition of mirogabalin to NSAIDs improved peripheral neuropathic pain associated with LSS and raised no new safety concerns. Trial Registration Japan Registry of Clinical Trials (jRCTs021200007).

Background and Objective: The aim of this review was to analyze the existing literature and investigate the outcomes or complications of lateral lumbar interbody fusion (LLIF) combined with indirect decompression for degenerative lumbar spondylolisthesis (DS). Materials and Methods: A database search algorithm was used to query MEDLINE, COCHRANE, and EMBASE to identify the literature reporting LLIF with indirect decompression for DS between January 2010 and December 2021. Improvements in outcome measures and complication rates were pooled and tested for significance. Results: A total of 412 publications were assessed, and 12 studies satisfied the inclusion criteria after full review. The pooled data available in the included studies showed that 438 patients with lumbar spondylolisthesis (mean age 65.2 years; mean body mass index (BMI) 38.1 kg/m²) underwent LLIF. A total of 546 disc spaces were operated on. The most frequently treated levels were L4–L5 and L3–L4. Clinically, the average improvement was 32.5% in ODI, 46.3 mm in low back pain, and 48.3 mm in leg pain estimated from the studies included. SF-36 PCS improved by 51.5% and MCS improved by 19.5%. For radiological outcomes, a reduction in slippage was seen in 6.3%. Disc height increased by 55%, foraminal height increased by 21.1%, the foraminal area on the approach side increased by 21.9%, and on the opposite side it increased by 26.1%. The cross-sectional spinal canal area increased by 20.6% after surgery. Post-operative complications occurred in 5–40% of patients with thigh symptoms, such as anterior thigh numbness, dysesthesia, discomfort, pain, and sensory deficits. Conclusions: Indirect decompression by LLIF for DS is an effective method for improving pain and dysfunction with less surgical invasion. In addition, it has the effect of significantly improving disc height, foraminal height and area, and segmental lordosis on radiological outcomes compared to the posterior approach.