Brief Pain Inventory Items Research Articles

Impact of zoledronic acid (Z) on pain in prostate cancer patients with bone metastases in a randomised placebo-control trial

4638 Background: Bone metastases occur in up to 80% of advanced prostate cancer patients and can results in painful Skeletal-Related Events (SREs). Z is the only biphosphonate approved for metastatic prostate cancer that decreases the occurrence of SREs which include pathologic fractures, severe bone pain requiring radiation therapy, spinal cord compression, surgery to bone and hypercalcemia of malignancy which may lead to daily activity limitations. We performed retrospective analyses on data from a placebo-controlled study of Z to investigate which items of the Brief Pain Inventory (BPI) were most sensitive to changes in patient’s pain due to treatment. Methods: Prostate cancer patients with bone metastases received Zoledronate 4 mg (n = 201) or placebo (n = 201). The BPI was administered at baseline (visit 2), and visits 3 (weeks 3–4), 4 (weeks 6–8), and then every second visit (every 6 weeks) until study end. Changes in BPI individual item scores and the Pain Severity and Pain Interference scale scores were compared between Z and placebo groups. Post-baseline missing data was replaced by Last Observation Carried Forward (LOCF). Results: Z was statistically significantly better than placebo for changes in BPI items ‘pain at its worst’, ‘pain at its least’, ‘pain on average’, and the BPI pain severity scale (p < 0.05) at visit 4 (weeks 6–8), and visit 6 (week 12). For ‘pain right now’ there were statistically significant differences at visit 4, but not visit 6. Z was also superior to placebo for ‘pain right now’ and the Pain Severity and Interference scales at visit 12 (week 30–32) (p < 0.05). Finally Z was superior to placebo for ‘interference with general activities’ at visits 12 (week 30–32), 16 (weeks 42–44), and LOCF (p < 0.05). Conclusion: Our findings suggest that Z significantly reduces bone pain and general activity limitations in prostate cancer patients with bone metastases. Several items in the BPI are more sensitive to Z treatment including ‘pain at its worst’, ‘pain at its least’, ‘pain on average’, and the BPI Pain Severity scale. [Table: see text]

Duloxetine 60 mg once-daily in the treatment of painful physical symptoms in patients with major depressive disorder

Background: While emotional symptoms such as depressed mood and loss of interest have traditionally been considered to constitute the core symptoms of major depressive disorder (MDD), the prevalence and importance of painful physical symptoms such as back pain, abdominal pain, and musculoskeletal pain is becoming increasingly appreciated. Antidepressants possessing dual serotonin/norepinephrine (5-HT/NE) reuptake inhibition may demonstrate greater efficacy in the alleviation of pain. The efficacy of duloxetine, a balanced and potent dual reuptake inhibitor of 5-HT and NE, was evaluated within a cohort of depressed patients with associated painful physical symptoms. Methods: In this multicenter, double-blind, placebo-controlled study, patients meeting DSM-IV criteria for MDD were randomized to receive placebo ( N=141) or duloxetine 60 mg QD ( N=141). Patients were required to have a 17-item Hamilton Rating Scale for Depression (HAMD 17) total score ⩾15, a Clinical Global Impression of Severity (CGI-S) score ⩾4, and a Brief Pain Inventory (BPI) Average Pain score ⩾2 at baseline. The primary efficacy measure was the BPI Average Pain score, while secondary measures included other BPI items, the HAMD 17 total score, CGI-S, the Patient Global Impression of Improvement (PGI-I) scale, Visual Analog Scales (VAS) for pain, and the Symptom Questionnaire, Somatic Subscale (SQSS). Safety was evaluated by recording treatment-emergent adverse events (spontaneously reported), vital signs, and laboratory analytes. Results: Mean changes in BPI Average Pain for duloxetine- and placebo-treated patients differed significantly at most visits, but only approached significance at endpoint ( p=0.066). For the main effect of treatment (pooling all visits), significant advantages for duloxetine-treated patients were found in 10 of 11 assessed BPI pain severity and pain interference items, in addition to VAS overall pain and back pain. Mean changes in pain measures for duloxetine-treated patients corresponded to improvements of 25–50%, compared with 19–39% for placebo. Mean changes at endpoint in depression rating scales (HAMD 17, CGI-S, PGI-I) did not differ significantly between duloxetine and placebo treatment groups due to unusually high placebo response. The magnitude of placebo treatment effects (as measured by HAMD 17 total score and Maier subscale) was significantly smaller in patients with ⩾1 previous depressive episode, compared to those patients with no previous episodes. In patients with ⩾1 previous depressive episode the advantage of duloxetine over placebo was similar to previous studies. Rates of discontinuation due to adverse events were 14.2% vs. 2.1% for duloxetine and placebo, respectively ( p<0.001). Treatment-emergent adverse events reported at a significantly higher rate by duloxetine-treated patients included nausea, dry mouth, fatigue, and decreased appetite. Conclusions: In this study, duloxetine (60 mg QD) was shown to be an effective treatment for the painful physical symptoms which are frequently associated with depression. Improvements in pain severity occurred independently of changes in depressive symptom severity.

The reliability and validity of pain interference measures in persons with cerebral palsy

Tyler EJ, Jensen MP, Engel JM, Schwartz L. The reliability and validity of pain interference measures in persons with cerebral palsy. Arch Phys Med Rehabil 2002;83:236-9. Objective: To evaluate the reliability and validity of 2 measures of pain interference in persons with cerebral palsy (CP). Design: Standardized interviews to assess pain and impact of pain on activities. Setting: University medical center. Participants: Fifty adults with CP. Interventions: Patients asked to rate pain's intensity, interference with general activities, and depression levels. Main Outcome Measures: Pain interference scales: Chronic Pain Grade (CPG) and Brief Pain Inventory (BPI); rating of disability: Craig Handicap Assessment and Reporting Technique (CHART); rating of depression: Center for Epidemiologic Studies Depression (CES-D) Scale. Results: Mean interference of pain on 3 CPG items (pain interference with daily activities, social activities, work) were 1.74 ± 2.45, 1.06 ± 2.05, and.89 ± 1.84 (out of 10), respectively. Mean interference on 10 modified BPI interference items ranged from 2.28 ± 3.01 to 3.67 ± 3.15 (out of 10). The composite CPG interference score did not correlate significantly with pain intensity. However, the composite BPI interference score did correlate significantly with pain intensity (r =.66, P <.01). There was no significant association shown between average pain and the CHART score (r = −.21, NS). Pain showed a significant association with CES-D score (r =.45, P <.05). Internal consistency of the 3 CPG items was inadequately low (Cronbach α =.59), whereas that of the 10 BPI items was excellent (.89). Conclusions: The pain interference items of the BPI serve as a reliable and valid measure of pain's impact on persons with CP-related pain. © 2002 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation