JCOA The Japanese Clinical Orthopaedic Association the questionnaire survey on the physical changes after the self-restraint of outdoor activities with the COVID-19 crisis (2nd report).

BACKGROUND: In March 2021, the 3rd wave of COVID-19 pandemic had ended and the second emergency declaration in January in Tokyo and 3 other prefectures had been lifted. The restrictions on the social activities imposed on the Japanese people and it had become established as "the new lifestyle norm" for each age group. Following our first survey, we conducted a questionnaire survey again to determine the physical changes in all age groups and compared the findings. METHODS: The 1st survey was conducted after the initial emergency declaration lifted in July 2020, and the 2nd survey was 10 months after the first survey March 2021. And the analysis was conducted by simple and cross tabulation. RESULTS: The number of valid responses were obtained over 12,000 samples for the both surveys. One year later, "Corona locomo" decreased from the previous year in all age groups, especially school students, while it increased in "80s∼". "Corona stress" decreased sharply among children, especially elementary school students, while it increased slightly in 20s, 30s, and "80s∼". The physical condition was closely related to the proportion of exercising population and duration in each age group. CONCLUSIONS: "The new lifestyle norm" as a countermeasure against COVID-19 crisis had a significant influence on physical condition in each age group as "the secondary health damage". Forcusing on "With Corona era", it is considered necessary for preventing "locomo-frail", to improve the exercise lifestyles by selecting tailor-made training methods.

JCOA The Japanese Clinical Orthopaedic Association the questionnaire survey on the physical changes after the self-restraint of outdoor activities with the COVID-19 crisis- corona locomo and corona stress.

BACKGROUND: Problems with COVD-19 are not limited to the infection itself, but also include the secondary health damage arising from the prolonged self-restraint, which has affected all age groups in the Japanese population. Numerous studies have reported clear evidence of the secondary health damage. Published reports cover a wide range of damages, from locomotive dysfunction caused by decreased physical activity to decreased cognitive function and changes in eating and oral functions, and further to decreased opportunities for social participation. Such damage can also lead to worsening of so-called frailty. Under this circumstance, orthopedic surgeons conducted a questionnaire survey to determine the physical changes observed after the start of the COVD-19 self-restraint period. In this article, we report findings of the survey, along with some literature considerations. METHODS: The survey was started two months after the state of emergency in Japan was lifted, July 20 to August 12, 2020 (16 days total). And the analysis was conducted by simple and cross tabulation. RESULTS: Valid responses to the questionnaire were obtained from 12,254 participants. Approximately 40% of the subjects felt a lack of physical strength (Corona stress), with the percentage peaking in high school, in the elderly it remained rather below average. On the other hand, locomotive dysfunction (Corona locomo) increased with age, independent of physical activity, and was not correlated with Corona stress. CONCLUSIONS: Japanese citizens need to change their behaviors for the purpose of improving their exercise and lifestyle habits towards shifting to a new lifestyle norm. Looking ahead to the ``With Corona'' era, it is considered necessary by selecting a tailor-made training method suitable for each age group.

Immediate effect of mechanical lumbar traction in patients with chronic low back pain: A crossover, repeated measures, randomized controlled trial.

BACKGROUND: Lumbar traction is a treatment method traditionally used for chronic low back pain (CLBP) in many countries. However, its clinical effectiveness has not been proven in medical practice. The purpose is to conduct a multi-center, crossover, randomized controlled trial (RCT) to prove the efficacy and safety of traction on CLBP patients, using equipment capable of precise traction force control and of reproducibility of the condition based on the previous biomechanical and pre-clinical studies. METHODS: Ninety-five patients with non-specific CLBP from 28 clinics and hospitals were randomly assigned to either the intermittent traction with vibration (ITV) first group (A: sequence ITV to ITO) or the intermittent traction only (ITO) first group (B: sequence ITO to ITV); the former was treated with repeated traction and vibration force added to preload. All patients were followed up weekly for 2 periods after study-initiation. The primary outcome measures were disability level including pain and quality of life (based on Japan Low back pain Evaluation Questionnaire; JLEQ), and JLEQ was measured repeatedly. Statistical analysis was performed using linear mixed model. RESULTS: Comparing to pre-traction data, both traction modes significant improvement except the first intervention of ITO treatment. The differences in JLEQ scores over time showed significant improvements in the treatment to which vibrational force was added in contrast to the conventional traction treatment; Mean difference was significant to compare ITV treatment and ITO treatment (-1.75 (p = 0.001), 95% CI; -2.69 to -0.80). However, neither difference between the two sequences (p = 0.884) nor carryover effect (p = 0.527) was observed. CONCLUSIONS: Altogether, the results indicate that lumbar traction was able to improve the pain and functional status immediately in patients with CLBP. This study contributes to add some evidence of the efficacy of lumbar traction.

Effect and usability of anti-inflammatory drug plasters for knee osteoarthritis: A crossover, double-blind, repeated measures, randomized controlled trial.

BACKGROUND: The use of plasters is a well-accepted treatment with high adherence. However, the characteristics such as its cool feeling or extensibility favored by elderly have a possibility to contribute to clinical utility. The purpose is to examine the effect of anti-inflammatory drug plasters for knee osteoarthritis and the clinical preference of the patients for using plasters. We conducted a crossover, double-blind, randomized controlled trial (RCT) recruited 168 patients with knee osteoarthritis. METHODS: We included a "run-in-period" to evaluate the patients' preference among A (first-generation; methyl salicylate), B (second-generation; indomethacin), and N (base substrate for B) before the crossover sequence of two treatment periods with A and B plasters; four arms (N-A-B, A-A-B, N-B-A, and B-B-A) were made to compare the assessment of A, B, and N plasters. We used two measures: The Japanese Knee Osteoarthritis Measure (JKOM), for clinical functions, and the usability questionnaire to evaluate the clinical value of plasters. RESULTS: At baseline, there were no significant differences in characteristics. The subjects in groups A and B showed improved overall JKOM scores at the end of each intervention. Comparison of the change of the mean difference showed that A and B were statistically significant improvement over N (-2.40, (95%CI = -3.58 to -1.21), -2.52, (-3.65 to -1.40)) but no significant difference between A and B - 0.13, (-1.14 to 0.89)). In network analysis for usability, twelve items were independent of JKOM's network structure and consisted of two domains. The analysis of usability showed that N and B were preferred over A significantly. CONCLUSION: Both the first- and second-generation plasters were statistically superior to the base only, but no significant difference between two generations. The patient is surely aware of the effect of the drug itself, but the two feelings are important in the preference.

Lumbar mechanical traction: a biomechanical assessment of change at the lumbar spine.

BACKGROUND: Lumbar traction is a traditional treatment modality for chronic low back pain (CLBP) in many countries. However, its effectiveness has not been demonstrated in clinical practice because of the following: (1) the lack of in vivo biomechanical confirmation of the mechanism of lumbar traction that occurs at the lumbar spine; (2) the lack of a precise delivery system for traction force and, subsequently, the lack of reproducibility; and (3) few randomized controlled trials proving its effectiveness and utility. METHODS: This study was planned as a preparatory experiment for a randomized clinical trial, and it aimed (1) to examine the biomechanical change at the lumbar area under lumbar traction and confirm its reproducibility and accuracy as a mechanical intervention, and (2) to reconfirm our clinical impression of the immediate effect of lumbar traction. One hundred thirty-three patients with non-specific CLBP were recruited from 28 orthopaedic clinics to undergo a biomechanical experiment and to assess and determine traction conditions for the next clinical trial. We used two types of traction devices, which are commercially available, and incorporated other measuring tools, such as an infrared range-finder and large extension strain gauge. The finite element method was used to analyze the real data of pelvic girdle movement at the lumbar spine level. Self-report assessments with representative two conditions were analyzed according to the qualitative coding method. RESULTS: Thirty-eight participants provided available biomechanical data. We could not measure directly what happened in the body, but we confirmed that the distraction force lineally correlated with the movement of traction unit at the pelvic girdle. After applying vibration force to preloading, the strain gauge showed proportional vibration of the shifting distance without a phase lag qualitatively. FEM simulation provided at least 3.0-mm shifting distance at the lumbar spine under 100 mm of body traction. Ninety-five participants provided a treatment diary and were classified as no pain, improved, unchanged, and worsened. Approximately 83.2% of participants reported a positive response. CONCLUSION: Lumbar traction can provide a distractive force at the lumbar spine, and patients who experience the application of such force show an immediate response after traction. TRIAL REGISTRATION: University Hospital Medical Information Network - Clinical Trial Registration: UMIN-CTR000024329 (October 13, 2016).

A multi-body model for comparative study of cervical traction simulation - comparison between inclined and sitting traction.

A computer simulation model was developed to compare the result of cervical traction therapy in inclined and sitting traction positions. The behavior of the model was shown to match with the intervertebral changes in the upper and lower spine from the data of a radiographic experiment. Both the results of the experiment and the simulation also showed that in the inclined position, the amount of posterior separations in the upper cervical spine remains constant regardless of traction angle, while the posterior separations at lower cervical spine increases along with traction angles. Using the simulation model, parametric studies were conducted to investigate the intervertebral space changes in response to different traction angles in the inclined and sitting positions. When using the sitting position, the subject's hip joint stiffness was shown to cause larger variations in the intervertebral space than in the inclined position. In addition, variations in the tension/compression stiffness was shown to cause the largest changes in the resulting separations in both positions but the variations in anterior space changes were larger in the sitting position. Our study suggests that the inclined position is less sensitive to variations in the subject's body parameters and is able to provide a more reliable and predictable traction result than the sitting position.

A multi-body model for comparative study of cervical traction simulation - development, improvement and validation.

A computer simulation model was developed to study the dynamic behavior of the cervical spine during cervical traction therapy in inclined and sitting traction positions. The model improved upon an old model with additional components to represent the behavior of the intervertebral discs and the posterior ligaments. The simulation result of the new model was compared against the cervical traction data from a radiographic experiment in both positions. The simulation results of the old model and new model were compared to illustrate the improvement. Using the new model, we compared the timing response of cervical traction in the inclined and sitting positions.

Effect of elcatonin versus nonsteroidal anti-inflammatory medications for acute back pain in patients with osteoporotic vertebral fracture: a multiclinic randomized controlled trial.

The aim of this study was to compare the efficacy of elcatonin injections and oral nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with osteoporosis who have acute lumbar pain after experiencing new vertebral compression fractures. Two hundred twenty-eight Japanese female patients (mean age 77.3 years) with acute lumbar pain from osteoporotic vertebral fractures were randomly divided into two groups. Patients in one group were given an NSAID (NSAIDs group) and patients in the other group were given weekly intramuscular injections of 20 units of elcatonin (elcatonin group). All patients underwent follow-up examinations up to 6 weeks from the start of the trial. Outcome measures were the level of functional impairment according to the Japan Questionnaire for Osteoporotic Pain (JQ22), the Roland-Morris Disability Questionnaire (RDQ), and a visual analog scale (VAS) of pain intensity. Statistical analyses focused on (1) the time course of pain and functional level using linear mixed effects models to analyze the longitudinal data and (2) the effectiveness of elcatonin injection with mean difference values and 95 % confidence intervals. Significant differences were seen over time between the initial values and the postintervention values (4 and 6 weeks) in JQ22, RDQ, and VAS scores (effect size d > 0.4) in each group. The mean differences between the elcatonin group and the NSAIDs group in each measure at 4 and 6 weeks were -4.8 and -8.3 for the JQ22, -1.3 and -2.6 for the RDQ, and -11.3 and -11.5 for the VAS, shifted to elcatonin. Once weekly elcatonin injection was more effective than NSAIDs for treating acute lumbar pain and improving mobility in Japanese women with osteoporotic vertebral fractures.

Prevalence and Location of Neuropathic Pain in Lumbar Spinal Disorders: Analysis of 1804 Consecutive Patients With Primary Lower Back Pain.

STUDY DESIGN: A cross-sectional study of 1804 consecutive patients. OBJECTIVE: The aim of this study was to investigate the prevalence of pathological pain and its distribution features in patients with chronic lumbar spinal disorders. SUMMARY OF BACKGROUND DATA: Clinical spinal disorders can involve pathological neuropathic pain (NeP) as well as physiological nociceptive pain (NocP), as they have varied pathology, including spinal cord injury, stenosis, and compression. A study conducted by the Japanese Society for Spine Surgery and Related Research (JSSR) has determined a prevalence of 29.4% for NeP in patients with lumbar spinal disorder. However, the data did not include information on pain location. METHODS: Patients aged 20 to 79 years with chronic lower back pain (≥3 months, visual analog scale score ≥30) were recruited from 137 JSSR-related institutions. Patient data included an NeP screening questionnaire score and pain location (lower back, buttock, and legs). The association between the pain pathology and its location was analyzed statistically using the unpaired t test and Chi-square test followed by Fisher test. P < 0.05 was considered significant. RESULTS: Low back pain subjects showed 31.9% of NeP prevalence, and the pain distribution showed [NocP(%)/NeP(%)] low back pain only cases: 44/22, while low back pain with leg pain cases showed a prevalence of 56/78. This indicates that low back pain alone can significantly induce NocP rather than NeP (P < 0.01). Buttock pain was revealed to significantly induce both lower back pain and leg pain with NeP properties (P < 0.01). Leg pain was revealed to be predominantly neuropathic, especially when it included peripheral pain (P < 0.01). CONCLUSION: Low back pain with no buttock pain induces NocP rather than NeP. Buttock pain is significantly associated with NeP prevalence whether or not leg pain exists. Leg pain can increase the prevalence of NeP, especially when it contains a peripheral element. LEVEL OF EVIDENCE: 3.

Dynamic change and influence of osteoporotic back pain with vertebral fracture on related activities and social participation: evaluating reliability and validity of a newly developed outcome measure.

The objective of this study was to record the clinical course of osteoporosis over time in Japanese women. We hypothesized that successful control of acute pain associated with osteoporosis will allow better treatment for health-related problems. To confirm this working hypothesis, we developed the Japan Questionnaire for Osteoporotic Pain (JQ22) to measure health status associated with osteoporosis. We examined the validity and reliability of the JQ22 compared with the current gold standard scale for back pain, the Roland Morris questionnaire (RDQ). A total of 125 women who were more than 65 years old, had an acute back pain episode, and had a fragile vertebral fracture confirmed by X-ray and clinical signs, participated in this study. The psychometric analyses for validity and reliability were tested for the JQ22 and the RDQ. The time course up to 6 weeks was observed by investigating both changes in pain characteristics and its influence on related activities and social participation. Cronbach's alpha coefficient was 0.979 and 0.919 for the JQ22 and RDQ, respectively. The Akaike Information Criterion (AIC) indicated that the JQ22 items were separated into four domains, which were sequentially arranged at the baseline and subsequently changed. This structure reflected osteoporotic back characteristics covering a range from pain to social activities. The JQ22 was shown to be a valid and reliable scale for patient-based measurement of osteoporotic back pain. It also revealed both changes in pain characteristics and the influence of pain on related activities and participation.

[Feasibility study of locomotion training in a home-visit preventive care program].

AIM: To evaluate the feasibility of locomotion training (single-leg standing and squats) in a home-visit preventive care program for the elderly. METHODS: We invited 246 people who were not attending any preventive care programs within the long-term care insurance system. Among these, 60 participated in the current program. We administered a hearing survey, measured the single-leg stance time with eyes open, and subjects underwent locomotion training. Each participant was asked to repeat 1 set of training exercises 3 times per day at home. One set consists of standing on each leg for 1 minute and squatting 5 to 6 times. We telephoned the participants regularly during the 3 month program (locomo call). At the end of the program, we visited the participants and measured the single-leg stance time with eyes open. RESULTS: A total of 60 elderly adults participated in the program (15 men, 45 women). Among subjects secondary prevention of musculoskeletal (n=313), 67 were participating in site-visit preventive care programs conducted by the local authorities (21.4%). Among these 313, 127 were participating in site-visit preventive care programs or locomotion training (40.6%). It shows the increasing of the participation rate 21.4% to 40.6%. The continuance rate was 91.7%. The single-leg stance time improved for both men (16.2±17.7 sec, p<0.05) and women (57.2±79.7 sec, p<0.01) compared to the baseline. Similarly, improvement was observed in the single-leg stance time for both the young-old (62.2±67.9 sec, p<0.01) and the old-old (39.2±73.8 sec, p<0.01). CONCLUSIONS: We consider that the locomotion training program which we introduced in the current home-visit preventive care program was effective and highly feasible for the elderly who have not previously responded conventional site-visit preventive care programs.

Multicenter randomized controlled trial to evaluate the effect of home-based exercise on patients with chronic low back pain: the Japan low back pain exercise therapy study.

STUDY DESIGN: Prospective, randomized, controlled trial. OBJECTIVE: To investigate the effectiveness of home-based exercise on pain, dysfunction, and quality of life (QOL) in Japanese individuals with chronic low back pain (CLBP). SUMMARY OF BACKGROUND DATA: Exercise therapy is a widely used treatment for CLBP in many countries. The studies on its effectiveness have been performed only in Western industrialized countries. The existence of cross-cultural differences and heterogeneity of patients in each country may influence the outcome of interventions for CLBP. Data that would enable researchers to compare the effectiveness of interventions between widely different societies is lacking. METHODS: A total of 201 patients with nonspecific CLBP were randomly assigned to either the control or exercise therapy group: 89 men and 112 women with a mean age of 42.2 years. The control group was treated with nonsteroidal anti-inflammatory drugs (NSAIDs), and the exercise group performed trunk muscle strengthening and stretching exercises. The primary outcome measures were pain intensity (visual analogue scale) and dysfunction level (Japan Low back pain Evaluation Questionnaire [JLEQ] and Roland-Morris Disability Questionnaire [RDQ]) over 12 months. The secondary outcome measure was FFD (Finger-floor distance). Statistical analysis was performed using Wilcoxon signed-ranks and Mann-Whitney U tests, and estimation of the median with 95% CI was calculated. RESULTS: In both groups, significant improvement was found at all points of follow-up assessment. However, JLEQ and RDQ were significantly more improved in the exercise group compared to the control group (P = 0.021 in JLEQ, P = 0.023 in RDQ). The 95% CI for the difference of medians of the change ratio between exercise and NSAID groups, [Exercise] - [NSAID], was -0.25 to -0.02 in JLEQ, -0.33 to 0.00 in RDQ, and -0.20 to 0.06 in visual analogue scale. CONCLUSION: The home-based exercise prescribed and monitored by board-certified orthopedic surgeons was more effective than NSAIDs for Japanese patients with CLBP.

Effect of nonsteroidal anti-inflammatory drug plasters for knee osteoarthritis in Japanese: a randomized controlled trial.

The objective of this study was to examine the effect of a nonsteroidal anti-inflammatory drug (NSAID) plaster for knee osteoarthritis among Japanese patients. An open-labeled, randomized, controlled, multiclinic trial was performed involving outpatient clinic groups. Two comparative groups-plaster NSAIDs and oral NSAIDs-were randomly allocated. The drugs used were limited to the current top three in both groups in Japan. Treatments were assessed after four weeks and compared with the baseline scores. Outcomes were evaluated by two psychometric measures: Japanese knee osteoarthritis measure, and pain with the visual analogue scale. The total number of patients included in the final evaluation was 165 (87 for the plaster group and 78 for the oral group). Between these two groups there were no significant differences in gender, age, body height and weight, body mass index, and X-ray grading. The subjects in both groups showed improvements in both scores at the end of intervention. The differences in the improvements in scores between the two groups were not significant, though the mean rank score and the 95% CI of the plaster group were slightly better than those of the oral group. In conclusion, the local application of a plaster with NSAIDs leads to the same level of improvement in knee osteoarthritis as oral NSAIDs.

Effect of home exercise of quadriceps on knee osteoarthritis compared with nonsteroidal antiinflammatory drugs: a randomized controlled trial.

OBJECTIVES: To examine the effect of home-based exercise on knee osteoarthritis among Japanese in comparison with that of nonsteroidal antiinflammatory drugs (NSAIDs). DESIGN: An open-labeled, randomized, controlled, multiclinic trial compared home-based quadriceps exercise with NSAIDs. Treatments were basically evaluated after 8 wks and compared with the baseline scores. Outcomes were evaluated with a set of psychometric measurements including the Western Ontario and McMaster Universities Arthritis Index (WOMAC), 36-Item Short-Form Health Survey (SF-36), Japanese Knee Osteoarthritis Measure (JKOM), and pain with the visual analog scale. RESULTS: A total of 142 patients entered this trial to provide the baseline data. After 21 cases withdrew, the final number analyzed was 121 cases: 63 for the exercise group and 58 for the NSAIDs group. Between these two groups, there was no significant difference in gender, age, body height and weight, body mass index, or each score at baseline. The subjects in both groups showed improvements in all scores at the end of intervention. The difference in improvement rate of each score between the two groups was not statistically significant, though the mean rank score measured with JKOM in the exercise was slightly better than that of the NSAIDs. CONCLUSIONS: Home-based exercise using quadriceps strengthening improves knee osteoarthritis no less than NSAIDs.

An outcome measure for Japanese people with chronic low back pain: an introduction and validation study of Japan Low Back Pain Evaluation Questionnaire.

STUDY DESIGN: Development of a nationwide patient-based outcome measure for patients with chronic low back pain (CLBP). OBJECTIVE: The purpose of this study was to develop and introduce a new means of measuring outcomes for Japanese individuals with CLBP (the Japan Low Back Pain Evaluation Questionnaire [JLEQ]), and to examine its validity and reliability by comparison with the Roland-Morris Disability Questionnaire (RDQ). SUMMARY OF BACKGROUND DATA: CLBP is a serious problem affecting the health and welfare of workers, especially laborers. The severity and disability it causes vary depending on cultural background and the psycho-emotional aspect of the patients. METHODS: The following items were tested for the JLEQ and the RDQ using psychometric analyses: content validity, construct validity, criterion validity, internal-consistency reliability, and test and retest reliability. RESULTS: A total of 195 patients with CLBP participated in this study. There were no floor and ceiling effects in the JLEQ. Cronbach's alpha coefficient was 0.971 and 0.893 for the JLEQ and RDQ, respectively. The test-retest interclass correlation coefficient in the JLEQ was 0.886, indicating good test-retest reliability. Categorical principal component analysis showed that the construct structure consisted of 3 item clusters in the JLEQ. The factor loading patterns indicated that the JLEQ items were separated into 3 domains, i.e., a moderately loaded group, a less loaded group, and psychological conditions. The degree of correlation between the question items in the JLEQ and RDQ was evaluated using Akaike Information Criteria. CONCLUSION: The JLEQ was shown to be a valid and reliable questionnaire scale for measurement of patient-based outcomes in CLBP patients.

An outcome measure for Japanese people with knee osteoarthritis.

OBJECTIVE: We describe a new outcome measure for Japanese patients with knee osteoarthritis, the Japanese Knee Osteoarthritis Measure (JKOM). METHODS: The outcome measure was designed to incorporate the concepts of the World Health Organization's International Classification of Functioning, Disability and Health 2001, and to reflect the specific Japanese cultural lifestyle, which differs from Western countries. To examine the validity and reliability of this measure and to determine the underlying set of measures, psychometric measurements including factor analysis were conducted in comparison with 2 other health related scales, the Western Ontario and McMaster Universities Arthritis Index (WOMAC) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36). The following psychometric properties were tested with this new measure: test and retest reliability, internal consistency, content validity, construct validity, and criterion related validity. RESULTS: The measure was proved to have sufficient reliability and validity by means of statistical evaluation and comparison with other health related scales. Three domains are clearly separated on the loading pattern by factor analysis: pain, limitation in mobility related to daily activity, and restriction of participation in social life and health perception. CONCLUSION: The JKOM, a new knee OA measure, has sufficient reliability and validity for studies of the clinical outcomes of Japanese people with knee OA.