Outcome Measures. (outcome + measures)

Distribution by Scientific Domains

Kinds of Outcome Measures.

  • main outcome measures.

  • Selected Abstracts

    Transcatheter versus Surgical Closure of Secundum Atrial Septal Defect in Adults: Impact of Age at Intervention.

    A Concurrent Matched Comparative Study
    Abstract Objectives., To compare the short- and mid-term outcomes of surgical (SUR) vs. transcatheter closure of secundum atrial septal defect (ASD) using Amplatzer septal occluder (ASO) in adults with a very similar spectrum of the disease; and to identify predictors for the primary end point. Design., Single-center, concurrent comparative study. Surgically treated patients were randomly matched (2:1) by age, sex, date of procedure, ASD size, and hemodynamic profile. Setting., Tertiary referral center. Patients., One hundred sixty-two concurrent patients with ASD submitted to ASO (n = 54) or SUR closure (n = 108) according with their preferences. Main Outcome Measures., Primary end point was a composite index of major events including failure of the procedure, important bleeding, critical arrhythmias, serious infections, embolism, or any major cardiovascular intervention-related complication. Predictors of these major events were investigated. Results., Atrial septal defects were successfully closed in all patients, and there was no mortality. The primary event rate was 13.2% in ASO vs. 25.0% in SUR (P = .001). Multivariate analysis showed that higher rate of events was significantly associated with age >40 years; systemic/pulmonary output ratio <2.1; and systolic pulmonary arterial pressure >50 mm Hg; while in the ASO group the event rate was only associated with the ASD size (>15 cm2/m2; relative risk = 1.75, 95% confidence interval 1.01,8.8). There were no differences in the event-free survival curves in adults with ages <40 years. Conclusions., The efficacy for closure ASD was similar in both groups. The higher morbidity observed in SUR group was observed only in the patients submitted to the procedure with age >40 years. The length of hospital stay was shorter in the ASO group. Surgical closure is a safe and effective treatment, especially in young adults. There is certainly nothing wrong with continuing to do surgery in countries where the resources are limited. [source]

    Treating Chronic Tension-type Headache Not Responding to Amitriptyline Hydrochloride With Paroxetine Hydrochloride: A Pilot Evaluation

    HEADACHE, Issue 9 2003
    Kenneth A. Holroyd PhD
    Context.,In some individuals, chronic tension-type headache fails to respond to tricyclic antidepressant medications that often serve as first-line therapy. Objective.,To evaluate the clinical efficacy of paroxetine hydrochloride for chronic tension-type headache not responding to amitriptyline hydrochloride. Design and Setting.,Open-label trial of paroxetine conducted at 2 outpatient sites in Ohio. Participants and Intervention.,Thirty-one adults (mean age, 37 years; 20 women) with chronic tension-type headache (mean, 25 headache days per month) who had failed to respond (less than 30% improvement) to treatment with either amitriptyline (n = 13) or matched placebo (n = 18). All participants were treated with paroxetine (up to 40 mg per day) in a 9-month protocol. Outcome Measures.,Monthly headache index calculated as the mean of pain ratings (0 to 10 scale) recorded by participants in a diary 4 times per day, number of days per month with at least moderate pain (pain rating of 5 or greater), and analgesic medication use. Results.,In patients who had not responded to amitriptyline, paroxetine failed to reduce chronic tension-type headaches or analgesic medication use. In patients who had not responded to placebo, paroxetine produced modest reductions in chronic tension-type headaches and analgesic use. Conclusions.,We found no evidence that chronic tension-type headaches that failed to respond to tricyclic antidepressant therapy with amitriptyline improved when subsequently treated with paroxetine. More support was found for the efficacy of paroxetine in patients with chronic tension-type headaches who had failed to respond to placebo. [source]

    Longitudinal Treatment Outcomes for Geriatric Patients with Chronic Non-Cancer Pain at an Interdisciplinary Pain Rehabilitation Program

    PAIN MEDICINE, Issue 9 2010
    Kathleen M. Darchuk PhD
    Abstract Objective., This study examined depression, pain catastrophizing, psychosocial functioning, and physical and emotional health attributes for geriatric patients admitted to an interdisciplinary pain rehabilitation center compared with middle and younger age groups. Design., Quasi-experimental time series. Setting., Interdisciplinary pain rehabilitation center at a tertiary referral medical center. Patients., In total, 411 patients with chronic non-cancer pain completed the pain rehabilitation program from October 2004 to April 2006. Patients were divided into three groups based on age: older (ages 60+; n = 78); middle-age (ages 40,59; n = 230) and younger (ages 18,39; n = 141). Intervention., A 3-week outpatient interdisciplinary pain rehabilitation program based on a cognitive-behavioral model that incorporates opioid withdrawal. Outcome Measures., The Multidimensional Pain Inventory (MPI), Short Form-36 Health Status Questionnaire (SF-36), Pain Catastrophizing Scale (PCS), and Center for Epidemiological Studies-Depression Scale (CES-D) were administered at admission, discharge, and 6 months following treatment. The frequency of patients using opioids, nonsteroidal anti-inflammatory drugs (NSAIDs), and benzodiazepines at each assessment point were compared. Results., Older patients reported reduced depression, catastrophizing, pain severity, and pain interference (P < 0.001) at discharge and 6 months follow-up. Older patients also reported increased perceived control, and physical and social functioning at discharge and follow-up (P < 0.001). Improvement in older patients was comparable in magnitude to that of middle-age patients on all variables, whereas younger patients exhibited greater improvement on four variables. Significant reductions in analgesic use were observed in all groups. Conclusion., Interdisciplinary pain rehabilitation incorporating opioid withdrawal can improve long-term psychological, social and physical functioning for geriatric chronic pain patients. [source]

    Negligible Analgesic Tolerance Seen with Extended Release Oxymorphone: A Post Hoc Analysis of Open-Label Longitudinal Data

    PAIN MEDICINE, Issue 8 2010
    R. Norman Harden MD
    Abstract Objective., To examine the development of analgesic tolerance in patients on oxymorphone extended-release (OxymER). Design.,Post hoc analysis of data from a previously conducted prospective 1 year multi-center open-label extension study in which patients were able to titrate as needed. Patients., Sample of 153 hip and knee osteoarthritis (OA) subjects on OxymER. Primary analyses were limited to study completers (n = 62) due to the large amount of missing data for the noncompleters (n = 91). Outcome Measures., Main outcome measures included OxymER doses (pill counts) and pain intensity ratings using a visual analog scale at monthly visits. Results., There were significant dose increases from weeks 1 to 2 and 2 to 6 (P < 0.05). Doses stabilized around week 6, suggesting the completion of what we defined as "titration." Both doses and pain ratings were stable when this titration phase was excluded from the analysis (P = 0.751; P = 0.056, respectively). Only 28% of the patients had any dose changes following this titration. While there was a significantly greater dose at week 52 compared with week 10 (P = 0.010), the increase in dose became insignificant after excluding four subjects who required two dose increases (P = 0.103). Conclusions., The results showed that most of the titration/dose stabilization changes occurred within the first 10 weeks. A minority (28%) of subjects required dosage increases after this (defined) titration period. Pain reports stabilized statistically after 2 weeks. The findings of this post hoc analysis suggest a lack of opioid tolerance in the majority (72%) of these OA patients who completed this study following a defined titration period on OxymER. Summary., This post hoc analysis of oxymorphone ER consumption in osteoarthritis pain vs pain report showed that most dose changes occurred during an initial "titration period" as defined. Following this titration few subjects increased dose and analgesia remained stable. These findings suggest a lack of longitudinal opioid tolerance in the majority of those OA subjects who completed the trial. [source]

    Pain in Long-Term Breast Cancer Survivors: Frequency, Severity, and Impact

    PAIN MEDICINE, Issue 7 2010
    Mark P. Jensen PhD
    Abstract Objective., To better understand the severity and impact of pain in women who are breast cancer survivors. Design., Cross-sectional survey. Setting., Cancer wellness clinic. Patients., Two hundred fifty-three women with a history of early-stage breast cancer who had completed therapy and were without evidence of disease. Interventions., None. Outcome Measures., A survey that included questions about cancer history, pain, sleep problems, and physical and psychological functioning. Results., About half of the participants (117 or 46%) reported some pain, although most rated its intensity as mild. Both average and worst pain ratings showed significant associations with physical functioning (rs, ,0.48 and ,0.43, respectively), severity of sleep problems (rs, 0.31 and 0.30), and psychological functioning (rs, ,0.27 and ,0.24). Age (with younger participants slightly more likely to report pain) and history of antiestrogen therapy showed nonsignificant trends to predict the presence of pain. Conclusions., The study findings provide new and important knowledge regarding the severity and impact of pain in female breast cancer survivors. The results indicate that clinicians should assess pain regularly in breast cancer survivors and treat this pain when indicated. The findings also support the need for research to determine whether improved pain management would result in improved quality of life for women with a history of breast cancer. [source]

    Effectiveness of Acupuncture in Patients with Category IIIB Chronic Pelvic Pain Syndrome: A Report of 97 Patients

    PAIN MEDICINE, Issue 4 2010
    Volkan Tugcu MD
    Abstract Objective., Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is of significant interest in urology and unfortunately, the therapy modalities recommended are not fully effective. Therefore, we undertook a pilot study to determine whether acupuncture improves the pain, voiding symptoms, and quality of life in men with category IIIB CP/CPPS. Design., Prospective, one-group trial, cohort study. Setting., Outpatient urology clinic. Patients and Interventions., Ninety-seven CP/CPPS patients received six sessions of acupuncture to the BL-33 acupoints once a week. The National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was completed by each patient before and after the treatment and on 12th and 24th weeks following the treatment. Outcome Measures., Mean values of total CPSI score, pain subscore, urinary subscore, and quality of life subscore after the treatment and on follow-up after the treatment were compared with the baseline values. Results., There was a statistically significant decrease in all of the subscores evaluated at all periods compared with the baseline. Eighty-six patients out of 93 (92.47%) were NIH-CPSI responders (more than 50% decrease in total NIH-CPSI score from baseline) at the end of the treatment. Conclusions., The results of this study suggest that acupuncture appears to be a safe and potentially effective treatment in improving the symptoms and quality of life of men clinically diagnosed with CP/CPPS. [source]

    Assessment of Celiac Plexus Block and Neurolysis Outcomes and Technique in the Management of Refractory Visceral Cancer Pain

    PAIN MEDICINE, Issue 1 2010
    Michael A. Erdek MD
    ABSTRACT Objective., To assess demographic and clinical factors associated with celiac plexus neurolysis outcomes. Design., Retrospective clinical data analysis. Setting., A tertiary care, academic medical center. Patients., Forty-four patients with terminal visceral (mostly pancreatic) cancer who failed conservative measures. Interventions., Fifty celiac plexus alcohol neurolytic procedures done for pain control after a positive diagnostic block. Outcome Measures., A successful treatment was predefined as >50% pain relief sustained for ,1 month. The following variables were analyzed for their association with treatment outcome: age, gender, duration of pain, origin of tumor, opioid dose, type of radiological guidance used, single- vs double-needle approach, type of block (e.g., antero- vs retrocrural), immediate vs delayed neurolysis, volume of local anesthetic employed for both diagnostic and neurolytic blocks, and use of sedation. Results., Those variables correlated with a positive outcome included lower opioid dose and the absence of sedation. Strong trends for a positive association with outcome were found for the use of computed tomography (vs fluoroscopy), and using <20 mL of local anesthetic for the diagnostic block. Conclusions., Celiac plexus neurolysis may provide intermediate pain relief to a significant percentage of cancer sufferers. Both careful selection of candidates based on clinical variables, and technical factors aimed at enhancing the specificity of blocks may lead to improved outcomes. [source]

    Pain Symptom Profiles in Persons with Spinal Cord Injury

    PAIN MEDICINE, Issue 7 2009
    Yenisel Cruz-Almeida MSPH
    ABSTRACT Objective., Persistent pain is a common consequence of spinal cord injury. A patient-specific assessment that combines both the identification of pain symptoms and psychosocial factors is needed for a tailored treatment approach. The aim of the study was to define pain symptom profiles and to determine their relationship with psychosocial factors in persons with spinal cord injury. Design., Face-to-face interview and examination. Setting., VA Medical Center and Miami Project to Cure Paralysis, Miami, Florida. Patients., Persons with spinal cord injury (135 men and 21 women) provided detailed descriptions of 330 neuropathic pains. Outcome Measures., The American Spinal Injury Impairment Scale, pain history and measures of pain interference, life satisfaction, locus of control, social support and depression. Results., The exploratory factor analyses and regression analyses revealed three distinct symptom profiles: 1) aching, throbbing pain, aggravated by cold weather and constipation predicted by a combination of chance locus of control and lower levels of life satisfaction; 2) stabbing, penetrating, and constant pain of high intensity predicted by a combination of pain interference, localized pain, powerful others locus of control and depressed mood; and 3) burning, electric, and stinging pain aggravated by touch and muscle spasms predicted by pain interference. Conclusions., Although these results need to be replicated in other spinal cord injury samples, our findings suggest that pain symptom profiles may be a useful way to further characterize pain in a comprehensive assessment strategy. [source]

    Women with Pain due to Osteoarthritis: The Efficacy and Safety of a Once-Daily Formulation of Tramadol

    PAIN MEDICINE, Issue 6 2009
    FRCP, Walter F. Kean MB ChB
    ABSTRACT Objective., This analysis assesses the efficacy and safety of treatment with a once-daily oral formulation of tramadol for up to 12 weeks compared with placebo in women with moderate-to-severe pain due to osteoarthritis of the knee. Design., Two parallel, placebo-controlled phase III clinical trials were analyzed; patients were randomized to a fixed dosage of Tramadol Contramid® once a day (OAD) 100, 200, and 300 mg daily, or placebo. Outcome Measures., The primary efficacy end points were the percentage difference from baseline of the Western Ontario and McMaster University Osteoarthritis Index (WOMAC) subscale scores for pain and physical function, and the patient global rating of pain relief after 12 weeks of maintenance therapy. Results., The analysis included 405 women receiving tramadol and 280 receiving placebo. At week 12, 179 of 204 women (87.7%) receiving tramadol rated their overall pain relief as effective or very effective compared with 134 of 177 (75.7%) receiving placebo. A time-weighted analysis revealed statistically significant improvements over placebo for all the WOMAC subscale scores across all three dosages. The percentage improvements from baseline of the WOMAC pain scores were significantly better than placebo for the 100-mg (58.8 ± 37.1%, P = 0.018) and 300-mg (58.9 ± 38.8%, P = 0.023) treatment arms; however, the 200-mg dosage was not significant (53.0 ± 38.5%, P = 0.175). The WOMAC physical function scores showed significant improvement for the 100 (56.9 ± 36.4%, P = 0.009), 200 (54.0 ± 33.8%, P = 0.034), and 300 mg (53.4 ± 41.4%, P = 0.043) daily dosages. Conclusion., For moderate-to-severe pain due to osteoarthritis of the knee, women experience significant analgesia and improvement of physical function over time with treatment with Tramadol Contramid® OAD. [source]

    The Prevalence and Impact of Chronic Pain with Neuropathic Pain Symptoms in the General Population

    PAIN MEDICINE, Issue 5 2009
    Cory Toth BSc, FRCPC
    ABSTRACT Objective., We performed a prevalence estimate of chronic pain with neuropathic pain (NeP) symptoms to determine its frequency and associations with morbidity. Design., We conducted a telephone-based survey based upon a random sampling of both urban and rural households of the general population in one Canadian province to determine NeP prevalence and its impact upon financial well-being and quality of life. Outcome Measures., Telephonic use of the DN4 questionnaire (DN4Q), used to identify NeP symptoms in those patients with chronic pain, was validated within selected clinical populations of chronic pain. Epidemiological data was obtained for all subjects. EuroQoL (EQ)-5D data estimating quality of life was measured. Results., Chronic pain was present in 35.0% of the surveyed population of 1,207 subjects, with NeP symptoms present in 17.9%. The NeP group had significantly more pain, was female predominant, had a greater belief of being economically disadvantaged, suffered from more restrictions in mobility and in usual activities, and had overall lower EQ-5D utility scores compared with subjects with non-NeP. DN4Q validation demonstrated that pain entities not normally defined as NeP are recorded as such using the DN4Q, and that a spectrum of NeP features may occur across a host of painful conditions. Conclusion., Despite limitations of the DN4Q, symptoms of NeP may be more prevalent in the general population than expected and has a greater impact upon patients' lives than non-NeP. Limitations of the DN4Q may relate to the concept of a spectrum of NeP existent amongst heterogenous NeP and non-NeP syndromes. [source]

    Intravenous Magnesium for Complex Regional Pain Syndrome Type 1 (CRPS 1) Patients: A Pilot Study

    PAIN MEDICINE, Issue 5 2009
    Susan Collins MSc
    ABSTRACT Objectives., To explore the feasibility of intravenous magnesium administration as a potential candidate intervention for a large size trial in Complex Regional Pain Syndrome Type 1 (CRPS 1). Design., Randomized clinical trial. Setting., Outpatient pain clinic. Patients., Ten CRPS 1 patients. Interventions., Eight patients received 70 mg/kg magnesium sulphate infusions in 4 hours for 5 days. For blinding purposes, 2 patients received equal amount NaCl 0.9% solutions (data not analyzed or presented). Interventions were accompanied by standardized physical therapy. Outcome Measures., Pain was assessed using an 11-point Box scale (three times daily for a week) and the McGill Pain Questionnaire. Skin sensitivity was measured with the Semmes Weinstein Monofilaments, (other) impairments with the Impairment Level Sumscore. In addition, functional limitations (Radboud Skills Questionnaire, questionnaire rising and sitting down) and quality of life (Short Form-36 [SF-36], EuroQol) were evaluated. Assessments were performed at baseline, 1, 3, 6, and 12 weeks after intervention. Results., Mild systemic side effects were experienced and the infusions were locally well tolerated. Pain was significantly reduced at all follow up compared with baseline (T1: P = 0.01, T3: P = 0.04, T6: P = 0.02, T12: P = 0.02). McGill sensory subscale improved significantly at T1 (number of words chosen: P = 0.03 and pain rating index: P = 0.03). Impairment level (P = 0.03) and quality of life (EuroQol P = 0.04, SF-36 physical P = 0.01) were significantly improved at T12. No improvement was found for skin sensitivity and functional limitations. Conclusion., Intravenous magnesium significantly improved pain, impairment and quality of life and was well tolerated. The results of this pilot study are encouraging and suggest that magnesium IV as a treatment in CRPS 1 should be further explored in a large size formal trial design. [source]

    Psychometric Properties of Commonly Used Low Back Disability Questionnaires: Are They Useful for Older Adults with Low Back Pain?

    PAIN MEDICINE, Issue 1 2009
    Gregory E. Hicks PT
    ABSTRACT Objectives., To evaluate the psychometric properties of two commonly used low back pain (LBP) disability questionnaires in a sample solely comprising community-dwelling older adults. Design., Single-group repeated measures design. Setting., Four continuing care retirement communities in Maryland and in Virginia. Participants., Convenience sample of 107 community-dwelling men and women (71.9%) aged 62 years or older with current LBP. Outcome Measures., All participants completed modified Oswestry Disability (mOSW) and Quebec Back Pain Disability (QUE) questionnaires, as well as the Medical Outcomes Survey Short-Form 36 questionnaire at baseline. At follow-up, 56 participants completed the mOSW and the QUE for reliability assessment. Results., Test,retest reliability of the mOSW and QUE were excellent with intraclass correlation coefficients of 0.92 (95% confidence interval [CI]: 0.86, 0.95) and 0.94 (95% CI: 0.90, 0.97), respectively. Participants with high pain severity and high levels of functional limitation had higher scores on the mOSW (P < 0.0001) and QUE (P < 0.001) scales than other participants, which represents good construct validity for both scales. The threshold for minimum detectable change is 10.66 points for the mOSW and 11.04 points for the QUE. Both questionnaires had sufficient scale width to accurately measure changes in patient status. Conclusions., It appears that both questionnaires have excellent test,retest reliability and good construct validity when used to evaluate LBP-related disability for older adults with varying degrees of LBP. Neither questionnaire appears to have superior psychometric properties; therefore, both the Oswestry and Quebec can be recommended for use among geriatric patients with LBP. [source]

    Role of Biphosphonates and Lymphatic Drainage Type Leduc in the Complex Regional Pain Syndrome (Shoulder,Hand Syndrome)

    PAIN MEDICINE, Issue 1 2009
    Andrea Santamato MD
    ABSTRACT Background., Complex regional pain syndrome (CRPS) is a clinical entity that has been termed in numerous ways in the last years. Clinically, CRPS describes an array of painful conditions that are characterized by a continuing (spontaneous and/or evoked) regional pain that is seemingly disproportionate in time or degree to the usual course of any known trauma or other lesion. The pain is regional and usually has a distal predominance of abnormal sensory, motor, sudomotor, vasomotor, and/or trophic findings. Design., Case report. Setting., University Medical Center. Patients., In this report, we described the case of a 68-year-old hemiplegic female affected by cerebrovascular accident that presented a clinical case of CRPS shoulder,hand syndrome (CRPS-SHS) at the right hand after a hemorrhagic stroke. Interventions., This report evaluated the effects of biphosphonates and lymphatic drainage type Leduc in CRPS-SHS. Outcome Measures., The pain level of the patients was measured with the visual analog scale. A scoring system for the clinical severity of CRPS-SHS, laboratory tests, and X-ray films were also performed. Results., We reported in this patient a great improvement of pain and edema of the right hand, with a significant reduction of bone demineralization. Conclusions., This combined treatment may be a viable alternative for this syndrome; however, further investigation is needed to determine its reproducibility in large case series. [source]

    A Prospective Controlled Study in the Prevalence of Posttraumatic Headache Following Mild Traumatic Brain Injury

    PAIN MEDICINE, Issue 8 2008
    ABSTRACT Objective., To establish the prevalence of post traumatic headache, persisting at 3 months following minor traumatic brain injury. Design., A prospective controlled study of patients admitted with a diagnosis of mild traumatic brain injury and matched orthopedic controls over 12 months during 2004. Setting., A level two inner city Emergency Department in Sydney, Australia. Patients., One hundred eligible sequential admissions with mild traumatic brain injury as defined by American Congress of Rehabilitation Medicine, 1993, and 100 matched minor injury controls with nondeceleration injuries. Interventions., Subjects were part of a study on prediction of postconcussive syndrome and had neuropsychological tests, balance test and pain recordings taken at the time of injury, at 1 month and at 3 months post injury. Outcome Measures., Main measures were the reporting of headache "worse than prior to the injury" and concordant with the definition of Posttraumatic Headache according to International Headache Society Classification of Headache Disorders 2003. Results., 15.34% of those with minor head injury continued to complain of perisistant posttraumatic headache at 3 months compared to 2.2% of the minor injury controls. Conclusions., To the authors' knowledge this is the first controlled prospective study in the prevalence of posttraumatic headache following mild traumatic brain injury. [source]

    Reduced Cold Pain Tolerance in Chronic Pain Patients Following Opioid Detoxification

    PAIN MEDICINE, Issue 8 2008
    Jarred Younger PhD
    ABSTRACT Objective., One potential consequence of chronic opioid analgesic administration is a paradoxical increase of pain sensitivity over time. Little scientific attention has been given to how cessation of opioid medication affects the hyperalgesic state. In this study, we examined the effects of opioid tapering on pain sensitivity in chronic pain patients. Design., Twelve chronic pain patients on long-term opioid analgesic treatment were observed in a 7- to 14-day inpatient pain rehabilitation program, with cold pain tolerance assessed at admission and discharge. The majority of participants were completely withdrawn from their opioids during their stay. Outcome Measures., We hypothesized that those patients with the greatest reduction in daily opioid use would show the greatest increases in pain tolerance, as assessed by a cold pressor task. Results., A linear regression revealed that the amount of opioid medication withdrawn was a significant predictor of pain tolerance changes, but not in the direction hypothesized. Greater opioid reduction was associated with decreased pain tolerance. This reduction of pain tolerance was not associated with opioid withdrawal symptoms or changes in general pain. Conclusions., These findings suggest that the withdrawal of opioids in a chronic pain sample leads to an acute increase in pain sensitivity. [source]

    Titration with Oxymorphone Extended Release to Achieve Effective Long-Term Pain Relief and Improve Tolerability in Opioid-Naive Patients with Moderate to Severe Pain

    PAIN MEDICINE, Issue 7 2008
    Richard Rauck MD
    ABSTRACT Objective., Assess the effectiveness and tolerability of a program of gradual dose titration with oxymorphone extended release (ER) for treatment of moderate to severe chronic pain in opioid-naive patients. Design., Open-label, nonrandomized 6-month study with a titration/stabilization period of ,1 month followed by a 5-month maintenance period. Setting., Multidisciplinary pain centers in the United States. Patients., Adult opioid-naive patients with moderate to severe chronic pain. Interventions., Patients were gradually titrated from a 5-mg dose of oxymorphone ER (taken every 12 hours) to a stabilized dose that provided effective pain relief and was well tolerated. Outcome Measures., Brief Pain Inventory Short Form questions 5 and 9, patient and physician global assessments of pain relief, adverse events (AEs), and discontinuations. Results., The majority (94/126; 75%) of patients were stabilized on a dose of oxymorphone ER that provided effective pain relief with tolerable AEs. Most (81/94; 86%) required <24 days to reach a stable dose. Sixteen percent of patients in the titration period and 17% of patients in the maintenance period discontinued because of AEs possibly or probably related to oxymorphone ER. Patients completing the entire 5-month maintenance period experienced effective pain relief with significant (>50%) reductions of pain interference with quality-of-life measures. There was minimal dose escalation over the 5 months and low use of rescue medication. Conclusions., Oxymorphone ER provided effective pain relief from moderate to severe chronic pain in opioid-naive patients. Gradual titration was well tolerated, with a low rate of discontinuations caused by AEs. [source]

    Defining Patient-Centered, Multidimensional Success Criteria for Treatment of Chronic Spine Pain

    PAIN MEDICINE, Issue 7 2008
    Jennifer L. Brown PhD
    ABSTRACT Objective., This study aimed to define patient-determined success criteria for treatment of chronic spine pain across four domains: pain, fatigue, emotional distress, and interference with daily activities. Patients., Seventy chronic spine pain patients were recruited from university-affiliated pain clinics. Design., The study design was longitudinal, with pretreatment and post-treatment assessments. Post-treatment assessment occurred approximately 2 months after treatment initiation. Outcome Measures., Participants completed the Patient-Centered Outcomes Questionnaire and Follow-Up Patient-Centered Outcomes Questionnaire. Results., At pretreatment, patient requirements for success were a 58% reduction in pain, 61% reduction in fatigue, 64% reduction in distress, and 66% reduction in interference. These criteria, derived using a direct-scaling approach, are more stringent than criteria developed using other methods. However, patients adjusted their success criteria over time by becoming less stringent, and they used these less stringent criteria to make global judgments of treatment success. Using a scale comparison approach, success criteria for pain were a raw change of 17.5 points (0,100 numerical rating scale) and percent change of 25%. Other criteria were 7.5 (11%) for fatigue, 5.0 (13%) for distress, and 9.5 (12%) for interference. Conclusions., Future research should validate these success criteria, particularly for the less studied domains of fatigue, distress, and interference, and investigate how these criteria evolve over the course of different treatments. [source]

    Sleep-Disordered Breathing and Chronic Opioid Therapy

    PAIN MEDICINE, Issue 4 2008
    Lynn R. Webster MD
    ABSTRACT Objective., To assess the relation between medications prescribed for chronic pain and sleep apnea. Design., An observational study of chronic pain patients on opioid therapy who received overnight polysomnographies. Generalized linear models determined whether a dose relation exists between methadone, nonmethadone opioids, and benzodiazepines and the indices measuring sleep apnea. Setting., A private clinic specializing in the treatment of chronic pain. Patients., Polysomnography was sought for all consecutive (392) patients on around-the-clock opioid therapy for at least 6 months with a stable dose for at least 4 weeks. Of these, 147 polysomnographies were completed (189 patients declined, 56 were directed to other sleep laboratories by insurance companies, and data were incomplete for seven patients). Available data were analyzed on 140 patients. Outcome Measures., The apnea,hypopnea index to assess overall severity of sleep apnea and the central apnea index to assess central sleep apnea. Results., The apnea,hypopnea index was abnormal (,5 per hour) in 75% of patients (39% had obstructive sleep apnea, 4% had sleep apnea of indeterminate type, 24% had central sleep apnea, and 8% had both central and obstructive sleep apnea); 25% had no sleep apnea. We found a direct relation between the apnea,hypopnea index and the daily dosage of methadone (P = 0.002) but not to other around-the-clock opioids. We found a direct relation between the central apnea index and the daily dosage of methadone (P = 0.008) and also with benzodiazepines (P = 0.004). Conclusions., Sleep-disordered breathing was common in chronic pain patients on opioids. The dose,response relation of sleep apnea to methadone and benzodiazepines calls for increased vigilance. [source]

    What Is the Relationship of Low Back Pain to Signs of Abnormal Skeletal Metabolism Detected by Bone Scans?

    PAIN MEDICINE, Issue 2 2008
    Brenda Breuer PhD
    ABSTRACT Background., In approximately 80,85% of patients with chronic nonspecific low back pain (NSLBP), a precise pathoanatomical diagnosis cannot be identified. Mechanisms of bone nociception may contribute to NSLBP. Objective., To determine whether findings on bone scans, which provide a pathophysiological picture of functional activity, are associated with self-reports of NSLBP intensity. Design., A cross-sectional study of the relationship of self-reported chronic NSLBP intensity to the uptake of radiolabeled technetium-99m-methylene diphosphonate in the lumbosacral area. Study Participants., Patients referred for bone scans who were at least 18 years old. Outcome Measures., Subject reports of pain intensity and intensity of uptake of radiolabeled technetium-99m-methylene diphosphonate in the lumbosacral area. Results., Among subjects who were 65 years or younger, the age-adjusted worst pain intensity accounted for 45% of the variability in the amount of tracer uptake (r = 0.67, P = 0.0006). The association was not significant for those older than 65 years. Conclusion., Further studies should be conducted on possible mechanisms relating bone nociception to chronic NSLBP in individuals who are 65 years or younger. [source]

    Open-Label Exploration of an Intravenous Nalbuphine and Naloxone Mixture as an Analgesic Agent Following Gynecologic Surgery

    PAIN MEDICINE, Issue 6 2007
    Assaf T. Gordon MD
    ABSTRACT Objective., The purpose of this series was to explore a 12.5:1 fixed-dose ratio of an intravenous nalbuphine and naloxone mixture (NNM) for use in patients following gynecologic surgery. Design and Patients., Open-label, nonrandomized case series. The first series was a dose-ranging investigation for 12 patients following elective total abdominal hysterectomy or myomectomy. In this series, fentanyl was used for intraoperative analgesia, and patients were assigned to a lower NNM (2.5 mg/0.2 mg) or to a higher NNM (5 mg/0.4 mg) dose group. The second series evaluated the fixed dose of 5 mg nalbuphine/0.4 mg naloxone for four patients undergoing ambulatory gynecologic procedures. In the second series, no opioid agents were administered intraoperatively to eliminate the possibility of mu-opioid reversal by naloxone postoperatively. Outcome Measures., Pain control was assessed using a Verbal Pain Scale (0,10). Vital signs, side effects, and adverse events were recorded to determine drug safety. Results., In the first series, there were no adverse events; however, each patient required rescue medication (either morphine or fentanyl). In the second series, two of the four patients reported a reduction in pain following drug administration and did not require any further analgesic agents in the 3-hour postoperative period. One patient had an asymptomatic lowering of heart rate after receiving the drug. Conclusion., Additional research of the unique combination therapy of nalbuphine and naloxone is warranted to further determine its potential clinical efficacy and safety. [source]

    Ethnic Differences in Pain Among Outpatients with Terminal and End-Stage Chronic Illness

    PAIN MEDICINE, Issue 3 2005
    Michael W. Rabow MD
    ABSTRACT Objective., To explore ethnic and country of origin differences in pain among outpatients with terminal and end-stage chronic illness. Design., Cohort study within a year-long trial of a palliative care consultation. Setting., Outpatient general medicine practice in an academic medical center. Patients., Ninety patients with advanced congestive heart failure, chronic obstructive pulmonary disease, or cancer, and with a prognosis between 1 and 5 years. Outcome Measures., Patients' report of pain using the Brief Pain Inventory and analgesic medications prescribed by primary care physicians. Differences in pain report and treatment were assessed at study entry, at 6 and 12 months. Results., The overall burden of pain was high. Patients of color reported more pain than white patients, including measures of least pain (P = 0.02), average pain (P = 0.05), and current pain (P = 0.03). No significant ethnic group differences in pain were found comparing Asian, black, and Latino patients. Although nearly all patients who were offered opioid analgesics reported using them, opioids were rarely prescribed to any patient. There were no differences in pain between patients born in the U.S. and immigrants. Conclusions., Pain is common among outpatients with both terminal and end-stage chronic illness. There do not appear to be any differences in pain with regard to country of origin, but patients of color report more pain than white patients. Patients of all ethnicities are inadequately treated for their pain, and further study is warranted to explore the relative patient and physician contributions to the finding of unequal symptom burden and inadequate treatment effort. [source]

    Relationship Between Post-traumatic Stress Disorder and Pain in Two American Indian Tribes

    PAIN MEDICINE, Issue 1 2005
    Dedra Buchwald MD
    ABSTRACT Objectives., To estimate the association of lifetime post-traumatic stress disorder (PTSD) and pain in American Indians, and determine if tribe, sex, cultural and psychosocial factors, or major depression influence the magnitude of this association. Design., A cross-sectional probability sample survey completed between 1997 and 2000. A structured interview was conducted by trained, tribal members to gather information on demographic and cultural features, physical health status, psychiatric disorders, and functional status. Setting., General community. Participants., A total of 3,084 individuals randomly selected from the tribal rolls of a Southwestern (N = 1,446) and a Northern Plains (N = 1,638) tribal group who were 15,54 years of age and lived on or within 20 miles of their reservations. Outcome Measures., Bodily pain subscale of the Short Form-36. Linear regression models were fit to examine the association between lifetime PTSD and pain, adjusting for demographic, cultural, psychosocial features, painful medical conditions, and major depression. Results., The prevalence of lifetime PTSD was 16% in the Southwestern and 14% in the Northern Plains; women were nearly twice as likely as men to have lifetime PTSD in both tribes. The final adjusted model demonstrated that mean Short Form-36 bodily pain subscale scores were lower (indicating more pain) among individuals with lifetime PTSD than those without lifetime PTSD. Effect modification by tribe, sex, and depression was not observed. Conclusions., Lifetime PTSD was strongly associated with bodily pain in this rural sample of American Indians. Clinicians should be aware of, and address, the link between physical pain syndromes and PTSD. [source]

    The Influence of Experimenter Gender and Race on Pain Reporting: Does Racial or Gender Concordance Matter?

    PAIN MEDICINE, Issue 1 2005
    Carol S. Weisse PhD
    ABSTRACT Background., Research on disparities in the treatment of pain has shown that minorities receive less aggressive pain management than nonminorities. While reasons include physician bias, the focus of this study was to examine whether differences in pain reporting behavior might occur when pain is reported to individuals of a different race or gender. Objective., To test whether gender and racial concordance might influence pain reporting and pain behavior in a laboratory setting. Design/Setting., By using a two (subject race)-by-two (subject gender)-by-two (experimenter race)-by two (experimenter gender) quasi-experimental design, pain was assessed in a laboratory through a standard cold pressor task administered by someone whose gender and/or race was similar or dissimilar. Subjects., Subjects were 343 (156 men; 187 women) undergraduates whose ages ranged from 17 to 43 years (mean 20.27 years). Outcome Measures., Pain tolerance was assessed by total immersion time in the ice bath. Pain ratings were obtained by using Gracely scales, which rate the intensity and unpleasantness of the task. Results., Total immersion time was shorter for both blacks and women, and both blacks and women reported higher pain intensity and unpleasantness. Racial and gender concordance did not influence pain reporting or pain tolerance, but interactions between subject race and experimenter gender, as well as subject gender and experimenter race, were revealed. Conclusions., Racial and gender concordance did not influence pain reporting; however, pain reporting was influenced by interactions between gender and race in the subject,experimenter dyads. [source]

    The Effects of Pain and Depression on Physical Functioning in Elderly Residents of a Continuing Care Retirement Community

    PAIN MEDICINE, Issue 4 2000
    Jana M. Mossey PhD
    Objective., Explore the relationships between pain, depression, and functional disability in elderly persons. Design.,A cross-sectional, observational study of 228 independently living retirement community residents. Methods., Self-report measures of pain (adaptation of McGill Pain Questionnaire), depression (Geriatric Depression Scale [GDS]) and physical functioning (Physical performance difficulties, activities of daily living [ADL], independent activities of daily living [IADL], and 3-meter walking speed) were employed. Outcome Measures.,Physical functioning variables were dichotomized. Individuals in the lowest quartiles of functional performance and of walking speed were contrasted to all others; for ADL and IADL, those needing some help were compared with those independent in activities. Results., Pain and depression levels were strongly related to physical performance; depression levels were related to ADL and walking speed. In multivariate analyses, an interaction effect was observed where the effects of pain were a function of level of depression. Individuals reporting activity-limiting pain and slightly elevated depressive symptom levels, sub-threshold depression, or major depression were significantly more likely (AOR 7.8; 95% CI, 3.07,20.03) than non-depressed persons to be in the lowest quartile of self-reported physical performance. Conclusions., While both pain and depression level affect physical performance, depressive symptoms rather than pain appear the more influential factor. When seeing elderly patients, identifying, evaluating, and treating both pain complaints and depressive symptoms and disorders may reduce functional impairment. [source]

    Modest Impact of a Brief Curricular Intervention on Poor Documentation of Sexual History in University-Based Resident Internal Medicine Clinics

    Danielle F. Loeb MD
    ABSTRACT Introduction., Providers need an accurate sexual history for appropriate screening and counseling. While curricula on sexual history taking have been described, the impact of such interventions on resident physician performance of the sexual history remains unknown. Aims., Our aims were to assess the rates of documentation of sexual histories, the rates of documentation of specific components of the sexual history, and the impact of a teaching intervention on this documentation by Internal Medicine residents. Methods., The study design was a teaching intervention with a pre- and postintervention chart review. Participants included postgraduate years two (PGY-2) and three (PGY-3) Internal Medicine residents (N = 25) at two university-based outpatient continuity clinics. Residents received an educational intervention consisting of three 30-minute, case-based sessions in the fall of 2007. Main Outcome Measures., We reviewed charts from health-care maintenance visits pre- and postintervention. We analyzed within resident pre- and postrates of sexual history taking and the number of sexual history components documented using paired t -tests. Results., In total, we reviewed 369 pre- and 260 postintervention charts. The mean number of charts per resident was 14.8 (range 8,29) pre-intervention and 10.4 (range 3,25) postintervention. The mean documentation rate per resident for one or more components of sexual history pre- and postintervention were 22.5% (standard deviation [SD] = 18.1%) and 31.7% (SD = 20.4%), respectively, P < 0.01. The most frequently documented components of sexual history were current sexual activity, number of current sexual partners, and gender of current sexual partner. The least documented components were history of specific sexually transmitted infections, gender of sexual partners over lifetime, and sexual behaviors. Conclusion., An educational intervention modestly improved documentation of sexual histories by Internal Medicine residents. Future studies should examine the effects of more comprehensive educational interventions and the impact of such interventions on physician behavior or patient care outcomes. Loeb DF, Aagaard EM, Cali SR, and Lee RS. Modest impact of a brief curricular intervention on poor documentation of sexual history in university-based resident internal medicine clinics. J Sex Med 2010;7:3315,3321. [source]

    Pubic Hair Removal among Women in the United States: Prevalence, Methods, and Characteristics

    Debra Herbenick PhD
    ABSTRACT Introduction., Although women's total removal of their pubic hair has been described as a "new norm," little is known about the pubic hair removal patterns of sexually active women in the United States. Aims., The purpose of this study was to assess pubic hair removal behavior among women in the United States and to examine the extent to which pubic hair removal methods are related to demographic, relational, and sexual characteristics, including female sexual function. Methods., A total of 2,451 women ages 18 to 68 years completed a cross-sectional Internet-based survey. Main Outcome Measures., Demographic items (e.g., age, education, sexual relationship status, sexual orientation), cunnilingus in the past 4 weeks, having looked closely at or examined their genitals in the past 4 weeks, extent and method of pubic hair removal over the past 4 weeks, the Female Genital Self-Image Scale (FGSIS) and the Female Sexual Function Index (FSFI). Results., Women reported a diverse range of pubic hair-grooming practices. Women's total removal of their pubic hair was associated with younger age, sexual orientation, sexual relationship status, having received cunnilingus in the past 4 weeks, and higher scores on the FGSIS and FSFI (with the exception of the orgasm subscale). Conclusion., Findings suggest that pubic hair styles are diverse and that it is more common than not for women to have at least some pubic hair on their genitals. In addition, total pubic hair removal was associated with younger age, being partnered (rather than single or married), having looked closely at one's own genitals in the previous month, cunnilingus in the past month, and more positive genital self-image and sexual function. Herbenick D, Schick V, Reece M, Sanders S, and Fortenberry JD. Pubic hair removal among women in the United States: Prevalence, methods and characteristics. J Sex Med 2010;7:3322,3330. [source]

    A Comparative Study of the Sexual Function of Institutionalized Patients with Schizophrenia

    María José Acuña MD
    ABSTRACT Introduction., Sexual dysfunction occurs frequently in patients with schizophrenia. Aim., To assess the sexual function of institutionalized patients with schizophrenia and compare it to both that of noninstitutionalized schizophrenic patients as well as patients without any mental illness. Methods., A cross-sectional comparative analysis between three groups: Group A: 75 patients with schizophrenia and/or schizoaffective disorder according to the International Classification of Diseases, 10th Edition (ICD-10) criteria, admitted into public psychiatric residential facilities; Group B: 41 patients with the same diagnosis who live in the community; Group C: 152 patients with no mental illness attended to by a Primary Care Medical Center. Main Outcome Measures., The Mini-International Neuropsychiatric Interview, Positive and Negative Syndrome Scale for Schizophrenia and Changes in Sexual Function Questionnaire were used to complete the study. Results., When institutionalized patients were compared to the control group, the impairment of sexual function was identified in all areas except Arousal in women and the percentage of dysfunction in Desire-Interest for both sexes. The results for noninstitutionalized schizophrenic males indicated a deficit in Pleasure and Orgasm and in Pleasure and Desire-Frequency for females, when compared with the control group. The overall subscale indicated that 71.2% of males and 57.1% of females in the institutionalized group experienced sexual dysfunction compared with 10% of males and 50% of females in the noninstitutionalized group, and only 12.7% of women in the control group. Conclusions., Most areas of sexual function are impaired among patients with schizophrenia, especially among institutionalized patients. However, their percentage of sexual dysfunction associated with sexual thoughts or fantasies was similar to that of patients without mental illness. Acuña MJ, Martín JC, Graciani M, Cruces A, and Gotor F. A comparative study of the sexual function of institutionalized patients with schizophrenia. J Sex Med 2010;7:3414,3423. [source]

    New Enhancements of the Scrotal One-Incision Technique for Placement of Artificial Urinary Sphincter Allow Proximal Cuff Placement

    Steven K. Wilson MD
    ABSTRACT Introduction., Urinary incontinence impairs sexual functioning and sexual satisfaction. Traditional artificial urinary sphincter (AUS) implantation requires perineal incision for cuff placement and a second inguinal incision for reservoir and pump placement. We believed AUS could be placed easier and quicker through one scrotal incision. Aim., In an effort to effect more proximal placement of the cuff while keeping the advantages of the one scrotal incision technique, we report enhancements to the original surgical technique. Methods., Thirty patients have been operated upon using the enhanced technique. A modification of the SKW retractor system (AMS) facilitates deep bulbar exposure. Twenty patients were first time implantations and 10 were revisions with five of the revisions having had the original AUS placed by traditional two-incision technique. Two of the first time AUS patients received an inflatable penile prosthesis through the same incision. Main Outcome Measures., We evaluated site of cuff placement, sizes of cuffs used, postoperative continence status. Results., All of the virgin AUS required dissection of the bulbocavernosus muscle prior to cuff placement. In scrotally placed revisions, replacement cuffs were situated considerably proximal (4.5,7.5 cm) to the original cuff site. The perineal placed revisions were accomplished through a scrotal incision with replacement of two cuffs in the same site and the three other patients immediately distal. No intraoperative complications were seen. One patient developed scrotal hematoma requiring drainage. Only 15 patients are available for follow-up and all are socially continent (one pad or less). Conclusions., Transscrotal approach is used safely and efficiently for penile implants and AUS implantation. The new enhancements to the one-scrotal incision technique allow more proximal cuff placement as evidenced by the bulbocavernosus muscle dissection and use of larger cuffs. Continence rate is similar to rates achieved with perineal placement of cuff found in the literature. Wilson SK, Aliotta PJ, Salem EA, and Mulcahy JJ. New enhancements of the scrotal one incision technique for placement of artificial urinary sphincter allow proximal cuff placement. J Sex Med 2010;7:3510,3515. [source]

    Sexual Behaviors, Condom Use, and Sexual Health of Americans Over 50: Implications for Sexual Health Promotion for Older Adults

    Vanessa Schick PhD
    ABSTRACT Introduction., In the contemporary U.S., men and women are living longer and healthier lives. As such, many people spend greater portions of their lives as sexually active individuals. Yet, little is known about the myriad of ways that older adults experience their sexual lives. Aim., This study sought to assess the context and frequency of sexual behaviors, condom use, sexual pleasure, and sexual experience of men and women over age 50. Methods., Information regarding the sexual experiences of a nationally representative sample of men and women over age 50 within the past year was examined. Main Outcome Measures., Sexual behavior over the past year was assessed in relation to several situational and contextual characteristics (e.g., event location, type of partner, health status, condom use). Participants were also asked about their experience (i.e., pleasure, arousal, pain, lubrication/erectile difficulties, and orgasm) during their most recent partnered sexual event. Bivariate or ordinal logistic regression models were used to investigate the relationship of age, health and partner status to sexual frequency and experience. Results., Although sizable proportions (20,30%) of both men and women remained sexually active well into their 80s age was related to a lower likelihood of solo and most partnered sexual behaviors. When controlling for age, relationship status, and health remained significant predictors of select sexual behaviors. The participant's evaluation of their most recent sexual experience in terms of arousal, erectile difficulty, and orgasm all declined with age. Health status was related to men's evaluation of the experience. Relationship status was the most consistent predictor of women's evaluation of the experience. Condom use rates remained low for participants across age groups. Conclusion., Many older adults continue be sexually active well into advanced age (80+). Thus, providers need to be attentive to the diverse sexual health needs of older adults. Schick V, Herbenick D, Reece M, Sanders SA, Dodge B, Middlestadt SE, and Fortenberry JD. Sexual behaviors, condom use, and sexual health of Americans over 50: Implications for sexual health promotion for older adults. J Sex Med 2010;7(suppl 5):315,329. [source]

    Sexual Health Among U.S. Black and Hispanic Men and Women: A Nationally Representative Study

    Brian Dodge PhD
    ABSTRACT Introduction., Little is known about the prevalence of sexual behaviors among the black and Hispanic populations in the United States outside the context of sexual risk and disease transmission in "high-risk" samples. Aim., This study sought to establish current rates of sexual behaviors, sexual health care practices (i.e., experiences with testing and diagnosis of sexually transmitted infections [STIs]), and condom use in a probability sample of black and Hispanic adult men and women in the United States. Main Outcome Measures., Sexual behaviors including solo masturbation, partnered masturbation, receiving oral sex and giving oral sex, vaginal intercourse, and anal intercourse were assessed. Self-reported rates of HIV and other STI testing, and self-reported history of STI diagnosis were examined. Also assessed were rates of condom use during most recent and past 10 vaginal intercourse events. Methods., Data from a probability sample of 1246 black and Hispanic adults were analyzed to explore sexual behaviors, condom use, and STI testing and diagnosis trends. Results., Masturbation, oral sex, and vaginal intercourse were prevalent among black and Hispanic men and women throughout the life course. Anal intercourse and same-gender sexual activities were less common. Self-reported rates of HIV testing were relatively high but varied by gender across age groups. Similarly, rates of testing for other STI were high and differed by gender across age groups. Overall rates of condom use among black and Hispanic men and women were relatively high and did not appear to be related to a variety of situational factors including location of sexual encounter, relationship status, other contraceptive use, and substance use during sexual activity. Conclusion., These data provide a foundation for understanding diverse sexual behaviors, sexual health-care practices, and condom use among the general population of black and Hispanic men and women in the United States. Dodge B, Reece M, Herbenick D, Schick V, Sanders SA, and Fortenberry JD. Sexual health among U.S. black and Hispanic men and women: a nationally representative study. J Sex Med 2010;7(suppl 5):330,345. [source]