Perimenstrual eletriptan prevents menstrual migraine: an open-label study.

OBJECTIVE: To prospectively evaluate the efficacy of perimenstrual prophylaxis with eletriptan to reduce headaches in women identified with menstrual migraine (MM). METHODS: Female migraineurs self-reporting a substantial relationship between migraine and menses were evaluated with 3 consecutive months of daily headache recording diaries. A relationship between menses and migraine was evaluated using International Classification of Headache Disorders (ICHD-II) criteria and a probability model called Probability MM. Women prospectively diagnosed with ICHD-II MM were treated for 3 consecutive months with perimenstrual eletriptan 20 mg 3 times daily starting 2 days prior to the expected onset of menstruation and continued for a total of 6 days. Headache activity was compared during the 3 months of recording prior to eletriptan therapy and 3 months with eletriptan perimenstrual prevention therapy. RESULTS: Three months of pretreatment prospective diaries were completed by 126 women. ICHD-II menstrually related migraine was diagnosed in 74%, with pure MM in 7%. Among those women diagnosed with ICHD-II MM, 61 completed at least 1 treatment month. Overall change in headache activity was a 46% decrease. The mean percentage of treated menses without migraine occurring during the 6 days of treatment was 71%. The percentage of subjects with 1, 2, and 3 migraine-free menstrual periods (no migraines occurring 2 days before menses through the first 3 days of menstruation) with eletriptan, respectively, were 14%, 19%, and 53%. Among those subjects who remained headache-free during the 6 days of eletriptan treatment, migraine occurred during the 3 days immediately after discontinuing eletriptan for 9%. Perimenstrual eletriptan was generally tolerated and no abnormalities were identified on the 6(th) day of treatment using either blood pressure recording or electrocardiogram. CONCLUSIONS: Among patients with prospectively identified MM, eletriptan 20 mg 3 times daily effectively reduced MM. A significant reduction in headache activity occurred for 53% of patients.

A prospective comparison between ICHD-II and probability menstrual migraine diagnostic criteria.

OBJECTIVE: To prospectively evaluate the diagnosis of menstrual migraine (MM) by comparing 2 diagnostic systems. METHODS: Female migraineurs self-reporting a substantial relationship between migraine and menses were evaluated with 3 consecutive months of daily headache recording diaries. A relationship between menses and migraine was evaluated using International Classification of Headache Disorders (ICHD-II) criteria and a probability model called Probability MM. RESULTS: Three months of pretreatment prospective diaries were completed by 126 women. ICHD-II menstrually related migraine was diagnosed in 73.8% with pure MM in 7.1%. ICHD-II and Probability diagnoses agreed for all cases of ICHD-II non-MM and pure MM, with disagreement among women diagnosed with ICHD-II menstrually related migraine, only half of whom were identified as having a relationship with menses greater than chance alone using the Probability model. Interestingly, 20% of those women self-reporting a substantial relationship between migraine and menses were not prospectively diagnosed with MM using either diagnostic system. Differences in menstrual vs nonmenstrual headaches were greater when using the Probability model. CONCLUSIONS: Prospective headache diaries are needed to diagnose MM. A probability-based method, which considers the chance occurrence of headaches during the menstrual cycle, identifies fewer women as having menstrually related migraine compared with the diary-based methods recommended by the current ICHD-II candidate criteria.

Classifying subgroups of chronic low back pain patients based on lifting patterns.

OBJECTIVE: To compare self-reported measures of chronic lower back pain (CLBP) patients who were assigned to 2 subgroups based on their lifting patterns performed during a repetitive lifting task. DESIGN: Cross-sectional study. SETTING: Research laboratory PARTICIPANTS: CLBP subjects (n=81) and pain-free controls (n=53). INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Measures of lifting patterns and self-reported disability, pain, and psychosocial aspects. RESULTS: Two CLBP subgroups were found: 1 group that lifts similarly to control subjects (n=35) and 1 group that lifts very differently from controls (n=46). The CLBP group that lifted differently than controls reported higher pain intensity (P=.005), higher pain severity (P=.025), and lower self-efficacy (P=.013) than the CLBP group that lifted similarly to controls. CONCLUSIONS: A classification system based on lifting patterns identified 2 CLBP subgroups that were significantly different on lifting and self-reported measures, indicating the importance of physical functioning measures in classification systems.

Efficacy of periosteal stimulation therapy for the treatment of osteoarthritis-associated chronic knee pain: an initial controlled clinical trial.

OBJECTIVES: To examine the efficacy of periosteal stimulation therapy (PST, osteopuncture) for the treatment of chronic pain associated with advanced knee osteoarthritis. DESIGN: Randomized, controlled clinical trial. SETTING: Outpatient pain clinic. PARTICIPANTS: Eighty-eight community-dwelling older adults with moderate knee pain or greater for 3 months or longer and Kellgren-Lawrence (K-L) grade 2 through 4 radiographic severity (80% had K-L 4). INTERVENTION: Participants were randomized to receive PST or control PST once a week for 6 weeks. MEASUREMENTS: Pain severity and self-reported function (Western Ontario and McMasters University Osteoarthritis Index (WOMAC)) and physical performance (Short Physical Performance Battery (SPPB)) were assessed at baseline, after the last PST session (post), and 3 months later (follow-up). Pain severity was also assessed monthly using the multidimensional pain inventory short form. RESULTS: Pain was reduced significantly more in the PST group than in the control PST group at post (P=.003; mean WOMAC pain subscale baseline 9.4 vs 6.4) and 1 month later (P<.001), but by 2 months, pain levels had regressed to pre-intervention levels. The group-by-time interaction for the WOMAC function scale was significant at post (P=.04) but not at follow-up (P=.63). No significant group differences were found for the SPPB. Neither analgesic use nor global improvement differed between groups. There were four treatment dropouts. CONCLUSION: PST affords short-term modest pain reduction for older adults with advanced knee OA. Future research should test the effectiveness of booster treatments in sustaining analgesic benefits and of combining PST with therapeutic exercise in ameliorating disability risk.

An interdisciplinary expert consensus statement on assessment of pain in older persons.

This paper represents an expert-based consensus statement on pain assessment among older adults. It is intended to provide recommendations that will be useful for both researchers and clinicians. Contributors were identified based on literature prominence and with the aim of achieving a broad representation of disciplines. Recommendations are provided regarding the physical examination and the assessment of pain using self-report and observational methods (suitable for seniors with dementia). In addition, recommendations are provided regarding the assessment of the physical and emotional functioning of older adults experiencing pain. The literature underlying the consensus recommendations is reviewed. Multiple revisions led to final reviews of 2 complete drafts before consensus was reached.

Older spouses' perceptions of partners' chronic arthritis pain: implications for spousal responses, support provision, and caregiving experiences.

This study of older patients with osteoarthritis and their spouses examined concordance between patients' and spouses' reports of patients' pain severity and the association of concordance with support and caregiving outcomes. Patients and spouses independently viewed videotapes of the patient performing simulated household tasks and provided ratings of patients' pain. Spousal overestimation of patients' pain was the most common type of nonconcordance. Spouses who were accurate in their perceptions of their partner's level of pain during a log-carrying task responded less negatively and provided emotional support that was more satisfying to patients. In addition, spouses who were accurate in their perceptions of their partner's pain during the log-carrying task reported less stress from providing support and assistance. Future research that uses such observational methods may be highly useful for understanding the effects of chronic illness on older couples.

The use of splines to calculate jerk for a lifting task involving chronic lower back pain patients.

Motion differences in a repetitive lifting task have been described previously using differences in the timing of body angle changes during the lift. These timing changes relied on small differences of motion and are difficult to measure. The purpose of this study was to evaluate shoulder jerk (rate of change of acceleration) in a repetitive lifting task as an alternative parameter to detect differences of motion between controls and chronic lower back pain (CLBP) patients and to measure the impact of a rehabilitation program on jerk. The jerk calculation was a noisy measure, since jerk is the third derivative of position; consequently a simulation was performed to evaluate smoothing methods. Woltring's generalized cross-validation spline produced the best estimates of the third derivative and was fit to subject data. The root mean square (rms) amplitude of jerk was used for comparison. Significant group differences were found. CLBP patients performed lifts with lower jerk values than controls and, as the task progressed, both groups increased jerk. After completion of a rehabilitation program, CLBP patients performed lifts with greater rms jerk. In general, patients performed lifts with lower jerk values than controls, suggesting that pain impacts lifting style.

Fibromyalgia and headache: an epidemiological study supporting migraine as part of the fibromyalgia syndrome.

Fibromyalgia is defined by widespread body pain, tenderness to palpation of tender point areas, and constitutional symptoms. The literature reports headache in about half of fibromyalgia patients. The current epidemiological study was designed to determine the prevalence and characteristics of headache in fibromyalgia patients. Treatment-seeking fibromyalgia patients were evaluated with measures for fibromyalgia, chronic headache, quality of life, and psychological distress. Multivariate analysis of variance (MANOVA) and t-tests were used to identify significant differences, as appropriate. A total of 100 fibromyalgia patients were screened (24 fibromyalgia without headache and 76 fibromyalgia with headache). International Headache Society diagnoses included: migraine alone (n = 15 with aura, n = 17 without aura), tension-type alone (n = 18), combined migraine and tension-type (n = 16), post-traumatic (n = 4), and probable analgesic overuse headache (n = 6). Fibromyalgia tender point scores and counts and most measures of pain severity, sleep disruption, or psychological distress were not significantly different between fibromyalgia patients with and without headache. As expected, the fibromyalgia patients with headache scored higher on the Headache Impact Test (HIT-6) (62.1 +/- 0.9 vs 48.3 +/- 1.6, p < 0.001). HIT-6 scores were >60 in 80% of fibromyalgia plus headache patients, representing severe impact from headache, and 56-58 in 4%, representing substantial impact. In summary, chronic headache was endorsed by 76% of treatment-seeking fibromyalgia patients, with 84% reporting substantial or severe impact from their headaches. Migraine was diagnosed in 63% of fibromyalgia plus headache patients, with probable analgesic overuse headache in only 8%. General measures of pain, pain-related disability, sleep quality, and psychological distress were similar in fibromyalgia patients with and without headache. Therefore, fibromyalgia patients with headache do not appear to represent a significantly different subgroup compared to fibromyalgia patients without headache. The high prevalence and significant impact associated with chronic headache in fibromyalgia patients, however, warrants inclusion of a headache assessment as part of the routine evaluation of fibromyalgia patients.

Neglected topics in the treatment of chronic pain patients--relapse, noncompliance, and adherence enhancement.

Although published treatment outcome studies for chronic pain have provided favorable support for the efficacy of many pain clinics and the use of specific modalities such as biofeedback and relaxation, there are several factors that mitigate against euphoria. Two related factors that influence interpretation of these reported outcomes are discussed, namely, noncompliance with therapeutic recommendations during treatment and subsequent to treatment termination, and relapse. Conceptual and methodological problems for establishing the prevalence of noncompliance and relapse are reviewed. Several factors that contribute to noncompliance (individual differences, nature of disease or injury, characteristics of the prescribed treatment regimen, health-care provider-patient relationship, and contextual) are discussed. The literature reveals that noncompliance with treatment regimens is quite prevalent across diverse treatment modalities and pain syndromes. The incidence of relapse following initially successful treatment of persistent pain also appears to be high, ranging from 30% to 60%. Studies on arthritis and heterogeneous pain clinic populations suggest that noncompliance and relapse are related; however, this association is less well established for headache patients. Strategies for assessing compliance (i.e., self-report, behavioral, biochemical, and clinical outcome) and the perspectives' of patients and health-care providers on the application of self-care recommendations are discussed. Strategic planning and adherence enhancement tactics to facilitate maintenance of post-treatment gains are described.

The robustness of an empirically derived taxonomy of chronic pain patients.

There is currently no classification system for chronic pain patients that has achieved consensus. The lack of a classification that is used consistently across settings has impaired advance of knowledge and treatment of chronic pain patients. Recently, an empirically derived multivariate classification system, the Multiaxial Assessment of Pain (MAP) patients, has been developed. In this paper, the generalizability of the MAP system was evaluated by contrasting the MAP classification of 3 common but diverse chronic pain syndromes, namely, low back pain, headache, and temporomandibular disorders. The results indicate that although the proportion of patients classified into the 3 subgroups of the MAP taxonomy differ, the profiles based on the pattern of interrelationship among the assessment scales were remarkably similar. These data suggest that the psychosocial and behavioral responses associated with chronic pain are common to diverse samples of pain patients despite differences in demographic characteristics and medical diagnosis. The implications of these results for research and clinical practice are discussed. The potential utility of a polydiagnostic approach using more traditional medically based classifications such as proposed by the IASP (Merskey, H., Pain, Suppl. 3 (1986) S1-S225) complemented by classification based on the MAP psychosocial-behaviorally based taxonomy are examined.

Neglected factors in chronic pain treatment outcome studies--referral patterns, failure to enter treatment, and attrition.

An increasing number of chronic pain treatment outcome studies have appeared in the literature. In general, these studies support the efficacy of multidisciplinary pain programs, as well as specific treatment modalities such as biofeedback and relaxation. Reviews of this literature have tended to be cautiously optimistic. Some concerns, however, have been raised about the methodological adequacy of these studies, particularly in terms of the lack of control groups, the brief duration of follow-up periods, and the vague criteria used for establishing the success of the therapeutic interventions. Other factors that mitigate conclusions regarding the generalizability of the favorable results reported need to be considered. In this paper 3 rarely discussed topics that are implicit within most treatment outcome studies and that need to be given greater attention are examined. These topics include: (1) referral patterns to pain clinics (who are referred to pain clinics, when, and how representative is the referred sample?); (2) failure to enter treatment (e.g., exclusion criteria, lack of available financial support to cover the cost of treatment, patient's refusal to accept recommendations), and consequently, the representativeness of the treated sample; and (3) patient's attrition. In this paper we discuss each of these factors as they underscore important qualifications that have to be made in evaluating treatment outcome studies.

IASP taxonomy of chronic pain syndromes: preliminary assessment of reliability.

Communication and consequently advancement of knowledge in understanding and treatment of chronic pain has been hindered by the absence of a taxonomy of chronic pain syndromes. Recently the IASP Subcommittee on Taxonomy proposed a classification method based on a multiaxial system. In the present study the interjudge reliability of 2 of the 5 axes, body location and presumed etiology are evaluated. Overall, axis I demonstrated good reliability, however, the reliability of several categories contained within this axis were low enough to suggest minor changes to this axis may increase its clinical utility. Axis V was found to have only fair reliability and many of the categories comprising this axis were demonstrated to have reliabilities that are not clinically acceptable. The implications of these results for future development and refinement of the IASP taxonomy are discussed.

The McGill Pain Questionnaire reconsidered: confirming the factor structure and examining appropriate uses.

A major problem in the understanding and psychological treatment of chronic pain patients is the inadequacy of available assessment procedures. Currently, the most frequently used instrument is the Pain Rating Index (PRI) of the McGill Pain Questionnaire, designed to assess 3 components of pain (i.e., sensory, affective, and evaluative) postulated by the Gate Control Theory. The PRI has been used in many studies to make differential diagnoses, to describe different groups of pain patients, and to identify the factor composition of the instrument itself. To date, however, no study has appropriately tested the a priori structure of the PRI or cross-validated it. Confirmatory factor analytic procedures employed in the present study supported Melzack's postulated tri-component structure of the PRI in 2 diverse samples of pain patients from different hospitals. However, the 3 components were found to be highly intercorrelated. Subsequent analyses revealed that the 3 components of the PRI do not display adequate discriminant validity. The current use of 3 subscales to establish differential diagnoses or patterns of different pain syndromes may lead to inappropriate classification and treatment decisions. The major conclusion of these findings is that use of only the total score of the PRI is appropriate for pain assessment.

Relationship of pain impact and significant other reinforcement of pain behaviors: the mediating role of gender, marital status and marital satisfaction.

The operant perspective of chronic pain emphasizes the important role of reinforcement contingencies in the maintenance of pain behaviors and the experience of pain. Patients' 'significant others' are viewed as primary reinforcing agents. The relationship between pain intensity, interference, and responses by significant others in maritally distressed, maritally satisfied, and unmarried samples of male and female pain patients and their significant others was examined in this study. Results revealed that only for married male patients significant other responses explained significant proportions of the variance in the impact of pain. Significant other responses failed to explain significant proportions of the variance for male patients living with non-married significant others. By way of contrast, for female patients pain impact and reinforcement variables were less highly associated in the married as compared to the unmarried patients. For both males and females, there were significantly higher correlations between significant other responses and pain impact levels for the maritally satisfied patients. These results provide qualified support for the operant formulation of the importance of reinforcement of pain behaviors by significant others, however, these responses appear to be dependent upon gender, marital status, and marital satisfaction. Thus, clinicians need to give greater attention to these variables when designing treatment plans.

Pain and families. II. Assessment and treatment.

This is the second part of an extended review on pain and families. The first paper dealt with the role of the family in the etiology and maintenance of chronic pain and discussed the impact of chronic pain on families. The paper will examine the role of the family in the assessment and treatment of chronic pain. Finally, problems of the theoretical models and empirical studies reviewed will be discussed and suggestions for future research will be presented.

Pain and families. I. Etiology, maintenance, and psychosocial impact.

This is the first part of a two-part extended review on the interdependency between chronic pain and families. This paper will address the role of the family in the etiology and maintenance of chronic pain and will describe the reciprocal impact of chronic pain on families. Different conceptualizations of the role of the family and the available empirical evidence related to 3 central questions, namely, 'do families play an etiological role in chronic pain?,' 'does the family maintain the chronic pain problem?,' and 'is there a negative impact of chronic pain on the family?' will be critically examined. The second, companion paper will address the issue of the inclusion of family members in the assessment and treatment of chronic pain. Finally, recommendations for future research will be made.

The disability determination dilemma: toward a multiaxial solution.

Recently the United States Social Security Administration Commission on the Evaluation of Pain recommended that a set of criteria be developed that could be used to determine 'impairment due primarily to pain.' The intention was to provide a specific and equitable system for determination of disability of social security claimants who alleged that they were disabled primarily by pain. In this paper, the social security disability determination process is described, criteria for the proposed listing of 'impairment due primarily to pain' are reviewed, and a multiaxial taxometric system for determining disability due primarily to pain is described. The social implications of the proposed listing as well as a multiaxial taxometric approach for the social security disability system are described. Impediments to solutions to the disability determination problems confronting the Social Security Administration are discussed, and a scientific approach is contrasted with the current legal decision making process, as it relates to the awarding of Social Security disability benefits.

Differential utility of medical procedures in the assessment of chronic pain patients.

Physicians are frequently called upon to evaluate patients with chronic pain to (1) establish the etiology, (2) determine the extent of impairment and disability, and (3) prescribe treatment. In many cases, there is little agreement as to what evaluation procedures should be used or how to weight and integrate these findings. Two studies were conducted to determine the domain of procedures pain specialists believe are most important in evaluation and the clinical utility of each. A survey of 75 physicians specializing in the treatment of chronic pain was conducted. Coefficients of concordance indicated that physicians displayed substantial agreement as to the differential utility of 18 physical examination and diagnostic procedures. The relevance of each of these procedures in the assessment of 100 pain patients was evaluated. Differential weights for each procedure derived from the survey were highly correlated with clinical practice. The results of the present studies provide a basis for development of a standardized assessment procedure that incorporates statistically derived weights to quantify medical findings.

Chronic pain and depression: toward a cognitive-behavioral mediation model.

Although considerable attention has recently been devoted to explaining why depression is a frequent concomitant of chronic pain, little empirical work has been conducted to test predictions based on these models. The present study was designed to test a cognitive-behavioral mediation model of pain and depression that proposes perceived reduction in instrumental activities along with a decline in perceptions of control and personal mastery are necessary prerequisites for the development of depressive symptomatology in pain patients. According to this model, in contrast to alternative models, the presence of pain is not sufficient condition for the subsequent development of depression. This model was tested and confirmed through the application of structural modeling with latent variables. Specifically, the direct link between pain and depression was found to be non-significant, however, measures of perceived life interference and self-control were found to be significant intervening variables between pain and depression. These results provide the first empirical demonstration that psychological mediators may be involved in the development of depression secondary to chronic pain. The findings of this study are contrasted with single-factor models that postulate both chronic pain and depression as resulting from a common cause.

Neglected topics in chronic pain treatment outcome studies: determination of success.

Although literature on chronic pain treatment outcome has made substantial strides in improving the quality of the studies reported, there remain a number of factors that lead to qualification of the generally positive results. In the two previous papers in this series a set of migrating factors was discussed, namely, representativeness of the samples treated in these outcome studies, relapse, and non-compliance with therapeutic recommendations. Additional limitations include the lack of agreement on the criteria on which to base evaluation of the success of treatment outcome and the percentage of treated patients included in follow-up data. In this paper, the most common methods for determining success are described (group effects based on standard and quasi-standard outcome measures). The limitations of this approach are discussed and alternative strategies are presented that focus not only on traditional criteria based on group means but on additional criteria including: (a) importance of change (i.e., clinical vs. statistical significance), (b) proportion of patients who improve, (c) cost, (d) efficiency in treatment delivery, (e) and consumer acceptance and satisfaction.