Dennis R. Wahlgren

A placebo-controlled randomized clinical trial of nortriptyline for chronic low back pain

&NA; To assess the efficacy of nortriptyline, a tricyclic antidepressant, as an analgesic in chronic back pain without depression, we conducted a randomized, double‐blind, placebo‐controlled, 8‐week trial in 78 men recruited from primary care and general orthopedic settings, who had chronic low back pain (pain at T‐6 or below on a daily basis for 6 months or longer). Of these 57 completed the trial; of the 21 who did not complete, four were withdrawn because of adverse effects. The intervention consisted of inert placebo or nortriptyline titrated to within the therapeutic range for treating major depression (50–150 ng/ml). The main outcome endpoints were pain (Descriptor Differential Scale), disability (Sickness Impact Profile), health‐related quality of life (Quality of Well‐Being Scale), mood (Beck Depression Inventory, Spielberger State Anxiety Inventory, Hamilton Anxiety/Depression Rating Scales), and physician rated outcome (Clinical Global Impression). Reduction in pain intensity scores was significantly greater for participants randomized to nortriptyline (difference in mean change 1.68, 95% −0.001, CI −3.36, P=0.050), with a reduction of pain by 22% compared to 9% on placebo. Reduction in disability marginally favored nortriptyline (P=0.055), but health‐related quality of life, mood, and physician ratings of overall outcome did not differ significantly between treatments. Subgroup analyses of study completers supported the intent‐to‐treat analysis. Also, completers with radicular pain on nortriptyline (n=5) had significantly (P<0.05) better analgesia and overall outcome than did those on placebo (n=6). The results suggest noradrenergic mechanisms are relevant to analgesia in back pain. This modest reduction in pain intensity suggests that physicians should carefully weigh the risks and benefits of nortriptyline in chronic back pain without depression.

Effects of noradrenergic and serotonergic antidepressants on chronic low back pain intensity.

To understand the relative efficacy of noradrenergic and serotonergic antidepressants as analgesics in chronic back pain without depression, we conducted a randomized, double-blind, placebo-control head-to-head comparison of maprotiline (a norepinephrine reuptake blocker) and paroxetine (a serotonin reuptake blocker) in 103 patients with chronic low back pain. Of these 74 completed the trial; of the 29 who did not complete, 19 were withdrawn because of adverse effects. The intervention consisted of an 8-week course of maprotiline (up to 150 mg daily) or paroxetine (up to 30 mg daily) or an active placebo, diphenhydramine hydrochloride (up to 37.5 mg daily). Patients were excluded for current major depression. Reduction in pain intensity (Descriptor Differential Scale scores) was significantly greater for study completers randomized to maprotiline compared to placebo (P=0.023), and to paroxetine (P=0.013), with a reduction of pain by 45% compared to 27% on placebo and 26% on paroxetine. These results suggest that at standard dosages noradrenergic agents may provide more effective analgesia in back pain than do selective serotonergic reuptake inhibitors.

The contribution of job satisfaction to the transition from acute to chronic low back pain

OBJECTIVE To determine the extent to which job satisfaction predicts pain, psychological distress, and disability 6 months after an initial episode of low back pain (LBP). DESIGN A longitudinal design was used to follow an inception cohort experiencing first-episode low back pain with assessment at 2 and 6 months after pain onset. SETTING Urban medical center outpatient orthopedic clinic. PATIENTS The consecutive sample was comprised of 82 men with initial-onset acute LBP (T6 or below, daily pain for 6 to 10 weeks). INTERVENTION Usual orthopedic care. MAIN OUTCOME MEASURES The primary study outcomes were pain (Descriptor Differential Scale, Visual Analog Scales); disability (Sickness Impact Profile, Quality of Well-Being); and psychological distress (Beck Depression Inventory, Hamilton Rating Scale for Depression, Automatic Thoughts Questionnaire); predictor variables were orthopedic impairment (Waddell Physical Impairment Index) and job satisfaction (Job Descriptive Index, Work APGAR). RESULTS Measures of job satisfaction, pain, disability, and psychological distress at baseline and 6 months after pain onset were separately reduced into factors using principle components factor analysis. In hierarchical multiple regression analyses, baseline job satisfaction significantly predicted variance in outcome scores at 6 months after pain onset, beyond the variance explained by control factors (demographics; baseline pain, mood, and disability; orthopedic impairment). Zero-order correlations between job satisfaction and orthopedic impairment were small and nonsignificant, suggesting that these two variables act independently in predicting outcome. Although type of work performed (desk work or work requiring light, moderate, or heavy lifting) and social position were correlated with job satisfaction at baseline, neither contributed to the prediction of outcome at 6 months. CONCLUSIONS Satisfaction with ones job may protect against development of chronic pain and disability after acute onset back pain and, alternatively, dissatisfaction may heighten risk of chronicity. Vocational factors should be considered in the rehabilitation of acute back injury.

Reduction of environmental tobacco smoke exposure in asthmatic children. A 2-year follow-up.

STUDY OBJECTIVE To examine the long-term maintenance of a previously reported behavioral counseling intervention to reduce asthmatic childrens exposure to environmental tobacco smoke (ETS). PARTICIPANTS Families of asthmatic children (6 to 17 years), including at least one parent who smoked in the home, recruited from four pediatric allergy clinics. DESIGN Participants were randomized to one of three groups: behavioral counseling to reduce ETS exposure, self-monitoring control, and usual medical care control. Counseling concluded at month 6, and the original trial ended at month 12. Two follow-up interviews occurred at months 20 and 30. MEASUREMENTS AND RESULTS The originally reported analysis of baseline to 12 months was reanalyzed with a more robust restricted maximum likelihood procedure. The 2-year follow-up period was analyzed similarly. Significantly greater change occurred in the counseling group than the control groups and was sustained throughout the 2 years of follow-up. Further exploratory analyses suggested that printed counseling materials given to all participants at month 12 (conclusion of the original study) were associated with decreased exposure in the control groups. CONCLUSION Such long-term maintenance of behavior change is highly unusual in the general behavioral science literature, let alone for addictive behaviors. We conclude that ETS exposure can be reduced and that a clinician-delivered treatment may provide substantial benefit.

One-year follow-up of first onset low back pain

&NA; Efforts to examine the process and risk of developing chronic back pain have relied generally upon retrospective study of individuals with already established pain. In an alternative approach to understanding the clinical course and evolution of low back disorders, a cohort of 76 men experiencing their first episode of back pain was assessed prospectively at 2, 6 and 12 months following pain onset. Standard measures of pain (Descriptor Differential Scale: DDS), disability (Sickness Impact Profile: SIP), and distress (Beck Depression Inventory: BDI) were employed to classify the sample into five groups: Resolved, Pain Only, Disability/Distress Only, Pain and Mild Disability/Distress, and Clinical Range. At both 6 and 12 months post pain onset, most (78%, 72% respectively) of the sample continued to experience pain. Many also experienced marked disability at 6 months (26%) and 12 months (14%). At 12 months, no participants had worsened relative to the 2‐month baseline. Doubly multivariate analyses of variance (MANOVAs) were employed to compare baseline groups (Pain Only, Pain and Mild Disability/Distress, Clinical Range) on the DDS, SIP, and BDI across time. The group by time interaction from 2 through 12 months was reliable, with greatest change occurring in the Clinical Range group in disability and distress; interestingly, the decrease in pain was comparable among all groups. Follow‐up tests across measures demonstrated greater change in the early (2–6‐month) interval and relative stability in the later (6–12‐month) interval. Comparison of those classified as ‘improvers’ with those who did not improve from 2 to 12 months showed similar findings. The clinical course of first onset back pain may be prolonged for many patients, and involves a continuum of related disability and distress. Individuals at risk for marked symptoms 1 year after an initial episode of back pain can be identified early, and prompt treatment might reduce the risk of pain chronicity.

Clinical Investigations: AsthmaReduction of Environmental Tobacco Smoke Exposure in Asthmatic Children: A 2-Year Follow-up

STUDY OBJECTIVE To examine the long-term maintenance of a previously reported behavioral counseling intervention to reduce asthmatic childrens exposure to environmental tobacco smoke (ETS). PARTICIPANTS Families of asthmatic children (6 to 17 years), including at least one parent who smoked in the home, recruited from four pediatric allergy clinics. DESIGN Participants were randomized to one of three groups: behavioral counseling to reduce ETS exposure, self-monitoring control, and usual medical care control. Counseling concluded at month 6, and the original trial ended at month 12. Two follow-up interviews occurred at months 20 and 30. MEASUREMENTS AND RESULTS The originally reported analysis of baseline to 12 months was reanalyzed with a more robust restricted maximum likelihood procedure. The 2-year follow-up period was analyzed similarly. Significantly greater change occurred in the counseling group than the control groups and was sustained throughout the 2 years of follow-up. Further exploratory analyses suggested that printed counseling materials given to all participants at month 12 (conclusion of the original study) were associated with decreased exposure in the control groups. CONCLUSION Such long-term maintenance of behavior change is highly unusual in the general behavioral science literature, let alone for addictive behaviors. We conclude that ETS exposure can be reduced and that a clinician-delivered treatment may provide substantial benefit.

Preventing Progression to Chronicity in First Onset, Subacute Low Back Pain: An Exploratory Study

OBJECTIVES To evaluate the effects of a behavioral medicine intervention, relative to an attention control, in preventing chronic pain and disability in patients with first-onset, subacute low back pain (LBP) with limitations in work-role function. DESIGN A 2-group, experimental design with randomization to behavioral medicine or attention control groups. SETTING Orthopedic clinic at a Naval Medical Center. PARTICIPANTS Sixty-seven participants with first-onset LBP of 6 to 10 weeks of duration and impairment in work function, of whom 50 completed all 4 therapy sessions and follow-up 6 months after pain onset. INTERVENTION Four 1-hour individual treatment sessions of either behavioral medicine, focused on back function and pain education, self-management training, graded activity increases, fear reduction, and pain belief change; or attention control condition, focused on empathy, support, and reassurance. MAIN OUTCOME MEASURES The primary outcome was proportion of participants classified as recovered, according to pre-established clinical cutoffs on standardized measures, signifying absence of chronic pain and disability at 6 months after pain onset. Secondary analyses were conducted on pain, disability, health status, and functional work category. Intervention credibility and pain belief manipulation checks were also evaluated. RESULTS Chi square analyses comparing proportions recovered at 6 months after pain onset for behavioral medicine and attention control participants found relative rates of 52% versus 31% in the modified intent-to-treat sample (P=.09) and 54% versus 23% for those completing all 4 sessions and 6-month follow-up (P=.02). At 12 months, 79% of recovered and 68% of chronic pain participants still met criteria for their respective groups (P<.0001). Recovered participants also had higher rates of functional work status recovery at 12 months (recovered: 96% full duty and 4% light duty; chronic pain: 61% full duty, 18% light duty, and 21% medical discharge, respectively; P=.03). CONCLUSIONS Early intervention using a behavioral medicine rehabilitation approach may enhance recovery and reduce chronic pain and disability in patients with first-onset, subacute LBP. Effects are stronger for participants attending all 4 sessions and the follow-up assessment.

Involuntary smoking and asthma.

Involuntary smoking is the third leading preventable cause of death, and among children it causes lower respiratory infections, middle ear disease, sudden infant death syndrome, and asthma. Half the worlds children may be exposed to environmental tobacco smoke (ETS), exacerbating symptoms in 20% of children with asthma. Recent studies have reinforced previous conclusions that ETS exposure causes onset of childhood asthma and exacerbation of symptoms throughout life. The exact mechanisms by which this is accomplished are still unclear, as are the relative contributions of prenatal versus postnatal exposure. However, favorable health outcomes can be attained with reduced exposure. Among the few studies of ETS exposure reduction interventions, low-intensity advice methods appeared ineffective, and counseling parent smokers appeared successful. Direct counseling of school-aged children to avoid ETS has yet to be tested. Community norms may need to shift further in favor of protecting children and others from ETS before minimal interventions can be successful. This will require combined and ongoing efforts of the medical and public health establishments, in concert with legislation mandating tobacco-free public places and with ETS-related media campaigns.

Increasing asthma knowledge and changing home environments for Latino families with asthmatic children

We tested an asthma education program in 204 underserved Latino families with an asthmatic child. The education program consisted of one or two sessions delivered in each familys home in the targeted participants preferred language by a bilingual, bicultural educator. We encouraged, but did not require, attendance by the child. The curriculum was culturally-tailored, and all participants received education on understanding asthma, preventing asthma attacks, and managing asthma. Outcomes included change in asthma knowledge and change in home environment asthma management procedures. Asthma knowledge increased significantly (39 to 50% correct from pre- to post-test, P < 0.001) and participants made significant changes to the childs bedroom environment (mean number of triggers decreased from 2.4 to 1.8, P < 0.001; mean number of controllers increased from 0.7 to 0.9, P < 0.001). The results support the value of asthma education and its importance in the national agenda to reduce health disparities among minorities.

Toward a simplified measure of asthma severity for applied research.

There is no universally accepted and validated measure of asthma severity. For community research, clinical tests are too costly, and epidemiological assessments provide inadequate data on severity. Symptom measures may offer a practical alternative. This study assessed psychometric properties of symptom ratings of 91 asthmatic children. Reliability and validity of scales created from these items were examined. A sum scale of symptom ratings was internally consistent, reliable across time, and associated with concurrent health indices. This scale may be a practical measure of severity for use in community-based research.