A double-blind, placebo-controlled study of oral nalmefene for alcohol dependence.

BACKGROUND: Nalmefene is a newer opioid antagonist that is structurally similar to naltrexone but with a number of potential pharmacological advantages for the treatment of alcohol dependence, including no dose-dependent association with toxic effects to the liver, greater oral bioavailability, longer duration of antagonist action, and more competitive binding with opioid receptor subtypes that are thought to reinforce drinking. METHODS: A double-blind, placebo-controlled trial was conducted to evaluate the safety and efficacy of 2 doses of oral nalmefene for alcohol dependence. The 105 outpatient volunteers were abstinent for a mean of 2 weeks prior to random assignment to the placebo or 20- or 80-mg/d dose nalmefene groups for 12 weeks. Cognitive behavioral therapy was provided weekly during treatment. Self-reported drinking or abstinence was confirmed by determinations of breath alcohol concentration and by collateral informant reports. RESULTS: Outcomes did not differ between the 20- and 80-mg dose nalmefene groups. Significantly fewer patients treated with nalmefene than patients given placebo relapsed to heavy drinking through 12 weeks of treatment (P<.02), with a significant treatment effect at the first weekly study visit (P<.02). The odds ratio of relapsing to heavy drinking was 2.4 times greater with placebo compared with nalmefene (95% confidence interval, 1.05-5.59). Patients treated with nalmefene also had fewer subsequent relapses (P<.03) than patients given placebo. CONCLUSIONS: Treatment with nalmefene was effective in preventing relapse to heavy drinking relative to placebo in alcohol-dependent outpatients and was accompanied by acceptable side effects.

What is the quality of the implemented meta-analytic procedures in chronic pain treatment meta-analyses?

OBJECTIVE: Meta-analysis (MA) is the application of quantitative techniques for the purposes of summarizing data from individual studies. This type of review has many advantages over traditional reviews. However, different investigators performing MAs on the same data set have reached different conclusions. These reliability problems have been attributed to differences in the quality of the implemented meta-analytic procedures. We, therefore, examined the chronic pain treatment meta-analytic literature for MA procedure quality and for the consistency of conclusions. DESIGN, SETTING, PARTICIPANTS, OUTCOME MEASURES: Chronic pain treatment MAs were isolated according to inclusion/exclusion criteria. Data from these MAs were abstracted into structured tables. Table format reflected eight meta-analytic procedures identified previously as being important to MA implementation quality. These were: adequacy of retrieval, publication bias, inclusion/exclusion criteria, abstraction of data, quality, homogeneity/heterogeneity, independence, and statistical versus clinical interpretation. Each meta-analytic procedure was then independently rated by two raters. Rating results were then analyzed by procedure for each individual MA for percentage scores out of 100%, and mean scores. For MAs addressing the same topic area (pain facility treatment, antidepressant treatment, manipulation treatment) direction of effect size was noted. Mean effect sizes were calculated for these subgroups. RESULTS: Sixteen chronic pain treatment MAs fulfilled inclusion/exclusion criteria. Mean procedure ratings indicated that four procedures may not be implemented adequately. These were publication bias, abstraction of data, quality, and homogeneity/heterogeneity. There was wide MA implementation score variability, with 37.5% scoring less than 50%. The effect sizes of the MA subgroups demonstrated replicate nonvariability. CONCLUSIONS: Some meta-analytic procedures could be interpreted to be implemented inadequately in some chronic pain treatment MAs. There is wide variability between individual chronic pain treatment MAs on adequacy of implementation of these procedures. However, the effect sizes of the different MA subgroups demonstrated consistency. This finding indicates that for these MA subgroups, MA results are consistent between authors. In addition, chronic pain MAs, as compared with other groups of MAs, appear to address some of the procedures in a more adequate fashion. Future chronic pain MAs should concentrate on improving the quality of their methods with particular emphasis on the above four procedures. Because of potential validity problems with these results, these data cannot and should not be used to make administrative decisions about previous MAs.

The problem-oriented psychiatric examination of the chronic pain patient and its application to the litigation consultation.

OBJECTIVE: The purpose of this paper is (a) to delineate the behavior problems or complaints of chronic pain patients (CPPs) as presented in the literature and to add those behavior problems that have not yet been identified; (b) to present a semistructured psychiatric interview format that would lead to the delineation of these problems; and (c) to present a format and structure for the proposed semistructured psychiatric interview that could be utilized for the purposes of medicolegal assessment of the CPP and the reporting of that assessment to the litigation process. SETTING: Any psychiatric/psychological examination of the CPP. METHODS: The pain literature was reviewed for any research reports that specifically addressed or delineated the types of behavior problems found within the chronic pain (CP) population. These behavior problems were placed in a semistructured interview format, organized in such a way as to facilitate reporting to the litigation process if necessary. RESULTS: This semistructured psychiatric examination format is presented. Controversial problem areas in this format are discussed with appropriate references. CONCLUSIONS: CPPs are seen for the psychiatric examination with a set of behavioral problems largely determined by their medical condition, the consequences of that condition, and the social circumstances surrounding that medical condition (e.g., the litigation process). The psychiatric examination should be tailored to this special set of problems.

Is there a relationship between nonorganic physical findings (Waddell signs) and secondary gain/malingering?

This is a structured evidence based review of all available studies addressing the concept of nonorganic findings (Waddell signs) and their potential relationship to secondary gain and malingering. The objective of this review is to determine what evidence, if any, exists for a relationship between Waddell signs and secondary gain and malingering. Waddell signs are a group of 8 physical findings divided into 5 categories, the presence of which has been alleged at times to indicate the presence of secondary gain and malingering. A computer and manual literature search produced 16 studies relating to Waddell signs and secondary gain or malingering. These references were reviewed in detail, sorted, and placed into tabular form according to topic areas, which historically have been linked with the alleged possibility of secondary gain and malingering: 1) Waddell sign correlation with worker compensation and medicolegal status; 2) Waddell sign improvement with treatment; 3) Waddell sign correlation with Minnesota Multiphasic Personality Inventory validity scores; and 4) Waddell sign correlation with physician dishonesty perception. Each report in each topic area was categorized for scientific quality according to guidelines developed by the Agency for Health Care Policy and Research. The strength and consistency of this evidence in each subject area was then also categorized according to Agency for Health Care Policy and Research guidelines. Conclusions of this review were based on these results. There was inconsistent evidence that Waddell signs were not associated with worker's compensation and medicolegal status; there was consistent evidence that Waddell signs improved with treatment; there was consistent evidence that Waddell signs were not associated with invalid paper-pencil test; and there was inconsistent evidence that Waddell signs were not associated with physician perception of effort exaggeration. Overall, 75% of these reports reported no association between Waddell signs and the 4 possible methods of identifying patients with secondary gain and/or malingering. Based on the above results, it was concluded that there was little evidence for the claims of an association between Waddell signs and secondary gain and malingering. The preponderance of the evidence points to the opposite: no association.

Impact of chronic pain patients' job perception variables on actual return to work.

OBJECTIVE: To examine the impact of preinjury job perceptions on chronic pain patients (CPPs) return to work after pain facility treatment. DESIGN: A total of 128 CPPs completed a series of rating scales and yes/no questions relating to their preinjury job perceptions and a question relating to "intent" to return to the same type of preinjury job following pain facility treatment. These CPPs were part of a grant study for prediction of return to work, and therefore their work status was determined at 1, 3, 6, 12, 18, 24, and 30 months after treatment. The preinjury job perceptions and other demographic variables were used to predict return to work. Stepwise discriminant analysis was used to predict return to work at the 1-month and final time points utilizing the above variables. Stepwise regression analysis was used to predict mean employment status (at all time points) also using the above variables. SETTING: Multidisciplinary Pain Center. PATIENTS: Consecutive CPPs. RESULTS: For the 1-month time point, employment status was predicted by "intent," educational status, work dangerous perception complaint, job stress, job physical demands, job liking, and job role conflicts. Here, 79.49% of the CPPs were correctly classified. For the final time point, employment status was predicted by the first three predictors for the 1-month time point (in the same order) and age, job stress, and gender. Here, 74.58% of the CPPs were correctly classified. Mean employment status was predicted by "intent" and educational status. CONCLUSIONS: There is a relationship between preinjury job perceptions and actual return to work after pain facility treatment. Voiced "intent" not to return to the preinjury type of job is highly predictive of not returning to work after pain facility treatment.

Validity of the dictionary of occupational titles residual functional capacity battery.

BACKGROUND DATA: The Dictionary of Occupational Titles (DOT) is a U.S. government publication that defines each job in the United States according to 20 job factors. Fishbain et al. (Spine 1994;19:872-80) developed a DOT residual functional capacity (RFC) battery whose predictive validity for employment/unemployment had not been tested previously. OBJECTIVES: The purposes of this study were as follows: (a) to determine whether results of a DOT-RFC battery performed at completion of pain facility treatment predicted employment status at 30 months' follow-up and (b) to determine whether the DOT-RFC battery predicted employment capacity as determined by the DOT employment levels of the chronic pain patients' (CPPs) jobs. STUDY DESIGN: This is a prospective low back pain CPP pain facility treatment study using employment status and the DOT occupational levels as outcome measures. METHODS: One hundred eighty-five consecutive CPPs who fitted the selection criteria completed a DOT-RFC battery at the completion of pain facility treatment and were contacted at 1, 3, 6, 12, 18, 24, and 30 months for determination of their employment status and DOT employment level. Eight DOT job factors plus pain and worker compensation status were found to be significantly different between employed and unemployed CPPs and between those employed in different DOT employment levels. For the 10 variables, stepwise discriminant analysis was used to select final predictor variables. Sensitivity and specificity were calculated along with pain level cutpoints that separated the groups. RESULTS: The eight DOT job factors found to be statistically significant between groups were the following: stooping, climbing, balancing, crouching, feeling shapes, handling left and right, lifting, carrying, and pain and worker compensation status. In the discriminant analysis, these variables could discriminate between the employed and unemployed categories, with a sensitivity and specificity of approximately 75%. The pain level cutpoint between employed and unemployed was 5.4 on a 10-point scale. CONCLUSIONS: We cannot as yet predict DOT-RFC employment levels. However, if a CPP can pass the above eight DOT job factors and has a pain level less than the 5.4 cutpoint, that CPP will have a 75% chance of being employed at 30 months after treatment at the pain facility. Therefore, some DOT-RFC battery job factors demonstrate a predictive validity in the "real work world."

Prediction of "intent", "discrepancy with intent", and "discrepancy with nonintent" for the patient with chronic pain to return to work after treatment at a pain facility.

OBJECTIVE: We previously determined that "intent" to return to work post pain facility treatment is the strongest predictor for actual return to work. The purposes of the present study were the following: to identify variables predicting "intent"; to predict membership in the "discrepant with intent" group [those chronic pain patients (CPPs) who do intend to return to work but do not]; and to predict membership in the "discrepant with nonintent" group (those CPPs who do not intend to return to work but do). DESIGN: A total of 128 CPPs completed a series of rating scales and yes/no questions relating to their preinjury job perceptions and a question relating to "intent" to return to the same type of preinjury job post-pain facility treatment. These CPPs were part of a grant study for prediction of return to work, and therefore their work status was determined at 1, 3, 6, 12, 18, 24, and 30 months posttreatment. Preinjury job perceptions and other demographic variables were utilized using stepwise discriminant analysis to identify variables predicting "intent" and predicting membership in the "discrepant with intent" and "discrepant with nonintent" groups. SETTING: Pain facility (multidisciplinary pain center). PATIENTS: Consecutive low back pain CPPs, mean age 41.66+/-9.54 years, with the most frequent highest educational status being high school completion (54.7%) and 60.2% being worker compensation CPPs. RESULTS: "Intent" was predicted by (in decreasing order of probability) postinjury job availability variables, job characteristic variables, and a litigation variable. "Discrepant with intent" was predicted by (in decreasing order of probability) for the 1-month follow-up time point, postinjury job availability variables, pain variables, a litigation variable, and a function perception variable, and for the final follow-up time point, pain variables only. "Discrepant with nonintent" was predicted by (in order of decreasing probability) for the 1-month follow-up time point, a job availability variable, a demographic variable, and a functional perception variable, and for the final follow-up time point a pain variable and a job availability variable. The percentage of CPPs correctly classified by each of these analyses was as follows: "intent" 81.25%, "discrepant with intent" 87.01% (at 1-month follow-up) and 74.03% (final follow-up), "discrepant with nonintent" 92.16% (at 1-month follow-up) and 75.00% (final follow-up). CONCLUSIONS: CPPs intentions of returning to their preinjury jobs are mainly determined by job availability and job characteristic variables but surprisingly not by pain variables. However, the results with "discrepant with intent" and "discrepant with nonintent" groups indicate that actual return to work is determined by an interaction between job availability variables and pain variables with pain variables predominating for long-term outcome.

I. Do chronic pain patients' perceptions about their preinjury jobs determine their intent to return to the same type of job post-pain facility treatment?

OBJECTIVE: To demonstrate that chronic pain patients' (CPPs') perceptions about their preinjury jobs determine their intent to return to the same type of job post pain facility treatment. DESIGN: A total of 225 CPPs completed a series of rating scales and yes/no questions relating to their preinjury job perceptions and a question relating to intent to return to the same type of preinjury job post-pain facility treatment. The CPPs were broken down into subgroups (males, females, college males, noncollege males, college females, noncollege females), and within each subgroup those not intending to return to the same type of pre-injury job were compared to those intending to return on the preinjury job perception questions. In addition for the whole group, stepwise discriminant analysis was used to predict who planned to return to the preinjury job utilizing the job perceptions questions. SETTING: Multidisciplinary Pain Center. PATIENTS: Consecutive chronic pain patients. RESULTS: For the whole group, CPPs not intending to return were more likely to complain of job excessive physical demands, job satisfaction, and job dislike. Job perception complaints that were significantly different between the intending and not intending to return groups differed between the subgroups. For example, noncollege males not intending to return were more likely to complain of excessive physical demands only versus satisfaction and liking as significant items for college males who did not intend to return. Within the discriminant analysis, the combination of job satisfaction, excessive physical demands, employee conflicts, job liking, job dangerousness, supervisory conflicts, job stress, and age classified 73.46% of the CPPs correctly as to intent to return to the same type of preinjury job. CONCLUSIONS: There appears to be a relationship between preinjury job perceptions and intent to return to the same type of job post pain treatment. However, subgroups of CPPs will differ by which job perceptions are important towards making that decision.

II. Do chronic pain patients' perceptions about their preinjury jobs differ as a function of worker compensation and non-worker compensation status?

OBJECTIVES: (1) To demonstrate a relationship between intent to return to preinjury job and preinjury job perceptions about that job; and (2) to demonstrate that worker compensation chronic pain patients (WC CPPs) would be more likely than non-worker compensation chronic pain patients (NWC CPPs) not to intend to return to a preinjury type of job because of preinjury job perceptions. STUDY DESIGN: The relationship between preinjury job perceptions and intent to return to the preinjury job was investigated and compared between worker compensation (WC) and nonworker compensation (NWC) chronic pain patients (CPPs). Within the WC and NWC groups CPPs not intending to return to their preinjury type of work were compared to those CPPs intending to return on preinjury job perception. BACKGROUND DATA: Compensation status, being a WC CPPs or being a non-WC CPPs, has been claimed to be predictive or not predictive of return to work post pain treatment. These studies have, however, ignored the preinjury job stress perception variable as an area of research. METHODS: WC CPPs were age- and sex-matched to NWC CPPs and statistically compared on their responses to rating scale and yes/no questionnaires for intent to return to work and perceived preinjury job stress. In a second analysis, both the WC and NWC groups were divided according to their intent to return to work and statistically compared on their responses to these questionnaires. RESULTS: Both male and female WC CPPs were less likely than their counterparts to intend to return to their preinjury job. Both WC and NWC were found to complain of preinjury job complaints, and these complaints were found to differ between WC and NWC CPPs. An association between intent not to return to work and the perceptions of preinjury job dissatisfaction and job dislike was found for male and female WC CPPs and for male and female NWC CPPs. CONCLUSIONS: There may be a relationship between some preinjury job perceptions and intent to return to the preinjury type of work in some groups of CPPs. However, a specific relationship between WC status, intent not to return to the preinjury type of work, and preinjury job perceptions in comparison to NWC CPPs could not be demonstrated.

Secondary gain concept: a review of the scientific evidence.

UNLABELLED: The "secondary gain" concept originated in the psychoanalytic literature, where it was never vigorously examined. The purpose of this review is to determine if there are scientific studies that have explored the validity of this concept. DESIGN: A computer and manual literature review yielded 166 references in which primary, secondary, and tertiary gain were mentioned. Twenty-four (14.5%) of these reports were "secondary gain" studies. Fourteen "reinforcement" studies were also found. These 38 studies were grouped according to topics and reviewed in detail. SETTING: Any medical treatment setting including pain treatment was utilized in the review procedure, i.e., no exclusion criteria. PATIENTS: Any patient type, including those suffering from chronic pain, were utilized in the review procedure, i.e., no exclusion criteria. RESULTS: A significant but limited number of studies have investigated the "secondary gain" concept, and the results of some of these studies are in conflict. Results of some studies, however, are remarkably consistent in supporting the importance of "secondary gain" to behavior. Some studies have methodological flaws, usually relating to how the presence of secondary gain was established. CONCLUSIONS: Overall the results of the reviewed studies support the potential importance of the "secondary gain" concept to understanding illness behavior and underscore a need for future research in this area.

Prediction of pain center treatment outcome for geriatric chronic pain patients.

OBJECTIVE: Geriatric chronic pain patients (age 65 and over) form an increasing percentage of the pain center treatment population. It is therefore important to be able to predict pain center treatment success or failure for these patients; this is the first study to address this concern. DESIGN: Chronic pain patients rated themselves at pain center admission and discharge on 43 rating scales for the areas of pain, functional status, behavioral variables, and other pain center modification categories. The 43 scores at admission were used as potential predictors, while the 43 change scores (from admission to discharge) were the outcome measures to be predicted. Additional possible predictors were 16 other variables that are considered prognostic of treatment outcome, including age, number of surgeries, and prior occupational level. The statistical analysis consisted of a five-step procedure: (a) mathematical techniques were used to remove redundant outcome measures; (b) each of the remaining outcome variables was correlated with the full set of predictor variables; (c) regression techniques were used to predict the outcome variables; (d) these outcome variables were combined into independent factors using factor analysis; and (e) regression techniques were used to predict the factors. RESULTS: The variable-reduction technique was successful in removing 26 of the 43 outcome variables. Factor analysis of change scores of the remaining variables resulted in four factors, which were identified as change in activity, change in pain and behavior, change in constant pain, and change in attitude to pain center goals. The analysis showed that the best predictor of a variable's change score was the initial level of that variable. Regression analysis, using all variables as predictors except initial level, found a number of statistically significant predictors. However, no predictor variable, alone or in combination, was able to account for > 30% of the variance of any outcome measure. CONCLUSION: These results indicate that we cannot as yet predict geriatric pain center treatment outcome. Potential reasons for these results are discussed.

Validity of self-reported drug use in chronic pain patients.

OBJECTIVE: Previous researchers have reported that in psychiatric populations many patients provide incorrect self-report information on current drug use. Therefore, the purposes of the present study were to determine the percentage of chronic pain patients (CPPs) using illicit drugs (cannabis, cocaine), to determine the percentage of CPPs who provide incorrect self-report drug use information in the psychiatric examination, and to identify some variables that could help in identifying the CPP likely to provide an incorrect drug use history using drug urine toxicologies. DESIGN/SETTING/PARTICIPANTS/OUTCOME MEASURES: Two hundred seventy-four CPP consecutive admissions to a pain facility were psychiatrically examined according to criteria in the Diagnostic and statistical manual of mental disorders (3rd ed., rev; DSM-III-R), with special emphasis on all current drug use. Immediately after the psychiatric examination, all CPPs were asked to consent to urine toxicology. Urine was tested for benzodiazepines, opioids, tricyclics, propoxyphene, cannabinoids, barbiturates, amphetamines, methadone, methaqualone, phencyclidine, alcohol, and cocaine. CPPs were then segregated into three groups: negative toxicology, positive toxicology but concordant with self-report of current drug use, and positive toxicology discordant with self-report of current drug use. These groups were statistically compared with each other with regard to age, gender, race, workers' compensation status, and prevalence of individual DSM-III-R psychoactive substance use disorders. Sensitivities were also calculated for two conditions: accuracy of toxicology and accuracy of self-report. RESULTS: Toxicologies were obtained from 226 (82.5%) of the CPPs. Toxicologies were negative in 121 (53.5%) and positive in 105 (46.5%) of the CPPs. Of the 226 CPPs, 8.4% had illicit drugs in the urine (6.2% cannabis, 2.2% cocaine). Twenty (8.8%) of the CPPs provided incorrect self-report information about current drug use, the incorrect information most frequently about illicit drugs. Drug urine toxicology sensitivity results indicated that a significant percentage of CPPs was claiming to be taking a drug but was not taking it or taking it incorrectly. The psychiatric examination drug self-report sensitivity results indicated that a significant percentage of CPPs was withholding or providing incorrect information on current drug use. Lowest self-report sensitivity results were in reference to illicit drugs. CPPs who were more likely to provide incorrect psychiatric examination self-report information about current drug use were more likely to be younger, to be a workers' compensation CPP, and to have been assigned a DSM-III-R diagnosis of polysubstance abuse in remission. CONCLUSIONS: A significant percentage of CPPs appears to provide incorrect information on current illicit drug use. Urine toxicology studies may have a place in the identification of drugs for which incorrect information may be provided by CPPs. There are many possible reasons, such as assay error, that could lead to apparent misinformation. In the clinical setting, these possibilities should be considered if urine toxicology results appear to be incongruent with psychiatric examination drug use self-report.

Does nonsurgical pain center treatment of chronic pain return patients to work? A review and meta-analysis of the literature.

Evidence in the literature relating to return to work as an outcome variable for nonsurgical treatment for chronic pain was examined. Study selection criteria were as follows: a detailed definition of patient work status, delineation of work status pre-treatment and at follow-up, and documentation of the proportion of patients employed at follow-up. Of 171 studies reviewed, 37 fulfilled these selection criteria. Because the data were objective in nature, they were abstracted by the senior author only. For the coded variables of time to follow-up, proportion of patients working pre-treatment and at follow-up and number of patients, descriptive statistics and correlations were calculated. Change in employment status at follow-up was significant (P < .005) for all groups examined. In addition, comparisons for work outcome between treated patients versus patients rejected due to lack of insurance, and between treated patients versus patients who dropped out of treatment were both significant (P < .001). The mean difference in employment at follow-up for treated patients versus those not treated was approximately 50%. The proportion of patients working increased from 20% to 54% post chronic pain nonsurgical treatment. Correlation analyses did not find a significant trend in percent employed with time to follow-up. These results indicate that (1) chronic pain nonsurgical treatment does return patients to work; (2) increased rates of return to work are due to treatment, and (3) benefits of treatment are not temporary.

"Movement" in work status after pain facility treatment.

STUDY DESIGN: This was a randomized prospective follow-up study of pain facility treatment of chronic pain patients with low back pain, with return to work and work capacity as the outcome measures. OBJECTIVES: To determine if after pain facility treatment chronic pain patients "move" in and out of work and in their work capacity; to determine the patterns of "movement;" and to determine the post-pain facility treatment follow-up sampling time points that would maximize the number of chronic pain patients correctly classified according to their final work and work capacity status. SUMMARY OF BACKGROUND DATA: Past research and empiric observation have indicated that chronic pain patients may "move" after pain facility treatment in and out of work and in their job work capacity. Such "movement" can affect the results of outcome studies. METHODS: Two hundred thirty-six consecutive chronic pain patients who fit study selection criteria were followed up at 1, 3, 6, 12, 18, 24, and 30 months after pain facility treatment for determination of work and work capacity status and separated according to the pattern of movement. Stepwise discriminant analysis was used to answer the study objectives. "Movement" in and out of work for these chronic pain patients also was compared with the US general population. RESULTS: Chronic pain patients demonstrated eight work and four work capacity movement patterns. The 24- and 1-month time points predicted final work status correctly for 97.0% and 77.0% of the chronic pain patients, respectively, whereas the most significant predictor for correct work capacity status was the 24-month point. The annual percentage change in employment status for these chronic pain patients was more than in the US general population. CONCLUSIONS: Because chronic pain patients "move" in and out of employment and for work capacity status after pain facility treatment, future outcome studies using these measures will have to consider carefully the impact of "movement" on their results.

Can patients taking opioids drive safely? A structured evidence-based review.

A structured evidence-based literature review was completed to determine if there was epidemiological evidence of an association of opioid use and intoxicated driving, motor vehicle accidents (MVA) and MVA fatalities; to rate the quality of this research evidence according to Agency for Health Care Policy and Research (AHCPR) type of evidence and strength and consistency of the evidence rating scales; and according to this evidence determine whether patients taking opioids can drive safely. Relevant references were located from Medline, Psychological Abstracts, Science Citation Index and the National Library of Medicine Data Query databases by appropriate subject headings. A manual search was also performed utilizing the reference lists of the retrieved articles. All references relating to intoxicated driving, MVA and MVA fatalities were retrieved and reviewed in detail. Of these, references addressing opioid use were isolated and research information from these references was placed into tabular form under three major headings: Intoxicated driving and opioids; MVA and opioids; and MVA fatalities and opioids. Data were extracted from these references according to the following format: research question addressed, sample size, statistical analysis and results. The type of evidence each study represented was rated according to the AHCPR type of evidence rating scale. Each research area (intoxicated driving, MVA, MVA fatalities) represented by all the studies in each table was then rated utilizing the strength and consistency of the evidence AHCPR rating scale. Of the 6 reports addressing intoxicated driving, 5 were well designed non-experimental studies and one was a well designed experimental study. All studies in this group reported a prevalence for opioid use which was approximately 1/10 that of the point prevalence use for opioids in the general population. This evidence indicated that opioids probably are not associated with intoxicated driving. Overall, the evidence indicates that opioids are not associated with MVA. Of the 9 studies addressing MVA, 5 were well designed quasi-experimental studies and 4 were well designed experimental studies. All reports in this group except one indicated that opioids are not associated with MVA. Of the 10 studies addressing MVA fatalities, 10 represented Type IV studies. For the vast majority of the studies, the prevalence percentages for an opioid association with MVA fatalities was 1/5 that of the point prevalence percentage for opioid use reported in the general population. Only 1 study reported a possible association between opioid use and MVA fatalities. The evidence in this review indicates that opioids do not appear to be associated with intoxicated driving, MVA and MVA fatalities, and consistently indicated that opioids are not associated with MVA. Although the comparison of point prevalence rates to the point prevalence may be problematic, the results of this systematic review support the contention that patients taking opioids may be allowed to drive. As in all clinical decisions, this determination should be individualized according to clinical factors.

Modafinil for the treatment of pain-associated fatigue: review and case report.

Fatigue is a symptom that is frequently found in chronic pain patients with low back pain and/or neck pain. At the present time, no specific psychopharmacological treatment for this problem has been identified. Modafinil is a wakefulness-promoting agent that the FDA has approved for the treatment of excessive daytime sleepiness associated with narcolepsy. There have been reports on the use of modafinil for the treatment of fatigue in various neurological syndromes. This literature is reviewed. As such, modafinil treatment was initiated for a patient with severe fatigue associated with chronic low back pain and neck pain. There was dramatic improvement in fatigue and associated function. This case is described. It is the first such case report in the literature. The significance of this finding to the treatment of pain-associated fatigue is discussed.

Clonazepam open clinical treatment trial for myofascial syndrome associated chronic pain.

OBJECTIVE: A number of case reports and nonplacebo controlled studies have documented the efficacy of clonazepam (Klonopin) in the treatment of a number of chronic pain syndromes including lancinating and neuropathic/deafferentation pain. There are, however, no data on the efficacy of clonazepam for chronic pain (CP) associated with myofascial pain syndrome (MFPS). Therefore, we wish to report the results of an open clinical treatment trial of clonazepam for CP associated with MFPS. DESIGN: Forty-six patients with chronic pain (PWCP) and a diagnosis of MFPS were recruited into a clonazepam pain treatment open clinical trial. At entrance and completion of the study the patients completed a 10-cm visual analog scale (VAS) requesting them to rate their pain over the last 24 hours. Clonazepam was titrated upwards from 0.5 mg per day, at 0.5 mg increments, every 2 days. These patients rated their perceived pain relief daily on a 3-point rating scale: none, partial, total. Once a patient claimed partial pain relief clonazepam increases were stopped. Patients who complained of intolerable side effects before partial pain relief were withdrawn from the study. For a subgroup of patients claiming partial pain relief, clonazepam serum levels were determined. Because of the reported efficacy of clonazepam for neuropathic/deafferentation type of pain, patients with this diagnosis were withdrawn from the partial response group. Statistical analyses were performed on this remaining patient group with myofascial pain syndrome without a secondary diagnosis of neuropathic/deafferentation pain and partially responsive to clonazepam. Descriptive statistics were calculated for this group. Drop in pain level from entrance to partial response was tested for statistical significance via t test. In addition, 17 independent variables such as presence of trigger points, presence of burning pain etc, were utilized in a regression analysis, with drop in pain level as the dependent variable. A Pearson correlation analysis was first performed in order to determine which of the independent variables significantly correlated with decrease in pain level. Independent variables having a Pearson r of.3687 or greater were selected for the regression procedure. SETTING: Multidisciplinary pain facility. PATIENTS: Patients with chronic pain with a diagnosis of MFPS and without neuropathic/deafferentation pain. RESULTS: Of the 46 patients entered into the study, 9 were not titrated to partial pain relief because of intolerable sedation and 9 had a diagnosis of neuropathic/deafferentation pain. For the remaining group (n = 28), mean drop in VAS pain level from beginning of the study to partial response was 2.78 (SD = 1.94). This was statistically significant (t = 5.49, P <.001). Mean clonazepam dosage to reach partial response was 2.41 (SD = 1.62) mg/day and the mean dosage per kilogram body weight per day was 0.04 (SD = 0.03) mg. Mean clonazepam serum level was 30.58 (SD = 24.53) microg/L. Decrease in pain level was associated with the presence of the following independent variables: trigger points (r =.451); range of motion restriction (r =.653); non anatomical sensory abnormalities (r =.370); chronic low back pain (r =.451); and burning pain (r =.482). In the regression analysis, restricted range of motion and presence of burning pain accounted for 42% and 16% of the variance respectfully. CONCLUSION: Clonazepam may have an antinociceptive effect for pain associated with myofascial pain syndrome.

Risk for violent behavior in patients with chronic pain: evaluation and management in the pain facility setting.

OBJECTIVE: Recent evidence indicates that physicians are at high risk for patient-perpetrated violence. The objectives of this article, in association with case reports of patients with chronic pain (PWCP), are the following: to review the literature and determine if pain physicians could be at risk for PWCP-perpetrated violence; to review the current evaluation and management procedures for potentially violent patients; and to identify some situations specific to PWCPs that can heighten the risk of PWCP-perpetrated violence. DESIGN: Previous literature on patient-perpetrated violence against physicians was reviewed. In addition, literature on the evaluation for risk of violent behavior and management of violent behavior was also reviewed. Seven potentially violent PWCPs are described, including some who had threatened pain physicians and institutions. PWCP-specific situations thought to be instrumental in increasing the risk of PWCP-associated violence were identified. SETTING: Pain facility (multidisciplinary center). RESULTS OF REVIEW AND ANALYSIS OF CASE REPORTS: The literature on patient-perpetrated violence against physicians indicates that, statistically, pain physicians could be at risk for this type of violence. Seven PWCP cases of threatened or potentially violent behavior are described. These case report data indicate that PWCPs with the potential for violence against physicians or institutions do present for treatment at pain facilities. All seven PWCPs were in a number of situations specific to chronic pain that increased the possibility of violent behavior. These situations are described. CONCLUSIONS: In the evaluation for risk of violence against physicians or institutions by PWCPs, one needs to understand PWCP-specific situations. Management of potential violent behavior cannot be effective without this understanding.

Outcomes in treatment of pain in geriatric and younger age groups.

Chronic pain treatment outcome studies have generated conflicting information on whether geriatric (age 65+) patients (1) benefit from pain center treatment, and (2) benefit as much as do other age groups. We asked chronic pain patients to rate themselves at pain center admission and discharge on 43 scales assessing area of pain, functional status, behavioral variables, and other areas (pain center modification goals). Patients were placed into one of three age groups: "geriatric" (n = 153); "middle aged" 45 to 64 years (n = 126); and "younger" 21 to 44 years (n = 191). First, tests of geriatric improvement were performed. Next, the three groups were compared on baseline variables and on overall admission, discharge, and change scores. Change scores of the three groups were compared using analysis of covariance, followed by pairwise post hoc tests. Overall, the geriatric group improved on 42 of the 43 scales (p < .001). Geriatric improvement was significant on 37 scales, with most scales being significant at p < .001. Geriatric patients were significantly different from the other two groups on most baseline variables. Their admission scores were better than the other two groups. Geriatric improvement was not significantly different from the other two groups on 37 of the scales. Geriatric change was significantly better on two scales and significantly worse on 4 scales. Geriatric chronic pain patients are (1) distinctly different from younger chronic pain patients, (2) show significant and meaningful improvement with pain center treatment, and (3) demonstrate as great an improvement as the other age groups in the majority of measures.