Evaluation of the performance improvement CME paradigm for pain management in the long-term care setting.

OBJECTIVE: A performance improvement continuing medical education (PI CME) activity was designed to assist clinicians with accurately identifying and appropriately managing persistent pain in long-term care facility (LTCF) residents. DESIGN: Volunteer LTCFs participated in a three-stage PI CME model consisting of: 1) baseline assessment, 2) implementation of practice improvement interventions, and 3) reassessment. Expert faculty chose performance measures and interventions for the activity. A champion was designated ateach LTCF to collect resident charts and enter data into an online database. SETTING: Eight LTCFs located across the United States participated in the activity. PATIENTS: Fifty resident charts were randomly selected by each LTCF champion (25 for stage 1 and 25 for stage 3); a total of 350 charts were reviewed. INTERVENTIONS: In addition to a toolkit containing numerous performance improvement resources, an in-service meeting led by an expert faculty member was conducted at each LTCF. OUTCOME MEASURES: Stage 3 data were collected 6 weeks after implementation of interventions and compared with stage 1 baseline data to measure change in performance. RESULTS: Aggregate data collected from seven LTCFs completing the PI CME activity through stage 3 revealed improvements from baseline in four of five performance measures. CONCLUSIONS: This CME activity allowed for collection of data demonstrating performance improvement in persistent pain management. The tools used as part of the intervention (available at http://www.achlpicme.org/LTC/toolkit) may help other clinicians enhance their management of LTCF residents with persistent pain.

National Institutes of Health grant awards for pain, nausea, and dyspnea research: an assessment of funding patterns in 2003.

UNLABELLED: We introduce an interactive database that permits description and exploration of National Institutes of Health (NIH) funding patterns for research on pain, nausea, and dyspnea. The database encompasses both basic science and clinical research. This article describes how we created the database, including the procedures we developed for reviewing and classifying research grants. In addition, it reports NIH grants and funding activity for the year 2003, with a breakdown of funding activity by Institute and funding comparisons across Institutes. It also describes a first attempt to identify clinically significant but underfunded research domains. In 2003, the NIH funded 1148 grants having relevance to the domain of pain, representing 2.5% of the total NIH research budget. Of those, 581 grants, or about 1% of the NIH budget, had a primary focus on pain. Of the diseases and conditions addressed by the current implementation, musculoskeletal conditions were the best represented with 105 grants, whereas cardiac conditions had the fewest number of grants with 7. The NIH funded 43 grants for dyspnea research and a scant 29 grants for nausea studies. We discuss the current limitations of the database and our plans for further development. PERSPECTIVE: The interactive database and classification system for pain, nausea, and dyspnea research funded by the NIH reported on in this article represents an objective and verifiable resource for health policy makers and others interested in NIH funding decisions. The high inter-rater reliability achieved attests to the objectivity of the classification method. Initial analyses demonstrate that these data can usefully track funding patterns by NIH institutes and reveal underfunded areas of research.

Pain and the defense response: structural equation modeling reveals a coordinated psychophysiological response to increasing painful stimulation.

The defense response theory implies that individuals should respond to increasing levels of painful stimulation with correlated increases in affectively mediated psychophysiological responses. This paper employs structural equation modeling to infer the latent processes responsible for correlated growth in the pain report, evoked potential amplitudes, pupil dilation, and skin conductance of 92 normal volunteers who experienced 144 trials of three levels of increasingly painful electrical stimulation. The analysis assumed a two-level model of latent growth as a function of stimulus level. The first level of analysis formulated a nonlinear growth model for each response measure, and allowed intercorrelations among the parameters of these models across individuals. The second level of analysis posited latent process factors to account for these intercorrelations. The best-fitting parsimonious model suggests that two latent processes account for the correlations. One of these latent factors, the activation threshold, determines the initial threshold response, while the other, the response gradient, indicates the magnitude of the coherent increase in response with stimulus level. Collectively, these two second-order factors define the defense response, a broad construct comprising both subjective pain evaluation and physiological mechanisms.

A psychophysiological causal model of pain report validity.

The validity of the pain report is vitally important but difficult to assess because pain is a personal experience. Human laboratory research affords an opportunity to investigate validity because one can measure the consistency and sensitivity of pain ratings produced in response to known stimuli. This article presents 2 levels of evidence characterizing the validity of the pain report measure. The within-subject agreement of pain report with known stimulus variation quantifies the criterion validity, or accuracy, of the measure. Causal modeling defines a second, between-subject, level of construct validity by suggesting a psychophysiological mechanism determining the observed individual variation in accuracy. We analyzed pain rating data obtained in a laboratory study where 100 subjects (56 men and 44 women) experienced varied levels of painful fingertip electrical stimulation, delivered in random order across 144 trials. Unknown to the subjects, there were only 3 stimulus intensities. Accuracy, defined operationally as the proportion of variance in pain report explained by stimulus level, ranged from 0.07 to 0.91 with a median of 0.64. Hypothesized determinants of accuracy comprised current intensity, event-related late near field evoked potentials, skin conductance response, heart rate, and pupil diameter change. We limited the evoked potential measures to the amplitude of the negative peak at 150 msec (N150amp) and combined the latter 3 measures to form a single index of overall sympathetic nervous system arousal (Arousal). Although men chose higher stimulus levels for the experiment and had higher Arousal than did women, their mean pain reports and their Accuracy did not differ from those of female subjects. We constructed a sequence of path analysis models designed to clarify the causal contributions of current intensity, N150amp, and Arousal, and to determine whether these relationships differ in men and women. The final model revealed a direct causal chain. Stimulus current determined the amplitude of N150amp (possibly an indicator of attention). N150amp in turn determined Arousal, and Arousal emerged as the sole determinant of the Accuracy of the pain report. In addition, this latter effect differed across the sexes. Men who experienced higher levels of Arousal gave more accurate pain reports than those who had lower levels, but women who had higher levels of Arousal gave less accurate pain reports than those with lower levels. Thus construct validation emerged, not from direct stimulus-response correlation, but from the elucidation of a causal chain that related stimulus to response.

Central noradrenergic mechanisms and the acute stress response during painful stimulation.

Events that threaten tissue integrity including noxious stimulation activate central noradrenergic circuits, particularly locus coeruleus and its projections. Recent advances in theory hold that an adaptive, defensive shift in brain activity takes place in response to threat. In principle, this shift may accentuate the autonomic and central biomarkers of the perception of painful events and the experience of pain itself. We have examined the effects of an alpha-2 agonist on pupil dilation responses, skin conductance responses, near field somatosensory evoked potentials and pain reports in normal volunteers undergoing repeated trials of painful fingertip stimulation delivered at low, medium and high intensities. In a double-blinded study, 114 healthy male and female volunteers underwent repeated noxious stimulation under baseline, placebo and active drug conditions where the active drug was the alpha-2 agonist tizanidine 4 mg. In contrast to baseline and placebo conditions, tizanidine 4 mg significantly reduced the magnitudes of the mean pupil dilation response, the mean skin conductance response, the mean near field somatosensory evoked potential peak-to-peak amplitude and the mean pain intensity rating. Stimulus intensity significantly altered all three biomarkers and the pain report in a graded fashion. There were no sex differences. These findings support the hypotheses that painful events activate central noradrenergic circuits, and that these circuits play a role in the autonomic and central arousal associated with pain.

Only modest long-term opioid dose escalation occurs over time in chronic nonmalignant pain management.

Clinical experience and the literature increasingly support differentiating chronic pain associated with malignant disease from chronic pain associated with nonmalignant conditions when defining optimal pharmacotherapy. The use of opioids for chronic nonmalignant pain has grown steadily despite the lack of a strong evidence base that can guide practice. A fundamental question is whether patients develop tolerance and need repeated dose escalations to sustain pain control. We examined opioid prescribing data from United Kingdom Clinical Practice Research Datalink longitudinal database of general practice records and tracked dose changes but not pain reports in a sample of 4035 patients who received oral or transdermal-extended release opioids for chronic nonmalignant pain. The median number of days on opioid pharmacotherapy for all patients was 311. Thirty percent of patients never changed doses during the course of treatment. In patients who never changed medications, the mean morphine equivalent 24-hour dose increased from beginning to end of opioid pharmacotherapy only by 1.4 fold, t = 25.73, Cohen's d = .427 and was independent of both age and gender. Comparison across extended release morphine, oxycodone, and fentanyl revealed that it was significantly greatest for patients using fentanyl and least for those using morphine.

Pain uncertainty in patients with fibromyalgia, yoga practitioners, and healthy volunteers.

BACKGROUND: Uncertainty about potentially painful events affects how pain is experienced. Individuals with fibromyalgia (FM) often exhibit anxiety and catastrophic thoughts regarding pain and difficulties dealing with pain uncertainty. OBJECTIVES: The effects of pain uncertainty in predictably high odds (HO), predictably low odds (LO), and even odds (EO) conditions on subjective ratings of pain (PR) and skin conductance responses (SCR) following the administration of a painful stimulus were examined for individuals with fibromyalgia (IWFM), healthy volunteers (HVs), and yoga practitioners (YPs). We hypothesized IWFM would demonstrate the greatest physiological reactivity to pain uncertainty, followed by HVs and YPs, respectively. METHODS: Nine IWFM, 7 YPs, and 10 HVs participated. RESULTS: Custom contrast estimates comparing responses for HO, LO, and EO pain conditions showed higher SCR for IWFM (CE = 1.27, p = 0.01) but not for HVs or for YPs. PR for the EO condition were significantly greater than for HO and LO conditions for IWFM (CE = 0.60, p = 0.012) but not for HVs or YPs. YPs had lower SCR and PR than did HVs. CONCLUSIONS: Results show that uncertainty regarding pain increases the experience of pain, whereas certainty regarding pain may reduce pain ratings for individuals with fibromyalgia.

Effects of music engagement on responses to painful stimulation.

OBJECTIVES: We propose a theoretical framework for the behavioral modulation of pain based on constructivism, positing that task engagement, such as listening for errors in a musical passage, can establish a construction of reality that effectively replaces pain as a competing construction. Graded engagement produces graded reductions in pain as indicated by reduced psychophysiological arousal and subjective pain report. METHODS: Fifty-three healthy volunteers having normal hearing participated in 4 music listening conditions consisting of passive listening (no task) or performing an error detection task varying in signal complexity and task difficulty. During all conditions, participants received normally painful fingertip shocks varying in intensity while stimulus-evoked potentials (SEP), pupil dilation responses (PDR), and retrospective pain reports were obtained. RESULTS: SEP and PDR increased with increasing stimulus intensity. Task performance decreased with increasing task difficulty. Mixed model analyses, adjusted for habituation/sensitization and repeated measures within person, revealed significant quadratic trends for SEP and pain report (Pchange<0.001) with large reductions from no task to easy task and smaller graded reductions corresponding to increasing task difficulty/complexity. PDR decreased linearly (Pchange<0.001) with graded task condition. We infer that these graded reductions in indicators of central and peripheral arousal and in reported pain correspond to graded increases in engagement in the music listening task. DISCUSSION: Engaging activities may prevent pain by creating competing constructions of reality that draw on the same processing resources as pain. Better understanding of these processes will advance the development of more effective pain modulation through improved manipulation of engagement strategies.

Investigating dose-dependent effects of placebo analgesia: a psychophysiological approach.

Investigating dose-dependent effects of placebo analgesia (PA) in laboratory subjects undergoing pain testing, we evaluated 2 hypotheses: (1) greater expectancy for relief produces greater PA, and (2) cued expectancy for relief triggered by a predictive cue leads to more enhanced analgesia than does passive expectancy (no predictive cue). We used conditioning procedures in which 84 subjects experienced reduced stimulation intensity following the application of purported analgesic creams to the 2 experimental fingers, while the control finger received the same levels of stimulation as in the baseline block. The dose of placebos was manipulated by creating 2 levels of expectations for relief. The form of expectation (cued vs uncued) was also manipulated by a predictive cue specifying the next finger to be stimulated. Subjective reports and psychophysiological responses served as critical indicators for evaluating impacts of the placebo manipulation on subsequent pain processing. The dose-dependent PA was unambiguously demonstrated by the predicted ordering of the 3 fingers (ie, manipulated expectation levels) in terms of both response sensitivity and average response magnitude, in mixed-effects analysis of 3 outcome indicators (evoked potential, skin conductance response, pain report). Greater expectation for relief led to both (1) greater reductions in the average dependent variable slope (response sensitivity) as a function of stimulus intensity, and (2) greater reductions in average response magnitude. Unexpectedly, uncued expectation led to a slightly larger PA than did cued expectation. The study provided clear evidence that PA can occur in a "dose"-dependent manner, mediated by the levels of expectancy for pain relief.

Improving individual measurement of postoperative pain: the pain trajectory.

UNLABELLED: The purpose of this study was to demonstrate a method for increasing the precision and information yield of postoperative pain assessment. We recorded pain intensity ratings over 6 days after surgery in 502 elective surgery patients and examined individual pain trajectories. A linear fit of an individual patient's scores defines a trajectory with two features: (1) the intercept or initial pain intensity; and (2) the slope, or rate of pain resolution. Three pain trajectory patterns emerged from examination of the pain trajectory slopes. Most patients (63% of the sample) demonstrated a negative slope trajectory characterized by a decline in pain intensity over days after surgery. Other patients (25% of the sample) demonstrated a flat trajectory with no meaningful change over 6 days from pain they reported initially. A third patient group (12% of the sample) had a positive slope trajectory in which pain scores increased over 6 days after surgery. Measures derived from individual pain trajectories yielded much lower standard errors of measurement and therefore had better measurement precision than did conventional pain assessment methods. Pain trajectory measures proved sufficiently precise to characterize pain patterns reliably in individual patients. PERSPECTIVE: Progress in acute pain management requires effective pain assessment. The acute pain trajectory quantifies rate of pain resolution as well as pain intensity. It affords more precise measurement than conventional pain assessment and can identify abnormal postoperative pain resolution.

Sequential analyses of daily symptoms in women with fibromyalgia syndrome.

UNLABELLED: Fibromyalgia syndrome (FMS) is a chronic musculoskeletal pain disorder characterized by generalized pain, chronic fatigue, sleep disturbance, and a range of other symptoms having no definitive pathology. Consequently, patient evaluations rely on self-report. Ecological Momentary Assessment (EMA) allows frequent real-time collection of self-report measures, removing recall bias and increasing external validity. We studied 81 females with FMS aged 18 to 42 years. Participants carried EMA devices (Palm Pilot M100) programmed to request ratings to 8 FMS symptoms/conditions 3 times daily for 30 days. Completeness of response rates varied across participants and over time. Controlling for immediately previous fatigue (ie, fatigue rating from the immediately preceding rating), unit increases in immediately previous pain and immediately previous emotional distress predicted 9 and 7% increases, respectively, in current fatigue. Controlling for immediately previous emotional distress, a unit increase in immediately previous pain predicted 7% increase in current emotional distress. Controlled for immediately previous pain, a unit increase in immediately previous fatigue predicted a 7% increase in current pain, enhanced by prior diurnal effects; immediately previous emotional distress was not significant. Collectively these results suggest an asymmetry in which emotional stress and pain may increase fatigue, fatigue but not emotional distress may increase pain, and pain but not fatigue may increase emotional distress. Despite small effects and person-to-person variability, these findings suggest that longitudinal data collection by EMA may reveal sequential or causal explanatory patterns with important clinical implications. PERSPECTIVE: Understanding how multiple symptoms covary in FMS is essential for optimal treatment planning. Our results show small but significant temporal relations among pain, fatigue, and emotional distress. Our results also provide support for the use of EMA as a viable data collection method that allows longitudinal, real-time assessment of multiple FMS symptoms.

Outcome evaluation of the Veterans Affairs Salt Lake City Integrative Health Clinic for Chronic Nonmalignant Pain.

OBJECTIVES: the purpose of this longitudinal outcome study was to investigate the effectiveness of the Integrative Health Clinic and Program, an innovative outpatient clinical service that provides nonpharmacologic, biopsychosocial interventions using research based mind-body skills and complementary and alternative therapies. The study assessed improvement in chronic nonmalignant pain and related depression, anxiety, and health-related quality of life. METHODS: the study was a retrospective post-hoc quasi-experimental design with a group analysis comparing chronic nonspinal-related pain (CNSP) (eg, joint pain, headache, and fibromyalgia) (n=53) to chronic spinal-related pain (CSP) (eg, back pain and neck pain) (n=88). Data were collected at intake and up to 4 follow-up visits. Hierarchical Linear Modeling was used for statistical analysis. Outcome measures included: Quality of Life (Short Form-36), the Beck Depression Inventory, and Beck Anxiety Inventory. RESULTS: there were statistically significant differences within and between the CNSP and CSP groups across all follow-up visits. For the CNSP group, depression, anxiety, and bodily pain significantly improved with moderate-to-large effect sizes at 6 months (Cohen's d=0.74, 0.53, and 0.66, respectively) and these benefits persisted across all follow-up visits. The CSP group showed an improvement trend in bodily pain (Cohen's d=0.26). DISCUSSION: significant study findings revealed that the greatest improvement after participation in Integrative Health Clinic and Program were seen in the CNSP group with benefits persisting to 24 months in mood and in some health-related quality of life subcategories.

Individual differences in the effects of music engagement on responses to painful stimulation.

UNLABELLED: Engaged attention, including music listening, has shown mixed results when used as a method for reducing pain. Applying the framework of constructivism, we extend the concept of engagement beyond attention/distraction to include all cognitive and emotional/motivational processes that may be recruited in order to construct an alternative experience to pain and thus reduce pain. Using a music-listening task varying in task demand, we collected stimulus-evoked potentials, pupil dilation, and skin conductance responses to noxious electrocutaneous stimulations as indicators of central and peripheral arousal, respectively. Trait anxiety (Spielberger State-Trait Anxiety Inventory) and absorption (Tellegen Absorption Scale) provided indicators of individual differences. One hundred and fifty-three healthy, normal volunteers participated in a test session in which they received 3 stimulus intensity levels while listening to background tones (No Task) or performing a music-listening task. Linear slopes indicating net engagement (change in stimulus arousal relative to task performance) decreased with increasing task demand and stimulus level for stimulus-evoked potentials. Slopes for pupil dilation response and skin conductance response varied with task demand, anxiety, and absorption, with the largest engagement effect occurring for high anxiety/high absorption participants. Music engagement reduces pain responses, but personality factors like anxiety and absorption modulate the magnitude of effect. PERSPECTIVE: Engaging in music listening can reduce responses to pain, depending on the person: people who are anxious and can become absorbed in activities easily may find music listening especially effective for relieving pain. Clinicians should consider patients' personality characteristics when recommending behavioral interventions like music listening for pain relief.

Outcome evaluation of the Veterans Affairs Salt Lake City Integrative Health Clinic for chronic pain and stress-related depression, anxiety, and post-traumatic stress disorder.

OBJECTIVES: The purpose of this longitudinal outcome research study was to determine the effectiveness of the Integrative Health Clinic and Program (IHCP) and to perform a subgroup analysis investigating patient benefit. The IHCP is an innovative clinical service within the Veterans Affairs Health Care System designed for nonpharmacologic biopsychosocial management of chronic nonmalignant pain and stress-related depression, anxiety, and symptoms of post-traumatic stress disorder (PTSD) utilizing complementary and alternative medicine and mind-body skills. METHODS: A post-hoc quasi-experimental design was used and combined with subgroup analysis to determine who benefited the most from the program. Data were collected at intake and up to four follow-up visits over a 2-year time period. Hierarchical linear modeling was used for the statistical analysis. The outcome measures included: Health-Related Quality of Life (SF-36), the Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI). Subgroup comparisons included low anxiety (BAI < 19, n = 82), low depression (BDI < 19, n = 93), and absence of PTSD (n = 102) compared to veterans with high anxiety (BAI > or = 19, n = 77), high depression (BDI > 19, n = 67), and presence of PTSD (n = 63). RESULTS: All of the comparison groups demonstrated an improvement in depression and anxiety scores, as well as in some SF-36 categories. The subgroups with the greatest improvement, seen at 6 months, were found in the high anxiety group (Cohen's d = 0.52), the high-depression group (Cohen's d = 0.46), and the PTSD group (Cohen's d = 0.41). CONCLUSIONS: The results suggest IHCP is an effective program, improving chronic pain and stress-related depression, anxiety, and health-related quality of life. Of particular interest was a significant improvement in anxiety in the PTSD group. The IHCP model offers innovative treatment options that are low risk, low cost, and acceptable to patients and providers.

Evaluating obesity in fibromyalgia: neuroendocrine biomarkers, symptoms, and functions.

The aim of this study was to investigate the associations between obesity and fibromyalgia syndrome (FMS). This study was conducted at the University of Utah Pain Management and Research Center, Salt Lake City, Utah. Thirty-eight FMS patients were included in this study. Neuroendocrine indices (catecholamines, cortisol, C-reactive protein [CRP], and interleukin-6), symptom measures (Fibromyalgia Impact Questionnaire), sleep indices (Actigraph), and physical functioning (treadmill testing) were measured. Body mass index (BMI) provided the primary indicator of obesity. Approximately 50% of the patients were obese and an additional 21% were overweight. Strong positive associations were found between BMI and levels of IL-6 (r=0.52) and epinephrine (r=0.54), and somewhat weaker associations with cortisol (r=0.32) and CRP (r=0.37). BMI was also related to maximal heart rate (r=0.33) and inversely related to distance walked (r= -0.41). BMI was associated with disturbed sleep: total sleep time (r= -0.56) and sleep efficiency (r= -0.44). No associations between self-reported symptoms and BMI were found. This study provides preliminary evidence suggesting that obesity plays a role in FMS-related dysfunction.

Trends in funding for research on pain: a report on the National Institutes Of Health grant awards over the years 2003 to 2007.

UNLABELLED: In recent years, the National Institutes of Health (NIH) has experienced unprecedented reductions in its customary annual budget increases. Consequently, researchers, health care policy planners and others have a pressing need for accurate information on NIH funding patterns. We created a unique and objective system for compiling, classifying, and analyzing data on NIH grant awards and funding for research on pain, nausea, and dyspnea using naïve observers, cross-validation by multiple raters, and face validation by experts. We present results of our method and analyses for the period from 2003 to 2007. Following a 12% increase from 2003 to 2004, funding for pain research fell by 9.4% per year on average over the next 3 years. The percent of the total NIH budget going to support pain research increased to 0.78% in 2004 but fell to 0.61% in 2007. A piecewise regression model confirmed the declining trend represented a significant fit to the data (R(2)=0.98, p=0.024). Separate breakdowns by Institutes showed similar patterns. Analyses of nausea and dyspnea research support revealed small but steady increases over the same period. Declining support for pain research disproportionate to decreases in the NIH budget signals a need for measures to promote funding for meritorious applications. PERSPECTIVE: Results of 5 year trends in numbers of grants and funding for research in pain, nausea, and dyspnea by the NIH show overall declines for pain but slight increases for nausea and dyspnea. Declining support for pain research that exceeds the reductions in the total NIH budget signals a need for measures to increase pain research funding.