Relationship between disability and physical activity frequency after cervical spine surgery: A linear mixed model analysis.

BACKGROUND: There is a paucity of data on physical activity and its effects in patients after cervical spine surgery. OBJECTIVE: This study aimed to examine the association between physical activity and disability in patients after cervical spine surgery while also considering age, sex, pain, and central sensitization (CS)-related symptoms. METHODS: Participants included individuals with a cervical degenerative condition who had undergone surgery. Neck disability index, physical activity frequency, numerical rating scale for pain intensity, and short form of the CS inventory were recorded more than 1 year postoperatively. The linear mixed model was performed to examine the association between physical activity and disability. RESULTS: The responses of 145 participants were analyzed. The linear mixed model results showed that the stretching and light-intensity exercise frequency (ß=-0.14, p= 0.039) was independently associated with disability, adjusted for age, sex, pain, and CS-related symptoms. Conversely, other physical activities, such as walking and muscle strength exercises, were not associated with a disability. CONCLUSION: The findings emphasize the importance of performing regular physical activity, regardless of pain and CS-related symptoms.

Cost-effectiveness of nirmatrelvir/ritonavir for high-risk adult outpatients with COVID-19 in Japan.

INTRODUCTION: This study aimed to evaluate the cost-effectiveness of nirmatrelvir/ritonavir (Nir/Rit) for adult outpatients with COVID-19 from the perspective of a Japanese public healthcare payer. METHODS: A cost-effectiveness simulation was conducted comparing Nir/Rit for the outpatient treatment of high-risk COVID-19 patients to best supportive care (BSC) without antiviral or antibody drugs. The analytical model was divided into two phases: the treatment phase, lasting 35 days from the start of COVID-19 treatment, and the post-treatment phase. Patients who survived the treatment phase were assumed to follow a general population survival curve. Expected costs and expected quality-adjusted life years (QALYs) for both BSC and Nir/Rit were calculated for ages 40 to 80 to obtain the incremental cost-effectiveness ratio (ICER). The robustness of the results was evaluated through deterministic and probabilistic sensitivity analysis (PSA). RESULTS: The ICERs for patients aged 40, 50, 60, 70, and 80 were 18,854,276 Japanese Yen (JPY)/QALY, 8,482,034 JPY/QALY, 4,976,612 JPY/QALY, 2,636,096 JPY/QALY, and 1,597,783 JPY/QALY, respectively. In the deterministic sensitivity analysis, both the mortality risk during the treatment phase and the relative mortality risk with Nir/Rit had a high impact on ICER across all ages. In the PSA, when the willingness-to-pay (WTP) threshold was set at 5 million JPY/QALY, the probability of the ICER being below the WTP threshold was 0%, 0.2%, 45.4%, 99.9%, and 100% at ages 40, 50, 60, 70, and 80, respectively. CONCLUSION: Nir/Rit is cost-effective for older individuals aged 60 and over but not for younger age groups.

Health-Related Quality of Life is Associated With Pain, Kinesiophobia, and Physical Activity in Individuals Who Underwent Cervical Spine Surgery.

OBJECTIVE: To determine the association between health-related quality of life (HRQOL) and neck pain, kinesiophobia, and modalities of physical activity in individuals with postoperative degenerative cervical myelopathy and radiculopathy (DCM/R) because postoperative pain after cervical spine surgery is likely to persist, causing kinesiophobia and avoidance of physical activity. METHODS: A questionnaire was distributed to 280 individuals with DCM/R. The questionnaire comprised the following four items: HRQOL (EuroQol 5-dimensions 5-level), neck pain (numerical rating scale [NRS]), kinesiophobia (11-item Tampa Scale for Kinesiophobia [TSK-11]), and physical activity (paid work, light exercise, walking, strength training, and gardening). Hierarchical multiple regression analysis was performed using the NRS, TSK-11, and physical activity as independent variables. RESULTS: In total, 126 individuals provided analyzable responses (45.0%). After including the NRS score as an independent variable to the multiple regression equation for participants' background, the independent rate of the regression equation significantly improved by only 4.1% (R2=0.153). The addition of the TSK-11 score significantly improved this effect by 11.1% (R2=0.264). Finally, the addition of physical activity also significantly improved the explanatory rate by 9.9% (R2=0.363). CONCLUSION: Neck pain, kinesiophobia, and physical activity (specifically paid work and walking) were independently associated with HRQOL in individuals with postoperative DCM/R.

Relationship Between Central Sensitization-Related Symptoms and Pain-Related Disability After Cervical Spine Surgery: A Structural Equation Model.

BACKGROUND: It is unknown if central sensitization (CS)-related symptoms have an intermediate role that might explain how disability develops from pain after cervical spinal surgery. AIMS: The study aim was to investigate the role of CS-related symptoms in the relationship between pain and disability reported after cervical spinal surgery. DESIGN: Cross-sectional study. SETTINGS: Tertiary care spinal surgery center. PARTICIPANTS/SUBJECTS: The participants included individuals with a cervical degenerative condition who had undergone surgery. METHODS: The following patient-reported outcome measures were evaluated: (1) Numerical Rating Scale; (2) Neck Disability Index; and (3) Short Form of the Central Sensitization Inventory. A hypothesized model containing the CS-related symptoms and the relationships between pain and disability was constructed and tested by structural equation modeling. RESULTS: Questionnaires were mailed to 280 individuals, and responses were obtained from 145 participants. Of these respondents, 99 (68.3%) were males and 46 (31.7%) were females, with a mean age of 64.4 ± 12.3 years. The latent variable for pain, represented by the neck (coefficient: 0.856, p < .001) and upper limb pain (0.568, p < .001), influenced CS-related symptoms (coefficient: 0.504, p < .001). Pain directly affected disability (coefficient: 0.497, p < .001) and indirectly through CS-related symptoms. Bootstrap analysis confirmed this indirect effect (point estimate: 2.85, 95% confidence interval: 1.04 to 6.30, p = .04). CONCLUSIONS: The results revealed that neck and upper limb pain affected disabilities both directly and through CS-related symptoms. Future research should focus on the efficacy of biopsychosocial approaches for patients after cervical spine surgery with a high risk of disability due to CS-related symptoms.

Physical therapist-led interventions based on the biopsychosocial model provide improvement in disability and pain for spinal disorders: A systematic review and meta-analysis.

OBJECTIVE: To summarize the effects of physical therapist-led interventions based on the biopsychosocial (BPS) model in spinal disorders compared to interventions with no BPS model through a systematic review and meta-analysis of randomized-controlled trials. TYPE: Systematic review and meta-analysis. LITERATURE SURVEY: We searched the Web of Science, CENTRAL, MEDLINE, PsycINFO, CINAHL, and PEDro up to October 27, 2022. METHODOLOGY: Pain intensity and disability were primary outcomes and psychological factors were secondary outcomes in spinal disorders. The included intervention was physical therapist-led interventions based on the BPS model. The control group received no physiotherapy intervention for BPS. Pooled effects were analyzed as standardized mean differences (SMDs) and 95% confidence intervals (CIs), and the random-effects model was used for the meta-analysis. The subgroup analysis was divided into low back pain group and neck pain group. Another subgroup analysis was conducted only of the groups that had received training of the BPS model. SYNTHESIS: Fifty-seven studies with 5471 participants met the inclusion criteria. For pain intensity, there was a statistically significant effect for the BPS model led by physical therapists in the short, medium, and long terms. The SMDs with 95% CIs were -0.44 (-0.62, -0.27), -0.24 (-0.37, -0.12), and -0.17 (-0.28, -0.06), respectively. Outcomes were clinically significant, except in the long term. For disability, there was a statistically significant effect in the short, medium, and long terms. The SMDs with 95% CIs were -0.48 (-0.69, -0.27), -0.44 (-0.64, -0.25), and -0.37 (-0.58, -0.15), respectively. All periods were clinically significant. The quality of the evidence was low for all of the main outcomes for all of the terms. CONCLUSION: Physical therapist-led interventions based on the BPS model effectively improve pain intensity and disability in patients with spinal disorders based on low-quality evidence.

Influence of radiological factors, psychosocial factors, and central sensitization-related symptoms on clinical symptoms in patients with lumbar spinal canal stenosis.

BACKGROUND: No study to date has concurrently evaluated the impact of radiological factors, psychosocial factors, and central sensitization (CS) related symptoms in a single lumbar spinal canal stenosis (LSS) patient cohort. OBJECTIVE: To investigate the associations between these factors and clinical symptoms in LSS patients. METHODS: We recruited 154 patients with LSS scheduled for surgery. Patient-reported outcome measures and imaging evaluation including clinical symptoms, psychosocial factors, CS-related symptoms, and radiological classifications. Spearman's rank correlation coefficient and multiple regression analyses were employed. RESULTS: Spearman's correlation revealed CS-related symptoms positively correlated with low back pain (r= 0.25, p< 0.01), leg pain (r= 0.26, p< 0.01), and disability (r= 0.32, p< 0.01). Pain catastrophizing positively correlated with leg pain (r= 0.23, p< 0.01) and disability (r= 0.36, p< 0.01). Regression analysis showed that pain catastrophizing was associated with disability (ß= 0.24, 95%CI = 0.03-0.18), and CS-related symptoms with low back pain (ß= 0.28, 95%CI = 0.01-0.09). Radiological classifications were not associated with clinical symptoms. CONCLUSION: Our findings suggest that psychosocial factors and CS-related symptoms, rather than radiological factors, seem to contribute to clinical symptoms in patients with LSS.

Supervised Exercise Therapy Reduces Presenteeism to Greater Extent Than Unsupervised Self-Care in Workers with Musculoskeletal Pain: a Systematic Review and Meta-Analysis.

PURPOSE: Presenteeism is defined as the loss of work productivity due to health issues in workers, which can be measured subjectively. This study aimed to compare the effectiveness of supervised exercise therapy and unsupervised self-care in reducing presenteeism in workers with musculoskeletal disorders. METHODS: PubMed, Embase, and Cochrane Library were searched for various keywords from their inception to January 2023. Two examiners independently assessed the eligibility of studies: (1) studies involving workers suffering from musculoskeletal pain, (2) those involving supervised exercise therapy intervention with interactive communication, and (3) those in which the comparison group was subjected to interventions other than supervised exercise therapy, and (4) those including patient-reported outcome measures of presenteeism or work productivity or ability. Standardized mean differences (SMD) were calculated using a random effects model, with higher scores indicating reduced presenteeism in the intervention group compared with that in the comparison group. The GRADE assesses the overall certainty of the evidence. RESULTS: Only the short-term effects of interventions on presenteeism could be obtained using four studies. The intervention group showed statistically significant short-term effects on presenteeism compared with the comparison group (p < 0.001; SMD, 0.52; 95% confidence interval, 0.27-0.77). The GRADE score was downgraded by two levels from high to low due to concerns for indirectness. CONCLUSIONS: Although the certainty of the evidence was low, it was assumed that supervised exercise therapy was more effective than unsupervised self-care in reducing presenteeism in workers with musculoskeletal disorders.

Quality of Japanese Online Information on Causes of Neck Pain: A Biopsychosocial Analysis.

Background While a considerable amount of information on neck pain is available online, the quality and comprehensiveness of this information can vary greatly. Particularly, the representation of the biopsychosocial model - which recognizes neck pain as an interplay of biological, psychological, and social factors - in online information remains unclear. Given the prevalence and accessibility of online health information, it is important to understand its quality and how it may shape individuals' understanding and management of neck pain. Therefore, the objective of this study was to analyze the quality of online Japanese information on the causes of neck pain from a biopsychosocial perspective. Methodology A descriptive cross-sectional study was conducted. The search term "neck pain" was utilized on Google's search engine in June 2023, and the websites from the first two pages of the search results were included in the study. Ten advertisement websites were excluded, resulting in 19 websites being analyzed. Each website was evaluated based on the presence of the Health-on-the-Net (HON) code. Biomedical and psychosocial factors present in each website were identified using the biopsychosocial analysis tool. Websites were then categorized as biomedical, limited biopsychosocial, or biopsychosocial based on the number of psychosocial factors they mentioned. Results Among the 19 evaluated websites, only one possessed the HON certification, indicating a potential lack of credibility for the remaining sites. Of these websites, a large majority (63.2%) were classified as biomedical, while the remaining (36.8%) were classified as limited biopsychosocial. All the websites included some form of biomedical information on the causes of neck pain, while only seven websites mentioned psychological factors and one website mentioned social factors. The most common biomedical causes of neck pain discussed were cervical muscle strain and radicular pain due to cervical disc prolapse. On the other hand, the limited biopsychosocial websites highlighted perceived stress, depressed mood, and job-related mental stress as psychosocial factors contributing to neck pain. Conclusions This analysis revealed that freely accessible Japanese online information on the causes of neck pain, as found through Google, predominantly focuses on the biomedical causes, often neglecting or insufficiently addressing the psychosocial aspects. This finding underscores a gap between the available online resources and the comprehensive understanding promoted by the biopsychosocial model of health. Healthcare professionals need to be proactive in guiding their patients toward reliable, well-rounded resources that acknowledge the crucial role of psychosocial factors in neck pain. Furthermore, developers of online health information must aim to improve the depth and breadth of psychosocial factors discussed, promoting a more holistic understanding of neck pain for the Japanese public.

Bibliometric analysis of the 100 most cited articles in nonspecific neck pain research: A STROBE-compliant study.

The purpose of this study was to identify and analyze the top 100 cited articles in nonspecific neck pain (NSNP) research. A set of search terms was entered into the Web of Science database, and the articles with the highest citation counts in the field of NSNP were chosen. The top 100 articles were examined for total citation count, annual citations count, first author, year of publication, journal, study design, and country of origin. The citation count for the list final articles ranged from 181 to 2067, with an average of 291.9. The journal Spine contributed the most articles (25), followed by pain (16). Between 2001 and 2010, the most prolific years, 66 articles were published. In terms of country of origin, the majority of articles were from Australia (22). Vernon H., published the most cited article in the Journal of Manipulative & Physiological Therapeutics in 1991, reporting the first instrument developed to assess self-reported disability in patients with neck pain. The bibliographic analysis to identify the top 100 most cited articles related to NSNP acknowledges the field historical advances and provides insight into the types of articles that have provided these advances.

Confirmatory factor analysis of the Japanese Health Locus of Control scales among people with musculoskeletal disorders.

[Purpose] To determine whether the 25-item Japanese Health Locus of Control (25-JHLC) scale satisfies a 5-factor structure among Japanese with musculoskeletal disorders. [Participants and Methods] The primary inclusion criterion was people undergoing physical therapy for musculoskeletal disorders in two medical facilities. The 25-JHLC scale and demographic data were obtained by conducting an anonymous survey. Confirmatory factor analysis was used to analyze data from the 25-JHLC scale in 200 patients with musculoskeletal disorders. Fits for the 5-factor structure (1-internal; 2-family; 3-professional; 4-chance; and 5-supernatural) and the 2-factor structure (1-internal; and 2-external, including family, professional, chance, and supernatural) were studied. The goodness-of-fit criteria included chi-squared/degree of freedom, goodness-of-fit index, adjusted goodness-of-fit index, and root mean square error of approximation. [Results] The mean (standard deviation) age of the participants was 46.3 (18.3) years of age. The 2-factor structure satisfied no criteria; however, the 5-factor structure satisfied two criteria for acceptable fit (chi-squared/degree of freedom, and root mean square error of approximation). [Conclusion] This study found that the 5-factor structure of the 25-JHLC scale can be accepted to some extent among Japanese with musculoskeletal disorders without comorbidities.

Influence of Pain Self-Efficacy and Gender on Disability in Postoperative Cervical Myelopathy.

BACKGROUND: Pain self-efficacy and gender may influence disability in patients with musculoskeletal disorders. The direct and interactive influence of pain self-efficacy and gender on postoperative disability with degenerative cervical myelopathy (DCM) is unclear. AIM: This study aimed to determine the effects of age, pain, and pain self-efficacy on disability postoperatively in patients with DCM, and explore whether these effects differ by gender. METHOD: A total of 180 participants who underwent DCM surgery were consecutively recruited. The following were evaluated: (1) demographic/descriptive data (age, gender, diagnosis, surgery date, procedure); (2) numerical rating scale pain and dysesthesia intensity; (3) Neck Disability Index; and (4) Pain Self-Efficacy Questionnaire. Hierarchical multiple regression analysis and simple slope analysis determined the effect of patients' biologic and psychosocial factors, and their interaction in terms of disability. RESULTS: The responses of 82 participants were analyzed. The hierarchical multiple regression final model analysis determined 57.1% participant disability variance; gender (B = 3.388; p < .01); pain (B = 3.574; p < .01); pain self-efficacy (B = -0.229; p < .01); age and gender (B = -0.201; p < .05); pain and gender (B = -3.749; p < .01); pain self-efficacy and gender (B = -0.304; p < .01) were significantly associated with disability. Simple slope test indicated that women showed weaker pain associations and stronger age and pain self-efficacy associations with disability than men. CONCLUSIONS: Pain self-efficacy improvement should be focused on after surgery in patients with DCM, especially women.

Validation of a Model Predicting That Physical Activities Improve Health-Related Quality of Life in Older Japanese Adults with Pain, Dysesthesia, and Kinesiophobia after Lumbar Surgery: Structural Equation Modeling.

Objectives: This study assessed the validity of a hypothesized model predicting that physical activity improves health-related quality of life (HRQOL) in older Japanese adults with pain, dysesthesia, and kinesiophobia following lumbar surgery. Methods: We included 431 elderly patients who underwent surgery for lumbar spinal stenosis at two hospitals. The frequency of physical activity, pain, dysesthesia, kinesiophobia (somatic focus and activity avoidance), and HRQOL were investigated using a questionnaire. Missing values were complemented by the stochastic regression imputation. We constructed the following model. (i) physical activity affects pain, dysesthesia, and kinesiophobia. (ii) pain, dysesthesia, and kinesiophobia separately affect HRQOL. This hypothetical model was tested by structural equation modeling. The model was improved based on a modified index. Results: Of the 431 respondents, 297 (median age 72 years, range 65-91 years; 158 men and 139 women) were analyzed (68.9%). The fit of the model improved based on the modification index and was acceptable comparative fit index, 0.948; Tucker-Lewis index, 0.919; root mean square error of approximation, 0.048 (90% confidence interval, 0.026-0.069), and standardized root mean square residual (0.046). The paths by which physical activities reduced pain or dysesthesia (standardized pass coefficients, -0.406) and somatic focus (-0.301) and consequently improved HRQOL were significant (pain/dysesthesia, -0.684; somatic focus, -0.218). Discussion. Our hypothesized model predicting that physical activity improves HRQOL in terms of pain, dysesthesia, and kinesiophobia in older Japanese adults after lumbar surgery was validated using cross-sectional data. Interventional studies on physical activity based on this model are required to establish the model.

Sex Differences in the Mediating Effect of Kinesiophobia on Chronic Pain, Dysesthesia, and Health-Related Quality of Life in Japanese Individuals Aged 65 Years Old and Older Treated with Surgery for Lumbar Spinal Stenosis.

Purpose: This study aimed to determine whether kinesiophobia mediates the relationship between low back pain (LBP), leg pain (LP), and leg dysesthesia (LD) and health-related quality of life (HRQOL) among Japanese individuals aged 65 years old and older treated with surgery for lumbar spinal stenosis (LSS). Patients and Methods: Data collection for this study took place between October 2019 and August 2020 at two Japanese medical facilities. Eligibility criteria for participants in this study were individuals aged 65 years or older and those who had undergone surgery for LSS at least more than one year ago. A self-administered questionnaire assessed the intensity of LBP, LP, and LD (numerical rating scale: NRS), HRQOL (EuroQol-5 Dimension-5 Levels: EQ-5D-5L), and kinesiophobia (Tampa Scale for Kinesiophobia-17 items: TSK-17). Mediation analysis using sex as a control variable was conducted. Results: Complete responses were obtained from 238 of 431 individuals (73.1 ± 5.1 years; 135 males and 103 females). The mediating effect of NRS scores for LBP, LP, and LD to EQ-5D-5L index on TSK-17 score was significant, respectively (LBP: -0.007 [95% confidence interval -0.012, -0.004], p = 0.000; LP and LD: -0.007 [-0.011, -0.004], p = 0.000). The strength of the association between NRS scores and EQ-5D-5L index decreased when the mediating effect of TSK-17 score (LBP: ß = -0.698 [-0.792, -0.603], p = 0.000 to ß = -0.616 [-0.707, -0.524], p = 0.000; LP: ß = -0.629 [-0.729, -0.529], p = 0.000 to ß = -0.539 [-0.638, -0.440], p = 0.000; LD: ß = -0.568 [-0.675, -0.460], p = 0.000 to ß = -0.482 [-0.586, -0.378], p = 0.000). The mediating effect of TSK score was greater in females than males. Conclusion: Kinophobia partially mediated the relationship between LBP, LP and LD, and HRQOL in Japanese aged 65 years and older after lumbar surgery. The mediating effect differed by sex.

Cost-effectiveness analysis of olanzapine in four-drug antiemetic therapy in Japanese patients treated with highly emetogenic cisplatin-containing chemotherapy.

BACKGROUND: Olanzapine has been shown to have an additive effect on the three-drug antiemetic therapy consisting of aprepitant, palonosetron, and dexamethasone, in a highly emetogenic cisplatin-containing chemotherapy. Although olanzapine may be more economical than aprepitant or palonosetron, an adequate cost-efficacy analysis has not been conducted. METHODS: We conducted a cost-utility analysis to evaluate the cost-effectiveness of olanzapine use in four-drug antiemetic therapy among Japanese patients. We simulated model patients treated with highly emetogenic cisplatin-containing chemotherapy and developed a decision-analytical model of patients receiving triple antiemetic therapy with or without olanzapine in an inpatient setting. The cost and probabilities of each treatment were calculated from the perspective of the Japanese healthcare payer. The probabilities, utility value, and other costs were obtained from published sources. One-way and probabilistic sensitivity analyses were conducted to examine the influence of each parameter on the model and the robustness of a base-case analysis. Threshold analysis was conducted to determine the cost of olanzapine that would make the incremental cost-effectiveness ratio (ICER) equivalent to the threshold ICER). The threshold incremental cost-effectiveness ratio was set at 5 million Japanese Yen (JPY) per quality-adjusted life-year (QALY) gained. RESULTS: The cost was 10,238 JPY in the olanzapine regimen and 9719 JPY in the non-olanzapine regimen. The QALY gained were 0.01065 QALYs and 0.01029 QALYs in the olanzapine and non-olanzapine regimen, respectively. The incremental cost of the olanzapine regimen relative to the non-olanzapine regimen was 519 JPY, and the incremental QALYs were 0.00036 QALY, resulting in an ICER of 1,428,675 JPY per QALY gained. In the one-way sensitivity analysis, the results were most sensitive to the utility value of incomplete control. The probabilistic sensitivity analysis revealed the probability that the ICER was below the willingness-to-pay, and the incremental QALYs was positive was 96.2%. The calculated cost of olanzapine per 5 mg that would make the incremental cost-effectiveness ratio equivalent to the threshold incremental cost-effectiveness ratio was calculated to be 475 JPY. CONCLUSIONS: Olanzapine was cost-effective in the four-drug antiemetic therapy for Japanese patients treated with highly emetogenic cisplatin-containing chemotherapy.

The effect of cognitive functional therapy for chronic nonspecific low back pain: a systematic review and meta-analysis.

BACKGROUND: To apply the Bio-Psych-Social (BPS) model into clinical practice, it is important not to focus on psychosocial domains only since biomedical factors can also contribute to chronic pain conditions. The cognitive functional therapy (CFT) is the management system based on the BPS model for chronic nonspecific low back pain (CNSLBP). OBJECTIVES: This study aimed to compare CFT with the other interventions for CNSLBP regarding pain, disability/functional status, QoL and psychological factors. DESIGN: This study was a systematic review and meta-analysis of a randomised controlled trial. METHOD: Literature Search was conducted in electronic search engines. Enrolled participants included 1) CNSLBP and 2) primary, secondary, or tertiary care patients. CFT was the interventions included. Comparisons were any types of treatment. RESULTS: Three studies met the eligibility criteria. The total number of participants was 336. For pain intensity, MD [95% CIs] was -1.38 [-2.78 - 0.02] and -1.01 [-1.92 - -0.10] at intermediate and long term for two studies, respectively. About disability/functional status, SMD [95% CIs] was -0.76 [-1.46 - -0.07] at the intermediate for three studies and MD [95% CIs] was -8.48 [-11.47 - -5.49] at long term for two studies. About fear of physical activity, MD [95% CIs] was -3.01 [-5.14 - -0.88] and -3.56 [-6.43 - -0.68] at intermediate and long term for two studies, respectively. No studies reported scores associated with QOL. All the quality of the evidence was very low. CONCLUSIONS: Three studies were included and the quality of all the evidence was very low. Although the study found statistically significant differences in some measures, the effectiveness of the CFT will need to be re-evaluated in the future. TRIAL REGISTRATION: PROSPERO registration number CRD42020158182 .

Cost-effectiveness analysis of pegfilgrastim in patients with non-small cell lung cancer receiving ramucirumab plus docetaxel in Japan.

PURPOSE: The dose-limiting factor of ramucirumab plus docetaxel (RAM + DTX) in patients with non-small cell lung cancer (NSCLC) is febrile neutropenia (FN), which has a high incidence in Asians. This study aimed to evaluate the cost-effectiveness of pegfilgrastim (Peg-G) in patients with NSCLC receiving RAM + DTX in Japan. METHODS: We simulated model patients treated with RAM + DTX in Japan and developed a decision-analytical model for patients receiving Peg-G prophylaxis or no primary prophylaxis. The expected cost, quality-adjusted life-year (QALY), and incremental cost-effectiveness ratio (ICER) of each treatment were calculated from the perspective of a Japanese healthcare payer. The willingness-to-pay (WTP) threshold was set at 45,867 United States dollars (USD) (5 million Japanese yen) per QALY gained. The probabilities, utility values, and other costs were obtained from published sources. Deterministic sensitivity analysis (DSA) and probabilistic analysis were conducted to evaluate the effect of each parameter and robustness of the base-case results. RESULTS: The expected cost and QALYs were 20,275 USD and 0.701 for Peg-G prophylaxis and 17,493 USD and 0.672 for no primary prophylaxis, respectively. The ICER was calculated to be 97,519 USD per QALY gained. The results were most sensitive to FN risk with Peg-G. When FN risk with no primary prophylaxis exceeded 51% or the cost of Peg-G was less than 649 USD per injection, the ICER was below the WTP threshold. The probabilistic analysis revealed a 9.1% probability that the ICER was below the WTP threshold. CONCLUSION: Peg-G is not cost-effective in patients with NSCLC receiving RAM + DTX in Japan.

Effects of a physiotherapist-led approach based on a biopsychosocial model for spinal disorders: protocol for a systematic review.

INTRODUCTION: Low back pain and neck pain are among the most common musculoskeletal disorders, and their related medical costs are rising every year. Many interventions are based on the biopsychosocial (BPS) model since the cause of pain is more multifaceted. Physiotherapists have increased opportunities to perform multidisciplinary interventions alone in clinical practice due to a lack of understanding of the model and its cost. Therefore, physiotherapist-led interventions using the BPS model are important and require an updated report summarising their effectiveness. Thus, the purpose of this study will be to summarise and synthesise the effects of physiotherapist-led interventions using the BPS model for spinal disorders. METHODS AND ANALYSIS: We will search the Web of Science, CENTRAL, MEDLINE, PsycINFO, CINAHL and PEDro electronic databases, using a date range from inception to September 2021. We will include only randomised controlled trials for patients diagnosed with spinal disorders who received physiotherapist-led interventions based on the BPS model. The search will be limited to English-language publications. Pain intensity and disability are the primary outcomes. Secondary outcomes are any psychological factors. We will examine the short-term, medium-term and long-term effects, and a subgroup analysis will be conducted, if possible, to investigate the role of additional physiotherapist training. ETHICS AND DISSEMINATION: This study is exempt from ethical approval because it involves publicly available documents. The findings will be submitted for publication in a relevant peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42021258071.

Patterns of physical activity and exercise after lumbar surgery among Japanese patients with lumbar spinal stenosis.

[Purpose] The purpose of this study was to assess the feasibility of classifying the patterns of physical activity and exercise after surgery for lumbar spinal stenosis in Japanese patients and describe the characteristics of the patient groups. [Participants and Methods] We evaluated Japanese patients diagnosed as having lumbar spinal stenosis and underwent surgery. The frequencies of the 15 types of physical activity and exercise recommended in Kenko Nippon 21 (Japanese policy for health promotion) were investigated by mail. The study included 102 respondents (median age, 69 years [range, 34-88 years]; 55 males and 47 females). A hierarchical cluster analysis was used for grouping according to the physical activity and exercise patterns. The Holm method and residual analysis were used for comparisons of the frequencies of the physical activity and exercise patterns and basic demographics among the groups. [Results] Three clusters, namely clusters A (younger), B (frail older), and C (active older), were identified from the dendrogram. The participants in cluster A frequently performed paid work. In cluster B, the frequencies of all the physical activity and exercise patterns were low. The older people in cluster C regularly performed stretching/light-intensity exercises, walking, muscle-strengthening exercises, and house and garden maintenance tasks. [Conclusion] We found that the physical activity and exercise after lumbar surgery in Japanese patients could be divided into three patterns.

New Factor Structure of the Tampa Scale for Kinesiophobia in Older Japanese Adults After Lumbar Surgery.

PURPOSE: The Tampa Scale for Kinesiophobia (TSK) has been used worldwide as a measure of kinesiophobia, but its factor structure in older Japanese adults after lumbar surgery is unknown. The purpose of this study was to fill this research gap by identifying the factors that comprise TSK in older Japanese adults after lumbar surgery. PATIENTS AND METHODS: Participants were older Japanese adults who had undergone surgery for lumbar spinal stenosis. Clinicodemographic data, TSK, intensity of low back pain and leg pain, dysesthesia (using an 11-point numerical rating scale), and HRQOL (using the EQ-5D-5L) were collected. After supplementing the missing values by the multiple assignment method, the hypothetical model of TSK was developed by categorical exploratory factor analysis (weighted least squares method, promax rotation). Confirmatory factor analysis (WLSMV method, promax rotation) was used to compare the hypothetical model and the traditional one-factor and two-factor models. Furthermore, we confirmed the relationship between factors extracted from the hypothetical model and HRQOL, pain, and dysesthesia. RESULTS: Questionnaires were mailed to 302 individuals, and responses were obtained from 211 (72.4±4.2 years [range: 65-88]; 115 men and 96 women; 804±343.1 [380-1531] days after surgery; 137 who had undergone decompression and fixation surgery, 74 who had undergone decompression surgery) (response rate: 69.9%). The hypothesized model consisted of "somatic focus," "activity avoidance," and "efficacy of physical activities," all of which were highly consistent. The fit of the hypothetical model was slightly inferior to that of the traditional two-factor model, but the hypothetical model met the criteria for fit. Somatic focus in the hypothetical model was significantly associated with HRQOL, pain, and dysesthesia. CONCLUSION: In older Japanese adults after lumbar surgery, the goodness of fit of the TSK model was maintained by adding efficacy of physical activities as a third factor to the traditional two factors.

Effects of Central Sensitivity Syndrome and Psychological Factors on the Clinical Features of Patients with Cervical Degenerative Disease: A Cross-Sectional Study.

STUDY DESIGN: Single-center cross-sectional study. PURPOSE: The present study aimed to clarify the effects of central sensitivity syndrome (CSS) and psychological factors on the clinical features in patients with cervical degenerative disease (CDD). OVERVIEW OF LITERATURE: The presence of CSS and psychological factors can influence the clinical features of patients with musculoskeletal disorders including CDD. However, the precise effects of CSS are unclear. METHODS: Patients admitted for surgical treatment of CDD were recruited. The following patient-reported outcome measures were recorded on the day before the surgery: the Numerical Rating Scale (NRS) for neck pain intensity, Neck Disability Index (NDI), EuroQol 5-Dimensions (EQ-5D) survey, Central Sensitization Inventory (CSI), Pain Catastrophizing Scale, Tampa Scale for Kinesiophobia, and the Hospital Anxiety and Depression Scale were used. We performed three multiple regression analyses to investigate the effects of CSS and psychological factors on the clinical features. RESULTS: Multiple regression analysis revealed that CSI had a significant effect on NRS (ß, 0.50; 95% confidence interval [CI], 0.29 to 0.71), NDI (ß, 0.64; 95% CI, 0.45 to 0.82), and EQ-5D (ß, -0.55; 95% CI, -0.75 to -0.35). Multiple regression analysis revealed that psychological factors did not exert a significant effect on the clinical features. CONCLUSIONS: Our results demonstrated that CSI was able to identify the clinical features in CDD patients, suggesting that CSS does affect the clinical features of such patients.