The journal of pain : official journal of the American Pain Society
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Standardized measures of efficacy are needed to compare analgesic efficacy across trials. The number needed to treat (NNT) is considered a statistically robust and readily interpretable measure to rank the efficacy of treatments, including analgesics. The NNT has become widely utilized to compare the efficacy of chronic pain treatments, helping physicians make treatment decisions and informing decisions for market access, reimbursement, and treatment guidelines. However, the NNT is associated with specific weaknesses in calculation and interpretation not associated with other methods for integrating trial data. These weaknesses include distortions in calculation as placebo effects approach treatment effects, with the possibility of infinite values; difficulties in estimating the NNT's confidence interval; and difficulties in interpretation. The NNT also requires selecting cutoffs of the original variable for dichotomization, with the NNT often changing depending on the cutoff. The NNT also suffers from problems common to other placebo-adjusted endpoints, including being sensitive to study-related and external factors (eg, year of publication). Therefore, clinicians and other stakeholders need to be aware of these issues to correctly calculate, use, and interpret the NNT. Nevertheless, efficacy, as measured by any variable, is only one aspect of a treatment to be considered in determining its place in therapy. ⋯ The NNT has become widely utilized to compare the efficacy of chronic pain treatments. This article reviews the uses of the NNT and the potential problems associated with its calculation, use, and interpretation. Clinicians should be aware of these issues when interpreting clinical trial data based on the NNT.
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This study examined the relationship of psychophysiological response patterns in fibromyalgia with psychological characteristics and comorbid mental disorders. Surface electromyographic data, systolic and diastolic blood pressure, heart rate (HR), and skin conductance levels were recorded continuously during baseline, stress, and relaxation tasks. Cluster analysis revealed 4 subgroups of patients who differed on pain characteristics and cognitive, affective, and behavioral responses to pain and stress. The largest group (46.7%) was characterized by elevated blood pressure levels and stress reactivity (a disposition assumed to be a vulnerability factor for the development of diseases) associated with pain, anxiety, physical interference, low activity, and pain behaviors. A second group (41.6%) showed low baseline blood pressure and reactivity, and high activity and stress. A third group (9.2%) displayed high baseline skin conductance level, reactivity, and depression, and a fourth small group (2.5%) displayed elevated baseline electromyographic response and reactivity with high levels of anxiety and depression. These data suggest that unique psychophysiological response patterns are associated with psychological coping and mental disorders in fibromyalgia patients. The identification of the mechanisms that contribute to these group differences will further our understanding of the mechanisms involved in the development and maintenance of fibromyalgia and suggest differential treatment strategies. ⋯ This article presents psychological characteristics and comorbidity with mental disorders of psychophysiological subgroups of fibromyalgia patients. This mechanistic analysis will assist scientific identification of systems-based pathways that contribute to autonomic and stress mechanisms that mediate chronic pain. Demonstration of distinct, homogeneous subgroups is an important step towards personalized, mechanism-oriented treatments.
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Insufficient pain education is problematic across the health care spectrum. Recent educational advancements have been made to combat the deficits in pain education to ensure that health care professionals are proficient in assessing and managing pain. The purpose of this survey was to determine the extent of pain education in current Doctorate of Physical Therapy schools in the United States, including how pain is incorporated into the curriculum, the amount of time spent teaching about pain, and the resources used to teach about pain. The survey consisted of 10 questions in the following subject areas: basic science mechanisms and concepts about pain, pain assessment, pain management, and adequacy of pain curriculum. The overall response was 77% (167/216) for the first series of responses of the survey (Question 1), whereas 62% completed the entire survey (Questions 2-10). The average contact hours teaching about pain was 31 ± 1.8 (mean ± standard error of the mean) with a range of 5 to 115 hours. The majority of schools that responded covered the science of pain, assessment, and management. Less than 50% of respondents were aware of the Institute of Medicine report on pain or the International Association for the Study of Pain guidelines for physical therapy pain education. Only 61% of respondents believed that their students received adequate education in pain management. Thus, this survey demonstrated how pain education is incorporated into physical therapy schools and highlighted areas for improvement such as awareness of recent educational advancements. ⋯ This article demonstrates how pain education is incorporated into physical therapy curricula within accredited programs. Understanding the current structure of pain education in health professional curriculum can serve as a basis to determine if recent publications of guidelines and competencies impact education.
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In addition to headache, persons with chronic migraine (CM) experience multiple symptoms, both ictal and interictal, that may contribute to their suffering. Translating clinical trial results into practice requires assessment of the results' clinical meaningfulness. When examining treatment benefit in this disabled patient population, multiple headache-symptom measures should be considered to fully reflect clinical relevance. Currently, only onabotulinumtoxinA is approved specifically for headache prophylaxis in adults with CM. Topiramate is the only other therapeutic agent with double-blind, placebo-controlled evidence in this population. Herein we evaluate the clinical meaningfulness of onabotulinumtoxinA and topiramate as headache prophylaxis in CM by comparing primary endpoints from the placebo-controlled, double-blind phase of the Phase 3 REsearch Evaluating Migraine Prophylaxis Therapy (PREEMPT) clinical program and the topiramate clinical trial (frequency of headache days [primary endpoint in PREEMPT; secondary in topiramate trial] and migraine/migrainous days [primary in topiramate trial, or "migraine/probable-migraine days"; secondary in PREEMPT]). Additionally, outcome measures such as responder rates, health-related quality of life, discontinuation rates, safety, and tolerability profiles are important clinical considerations. The clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate. These data support these treatments as meaningful headache prophylaxis in adults with CM. ⋯ CM is a chronic pain condition. We sought to determine the clinical relevance of recent trials in this disabled population. Clinical data indicate that statistically significant, clinically relevant treatment benefits exist for both onabotulinumtoxinA and topiramate, and support use of these treatments as meaningful headache prophylaxis in CM.
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Limited research examines the risk of therapeutic opioid addiction (TOA) in patients with chronic noncancer pain. This study examined TOA among 199 patients undergoing long-term opioid therapy at the time of admission to a pain rehabilitation program. It was hypothesized that nonopioid substance use disorders and opioid dosage would predict TOA. Daily mean opioid dose was 132.85 mg ± 175.39. Patients with nonopioid substance use disorders had 28 times the odds (odds ratio [OR] = 28.58; 95% confidence interval [CI] = 10.86, 75.27) of having TOA. Each 50-mg increase in opioid dose nearly doubled the odds of TOA (OR = 1.73; 95% CI = 1.29, 2.32). A 100-mg increase was associated with a 3-fold increase in odds (OR = 3.00; 95% CI = 1.67, 5.41). Receiver operating characteristic analysis revealed that opioid dose was a moderately accurate predictor (area under the curve = .75; 95% CI = .68, .82) of TOA. The sensitivity (.70) and specificity (.68) of opioid dose in predicting TOA was maximized at 76.10 mg; in addition, 46.00 mg yielded 80% sensitivity in identifying TOA. These results underscore the importance of obtaining a substance use history prior to prescribing and suggest a low screening threshold for TOA in patients who use opioids in the absence of improvement in pain or functional impairment. ⋯ This article examines TOA in patients with chronic noncancer pain undergoing long-term opioid therapy. Results suggest that patients should be screened for nonopioid substance use disorders prior to prescribing. In the absence of improvement in pain or function, there is a low threshold (∼50 mg daily opioid dose) for addiction screening.