(876) Validation and clincial application of actigraphy for paintreatment outcomes assessment

R Gironda, M Clark; James A. Haley Veterans Hospital, Tampa, FLFunctional restoration is a primary objective of most chronic pain reha-bilitative interventions, yet few clinically practical objective measures ofphysical activation exist. Actigraphy recently has been recognized as atechnology that could fill this void in the field of pain outcomes assess-ment. Typically configured as small, watch-like devices, actigraphs pro-vide a relatively unobtrusive method for capturing activity over an ex-tended period of time while patients are living in the naturalenvironments. The purpose of this paper is to discuss preliminary datafrom two phases of a multiphase project to validate the Actiwatch-Score(AW-S) as a pain treatment outcome measure and to consider the rangeof potential clinical applications of this accelerometer-based technol-ogy. In Phase I of the project, separate trials were conducted to examineconcordance between units when worn at the same and different bodysites and to compare the AW-S to a validated, optical three-dimensionalmotion tracking system. Phase II of the project is an evaluation of theAW-S’s accuracy in predicting the energy expenditure (as measured byoxygen uptake analysis) of chronic pain patients during a series of stan-dardized physical tasks. The results of these studies indicate that theAW-S has excellent inter-unit reliability and good criterion validity. Thepotential clinical applications of actigraphy will be discussed, and rele-vant case examples will be presented.

(877) Application of selected American Pain Society 2005quality indicators for acute and cancer pain

K Kaiser, J Dupee, L Petri, J Hill, D Smith; University of Maryland Medical Center,Baltimore, MDInadequate management of pain in hospitalized patients continues tobe a prevalent problem despite over 10 years of quality improvementefforts. To facilitate improvement, the American Pain Society (APS) up-dated recommendations for measuring the quality of acute and cancerpain management in 2005. Use of these new indicators has not beendescribed. This secondary analysis uses data collected from over 800patients in a tertiary academic medical center’s pain quality improve-ment program during January to June 2005 to: 1) describe results asso-ciated with selected 2005 APS quality indicators, 2) describe benefits andlimitations associated with these measures and 3) compare and contrastthese measures to measures utilized by the data collection site. Use ofthe APS recommended measure - documentation of pain intensity atfrequent intervals - resulted in over 4175 (M�5.15, SD�3.32), 2032(M�2.51, SD�2.34), and 1922 (M�2.37, SD �2.29), pain scores docu-mented with routine vital signs, pre analgesic administration, and postanalgesic administration, respectively for a total of over 8,129 docu-mented pain scores. This recommended APS measure lacks a metric,making it difficult to measure compliance with institutional standardsand demonstrate improvement over time since the number of painscores obtained varies based on the patient. Establishment of popula-tion specific standards (e.g., with routine vital signs, pre- and post-anal-gesic administration) and use of these as denominators provides a com-pliance rate. Use of such metrics resulted in the following approximaterates: 93% - pain scores with screening, 88% - pre-analgesic pain scores,and 84% - post analgesic pain scores for the 6 month period and eluci-dates where pain score monitoring improvements are needed. Resultsfrom other recommended APS quality improvement measures and al-ternative measures are similarly described. The results of this study sug-gest some revised 2005 APS quality measures warrant modification toprovide institutions with actionable quality improvement data.

(878) Chronic low back pain: Neurophysiological outcomes oftreatment

A Fann, M Preston, R Skinner, E Garcia-Rill; Central Arkansas Veterans Health-care System, Little Rock, ARChronic low back pain (CLBP) is associated with attentional deficits.Previous work has shown that patients with CLBP with and withoutco-morbidities of depression (DEP) and post-traumatic stress disorder(PTSD) appear to have a dysfunction in their pre-attentional and atten-tional pathways. The overall goals of this study were to determine iftreatment modulated pre-attentional (measured by P50 AuditoryEvoked Potential [AEP] studies), attentional (measured by PsychomotorVigilance Task [PVT]) and frontal lobe function (determined by relativefrontal lobe blood flow measured using Near Infrared Spectroscopy[NIRS]) in subjects with CLBP. We hypothesized that the neurophysiolog-ical measures would normalize if clinical measures improved. Thirteensubjects with CLBP only, 11 with CLBP�DEP, and 6 with CLBP�PTSDwere recruited. Assessments were administered at baseline and eightweeks after the beginning of treatment. These assessments included P50AEP, PVT, NIRS, McGill Pain Questionnaire (MPQ-SF) and General HealthSurvey-Short Form (SF-36). After treatment, the MPQ-SF total pain scoreimproved in CLBP and CLBP�DEP (p�0.05), but not in those withCLBP�PTSD (p�0.16). Physical functioning as measured by the SF-36improved in CLBP only and CLBP�DEP (p�0.05). P50 AEP amplitude(measure of arousal) increased significantly in CLBP and CLBP�DEP(p�0.05). There was no significant change in P50 AEP habituation in anygroup. There was a trend of improvement in the PVT minimal values andlapses in all groups, but none reached significance except PVT minimumvalues in CLBP�PTSD (p�0.05). There were no significant differences inthe NIRS values. In conclusion, the patients with CLBP with and withoutco-morbidities of DEP and PTSD respond differently to treatment. Neu-rophysiological measures of arousal and attention may be useful out-come measures for patients with chronic pain because they can be anobjective physiological measure of decreased pain independent of asubjective measure of pain.

(879) Outcomes associated with tramadol extended release:Relationships between pain reduction, sleep, andhealth-related quality of life in patients with osteoar-thritis

J Schein, M Kosinski, C Janagap, K Gajria, P Lin, J Freedman; Ortho-McNeilJanssen Scientific Affairs, LLC, Raritan, NJChronic osteoarthritis (OA) pain impacts many aspects of a patient’s lifeincluding sleep, functional status, activities of daily living, and health-related quality of life (HRQoL). This 12-week, randomized, double-blind,placebo-controlled study included 1,020 adults with OA of the knee orhip. Patients were randomly assigned to receive either placebo or ti-trated tramadol Extended Release (ER) to a target dose of 100, 200, 300,or 400 mg once daily. At baseline and after 12 weeks of treatment,patients completed a pain intensity visual analog scale, the WOMACOA-Index, the SF-36 Health Survey, and a sleep problems index. Analysisof variance with treatment and study site as factors were used to com-pare changes from baseline to 12 weeks between tramadol ER andplacebo. Compared with placebo, patients receiving all tramadol ERstrengths showed significant improvements in pain intensity (p�0.01).All tramadol ER dose groups showed significantly larger improvementscompared with placebo on the pain, physical function, and stiffnessscales and the summary index of the WOMAC (p�0.05). Sleep improvedsignificantly (p�0.02) relative to placebo for tramadol ER 100-, 200-, and300-mg strengths. While all tramadol dose groups showed significantlygreater improvement (p�0.01) on the SF-36 bodily pain scale comparedwith placebo, the tramadol 200-mg group showed the greatest HRQoLimprovements -- 5 of 8 SF-36 scales and both physical and mental sum-mary measures reached statistical significance (p�0.05). The largest im-provements in sleep and functionality were also observed with the200-mg dose. Tramadol ER showed significant improvements in painreduction, sleep, functionality, and HRQoL. The 200-mg strengthshowed the best response in most outcomes. The most commonly re-ported adverse events in this study were constipation, dizziness, nausea,somnolence, and headache. The determinants of these improvementsand relationships between outcomes are important to better under-stand since chronic pain is multidimensional.

S70 Abstracts