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Hiroshi Kobayashi,1 Miho Sekiguchi,1 Koji Otani,1 Rei Ono,2 Takuya Nikaido,1 Kazuyuki Watanabe,1 Kinshi Kato,1 Yoshihiro Kobayashi,1 Shoji Yabuki,1 Shin-ichi Konno,1 Yoshihiro Matsumoto1 1Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, Japan; 2Department of Physical Activity Research, National Institute of Health and Nutrition, National Institutes of Biomedical Innovation, Health and Nutrition, Settsu, JapanCorrespondence: Hiroshi Kobayashi, Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, Tokyo, 960-1295, Japan, Tel +8124-547-1276, Fax +8124-548-5505, Email hiroshik@fmu.ac.jpPurpose: Insomnia has been reported to coexist with various musculoskeletal disorders. Although lumbar spinal stenosis (LSS) is the most frequently operated on spinal disease, the causal relationship between LSS and development of sleep disorders remains unclear due to lack of longitudinal studies. This study aimed to determine whether LSS was a risk factor for developing new sleep disorders, primarily insomnia, using a prospective cohort of community residents.Patients and Methods: This study was a prospective cohort study. Participants aged ≥ 65 years from the “Locomotive Syndrome and Health Outcomes in Aizu Cohort Study (LOHAS)” conducted in 2008 formed our study population. LSS was diagnosed using the self-administered, self-reported history questionnaire, a validated diagnostic support tool for LSS. Sleep disorder was investigated using a questionnaire during the 2-year follow-up. The impact of LSS on sleep disorder onset was analyzed after adjusting for potential confounders, such as age, sex, obesity, hypertension, diabetes, depression, and smoking habits, using propensity score matching.Results: Of the 489 participants who were followed up for two years, 38 (7.8%) had newly developed a sleep disorder in 2010. After adjusting for confounding factors, a comparison of 133 participants each in

Hiroshi Kobayashi, Koji Otani, Takuya Nikaido, Kazuyuki Watanabe, Kinshi Kato, Junichi Handa, Shoji Yabuki, Shin-Ichi Konno Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, JapanCorrespondence: Hiroshi Kobayashi 1-Hikarigaoka, Fukushima, 960-1295, JapanTel +8124-547-1276Fax +81 24-548-5505Email hiroshik@fmu.ac.jpPurpose: Early diagnosis of degenerative cervical spondylosis (DCM) is desirable because late treatment can lead to irreversible sequelae. No screening method has yet been established. Grip strength is commonly used in primary care settings to evaluate disease activity and diagnose sarcopenia. This single-center, cross-sectional study aimed to determine the diagnostic accuracy of grip strength for cervical myelopathy (DCM) and cutoff values for primary care DCM screening using area under the curve (AUC) and sensitivity values.Patients and Methods: The DCM group comprised 249 consecutive participants (165 males, 84 females; mean age, 65.1 years) with DCM who had undergone surgery at the affiliated hospital. The control group comprised 735 (280 males, 455 females; mean age, 65.8 years) participants undertaking a local government health checkup. Stratifying by age and sex, receiver operating characteristic (ROC) analyses were constructed for each group using minimum grip strength values for both hands. Based on ROC analysis, cut-off values were established so that the screening sensitivity would be 90% for either sex or age group, respectively.Results: According to age group and sex (males/females [M/F]), AUC values for a diagnosis of DCM in M/F were as follows: 40– 59 years, 0.92/0.87; 60– 69 years, 0.94/0.89; 70– 79 years, 0.89/0.91; and 80– 89 years, 0.97/0.97. Calculated M/F cutoff values were 41/24.5, 27/16, 27/15, and 20/10 kg, which were similar to cutoff scores for sarcopenia in M/F patients aged 60– 69 and 70– 79 years. M/F sensitivities in each age groups were 0.94/0.91, 0.92/0.90, 0.95/0.96, a

Mikito Kawamata,1 Masako Iseki,2 Mamoru Kawakami,3 Shoji Yabuki,4 Takuma Sasaki,5 Mitsuhiro Ishida,5 Atsushi Nishiyori,5 Hideaki Hida,6 Shin-ichi Kikuchi4 1Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, Matsumoto, Japan; 2Department of Anesthesiology and Pain Medicine, Juntendo University Faculty of Medicine, Tokyo, Japan; 3Spine Care Center, Wakayama Medical University Kihoku Hospital, Wakayama, Japan; 4Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, Japan; 5Clinical Development Department, Shionogi & Co., Ltd., Osaka, Japan; 6Biostatistics Center, Shionogi & Co., Ltd., Osaka, JapanCorrespondence: Takuma SasakiClinical Development Department, Shionogi & Co., Ltd., 12F, Hankyu Terminal Bld., 1-4, Shibata 1-chome, Kita-ku, Osaka 530-0012, JapanTel +81-6-6485-5090Fax +81-6-6375-5780Email Takuma.sasaki@shionogi.co.jpPurpose: To assess the efficacy and safety of S-8117, an oral, controlled-release formulation of oxycodone hydrochloride, in Japanese patients with chronic non-cancer pain (CNCP).Patients and methods: In this multicenter, non-randomized, open-label, 2-part (part 1, dose-titration followed by maintenance period; part 2, long-term administration period) study at 38 centers in Japan (2013–2015), adult patients with CNCP for ≥12 weeks were administered S-8117. The primary endpoint was proportion of patients with successful maintenance of pain control in part 1 and long-term safety in part 2. Secondary endpoints included time to inadequate analgesia, rate of transition to the maintenance period, and discontinuation due to inadequate analgesia/adverse events (AEs), Brief Pain Inventory (BPI) pain severity, BPI pain interference, 36-item Short Form Health Survey (SF-36) score, and Western Ontario and McMaster Universities (WOMAC) index, Subjective Opioid Withdrawal Scale (SOWS), Clinical Opioid Withdrawal Scale (COWS), Dependency-2-A (D-2

Mikito Kawamata,1 Masako Iseki,2 Mamoru Kawakami,3 Shoji Yabuki,4 Takuma Sasaki,5 Mitsuhiro Ishida,5 Atsushi Nishiyori,5 Hideaki Hida,6 Shin-ichi Kikuchi4 1Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine, Matsumoto, Japan; 2Department of Anesthesiology and Pain Medicine, Juntendo University Faculty of Medicine, Tokyo, Japan; 3Spine Care Center, Wakayama Medical University Kihoku Hospital, Wakayama, Japan; 4Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, Japan; 5Clinical Development Department, Shionogi & Co. Ltd., Osaka, Japan; 6Biostatistics Center, Shionogi & Co. Ltd., Osaka, Japan Background: Oxycodone is one of the options for the management of CLBP in patients with an inadequate response to other analgesics. However, oxycodone is not yet approved for noncancer pain in Japan. Here, we assessed the efficacy and long-term safety of S-8117, a controlled-release oxycodone formulation, for the management of Japanese CLBP patients. Patients and methods: An initial enriched enrollment randomized withdrawal, double-blind, placebo-controlled, 5-week phase III trial was conducted across 54 centers in Japan to assess the efficacy of S-8117 vs placebo in moderate-to-severe CLBP patients. Subsequently, a 52-week, open-label, single-arm study was conducted across 53 centers in Japan to evaluate the long-term safety of S-8117. The primary endpoint was the time to inadequate analgesic response during 35 days of the double-blind period. Secondary endpoints were the percentages of patients with inadequate analgesic response, discontinuation rate due to inadequate analgesic effects or AEs, and changes in scores of BPI severity, BPI pain interference, SF-36, and Roland-Morris Disability Questionnaire. Safety was assessed as the incidence of AEs and ADRs. Results: Of the 189 patients enrolled in the double-blind study, 130 patients who completed the initial titration period were rand

Koji Otani, Shin-Ichi Kikuchi, Shoji Yabuki, Akira Onda, Takuya Nikaido, Kazuyuki Watanabe, Shin-Ichi Konno Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, Japan Purpose: Lumbar spinal stenosis (LSS) is a common condition in the aging population. However, limited information exists on discrepancies between LSS symptoms and imaging findings and/or prognostic factors of LSS, as well as the relationship between changes in LSS symptoms and quality of life (QoL) during the natural course of LSS. The purpose of the current study was to clarify any changes in clinically diagnosed LSS at a one-year follow-up, and identify its prognostic factors, using a community-dwelling cohort.Participants and methods: In this study, the presence of LSS, its associated comorbidities, and the status of QoL pertaining to general health and low-back pain were assessed in 1,080 community-dwelling volunteers. The same assessment was carried out a year after the initial survey. Clinically diagnosis as LSS (LSS-positive) was determined by a validated diagnostic support tool in the form of a self-administered, self-reported history questionnaire. QoL was assessed using the 36-Item Short Form Health Survey and the Roland–Morris Disability Questionnaire.Results: Among subjects who were LSS-positive in the initial assessment, 54% were clinically diagnosed as negative for LSS (LSS-negative) after the one-year period, whereas 10% of those who were initially diagnosed as LSS-negative changed to LSS-positive during the same period. With the improvement or deterioration of LSS-positive/negative status, low-back pain-related QoL and some components of the 36-Item Short Form Health Survey similarly improved or deteriorated. Decisive prognostic factors of LSS-positive status were not determined at the one-year follow-up.Conclusion: Approximately half of the subjects who had initially been diagnosed as LSS-p

Naoto Takahashi,1,2 Satoshi Kasahara,1,2 Shoji Yabuki1,2 1Department of Pain Medicine, Fukushima Medical University School of Medicine, Fukushima, 2Pain Management Center, Hoshi General Hospital, Koriyama, Japan Introduction: Multidisciplinary pain management is a useful method to treat chronic musculoskeletal pain. Few facilities in Japan administer a multidisciplinary pain management program, especially an inpatient program. Therefore, we implemented a multidisciplinary pain management program in our hospital based on biopsychosocial factors guided by the recommendations of the International Association for the Study of Pain. The purpose of this study is to describe our inpatient pain management program for Japanese patients, which uses the biopsychosocial method of pain self-management. Materials and methods: Fourteen patients with intractable chronic musculoskeletal pain, who were implemented a multidisciplinary pain management program in our hospital, were studied using the evaluation of the pain and associated factors and physical function. Results: Significant improvement in outcomes were seen in the brief pain inventory, the pain catastrophizing scale (rumination, magnification, and helplessness), the pain disability assessment scale, the hospital anxiety and depression scale (anxiety and depression), the pain self-efficacy questionnaire, the EuroQol five dimensions questionnaire, and muscle endurance and physical fitness. We found no statistically significant differences in static flexibility or walking ability. Conclusion: We developed an inpatient chronic pain management program for Japanese patients. Our results suggest that our program improves chronic musculoskeletal pain coping mechanisms, and that the program can improve patients’ quality of life and some physical function. This inpatient pain management program is being expanded to better help intractable chronic musculoskeletal pain patients. Keywords: chronic musculoskeletal pain, multid

Takuya Nikaido,1 Shingo Fukuma,2,3 Takafumi Wakita,4 Miho Sekiguchi,1 Shoji Yabuki,1 Yoshihiro Onishi,5 Shunichi Fukuhara,2,3 Shin-ichi Konno1 On behalf of the profile scoring system for multilateral assessment of social factors in patients with chronic musculoskeletal pain study group 1Department of Orthopaedic Surgery, Fukushima Medical University School of Medicine, Fukushima, 2Department of Healthcare Epidemiology, Kyoto University, Graduate School of Medicine and Public Health, Kyoto, 3Center for Innovative Research for Communities and Clinical Excellence (CIRC2LE), Fukushima Medical University, Fukushima, 4Department of Sociology, Kansai University, Osaka, 5Institute for Health Outcomes and Process Evaluation Research (iHope International), Kyoto, Japan Abstract: Chronic pain is a manifestation of interactions among physical, psychological, and social conditions, but the latter two, that is, the nonphysical correlates of chronic pain, are only rarely measured. This study aimed to develop a profile scoring system for assessing the psychosocial situation of patients with chronic musculoskeletal pain. An expert panel chose social and psychological domains considered to be relevant to patients with chronic pain and wrote questions asking about each of those domains. The questionnaire was completed by 252 patients with chronic musculoskeletal pain. Factor analysis was used to select questionnaire items for each domain. Associations and interactions of pain severity and each domain score with pain-related quality of life (PRQOL) were examined using linear regression models. Five domains were chosen: work, family, sleep, mental health, and PRQOL. Then, a total of 17 questions were created for the work, family, and sleep domains. Using the likelihood-ratio test, we found significant interactions with PRQOL in four pairs: severity–family, severity–mental, family–sleep, and work–mental. The association between pain severity and PR