Development of a consensus operational definition of child assent for research.

BACKGROUND: There is currently no consensus from the relevant stakeholders regarding the operational and construct definitions of child assent for research. As such, the requirements for assent are often construed in different ways, institutionally disparate, and often conflated with those of parental consent. Development of a standardized operational definition of assent would thus be important to ensure that investigators, institutional review boards, and policy makers consider the assent process in the same way. To this end, we describe a Delphi study that provided consensus from a panel of expert stakeholders regarding the definitions of child assent for research. METHODS: Based on current guidelines, a preliminary definition of assent was generated and sent out for review to a Delphi panel including pediatric bioethicists and researchers, Institutional Review Board members, parents, and individuals with regulatory/legal expertise. For each subsequent review, the process of summarizing and revising responses was repeated until consensus was achieved. Panelists were also required to rank order elements of assent that they believed were most important in defining the underlying constructs of the assent process (e.g., capacity for assent, disclosure). In providing these rankings, panelists were asked to frame their responses in the contexts of younger (≤ 11 yrs) and adolescents/older children (12-17 yrs) in non-therapeutic and therapeutic trials. Summary rankings of the most important identified elements were then used to generate written construct definitions which were sent out for iterative reviews by the expert panel. RESULTS: Consensus regarding the operational definition was reached by 14/18 (78%) of the panel members. Seventeen (94%) panelists agreed with the definitions of capacity for assent, elements of disclosure for younger children, and the requirements for meaningful assent, respectively. Fifteen (83%) members agreed with the elements of disclosure for adolescents/older children. CONCLUSIONS: It is hoped that this study will positively inform and effect change in the way investigators, regulators, and IRBs operationalize the assent process, respect children's developing autonomy, and in concert with parental permission, ensure the protection of children who participate in research.

History of abuse and its relationship to pain experience and depression in women with chronic pelvic pain.

OBJECTIVE: We sought to determine the relationship among a history of physical or sexual abuse, pain experience, and depressive symptoms among women with chronic pelvic pain (CPP). STUDY DESIGN: This was a cross-sectional study of women who presented to a tertiary referral center for evaluation of CPP (N = 273). All participants completed standardized questionnaires to assess a history of physical or sexual abuse, pain severity, pain disability, and depressive symptoms. Subjects were grouped by abuse category and compared to CPP participants without history of abuse. Multinomial logistic regression models were used to determine the association between adolescent or adult and childhood physical or sexual abuse with pain intensity, pain-related disability, and depressive symptoms. RESULTS: Logistic regression analyses indicated that, after controlling for age and education, none of the abuse categories was associated with pain severity. However, adolescent or adult sexual abuse predicted greater pain-related disability (odds ratio, 2.39; 95% confidence interval, 1.05-5.40), while both adolescent or adult physical and sexual abuse were associated with higher levels of depression (both P < .05). Level of education was significantly associated with pain intensity, pain disability, and depression. CONCLUSION: For our sample of women with CPP, a history of abuse during childhood or adulthood was not associated with differences in pain intensity, but adolescent or adult sexual abuse was associated with greater pain-related disability. A history of physical abuse or sexual abuse appears to hold a stronger relationship with current depressive symptoms than pain experience for women with CPP. Educational achievement holds a robust relationship with pain morbidity and depression for this population.

Agreement between Patient-reported Pain Medication Use and Electronic Medical Record Data in Surgical Amputation Patients.

Background: Opioid misuse after surgery remains a public health crisis in the United States. Recent efforts have focused on tracking pain medication use in surgical populations. However, accurate interpretations of medication use remain quite challenging given inconsistent usage of different datasets. The purpose of this study was to investigate the agreement between electronic medical records (EMR) versus patient self-reported use of pain medications in a surgical amputation population. Methods: Patients undergoing major lower extremity amputation or amputation-related procedures were included in this study. Both self-reported and EMR data for pain medication intake were obtained for each patient at three time points (preoperatively, 4 months postoperatively, and 12 months postoperatively). Percentage agreement and the kappa statistic were calculated for both usage (yes/no) and dose categories. Results: Forty-five patients were included in this study, resulting in 108 pairs of self-reported and EMR datasets. Substantial levels of agreement (>70% agreement, kappa >0.61) for opioid use was seen at preoperative and 12 months postoperative. However, agreement dropped at 4 months postoperatively. Anticonvulsant medication showed high levels, whereas acetaminophen showed lower levels of agreements at all time points. Conclusions: Either self-reported or EMR data may be used in research and clinical settings for preoperative or 12-month postoperative patients with little concern for discrepancies. However, at time points immediately following the expected end of acute surgical pain, self-reported data may be needed for more accurate medication reporting. With these findings in mind, usage of datasets should be driven by study objectives and the dataset's strength (eg, accuracy, ease, lack of bias).

Ethical Perspectives of Chinese and United States Physicians at Initiation of a Research Collaborative.

Variances in perceived standards regarding research integrity appear to exist between China and the U.S. An established joint institute for translational and clinical research between one Chinese and one U.S. health system provides a valuable venue in which to evaluate these perceptions better. We therefore undertook a survey of 209 physicians at the two institutions in 2013-14. The vast majority of physicians from both institutions understood the necessity of obtaining informed consent from research participants, the need to provide a description of the risks of participation, and the voluntary nature of research participation. However, there were differences in responses between the two sites in willingness to report plagiarism (U.S. 95.65% vs. Chinese 40.21%; p < .0001) and data falsification (U.S. 100% vs. Chinese 81.25%; p < .0001) and in willingness to attend biomedical industry-funded promotional events (U.S. 11.0% vs. Chinese 74.0%; p < .0001). When planning to conduct collaborative clinical research across cultures, particularly when uncertainty regarding the similarity of research cultures exists, exploration of cultural and ethical norms in research may be informative regarding educational needs and the risks of research and academic misconduct.

Activity pacing for osteoarthritis symptom management: study design and methodology of a randomized trial testing a tailored clinical approach using accelerometers for veterans and non-veterans.

BACKGROUND: Osteoarthritis (OA) is a prevalent chronic disease and a leading cause of disability in adults. For people with knee and hip OA, symptoms (e.g., pain and fatigue) can interfere with mobility and physical activity. Whereas symptom management is a cornerstone of treatment for knee and hip OA, limited evidence exists for behavioral interventions delivered by rehabilitation professionals within the context of clinical care that address how symptoms affect participation in daily activities. Activity pacing, a strategy in which people learn to preplan rest breaks to avoid symptom exacerbations, has been effective as part of multi-component interventions, but hasn't been tested as a stand-alone intervention in OA or as a tailored treatment using accelerometers. In a pilot study, we found that participants who underwent a tailored activity pacing intervention had reduced fatigue interference with daily activities. We are now conducting a full-scale trial. METHODS/DESIGN: This paper provides a description of our methods and rationale for a trial that evaluates a tailored activity pacing intervention led by occupational therapists for adults with knee and hip OA. The intervention uses a wrist accelerometer worn during the baseline home monitoring period to glean recent symptom and physical activity patterns and to tailor activity pacing instruction based on how symptoms relate to physical activity. At 10 weeks and 6 months post baseline, we will examine the effectiveness of a tailored activity pacing intervention on fatigue, pain, and physical function compared to general activity pacing and usual care groups. We will also evaluate the effect of tailored activity pacing on physical activity (PA). DISCUSSION: Managing OA symptoms during daily life activity performance can be challenging to people with knee and hip OA, yet few clinical interventions address this issue. The activity pacing intervention tested in this trial is designed to help people modulate their activity levels and reduce symptom flares caused by too much or too little activity. As a result of this trial, we will be able to determine if activity pacing is more effective than usual care, and among the intervention groups, if an individually tailored approach improves fatigue and pain more than a general activity pacing approach. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01192516.

A pooled analysis of two randomized, double-blind, placebo-controlled trials of milnacipran monotherapy in the treatment of fibromyalgia.

Milnacipran has been shown to significantly improve the pain, global well-being, and physical function of fibromyalgia (FM), and is approved by the U.S. Food and Drug Administration for the management of this disorder. Post hoc analyses of data from two pivotal trials were conducted to further assess the clinical benefits of milnacipran, to determine the impact of baseline pain severity on treatment outcomes, and to confirm the safety and tolerability of this medication in patients with FM. Patients in these trials were randomized to placebo (n=624), milnacipran 100 mg/day (n=623), or milnacipran 200 mg/day (n=837). Two different composite responder analyses were used to evaluate efficacy: a 2-measure analysis, requiring ≥30% improvement from baseline visual analog scale 24-hour recall pain scores and a Patient Global Impression of Change (PGIC) score of "very much improved" or "much improved"; and a 3-measure analysis, requiring a ≥6-point improvement from baseline in SF-36 Physical Component Summary scores in addition to the pain and PGIC criteria. Additionally, a pooled analysis of mean changes from baseline pain scores was conducted in order to evaluate the efficacy of milnacipran over the entire course of treatment. At 3 months, composite responder rates were significantly higher in the milnacipran treatment groups than in the placebo group (2- and 3-measure composite responder analyses: P ≤ 0.001, both doses vs. placebo). These improvements were not dependent on baseline pain severity. Similar composite responder results were observed in patients who continued treatment for up to 6 months. Significant improvements in mean pain scores were seen with both doses of milnacipran vs. placebo as early as 1 week after treatment initiation and were sustained for up to 6 months of milnacipran treatment. The most common adverse events associated with milnacipran were nausea, headache, and constipation.

The Effects of a Pain Psychology and Neuroscience Self-Evaluation Internet Intervention: A Randomized Controlled Trial.

OBJECTIVES: Many patients' chronic musculoskeletal pain is strongly influenced by central nervous system processes such as sensitization or amplification. Education about pain neuroscience can change patients' beliefs but has less consistent effects on pain outcomes. Patients may have greater clinical benefits if the educational intervention is personalized, and they evaluate various psychosocial risk factors with respect to their pain. We developed and tested a brief, internet-based Pain Psychology and Neuroscience (PPN) self-evaluation intervention. MATERIALS AND METHODS: From a patient registry, 104 adults reporting chronic musculoskeletal pain were randomized to the PPN intervention or a matched, active, education control condition. At baseline and 1-month (primary endpoint) and 10-month follow-ups, participants reported pain severity (primary outcome) and multiple secondary outcomes. Primary analyses compared the 2 experimental conditions using analyses of covariances; post hoc exploratory analyses compared the effects of PPN in subgroups of patients who met criteria for fibromyalgia (FM; n=50) or who did not (n=54; primarily spinal pain). RESULTS: At 1-month follow-up, compared with the control condition, PPN led to significantly lower pain severity (ηp =0.05) and interference (ηp =0.04), greater brain (ηp =0.07) and psychological (ηp =0.07) attributions for pain, and greater readiness for pain self-management (ηp =0.08). Effects on distress, pain catastrophizing, kinesiophobia, and life satisfaction were not significant. Exploratory analyses showed that the PPN intervention was especially beneficial for patients without FM but was of less benefit for those with FM. Most of the effects (except attributions) were lost at 10 months. DISCUSSION: A brief PPN self-evaluation intervention, presented on-line, can yield short-term improvements in musculoskeletal pain severity and interference, especially for people with spinal/localized pain rather than FM, perhaps because the psychology/neuroscience perspective is more novel for such patients.

A psychophysical study of auditory and pressure sensitivity in patients with fibromyalgia and healthy controls.

UNLABELLED: Fibromyalgia (FM) is characterized by widespread tenderness. Studies have also reported that persons with FM are sensitive to other stimuli, such as auditory tones. We hypothesized that subjects with FM would display greater sensitivity to both pressure and auditory tones and report greater sensitivity to sounds encountered in daily activities. FM subjects (n = 30) and healthy control subjects (n = 28) were administered auditory tones and pressure using the same psychophysical methods to deliver the stimuli and a common way of scaling responses. Subjects were also administered a self-report questionnaire regarding sensitivity to everyday sounds. Participants with FM displayed significantly greater sensitivity to all levels of auditory stimulation (Ps < .05). The magnitude of difference between FM patients' lowered auditory sensitivity (relative to control subjects) was similar to that seen with pressure, and pressure and auditory ratings were significantly correlated in both control subjects and subjects with FM. FM patients also were more sensitive to everyday sounds (t = 8.65, P < .001). These findings support that FM is associated with a global central nervous system augmentation in sensory processing. Further research is needed to examine the neural substrates associated with this abnormality and its role in the etiology and maintenance of FM. PERSPECTIVE: Muscle tenderness is the hallmark of FM, but the findings of this study and others suggest that persons with FM display sensitivity to a number of sensory stimuli. These findings suggest that FM is associated with a global central nervous system augmentation of sensory information. These findings may also help to explain why persons with FM display a number of comorbid physical symptoms other than pain.

Nociception before and after exercise in rats bred for high and low aerobic capacity.

Exercise and stress are known to influence pain perception. However, little is known about how level of fitness influences pain perception and the experience of pain. In the present study, pain perception before and after exercise to exhaustion was examined in 6 rats systematically bred to have a high aerobic capacity (HCR animals) and 6 rats systematically bred to have a low aerobic capacity (LCR animals). HCR animals had significantly higher pain thresholds compared to LCR animals before and after exercise (7.66 s compared to 6.01 s, t=-3.07, p<0.05; and 6.89 s versus 4.73 s, t=-3.73, p<0.01, respectively). In addition, both groups of animals displayed evidence of hyperalgesia following exercise compared to baseline. However, the pain thresholds of HCR animals returned to baseline levels faster than LCR animals following exercise. The findings support the hypothesis that level of fitness plays a role in the perception of pain. In addition, a higher level of fitness may serve as buffer against the effects of stress and help to reduce or prevent the experience of clinical pain. Further research is needed to examine the mechanisms that underlie this phenomenon.

Disclosing Study Information to Children and Adolescents: Is What They Want, What Their Parents Think They Want?

OBJECTIVE: Despite the importance of child assent, there is little consensus on what information should be disclosed and what information is most important to children for decision-making. This study was designed to compare children's/adolescents' priorities for research information with the information parents believe is most important to their children. METHODS: Child-parent dyads completed separate and independent surveys regarding information (risks, benefits, etc) that they perceived to be most important to the child to make decisions about participating in a hypothetical randomized controlled trial. Parents responded in the context of what information they believed their child (not themselves) would think important. RESULTS: Fifty-five parent-child dyads completed surveys. Although all information was deemed important, children/adolescents put greater emphasis on privacy and less on knowing the purpose of the study and the benefits compared with what their parents believed was important to their child. Adolescents (13-17 years old) placed greater importance on knowing the procedures, direct benefits, and the voluntary nature of participation compared with younger children (8-12 years old). Parents of older girls in particular placed greater emphasis on their daughter's need to know the purpose of the study, the procedures, benefits, and voluntary nature, compared with parents of boys. CONCLUSIONS: Results show that the information priorities of children/adolescents considering participation in a randomized controlled trial differ from that which their parents think is important to them. Pediatric researchers can use this knowledge to ensure that parents do not conflate their own expectations/priorities with those of their child and that children receive the information they need.

The association between experimental and clinical pain measures among persons with fibromyalgia and chronic fatigue syndrome.

Evoked or experimental pain is often used as a model for the study of clinical pain, yet there are little data regarding the relationship between the two. In addition, there are few data regarding the types of stimuli and stimulus intensities that are most closely related to clinical pain. In this study, 36 subjects with fibromyalgia (FM), chronic fatigue syndrome (CFS), or both syndromes were administered measures of clinical pain and underwent a dolorimetry evaluation. Subjects also underwent experimental pain testing utilizing heat and pressure stimulation. Stimulation levels evoking low, moderate and high sensory intensity, and comparable levels of unpleasantness, were determined for both types of stimuli using random staircase methods. Clinical pain was assessed using visual analogue ratings and the short form of the McGill Pain Questionnaire (MPQ). Ratings of heat pain sensation were not significantly associated with clinical pain ratings, with the exception of unpleasantness ratings at high stimulus intensities. Pain threshold and tolerance as assessed by dolorimetry were significantly associated with average measures of clinical pain. Both intensity and unpleasantness ratings of pressure delivered using random staircase methods were significantly associated with clinical pain at low, moderate and high levels, and the strength of the association was greater at increasingly noxious stimulus intensities. These findings suggest that random pressure stimulation as an experimental pain model in these populations more closely reflects the clinical pain for these conditions. These findings merit consideration when designing experimental studies of clinical pain associated with FM and CFS.

Spinal canal size and clinical symptoms among persons diagnosed with lumbar spinal stenosis.

OBJECTIVE: Clinical symptoms associated with lumbar spinal stenosis (LSS) are believed to be due to neurogenic claudication caused by narrowing of the central and lateral spinal canals. However, there is a paucity of published data on these relationships. The purpose of the present study was to examine the relationship between clinical symptoms associated with LSS and osseous anterior-posterior (AP) spinal canal diameter as measured on axial magnetic resonance imaging. DESIGN: Cross-sectional study conducted at a University Spine Program. Fifty persons with a clinical diagnosis of LSS were administered measures of clinical pain and perceived function. Walking distance in the laboratory and community was also assessed. Participants also underwent magnetic resonance imaging of the spine. RESULTS: Using recommended upper limits from the literature, patients with smaller canals reported greater perceived disability, but no other group differences emerged. In the entire sample, AP spinal canal diameter was not significantly associated with any of the clinical symptom measures examined. Body mass index was found to be significantly related to walking distance, but not perceived function or pain. CONCLUSIONS: AP spinal canal diameter is not predictive of clinical symptoms associated with LSS. The findings also suggest that body mass may play a significant role in functional limitations observed in this population.

Electromyographic and magnetic resonance imaging to predict lumbar stenosis, low-back pain, and no back symptoms.

BACKGROUND: Magnetic resonance imaging is commonly used to diagnose lumbar spinal stenosis. Some persons without symptoms have a small lumbar spinal canal. Electrodiagnosis has been used to diagnose spinal stenosis for over sixty years, but we are aware of no masked, controlled trials of the use of electrodiagnosis for that purpose. This study was performed to evaluate the relationships of magnetic resonance imaging measures and electrodiagnostic data with the clinical syndrome of spinal stenosis. METHODS: One hundred and fifty persons between the ages of fifty-five and eighty years old, including asymptomatic volunteers and persons referred for lumbar magnetic resonance imaging, underwent clinical examination, electrodiagnosis, and magnetic resonance imaging. Subjects were excluded if they had neuromuscular disease, sacral cancer, or inadequate test results, which left 126 subjects for the final analysis. The final cohort was divided into three groups--no back pain, mechanical back pain, and clinical spinal stenosis--on the basis of the impression of the examining physician, for whom the results of the magnetic resonance imaging and electrodiagnostic testing were masked. A spine surgeon also reviewed both the imaging and clinical examination data. RESULTS: The examining physician's diagnosis of clinical spinal stenosis was significantly related to the neurological findings on examination (p < 0.05) and to the spine surgeon's diagnosis (p < 0.001). The diagnosis of clinical spinal stenosis was also significantly related to the presence of fibrillations on electrodiagnostic testing (p < or = 0.003), the minimum anteroposterior diameter of the spinal canal on the magnetic resonance images (p = 0.016), and the average of the two smallest spinal canal diameters (p = 0.008) on the images. Measurements on magnetic resonance imaging did not differentiate subjects with clinical spinal stenosis from controls better than chance, whereas paraspinal mapping electrodiagnosis scores did. CONCLUSIONS: This prospective, controlled, masked study of electrodiagnosis and magnetic resonance imaging for older subjects showed that imaging does not differentiate symptomatic from asymptomatic persons, whereas electrodiagnosis does. We believe that radiographic findings alone are insufficient to justify treatment for spinal stenosis.

Psychometric properties of the mood and anxiety symptom questionnaire in patients with chronic pain.

OBJECTIVE: Previous studies have demonstrated that the Mood and Anxiety Symptom Questionnaire is able to discriminate between depressive and anxious symptoms. Factor analysis of the scale has revealed 3 factors: general distress, positive affect, and physiological hyper-arousal. However, the properties of the Mood and Anxiety Symptom Questionnaire have not been extensively examined in medical populations, in which the measurement of depressive and anxious symptoms is complicated by the presence of comorbid physical symptoms such as pain. Therefore, the purpose of the present study was to evaluate the psychometric properties of the Mood and Anxiety Symptom Questionnaire in patients with chronic pain. MATERIALS AND METHODS: A total of 230 persons with chronic musculoskeletal pain were recruited from a multidisciplinary pain clinic (n=110) and a large urban community (n=120). Participants completed the Mood and Anxiety Symptom Questionnaire and were interviewed for the presence of depressive disorders using the Structured Clinical Interview for the DSM-IV. Factor analyses, scale reliability analyses, and discriminative function analyses were performed on the data. RESULTS: Utilizing principal factor analysis and orthogonal rotation, the factor structure of the Mood and Anxiety Symptom Questionnaire in both chronic pain samples was similar to previously reported factor analyses. Three factors emerged: positive affect, general distress, and physiological hyper-arousal. Coefficients of congruence calculated from the factor structures of each subsample of persons with chronic pain suggested that the factors were highly similar (0.83-0.93). Given that the factor structures were comparable in both populations, a final analysis was conducted on the entire sample. Again, this analysis revealed a 3-factor solution. Examination of the factor loadings and item-to-total correlations revealed that some of the original scale items failed to load on or correlate with a specific factor, or correlated highly with 2 or more factors (thus lacking discriminatory power). A revised scale, eliminating items with low factors loadings and/or high cross loadings, was examined. Reliabilities for the subscales were high, and the subscales demonstrated the ability to predict clinical diagnoses of depression in a hypothesized fashion. DISCUSSION: The results support the utility of the Mood and Anxiety Symptom Questionnaire with samples of patients with chronic pain and provide further support for the tripartite model of anxiety and depression.

The Spine Team Assessment for chronic back pain disability. Part 1: basic protocol and performance in 500 patients.

PURPOSE: For persons with chronic back pain disability, customized, effective, and efficient treatment depends on the initial assessment. Functional capacity evaluations and intake screenings for particular programs are not independent or goal-directed. This paper describes a standardized independent multidisciplinary assessment for treatment planning, and characteristic findings in a population of chronically disabled persons. METHODS: The Spine Team Assessment (STA), a (1/2)-day assessment including extensive intake information, evaluations by therapists and counselors, a team meeting with a physician, and a comprehensive report, was performed on 500 consecutive persons with chronic back pain. RESULTS: Representative findings included maximum cardiac performance of 5.33 (+/-4.08 SD) METS; Progressive Isoinertial Lifting Evaluation floor-to-waist of 36.4% (+/-23.9% of norms, and CESD depression scores of 24.7 (+/-13.5 SD). Fear and avoidance and poor physiologic effort were common. CONCLUSION: Deconditioning, psychosocial factors and functional deficits are common, complex, and variable among chronic back pain patients. This description of the STA provides a potentially reproducible standard for research into individualized treatment. The work provides benchmark data for independent multidisciplinary assessments.

The Spine Team Assessment for chronic back pain disability. Part 2: team decision making and a preliminary outcome study.

PURPOSE: Back pain disability is complex, involving medical, physical, functional, social, and financial issues. This study aims to develop the first codified decision making process for individualized treatment planning. METHODS: In a multidisciplinary assessment protocol for chronic low back pain disability, the Spine Team Assessment (see Part I), a 'case law' qualitative approach to decision making began with a basic framework. Details were established over 103 cases at a community hospital. Through 500 more cases, a university spine program developed new exceptions, definitions, and rule clarifications. RESULTS: The final framework includes physical deconditioning, psychosocial factors, and potential for cure, with dozens of subcategories. Seventeen different combinations of therapy were recommended. Of 68 persons referred to one multidisciplinary treatment protocol, at 6 - 12 months the 17 completers had less work disability (31 vs. 62%, p = 0.032) and tended towards fewer subsequent diagnostic tests (17.6 vs. 34.7%) and less surgery (0 vs. 4). CONCLUSIONS: The data suggests that the process is complex, that customization did occur, and that at least one team decision led to better outcomes. While derived qualitatively, this decision-making tree provides a road map for less experienced teams and a precedent for researchers who wish to study individualized treatment.

Ability of early response to predict discharge outcomes with physical therapy for chronic low back pain.

OBJECTIVE: To determine how well early responses to physical therapy for chronic low back pain predict outcomes at discharge. METHODS: A prospective single cohort study of chronic low back pain patients seen at a university spine physical therapy clinic. Self-reported pain severity on a 100-mm visual analog scale was measured before each physical therapy visit. The predictive variables were the change in pain score at the second, third, and fourth visits. The first outcome variable was discharge change in pain severity for a correlation analysis. The second outcome variable was a dichotomous variable of whether the subjects had achieved at least a 30% reduction in pain severity at discharge for a discriminant analysis. RESULTS: Spearman's rank order correlation coefficient showed that early responses at the second (r = 0.324, P = 0.02) third (r = 0.342, P = 0.01), and fourth visits (r = 0.615, P < 0.001) were all significantly correlated with discharge change in pain. The discriminant analysis showed that early responses from the second to fourth visits were able to correctly predict 80.4% of the discharge outcomes (P < 0.001). CONCLUSIONS: Early responses with physical therapy help predict discharge outcomes for chronic low back pain.

Brief time-based activity pacing instruction as a singular behavioral intervention was not effective in participants with symptomatic osteoarthritis.

Osteoarthritis (OA) of the lower extremities is a prevalent cause of disability in which symptoms interfere with mobility and activity participation. Behavioral self-management for OA symptomatology is commonly recommended; but these interventions are underutilized, unstandardized in application, and at times, unavailable in the context of clinical care. For people with chronic pain, rehabilitation professionals may select to apply activity pacing instruction as one behavioral strategy to manage symptoms. Activity pacing is widely used in combination with other pharmacological and behavioral interventions but has not been studied as a singular behavioral intervention for people with OA. The purpose of this study was to evaluate the effectiveness of an occupational therapist-delivered, time-based activity pacing program for treatment of pain, fatigue, and physical function in people with symptomatic knee or hip OA. A 3-arm randomized controlled trial was conducted in which 193 people were randomized into tailored activity pacing, general activity pacing, or usual care arms. Assessments were done at 10 weeks and 6 months after baseline. Using linear mixed models, Western Ontario and McMaster Universities Osteoarthritis Index pain scores changed over time, decreasing the most in the general and usual care groups; only the usual care group had decreased pain over 6 months. The tailored and general activity pacing groups reported higher frequency of pacing behaviors than the usual care group at 10 weeks, but pacing was not sustained at 6 months. This trial does not support the use of time-based pacing as a singular behavioral strategy for people with knee or hip OA.

Factors associated with marital satisfaction and mood among spouses of persons with chronic back pain.

UNLABELLED: Few studies have examined the impact of chronic pain on the spouse. In this study the impact of pain and disability as rated by both the patient and the spouse on spouse marital satisfaction and affective distress was examined in 110 couples. Zero-order correlations indicated that absolute ratings of perceived disability by the spouse, rather than discrepancies between spouse and patient ratings, were most highly associated with spouse marital dissatisfaction and affective distress. Predictors of spouse marital satisfaction and distress were examined by using simultaneous multiple regression. Spouse ratings of greater physical disability were significantly related to greater spouse affective distress. Spouse ratings of higher psychosocial disability, lower spouse marital satisfaction, and being a patient of male gender were marginally related to higher spouse affective distress. Spouse marital dissatisfaction was significantly associated with patient ratings of greater psychosocial disability and lower pain. Spouse-rated psychosocial disability and affective distress were also marginally related to spouse marital satisfaction. These findings highlight the importance of patient disability, particularly limitations in function as perceived by the spouse, on spouse adjustment. PERSPECTIVE: The impact of chronic pain on the spouse of the person with pain has received little empirical attention. The present study examines the relationship between patient and pain-related factors and psychosocial adjustment in the spouse.

A meta-analytic review of surface electromyography among persons with low back pain and normal, healthy controls.

UNLABELLED: Significant differences in surface electromyography (SEMG) have been reported between persons with low back pain (LBP) and normal, healthy controls. This manuscript presents a systematic meta-analytic review of studies examining SEMG differences between these groups. Forty-four articles were identified using MEDLINE and a review of reference lists in articles. For static SEMG, the largest effect size was observed for SEMG while standing, with subjects having LBP demonstrating higher SEMG. The effect size for flexion/relaxation measures was found to be very high (d = -1.71). Studies examining SEMG during isometric exercise or muscle recovery following exercise produced inconsistent findings. Sensitivity and specificity of SEMG for dynamic SEMG measures averaged 88.8% and 81.3%. Most classification schemes were statistically determined and utilized a combination of measures. Only one published study prospectively validated a classification scheme. SEMG measures of flexion-relaxation appear to distinguish LBP subjects from controls with good accuracy, and the sensitivity and specificity of SEMG can be increased by using multiple measures. Further research is needed to determine the combination of measures that are cost-effective, reliable, valid and discriminate with a high degree of accuracy between healthy persons and those with LBP. PERSPECTIVE: SEMG is a simple and noninvasive measure of muscle activity. SEMG measures hold promise as an objective marker of LBP.