The aim of this study was to report on the extent of physical, social and role activity limitations among CLBP patients receiving short-acting opioid therapy, and after at least 9 weeks of the fentanyl transdermal system. Data were from an observational study at 17 U.S. pain centers. Eligible patients (N=131) had a CLBP diagnosis for at least 3 months and were receiving short-acting opioids when transdermal fentanyl was added. Patients were asked to report on the extent to which their pain or health in general limited their functioning before and after at least 9 weeks of transdermal fentanyl using a validated pain-specific instrument, the Treatment Outcomes in Pain Survey (TOPS). Differences in the percentage of reported overall as well as specific limitations before and after treatment were tested with McNemar's chi-square test. At baseline, a substantial proportion of CLBP patients reported limitations in basic activities: 60% reported difficulty lifting and carrying groceries, walking several blocks, or bathing and dressing; 74% reported that pain interfered with participating in usual social activities; 81% reported that pain interfered with work inside and outside the home; and 77% were "completely" or "very" dissatisfied with their physical ability. After transdermal fentanyl therapy, there was a significant reduction in the proportion of CLBP patients reporting these limitations: lifting and carrying groceries (21% reduction, p=0.009), walking several blocks (19%, p=0.014), bathing and dressing (23%, p=0.008), participating in usual social activities (32%, p<0.0001), pain interfering with work inside and outside the home (29%, p<0.0001) and the percent "completely" or "very" dissatisfied with their physical ability dropped (improved) 48% (p<0.0001). We conclude that CLBP patients experience substantial limitations in physical, social and role functioning. In addition to pain relief, an objective of an effective treatment plan should include the restoration of basic functioning.

The aim of this study was to assess the impact of pain relief on HRQoL and disability in CLBP patients treated with the fentanyl transdermal system. Data come from an observational study conducted at 17 clinical centers in the U.S. Eligible patients (N=131) had a CLBP diagnosis for at least 3 months and were receiving short-acting opioids when transdermal fentanyl was added. Patients completed the Treatment Outcomes in Pain Survey (TOPS), the SF-36 Health Survey, the Oswestry Disability Index (ODI) and a 10-point numerical rating scale (NRS) of pain severity at baseline and after at least 9 weeks of transdermal fentanyl treatment. Patients were categorized into 5 groups according to NRS changes from baseline to endpoint: worse (increase in NRS), same (no change in NRS), “small” pain relief (NRS improved 1–2 points), “moderate” pain relief (NRS improved 3–4 points), and “large” pain relief (NRS improved 5–8 points). Multivariate analysis of variance (MANOVA) was used to test the significance of differences in mean score changes on the TOPS, SF-36 and ODI across the 5 pain relief groups. Overall, mean score changes differed significantly across patients stratified by differences in pain relief on the TOPS (MANOVA F=4.0, p<0.001), SF-36 (MANOVA F=2.3, p<0.001) and ODI (ANOVA F=10.5, p<0.001). Patients who experienced greater pain relief showed substantially larger HRQoL improvement and decreased disability than patients who experienced little or no pain relief. Even patients who experienced “small” pain relief showed a clinically meaningful reduction in disability (ODI improvement of 7.6 points) and statistically significant improvement in several HRQoL domains. We conclude that pain relief provided by treatment with transdermal fentanyl significantly reduces the HRQoL burden and disability reported by CLBP patients. The aim of this study was to assess the impact of pain relief on HRQoL and disability in CLBP patients treated with the fentanyl transdermal system. Data come from an observational study conducted at 17 clinical centers in the U.S. Eligible patients (N=131) had a CLBP diagnosis for at least 3 months and were receiving short-acting opioids when transdermal fentanyl was added. Patients completed the Treatment Outcomes in Pain Survey (TOPS), the SF-36 Health Survey, the Oswestry Disability Index (ODI) and a 10-point numerical rating scale (NRS) of pain severity at baseline and after at least 9 weeks of transdermal fentanyl treatment. Patients were categorized into 5 groups according to NRS changes from baseline to endpoint: worse (increase in NRS), same (no change in NRS), “small” pain relief (NRS improved 1–2 points), “moderate” pain relief (NRS improved 3–4 points), and “large” pain relief (NRS improved 5–8 points). Multivariate analysis of variance (MANOVA) was used to test the significance of differences in mean score changes on the TOPS, SF-36 and ODI across the 5 pain relief groups. Overall, mean score changes differed significantly across patients stratified by differences in pain relief on the TOPS (MANOVA F=4.0, p<0.001), SF-36 (MANOVA F=2.3, p<0.001) and ODI (ANOVA F=10.5, p<0.001). Patients who experienced greater pain relief showed substantially larger HRQoL improvement and decreased disability than patients who experienced little or no pain relief. Even patients who experienced “small” pain relief showed a clinically meaningful reduction in disability (ODI improvement of 7.6 points) and statistically significant improvement in several HRQoL domains. We conclude that pain relief provided by treatment with transdermal fentanyl significantly reduces the HRQoL burden and disability reported by CLBP patients.

Fentanyl is a potent opioid medication used in the management of moderate to severe chronic pain. This study involves the conduct of a series of fentanyl extraction/recovery experiments to determine the relative ease of obtaining fentanyl in an abusable form from the Duragesic" reservoir patch and a prototypical fentanyl matrix patch. The experiments were designed to evaluate fentanyl recovery using readily available solvents in a manner consistent with drug abuser capability. The Duragesic® and matrix patches were readied for extraction by removing the adhesive covering and placing them in the selected solvent. The patches were subjected to extraction techniques including soaking and percolation at various times and temperatures. Extraction efficiency was evaluated by liquid chromatography/tandem mass spectrometry (LC-MS/MS) at various time points. Experiments involving minimal time and effort yielded significant amounts of fentanyl in the free base form from the matrix patch system. For example, soaking for 15 minutes at room temperature in three readily available solvents yielded 61%, 75%, and 97%, respectively, for the matrix patch, and at 3 hours yielded 89%, 93%, and 100%, respectively. Yields for the Duragesic patch did not exceed 10% at any time point in any of the solvents tested. More complex extraction processes like percolating for 3 hours or boiling in various solvents were required to obtain significant yields from the Duragesic® reservoir patches. Overall, these extraction techniques resulted in a greater quantity of fentanyl being extracted in a shorter time period with less complex techniques from the matrix patch versus the Duragesic reservoir patch. Fentanyl is a potent opioid medication used in the management of moderate to severe chronic pain. This study involves the conduct of a series of fentanyl extraction/recovery experiments to determine the relative ease of obtaining fentanyl in an abusable form from the Duragesic" reservoir patch and a prototypical fentanyl matrix patch. The experiments were designed to evaluate fentanyl recovery using readily available solvents in a manner consistent with drug abuser capability. The Duragesic® and matrix patches were readied for extraction by removing the adhesive covering and placing them in the selected solvent. The patches were subjected to extraction techniques including soaking and percolation at various times and temperatures. Extraction efficiency was evaluated by liquid chromatography/tandem mass spectrometry (LC-MS/MS) at various time points. Experiments involving minimal time and effort yielded significant amounts of fentanyl in the free base form from the matrix patch system. For example, soaking for 15 minutes at room temperature in three readily available solvents yielded 61%, 75%, and 97%, respectively, for the matrix patch, and at 3 hours yielded 89%, 93%, and 100%, respectively. Yields for the Duragesic patch did not exceed 10% at any time point in any of the solvents tested. More complex extraction processes like percolating for 3 hours or boiling in various solvents were required to obtain significant yields from the Duragesic® reservoir patches. Overall, these extraction techniques resulted in a greater quantity of fentanyl being extracted in a shorter time period with less complex techniques from the matrix patch versus the Duragesic reservoir patch.

Chronic low back pain (CLBP) patients often have much difficulty conducting daily activities. While certain physical functions measures are determined objectively (eg, decreased range of movement; gait speed), limitations in daily activities are typically measured subjectively. These measures of functioning are critical to improved patient outcomes. The aim was to determine the impact of chronic low back pain and of treatment with transdermal fentanyl on daily activities, and offer an interpretation regarding functioning. Observational study conducted at 17 clinical centers in the U.S. Eligible patients had CLBP diagnosis for at least 3 months and were transitioned from short-acting opioids to transdermal fentanyl. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF-36 Health Survey, at baseline and follow up. To interpret the meaning of score changes with this instrument, the content of several items was examined, focusing on limitations in the physical and social areas. Activity limitation is widespread in the CLBP population. In this study, 52% of patients were limited in their ability to walk one block, climb one flight of stairs, and bath/dress themselves. After treatment with transdermal fentanyl, 41% of patients reported these limitations, a reduction of 22% (p=0.034). At baseline, 81% of patients reported that their pain substantially interfered with their ability to conduct normal work (inside or outside of the home); after transdermal fentanyl treatment, 62% of patients reported this finding, a reduction of 23% (p=0.0001). At baseline, 67% of patients reported that their health substantially interfered with social activities; after transdermal fentanyl treatment, 47% of patients reported this finding, a reduction of 30% (p=0.0003). In this preliminary analysis in a usual-care setting, transdermal fentanyl treatment for at least 9 weeks significantly improved activity limitation in CLBP patients. Improvement was especially noted in patients with more severe activity limitations.

Chronic low back pain (CLBP) burdens patients with numerous challenges, including functional limitations and disability. Restoration of function - including physical, social, and mental functioning - is essential for a successful treatment plan. Although pain relief is an important outcome, the subjective report of pain relief is a problematic measure. Given the complexity of CLBP and its assessment, functional and health-related quality of life measures are extremely valuable. The objective was to determine the impact of treatment with transdermal fentanyl (TDF) on functional disability in CLBP patients. An observational, naturalistic trial at 17 clinical centers in the US; CLBP patients were eligible if their physicians were transitioning them from short-acting opioids to TDF. Patients completed the Oswestry Disability Index (ODI), an instrument consisting of 10 questions designed to assess disability in patients with back pain. A 10-point numeric rating scale (NRS) of pain intensity was also used. Both measurements were taken at baseline and following a minimum of 9 weeks of treatment. 122 patients completed the baseline and follow-up visits; 36% male; mean age 46.1±10.6 years; mean CLBP duration 106.4±98.2 months). At baseline, mean total ODI score was 53.6±13.1, suggesting relatively high disability; mean NRS was 7.5±1.5. At follow-up, mean ODI score improved 6.5±13.1 points (p<0.001), corresponding to a moderate effect size (0.50). The NRS score improved 1.4±2.0 points (p<0.001). The change in ODI exceeds the accepted minimal clinically important difference, indicating that patients experienced a clinically significant improvement in functioning. Significant improvements on the ODI and NRS were observed for both genders. In this preliminary analysis in a usual-care setting, TDF treatment for at least 9 weeks significantly reduced disability and pain intensity in patients with CLBP.

Measures of pain frequency and intensity do not capture the extent to which chronic low back pain (CLBP) affects a person’s life and may underestimate the broad benefits of treatment. Understanding the full impact of CLBP and its treatment requires a multidimensional approach that includes health-related quality of life (HRQoL) measures. To assess the impact of CLBP on HRQoL and the effect of transdermal fentanyl treatment on HRQoL. An observational study conducted at 17 clinical centers in the U.S. Eligible patients had CLBP diagnosis for at least 3 months and were transitioned from short-acting opioids to transdermal fentanyl. Patients completed the Treatment Outcomes in Pain Survey (TOPS), which includes the SF-36 Health Survey, at baseline and ≥ 9 weeks of treatment. The HRQoL burden of CLBP was determined by comparing patient's SF-36 scores to general U.S. population norms. The HRQoL impact of transdermal fentanyl was determined by comparing baseline and follow-up TOPS and SF-36 scores. At baseline CLBP patients (N=122) scored one to two standard deviations (SD) below age and gender adjusted SF-36 general population norms (MANOVA F(8,2102)=119.3, p<0.0001). Significant improvement (p<0.05) was observed on the SF-36 physical functioning, role physical, bodily pain, vitality, social functioning, and physical summary scales and the TOPS total pain summary scale. The magnitude of change in scores in standard deviation units among these scales ranged from 0.21 to 0.73, which are considered small to moderate effect size changes. These changes suggest significant improvements not only in pain relief, but also physical and social functioning. In this preliminary analysis in a usual care setting, CLBP patients who chronically used short-acting opioids showed tremendous HRQoL burden that was significantly reduced after transitioning to transdermal fentanyl.