Publications

Removal of opioid/acetaminophen combination pain medications: evidence for hepatotoxicity and consequences of removal.

Michna E, Duh MS, Korves C, et al.
Pain Med. 2010;11(3):369-78.

Opioid/acetaminophen combination products are widely prescribed for the management of moderate to moderately severe pain. Acetaminophen, when improperly used, can lead to liver damage and even acute liver failure. In June 2009, an FDA advisory committee recommended elimination of prescription acetaminophen combination products because of the risk of hepatotoxicity associated with use of these medications. The FDA advisory committee reviewed numerous observational studies and adverse event reporting data. The aims of this article are to: 1) provide a summary and epidemiologic critique of the studies and evidence the FDA advisory committee reviewed; 2) examine the potential consequences, such as poorly managed pain or a shift to treatment with other medications with greater potential toxicity and/or restricted availability, if the FDA follows the advisory committee vote; and 3) outline alternate strategies the FDA should consider for reducing hepatotoxicity associated with opioid/acetaminophen combination products.

A comprehensive protocol to diagnose and treat pain of muscular origin may successfully and reliably decrease or eliminate pain

Marcus NJ, Gracely EJ, Keefe KO.
Pain Med. 2010 Jan;11(1):25-34.

OBJECTIVE: A comprehensive protocol is presented to identify muscular causes of regional pain syndromes utilizing an electrical stimulus in lieu of palpation, and combining elements of Prolotherapy with trigger point injections. METHODS: One hundred seventy-six consecutive patients were evaluated for the presence of muscle pain by utilizing an electrical stimulus produced by the Muscle Pain Detection Device. The diagnosis of "Muscle Pain Amenable to Injection" (MPAI), rather than trigger points, was made if pain was produced for the duration of the stimulation. If MPAI was found, muscle tendon injections (MTI) were offered to patients along with post-MTI physical therapy, providing neuromuscular electrical stimulation followed by a validated exercise program [1]. A control group, evaluated 1 month prior to their actual consultation/evaluation when muscle pain was identified but not yet treated, was used for comparison. RESULTS: Forty-five patients who met criteria completed treatment. Patients' scores on the Brief Pain Inventory decreased an average of 62%; median 70% (P < 0.001) for pain severity and 68%; median 85% (P < 0.001) for pain interference one month following treatment. These changes were significantly greater (P < 0.001) than those observed in the untreated controls. CONCLUSION: A protocol incorporating an easily reproducible electrical stimulus to diagnose a muscle causing pain in a region of the body followed by an injection technique that involves the entirety of the muscle, and post injection restoration of muscle function, can successfully eliminate or significantly reduce regional pain present for years.

Chronic opioid therapy and preventive services in rural primary care: an Oregon rural practice-based research network study.

Buckley DI, Calvert JF, Lapidus JA, et al.
Ann Fam Med. 2010;8(3):237-44.

PURPOSE: For clinicians, using opioid therapy for chronic noncancer pain (CNCP) often gives rise to a conflict between treating their patients' pain and fears of addiction, diversion of medication, or legal action. Consequent stresses on clinical encounters might adversely affect some elements of clinical care. We evaluated a possible association between chronic opioid therapy (COT) for CNCP and receipt of various preventive services. METHODS: We conducted a retrospective cohort study in 7 primary care clinics within the Oregon Rural Practice-based Research Network (ORPRN). Using medical records of 704 patients, aged 35 to 85 years, seen during a 3-year period, we compared the receipt of 4 preventive services between patients on COT for CNCP and patients not on chronic opioid therapy (non-COT). We used multivariate log-binomial regression analyses to estimate the relative risk of receipt of each preventive service. RESULTS: After adjustment for plausible confounders, we found that patients using COT had a statistically significantly lower relative risk (RR) of receipt of cervical cancer screening (RR = 0.60; 95% confidence interval [CI], 0.47-0.76) and colorectal cancer screening (RR = 0.42; 95% CI, 0.22-0.80) when compared with non-COT patients. The RR was reduced, without statistical significance, for lipid screening (RR = 0.77; 95% CI, 0.54-1.10), and not notably reduced for smoking cessation counseling (RR = 0.95; 95% CI, 0.78-1.15). CONCLUSIONS: Patients using COT for CNCP were less likely to receive some preventive services. Research is needed to better understand barriers to and improved methods for providing preventive services for these patients.

Cost Utility Analysis of Interdisciplinary Early Intervention vs Treatment as Usual For High-Risk Acute Low Back Pain Patients

Rogerson MD, Gatchel RJ, Bierner SM.
Pain Pract. 2010 Apr 5.

Abstract Chronic pain is a costly and debilitating condition that has proven difficult to treat, solely with medical interventions, due to the complex interplay of biological, psychological, and social factors in its onset and persistence. Many studies have demonstrated the effectiveness of interdisciplinary treatment that includes psychosocial interventions for low back pain. Nevertheless, these interventions continue to be under-utilized due to concerns of cost and applicability. The present study utilized a cost utility analysis to evaluate effectiveness and associated costs of interdisciplinary early intervention for individuals with acute low back pain that was identified as high-risk for becoming chronic. Treatment effectiveness was evaluated using a standard pain measure and quality-adjusted life years, and associated medical and employment costs were gathered for 1 year. Results indicated that subjects improved significantly from pretreatment to 1-year follow-up, and that the early intervention group reported fewer health-care visits and missed workdays than the treatment as usual group. The majority of 1,000 bootstrapped samples demonstrated the dominance of the early intervention program as being both more effective and less costly from a societal perspective. The early intervention treatment was the preferred option in over 85% of samples within an established range of acceptable costs. These results are encouraging evidence for the cost-effectiveness of interdisciplinary intervention and the benefits of targeted early treatment.

Validation of proposed diagnostic criteria (the "Budapest Criteria") for Complex Regional Pain Syndrome.

Harden RN, Bruehl S, Perez RS, et al.
Pain. 2010 May 19.

rrent IASP diagnostic criteria for CRPS have low specificity, potentially leading to overdiagnosis. This validation study compared current IASP diagnostic criteria for CRPS to proposed new diagnostic criteria (the "Budapest Criteria") regarding diagnostic accuracy. Structured evaluations of CRPS-related signs and symptoms were conducted in 113 CRPS-I and 47 non-CRPS neuropathic pain patients. Discriminating between diagnostic groups based on presence of signs or symptoms meeting IASP criteria showed high diagnostic sensitivity (1.00), but poor specificity (0.41), replicating prior work. In comparison, the Budapest clinical criteria retained the exceptional sensitivity of the IASP criteria (0.99), but greatly improved upon the specificity (0.68). As designed, the Budapest research criteria resulted in the highest specificity (0.79), again replicating prior work. Analyses indicated that inclusion of four distinct CRPS components in the Budapest Criteria contributed to enhanced specificity. Overall, results corroborate the validity of the Budapest Criteria and suggest they improve upon existing IASP diagnostic criteria for CRPS. Copyright © 2010. Published by Elsevier B.V.

Chronic musculoskeletal pain and the occurrence of falls in an older population.

Leveille SG, Jones RN, Kiely DK, et al.
JAMA. 2009;302(20):2214-21.

CONTEXT: Chronic pain is a major contributor to disability in older adults; however, the potential role of chronic pain as a risk factor for falls is poorly understood. OBJECTIVE: To determine whether chronic musculoskeletal pain is associated with an increased occurrence of falls in a cohort of community-living older adults. DESIGN, SETTING, AND PARTICIPANTS: The Maintenance of Balance, Independent Living, Intellect, and Zest in the Elderly (MOBILIZE) Boston Study is a population-based longitudinal study of falls involving 749 adults aged 70 years and older. Participants were enrolled from September 2005 through January 2008. MAIN OUTCOME MEASURE: Participants recorded falls on monthly calendar postcards mailed to the study center during an 18-month period. RESULTS: There were 1029 falls reported during the follow-up. A report of 2 or more locations of musculoskeletal pain at baseline was associated with greater occurrence of falls. The age-adjusted rates of falls per person-year were 1.18 (95% confidence interval [CI], 1.13-1.23) for the 300 participants with 2 or more sites of joint pain, 0.90 (95% CI, 0.87-0.92) for the 181 participants with single-site pain, and 0.78 (95% CI, 0.74-0.81) for the 267 participants with no joint pain. Similarly, more severe or disabling pain at baseline was associated with higher fall rates (P < .05). The association persisted after adjusting for multiple confounders and fall risk factors. The greatest risk for falls was observed in persons who had 2 or more pain sites (adjusted rate ratio [RR], 1.53; 95% CI, 1.17-1.99), and those in the highest tertiles of pain severity (adjusted RR, 1.53; 95% CI, 1.12-2.08) and pain interference with activities (adjusted RR, 1.53; 95%CI, 1.15-2.05), compared with their peers with no pain or those in the lowest tertiles of pain scores. CONCLUSIONS: Chronic pain measured according to number of locations, severity, or pain interference with daily activities was associated with greater risk of falls in older adults.

Alteration of cortical excitability in patients with fibromyalgia.

Mhalla A, de Andrade DC, Baudic S, Perrot S, Bouhassira D.
Pain. 2010 Mar 30.
We assessed cortical excitability and intracortical modulation systematically, by transcranial magnetic stimulation (TMS) of the motor cortex, in patients with fibromyalgia. In total 46 female patients with fibromyalgia and 21 normal female subjects, matched for age, were included in this study. TMS was applied to the hand motor area of both hemispheres and motor evoked potentials (MEPs) were recorded for the first interosseous muscle of the contralateral hand. Single-pulse stimulation was used for measurements of the rest motor threshold (RMT) and suprathreshold MEP. Paired-pulse stimulation was used to assess short intracortical inhibition (SICI) and intracortical facilitation (ICF). Putative correlations were sought between changes in electrophysiological parameters and major clinical features of fibromyalgia, such as pain, fatigue, anxiety, depression and catastrophizing. The RMT on both sides was significantly increased in patients with fibromyalgia and suprathreshold MEP was significantly decreased bilaterally. However, these alterations, suggesting a global decrease in corticospinal excitability, were not correlated with clinical features. Patients with fibromyalgia also had lower ICF and SICI on both sides, than controls, these lower values being correlated with fatigue, catastrophizing and depression. These neurophysiological alterations were not linked to medication, as similar changes were observed in patients with or without psychotropic treatment. In conclusion, fibromyalgia is associated with deficits in intracortical modulation involving both GABAergic and glutamatergic mechanisms, possibly related to certain aspects of the pathophysiology of this chronic pain syndrome. Our data add to the growing body of evidence for objective and quantifiable changes in brain function in fibromyalgia. Copyright © 2010 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.

Pain Quality Predicts Lidocaine Analgesia among Patients with Suspected Neuropathic Pain

Carroll IR, Younger JW, Mackey SC.
Pain Med. 2010 Mar 4.
Abstract Objective. Oral sodium channel blockers have shown mixed results in randomized controlled trials despite the known importance of sodium channels in generating pain. We hypothesized that differing baseline pain qualities (e.g. "stabbing" vs "dull") might define specific subgroups responsive to intravenous (IV) lidocaine-a potent sodium channel blocker. Design. A prospective cohort study of 71 patient with chronic pain suspected of being neuropathic were recruited between January 2003 and July 2007 and underwent lidocaine infusions at Stanford University Hospital in a single-blind nonrandomized fashion. Baseline sensory pain qualities were measured with the Short-Form McGill Pain Questionnaire (SF-MPQ). Pain intensity was measured with a visual analog scale (VAS). Results. Factor analysis demonstrated two underlying pain quality factors among SF-MPQ sensory items: a heavy pain and a stabbing pain. Baseline heavy pain quality, but not stabbing quality predicted subsequent relief of pain intensity in response to lidocaine. In contrast, these factors did not predict divergent analgesic responses to placebo infusions. In response to each 1 mcg/mL increase in lidocaine plasma level, patients with high heavy pain quality drop their VAS 0.24 (95% CI 0.05-0.43) more points than those with low heavy pain quality (P < 0.013). Conclusions. "Heavy" pain quality may indentify patients with enhanced lidocaine responsiveness. Pain quality may identify subgroups among patients with suspected neuropathic pain responsive to IV lidocaine. Further investigation is warranted to validate and extend these findings.

Indirect costs associated with surgery for low back pain-a secondary analysis of clinical trial data.

Fayssoux R, Goldfarb NI, Vaccaro AR, Harrop J.
Popul Health Manag. 2010;13(1):9-13.

This study examines the indirect costs associated with surgery for axial low back pain using data obtained from a prospective multicenter clinical trial that compared Charité artificial disc replacement with anterior lumbar interbody fusion using iliac crest bone graft. While 75% of study subjects reported full- or part-time employment prior to surgery, this percentage dropped to 45% at 6 weeks postoperatively. Return to preoperative employment levels occurred at approximately 6 months postoperatively. Two years after surgery, employment levels were 16% higher than preoperative levels. Lost productivity related to absenteeism resulted in lost wages averaging $2884 per patient during the first postoperative year. Although short-term indirect costs of surgery are substantial from a societal perspective, the higher employment rate at 2 years suggests a long-term economic benefit. The findings demonstrate the significant, though not surprising, impact of spinal disability on productivity, and the importance of including measurement of lost productivity and return to work in the economic evaluation of related interventions.

Developing a minimum standard of care for treating people with osteoarthritis of the hip and knee.

March L, Amatya B, Osborne RH, Brand C.
Best Pract Res Clin Rheumatol. 2010;24(1):121-45.
We reviewed three recently published guidelines for the management of osteoarthritis (OA) and considered the evidence and potential for implementation. From this we propose a minimum standard of care, or a 'core set' of interventions, that should be offered to all patients with OA of the hip and/or knee. Eight core recommendations emerged where it is recommended that health-care professionals: Provide advice about, and offer access to appropriate information for OA self-management and lifestyle change; Provide advice about weight loss if patient is overweight or obese and refer to services as required; Provide advice for land-based exercises incorporating aerobic and strengthening components and refer to services as required; Recommend adequate paracetamol for pain relief; Make patients aware that non-steroid anti-inflammatory drugs (NSAIDs) or coxibs can improve symptoms in majority but this comes with potential for harm and that risk potential varies--be aware of and minimise the individual's risk potential; Offer intra-articular steroids for short-term relief of a flare or acute deterioration in symptoms; Offer stronger analgesic relief if prolonged severe symptoms; Offer access to assessment for arthroplasty for consumers with severe symptomatic OA not responding to conservative therapy. An integrated, chronic disease model of care is proposed to best implement OA management and a check list of clinical indicators/performance measures is provided. Copyright 2009. Published by Elsevier Ltd.

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