Pain relief, Health-Related Quality of Life (HRQoL) and disability in Chronic Low Back Pain (CLBP) patients: Results of an observational study

Abstract

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.