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Objective: The purpose of this study was to evaluate the feasibility of a randomized controlled trial investigating the effectiveness of a multimodal program (PAT-Back) compared to best practice advice on pain and disability in older adults with chronic low back pain (LBP) in primary care., Methods: This feasibility study took place in Fortaleza, Northeast Brazil. The PAT-Back intervention consisted of a program including exercises, pain education, and motivational text messages for the in-home component. The control group received an evidence-based educational booklet. Feasibility outcomes were recruitment, adherence and retention rates, level of difficulty of the education and intervention content, perception of utility of mobile technology, and adverse events. The feasibility criteria were previously defined., Results: A total of 248 people were screened, of which 46 older adults were eligible. The retention rate was high (100% in the PAT-Back group and 95% in the control group). The adherence rate to intervention was partially met (60%), whereas the adherence rate to unsupervised exercises was adequate (75%), and perception about safety to perform home exercise was partially acceptable (70%) in the PAT-Back group. In addition, 100% of older adults reported which text messages motivated them to perform the exercises in the PAT-Back group. Difficulty reported by participants in understanding and performing the intervention was small in both groups. Six participants reported transient adverse events in both groups., Conclusion: Older adults accepted both interventions. Results demonstrated that the program is feasible, although minor changes targeting adherence and safety in home exercise are needed., Impact: This feasibility study supports progression to a full trial investigating the effectiveness of a multimodal program (PAT-Back) on pain and disability in older adults with chronic LBP within a primary health care setting in low to middle income countries where such data from the older population are scarce and the burden of LBP is increasing., (© The Author(s) 2023. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: In infancy, males are at higher risk of dying than females. Birthweight and gestational age are potential confounders or mediators but are also familial and correlated, posing epidemiological challenges that can be addressed by studying male-female twin pairs., Methods: We studied 28 558 male-female twin pairs born in Brazil between 2012 and 2016, by linking their birth and death records. Using a co-twin control study matched for gestational age and familial factors, we applied logistic regression with random effects (to account for paired data) to study the association between male sex and infant death, adjusting for: birthweight, within- and between-pair effects of birthweight, birth order and gestational age, including interactions. The main outcome was infant mortality (0-365 days) stratified by neonatal (early and late) and postneonatal deaths., Results: Males were 100 g heavier and more at risk of infant death than their female co-twins before [odds ratio (OR)  = 1.28, 95% confidence interval (CI): 1.11-1.49, P = 0.001] and after (OR = 1.60, 95% CI: 1.39-1.83, P <0.001) adjusting for birthweight and birth order. When adjusting for birthweight within-pair difference and mean separately, the OR attenuated to 1.40 (95% CI: 1.21-1.61, P <0.001), with evidence of familial confounding (likelihood ratio test, P <0.001). We found evidence of interaction (P = 0.001) between male sex and gestational age for early neonatal death., Conclusions: After matching for gestational age and familial factors by design and controlling for birthweight and birth order, males remain at greater risk of infant death than their female co-twins. Birthweight's role as a confounder can be partially explained by familial factors., (© The Author(s) 2021. Published by Oxford University Press on behalf of the International Epidemiological Association.)

Objective: The authors sought to describe the protocol of a randomized controlled trial that will investigate the effects of the TEXT4myBACK self-management text message intervention compared with control in people with low back pain (LBP)., Methods: A single-blind (assessor and statistician), randomized controlled trial with economic analysis and process evaluation will be conducted. A total of 304 people with non-specific LBP of less than 12 weeks will be enrolled and randomly allocated either to TEXT4myBACK intervention or control groups. The TEXT4myBACK intervention group will receive 4 semi-personalized text messages per week providing advice, motivation, and information about LBP, physical activity, sleep, mood, use of care, and medication during 12 weeks. The control group will receive 1 text message with a link to a LBP and diet online information package. Outcomes will be assessed at baseline and 3, 6, and 12 months. The primary outcome will be function assessed with the Patient-Specific Functional Scale. Secondary outcomes will include pain intensity, physical activity participation, sedentary behavior, global impression of change, health-related quality of life, and eHealth literacy. Data on demographic characteristics, smallest worthwhile change (ie, smallest function scored needed to be achieved at the end of the intervention to consider it to be worthwhile), health care utilization, and adverse events (ie, any new health issue that occurs during participation in the study) will be collected. An economic and process evaluation will also be conducted., Impact: This study will assess if a self-management text message intervention is effective and cost-effective in improving function of people with LBP. This study can inform clinical practice of a simple, scalable, and affordable intervention for managing LBP., (© The Author(s) 2021. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: More than one-half of pregnant women experience pregnancy-related low back pain (LBP). Pregnancy-related LBP greatly affects activities of daily life, and although many interventions have been proposed, the optimal treatment for pregnancy-related LBP remains unclear. The purpose of this study was to compare conservative care strategies on their efficacy and safety for women with pregnancy-related LBP through systematic review with pairwise meta-analysis and network meta-analysis., Methods: MEDLINE, Embase, the Cochrane Library, AMED, CINAHL, PEDro, PsycINFO, and ClinicalTrials.gov were searched from inception to November 2019. Randomized controlled trials and observational controlled studies were included without restriction to language, sample size, or duration of follow-up. Two independent investigators extracted the data and assessed the risk of bias. The quality of evidence was evaluated through Grading of Recommendations Assessment, Development and Evaluation., Results: Twenty-three studies were included in the qualitative synthesis (18 randomized controlled trials were included in the network meta-analysis). For women with LBP during pregnancy, progressive muscle relaxation therapy (mean difference = -3.96; 95% CI = -7.19 to -0.74; moderate-quality evidence) and Kinesio Taping (mean difference = -3.71; 95% CI = -6.55 to -0.87; low-quality evidence) reduced pain intensity (Visual Analog Scale, range = 0 to 10) compared with placebo. Moderate-quality evidence suggested that transcutaneous electrical nerve stimulation improved physical function (mean difference = -6.33; 95% CI = -10.61 to -2.05; Roland Morris Disability Questionnaire, range = 0-24) compared with placebo., Conclusion: For patients with LBP during pregnancy, progressive muscle relaxation therapy and Kinesio Taping may help to decrease pain, and transcutaneous electrical nerve stimulation may improve physical function., Impact: This review helps fill the gap in evidence regarding optimal treatment for pregnancy-related LBP., Lay Summary: If you have LBP during pregnancy, your physical therapist has evidence to support the use of progressive muscle relaxation therapy and Kinesio Taping to help decrease pain and the use of transcutaneous electrical nerve stimulation to help improve physical function., (© The Author(s) 2020. Published by Oxford University Press on behalf of the American Physical Therapy Association. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: to determine whether pain increases the risk of developing the frailty phenotype and whether frailty increases the risk of developing chronic or intrusive pain, using longitudinal data., Design/setting: longitudinal data from the Concord Health and Ageing in Men Project (CHAMP), a prospective population based cohort study., Participants: a total of 1,705 men aged 70 years or older, living in an urban area of New South Wales, Australia., Measurements: data on the presence of chronic pain (daily pain for at least 3 months), intrusive pain (pain causing moderate to severe interference with activities) and the criteria for the Cardiovascular Health Study (CHS) frailty phenotype were collected in three waves, from January 2005 to October 2013. Data on age, living arrangements, education, smoking status, alcohol consumption, body mass index, comorbidities, cognitive function, depressive symptoms and history of vertebral or hip fracture were also collected and included as covariates in the analyses., Results: a total of 1,705 participants were included at baseline, of whom 1,332 provided data at the 2-year follow-up and 940 at the 5-year follow-up. Non-frail (robust and pre-frail) men who reported chronic pain were 1.60 (95% confidence interval (CI): 1.02-2.51, P = 0.039) times more likely to develop frailty at follow-up, compared to those with no pain. Intrusive pain did not significantly increase the risk of future frailty. Likewise, the frailty status was not associated with future chronic or intrusive pain in the adjusted analysis., Conclusions: the presence of chronic pain increases the risk of developing the frailty phenotype in community-dwelling older men.

Background: Although recurrence is common after an acute episode of low back pain, estimates of recurrence rates vary widely and predictors of recurrence remain largely unknown., Objective: The purposes of the study were to determine the 1-year incidence of recurrence in participants who recovered from an acute episode of low back pain and to identify predictors of recurrence., Design: The design was an inception cohort study nested in a case-crossover study., Methods: For 12 months, 832 of the 999 participants who initially presented to primary care within the first 7 days of an episode of low back pain were followed. Of these participants, 469 recovered (1 month pain free) from the index episode within 6 weeks and were included in this study. Recurrence was defined as a new episode lasting more than 1 day, or as an episode of care seeking. Putative predictors were assessed at baseline and chosen a priori. Multivariable regression analysis was used to calculate odds ratios (OR) and 95% confidence intervals (CI)., Results: The 1-year incidence of recurrence of low back pain was 33%, and the 1-year incidence of recurrence of low back pain with care seeking was 18%. Participants reporting more than 2 previous episodes of low back pain had increased odds of future recurrences (OR = 3.18, CI = 2.11-4.78). This factor was also associated with recurrent episodes that led to care seeking (OR = 2.87, CI = 1.73-4.78). No other factors were associated with recurrences., Limitations: There are limitations inherent in reliance on recall., Conclusions: After an acute episode of low back pain, one-third of patients will experience a recurrent episode, and approximately half of those will seek care. Experiencing more than 2 previous episodes of low back pain triples the odds of a recurrence within 1 year., (© 2017 American Physical Therapy Association)

Background: although back pain is most prevalent in older adults, there is a paucity of studies investigating back pain in older people. Our objective was to characterize and compare Brazilian and Dutch older adults presenting to primary care with a new episode of back pain. We also aimed to investigate whether socio-demographic characteristics were associated with pain severity and disability., Methods: we sourced data on 602 Brazilian and 675 Dutch participants aged ≥55 years with a new episode of back pain from the Back Complaints in the Elders consortium. We analyzed country differences in participants' characteristics, and associations between socio-demographic/clinical characteristics and pain severity and pain-related disability., Results: the two populations differed in most characteristics. More Dutch participants were smokers, heavy drinkers, and reported back stiffness. More Brazilian participants were less educated, had higher prevalence of comorbidities; higher levels of pain intensity, disability and psychological distress. When controlling for the effect of country, being female and having altered quality of sleep were associated with higher pain intensity. Altered quality of sleep, having two or more comorbidities and physical inactivity were associated with higher disability. Higher educational levels were negatively associated with both pain and disability outcomes., Conclusions: back pain is disabling in the older population. Our country comparison has shown that country of residence is an important determinant of higher disability and pain in older people with back pain. Irrespective of country, women with poor sleep quality, comorbidities, low education and who are physically inactive report more severe symptoms., (© The Author 2017. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com)

Background: the smallest worthwhile effect (SWE) of an intervention is the smallest treatment effect that justifies the costs, risks and inconveniences associated with that health intervention., Objective: to estimate the SWE of exercise programs designed to prevent falls among older people and to compare estimates derived by two methodological approaches., Study Design and Setting: discrete choice experiment (n = 220) and benefit-harm trade-off (subsample n = 66) methods were used., Participants: community-dwelling older people who reported a past fall or a mobility limitation answered online or face-to-face questionnaires., Results: a substantial proportion of participants (82% in the discrete choice experiment and 50% in the benefit-harm trade-off study) did not consider that participation in the proposed exercise programs would be worthwhile, even if it reduced their risk of falling to 0%. Among remaining participants, the average SWE of participation in an exercise program was an absolute reduction in the risk of falling of 35% (standard deviation [SD] = 13) in the discrete choice experiment and 16% (SD = 11) in the benefit-harm trade-off study., Conclusions: many participants did not consider the hypothetical falls' risk reduction of the proposed exercise programs to be worth the associated costs and inconveniences. Greater community awareness of the fall prevention effects of exercise for older people is required., (© The Author 2016. Published by Oxford University Press on behalf of the British Geriatrics Society. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: Soft tissue massage and exercise are commonly used to treat episodes of shoulder pain., Objective: The study objective was to compare the effects of soft tissue massage and exercise with those of exercise alone on pain, disability, and range of motion in people with nonspecific shoulder pain., Design: This was a randomized controlled trial., Setting: The study was conducted in public hospital physical therapy clinics in Sydney, New South Wales, Australia., Participants: The study participants were 80 people with an average age of 62.6 years (SD=12.2) who were referred to physical therapists for treatment of nonspecific shoulder pain., Intervention: Participants were randomly assigned to either a group that received soft tissue massage around the shoulder and exercises (n=40) or a group that received exercise only (n=40) for 4 weeks., Measurements: The primary outcome was improvement in pain, as measured on a 100-mm visual analog scale, 1 week after the cessation of treatment. Secondary outcomes were disability and active flexion, abduction, and hand-behind-back range of motion. Measurements were obtained at baseline, 1 week after the cessation of treatment, and 12 weeks after the cessation of treatment., Results: The between-group difference in pain scores from the baseline to 12 weeks after the cessation of treatment demonstrated a small significant difference in favor of the group receiving exercise only (mean difference=14.7 mm). There were no significant differences between groups in any other variable., Limitations: It was not possible to mask therapists or participants to group allocation. Diagnostic tests were not used on participants to determine specific shoulder pathology., Conclusions: The addition of soft tissue massage to an exercise program for the shoulder conferred no additional benefit for improving pain, disability, or range of motion in people with nonspecific shoulder pain., (© 2015 American Physical Therapy Association.)

Background: Low back pain (LBP) is an important health problem in all developed countries and is associated with high levels of disability. Evidence-based clinical practice guidelines usually recommend different physical therapy interventions to manage this condition. However, those interventions usually result in small to moderate clinical effects. Recent studies suggest that interventions based on subgroup classifications may improve the effect sizes compared with rehabilitation programs where the same interventions were applied to all patients., Objective: This study will investigate the efficacy of treatment based on a Movement System Impairment (MSI)-based classification model for patients with chronic LBP compared with general exercise. The primary outcomes will be pain intensity and disability at 2 months after randomization., Design: The study is a 2-arm, prospectively registered, randomized controlled trial with a blinded assessor., Setting: The study setting will be a university physical therapy clinic in Brazil., Participants: A total of 148 individuals with chronic LBP will participate in the study., Intervention: Included individuals will be randomly allocated to participate in an 8-week treatment program based on the MSI-based classification or a general exercise program of stretching and strengthening exercises., Measurements: Pain intensity, disability, and global impression of recovery will be assessed by a blinded assessor at baseline and at follow-up appointments after treatment (2 months) and 4 and 6 months after randomization., Limitations: Therapists will not be blinded., Conclusions: The results of this study may contribute to a better understanding of the efficacy of treatments based on classification of participants with chronic LBP into subgroups., (© 2015 American Physical Therapy Association.)

Background: The impact of the relationship (therapeutic alliance) between patients and physical therapists on treatment outcome in the rehabilitation of patients with chronic low back pain (LBP) has not been previously investigated., Objective: The purpose of this study was to investigate whether the therapeutic alliance between physical therapists and patients with chronic LBP predicts clinical outcomes., Design: This was a retrospective observational study nested within a randomized controlled trial., Methods: One hundred eighty-two patients with chronic LBP who volunteered for a randomized controlled trial that compared the efficacy of exercises and spinal manipulative therapy rated their alliance with physical therapists by completing the Working Alliance Inventory at the second treatment session. The primary outcomes of function, global perceived effect of treatment, pain, and disability were assessed before and after 8 weeks of treatment. Linear regression models were used to investigate whether the alliance was a predictor of outcome or moderated the effect of treatment., Results: The therapeutic alliance was consistently a predictor of outcome for all the measures of treatment outcome. The therapeutic alliance moderated the effect of treatment on global perceived effect for 2 of 3 treatment contrasts (general exercise versus motor control exercise, spinal manipulative therapy versus motor control exercise). There was no treatment effect modification when outcome was measured with function, pain, and disability measures., Limitations: Therapeutic alliance was measured at the second treatment session, which might have biased the interaction during initial stages of treatment. Data analysis was restricted to primary outcomes at 8 weeks., Conclusions: Positive therapeutic alliance ratings between physical therapists and patients are associated with improvements of outcomes in LBP. Future research should investigate the factors explaining this relationship and the impact of training interventions aimed at optimizing the alliance.

Background: Clinical trial registration has several putative benefits: prevention of selective reporting, avoidance of duplication, encouragement of participation, and facilitation of reviews. Previous surveys suggest that most trials are registered. However, these surveys examined only trials in journals with high impact factors, which may bias the results., Purpose: This study examined the completeness of clinical trial registration and the extent of selective reporting of outcomes in a random sample of published randomized trials in physical therapy., Data Sources: This was a retrospective cohort study in which 200 randomized trials of physical therapy interventions were randomly selected from those published in 2009 and indexed in the Physiotherapy Evidence Database (PEDro), regardless of the publishing journal., Data Extraction: Evidence of registration was sought for each trial in the study, on clinical trial registers, and by contacting authors., Data Synthesis: The proportion of randomized trials that were registered was 67/200 (34%). This proportion was significantly lower than among the trials in journals with high impact factors, where the proportion was 75% (odds ratio=7.4, 95% confidence interval=2.6-21.4). Unambiguous primary outcomes (ie, method and time points of measurement clearly defined in the trial registry entry) were registered for 32 trials, and registration was adequate (ie, prospective with unambiguous primary outcomes) for 5/200 (2.5%) trials. Selective outcome reporting occurred in 23 (47%) of the 49 trials in which selective reporting was assessable., Limitations: The inclusion of only English-language trials prevents generalization of the results to non-English-language trials., Conclusions: Registration of randomized trials of physical therapy interventions is rarely adequate. Consequently, the putative benefits of registration are not being fully realized.

Background: Exercise programs may vary in terms of duration, frequency, and dosage; whether they are supervised; and whether they include a home-based program. Uncritical pooling of heterogeneous exercise trials may result in misleading conclusions regarding the effects of exercise on chronic low back pain (CLBP)., Purpose: The purpose of this study was to establish the effect of exercise on pain and disability in patients with CLBP, with a major aim of explaining between-trial heterogeneity., Data Sources: Six databases were searched up to August 2008 using a computerized search strategy., Study Selection: Eligible studies needed to be randomized clinical trials evaluating the effects of exercise for nonspecific CLBP. Outcomes of interest were pain and disability measured on a continuous scale., Data Extraction: Baseline demographic data, exercise features, and outcome data were extracted from all included trials., Data Synthesis: Univariate meta-regressions were conducted to assess the associations between exercise effect sizes and 8 study-level variables: baseline severity of symptoms, number of exercise hours and sessions, supervision, individual tailoring, cognitive-behavioral component, intention-to-treat analysis, and concealment of allocation., Limitations: Only study-level characteristics were included in the meta-regression analyses. Therefore, the implications of the findings should not be used to differentiate the likelihood of the effect of exercise based on patient characteristics., Conclusions: The results show that, in general, when all types of exercise are analyzed, small but significant reductions in pain and disability are observed compared with minimal care or no treatment. Despite many possible sources of heterogeneity in exercise trials, only dosage was found to be significantly associated with effect sizes.

Background: The working alliance, or collaborative bond, between client and psychotherapist has been found to be related to outcome in psychotherapy., Purpose: The purpose of this study was to investigate whether the working alliance is related to outcome in physical rehabilitation settings., Data Sources: A sensitive search of 6 databases identified a total of 1,600 titles., Study Selection: Prospective studies of patients undergoing physical rehabilitation were selected for this systematic review., Data Extraction: For each included study, descriptive data regarding participants, interventions, and measures of alliance and outcome-as well as correlation data for alliance and outcomes-were extracted., Data Synthesis: Thirteen studies including patients with brain injury, musculoskeletal conditions, cardiac conditions, or multiple pathologies were retrieved. Various outcomes were measured, including pain, disability, quality of life, depression, adherence, and satisfaction with treatment. The alliance was most commonly measured with the Working Alliance Inventory, which was rated by both patient and therapist during the third or fourth treatment session. The results indicate that the alliance is positively associated with: (1) treatment adherence in patients with brain injury and patients with multiple pathologies seeking physical therapy, (2) depressive symptoms in patients with cardiac conditions and those with brain injury, (3) treatment satisfaction in patients with musculoskeletal conditions, and (4) physical function in geriatric patients and those with chronic low back pain., Limitations: Among homogenous studies, there were insufficient reported data to allow pooling of results., Conclusions: From this review, the alliance between therapist and patient appears to have a positive effect on treatment outcome in physical rehabilitation settings; however, more research is needed to determine the strength of this association.

Study Objective: Examine the effects of donepezil on sleep and rapid eye movement (REM) sleep electroencephalogram (EEG) in patients with Alzheimer disease, using polysomnography, and the correlation between REM sleep EEG parameters and cognitive scores., Design: Randomized, double-blind, placebo-controlled design., Settings: Two sleep research centers, University Hospital., Participants: Thirty-five patients with mild to moderate Alzheimer disease, allocated to 2 groups: donepezil treated (n=17) and placebo treated (n=18)., Intervention: Patients were administered donepezil or placebo., Outcome Measures: Polysomnography with REM sleep EEG spectral analysis and cognitive evaluation using the Alzheimer Disease Assessment Scale, cognitive subscale, were performed at baseline and after 3 and 6 months. Slowing ratio was the ratio between slow and fast EEG frequency bands. Cognitive and sleep data were analyzed using analysis of variance. Correlations between cognitive improvement and REM sleep EEG were also calculated., Results: REM sleep increased significantly after 3 and 6 months of donepezil treatment compared with baseline and placebo (p < .01). Overall theta (p = .04), frontal theta (p < .01) and frontal delta (p = .03) absolute power during REM sleep decreased after 6 months of donepezil treatment. The occipital slowing ratio decreased during treatment (p = .04). REM sleep overall and frontal and centroparietal alpha absolute power significantly correlated with the cognitive improvement rate on the Alzheimer Disease Assessment Scale, cognitive subscale (r = 0.75, r = 0.71, r = 0.78); p < .01)., Conclusions: Donepezil treatment enhanced REM sleep and reduced slow frequencies of REM sleep EEG, suggesting a possible action upon REM sleep-related cholinergic neurons in patients with Alzheimer disease. Furthermore, REM sleep alpha power may predict the cognitive response to donepezil.