Brief Pain Inventory Short Form Research Articles

A Pilot Study in the Use of Activity Trackers for Assessing Response to Palliative Radiotherapy.

PurposeRadiation therapy (RT) has been a frequently used treatment for painful bone metastasis. The aim of this study was to determine the feasibility of using activity trackers (AT) to assess the patient prognosis and the effects of palliative RT.Methods and materialsTwelve patients planned to receive palliative RT for axial metastases and were prospectively recruited to participate in this pilot clinical trial. The patients were eligible if there was no intent to change the analgesic medications prior to or within seven days of palliative RT. All the patients were lent a Misfit FlashTM activity tracker (Misfit, Burlingame, California, United States of America) and were asked to wear it from the time of baseline assessment prior to RT until seven days after RT. The patients completed the European Organisation for Research and Treatment of Cancer quality of life (QOL) questionnaire (EORTC-QLQ C30) and the Short Form Brief Pain Inventory (SF-BPI) before the treatment and at days seven, 30 and 90 after completion of the RT. The patients' Karnofsky Performance Status (KPS) was assessed at each visit. The patients' overall survival at the end of the RT was recorded. Average daily steps before and after RT were compared using paired Wilcoxon signed-rank test. The patients' overall survival was estimated using the Kaplan-Meier curve and analyzed using the Log-Rank test.ResultsThe median age of the patients was 62 years (range: 40-79 years). Of the 12 patients, there were five prostate, three breasts, three lungs, and one colon cancer-related patients. Six patients received 20 Gray (Gy) in five fractions and six received 8 Gy in one fraction. By day seven, post-RT, there was a 30% (p <0.02) reduction in the patients' daily activity level. There was no correlation between improvements in the QOL or with the level of pain and with the number of daily steps. While baseline KPS was not prognostic of the patient survival, the patients who on average took more than 7800 steps per day prior to RT lived significantly (p=0.034) longer than those who were less active.ConclusionsThe baseline activity level is associated with the patient prognosis. A significant decline in the physical activity was observed at one week after palliative RT. The use of activity trackers was to prognosticate and to monitor the patients' response to the palliative RT and should be evaluated further.

Randomized placebo-controlled pilot trial of omega 3 fatty acids for prevention of aromatase inhibitor-induced musculoskeletal pain.

Aromatase inhibitor (AI)-induced joint symptoms negatively impact drug adherence and quality of life in breast cancer survivors. Mechanisms underlying symptoms may include inflammation. It is hypothesized that n - 3 polyunsaturated fatty acids (PUFAs) have anti-inflammatory properties and may reduce symptoms. We conducted a randomized, double-blind, placebo-controlled study comparing 4.3g/day n - 3 PUFA supplements vs placebo for 24weeks in postmenopausal breast cancer patients starting adjuvant AIs. Primary endpoints were adherence and tolerability; secondary outcomes included inflammatory cytokines and symptoms assessed by the Brief Pain Inventory short form (BPI-SF) and Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) at 0, 12, and 24weeks. Forty-four women were randomized, of which 35 completed the study. Adherence was ≥88% based on these 35 patients with pill counts as well as change in red blood cell (RBC) n - 3 PUFAs. Common toxicities included grade 1 flatulence (55% of both groups) and belching (45% of n - 3 group). Mean pain severity scores (BPI-SF) did not change significantly by time or treatment arm. Quality of life, based on FACT-ES scores, significantly decreased within placebo (p=0.04), but not the n - 3 group (p=0.58), with a trend toward between-group differences (p=0.06) at 12weeks, but no significant differences at 24weeks. RBC n - 3 levels were strongly positively correlated with FACT-ES at 12weeks, but attenuated at 24weeks. High-dose n - 3 PUFA supplementation is feasible and well tolerated when administered with AIs. Additional studies are needed to evaluate efficacy in prevention of joint symptoms.

Effects of the Chinese medicine Yi Shen Jian Gu granules on aromatase inhibitor-associated musculoskeletal symptoms: A randomized, controlled clinical trial

Aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) are prevalent among patients on AI therapy, which leads to a lower quality of life and poor adherence to AI treatment. We evaluated whether Yi Shen Jian Gu granules (YSJG) is effective and safe to relieve AIMSS in patients with breast cancer.Eligible participants were randomly assigned to the YSJG group or the placebo group. Both groups had a 12-week treatment period and a 12-week follow-up period. Brief Pain Inventory-Short Form (BPI-SF), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index, and the Modified Score for the Assessment and Quantification of Chronic Rheumatoid Affections of the Hands (M-SACRAH) were obtained at baseline and at 4, 8, 12 and 24 weeks.Of 146 participants enrolled, 84 were randomly assigned, and 77 were evaluable at 12 weeks. Baseline characteristics were comparable between two groups. The primary outcome was the differences in mean BPI-SF scores at 12 weeks. The worst pain scores decreased by 3.10 points (50.2%; 95% CI, 2.50 to 3.65) for YSJG group compared with a 1.63-point decrease (26.9%; 95% CI, 3.86 to 4.97) for the placebo group (P = 0.001). Significantly improvements were also observed for the WOMAC and M-SACRAH. Possibly YSJG-related side effects were grade 1 nausea (10%) and grade 2 diarrhea (2%). Serum follicle-stimulating hormone and serum estradiol were kept in the postmenopausal range before and after YSJG treatment.Patients with AIMSS treated with YSJG granules had significant improvements in musculoskeletal symptoms. YSJG is effective, safe and well-tolerated in managing AIMSS. Trial registrationISCTN: ISRCTN06129599 (assigned 14 August 2013).

The Phase 3 COU-AA-302 Study of Abiraterone Acetate Plus Prednisone in Men with Chemotherapy-naïve Metastatic Castration-resistant Prostate Cancer: Stratified Analysis Based on Pain, Prostate-specific Antigen, and Gleason Score

BackgroundIn the COU-AA-302 study (NCT00887198), abiraterone acetate plus prednisone (AAP) significantly improved outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) versus prednisone alone. Baseline clinical parameters predicting that treatment response could help inform clinical decisions were explored. ObjectiveTo identify patients who derive the greatest clinical benefit from AAP treatment. Design, setting, and participantsA total of 1088 mCRPC patients treated with either AAP or prednisone in the first-line setting in COU-AA-302 were included in this post hoc analysis. InterventionAbiraterone acetate1000mg daily versus placebo, both plus prednisone 10mg daily. Outcome measurements and statistical analysisUnivariate and multivariable Cox regression analyses were performed, including clinical and pathological parameters for the primary end points overall survival (OS) and radiographic progression-free survival (rPFS), and secondary study end points. Tumor-associated baseline parameters independently impacting OS were applied to stratify patients according to possible treatment effects. Results and limitationsBaseline prostate-specific antigen (PSA), tumor-related pain as assessed by the Brief Pain Inventory-Short Form (BPI-SF), and Gleason score (GS) at primary diagnosis were identified as tumor-associated variables that independently impacted OS. AAP significantly improved outcomes versus prednisone in both group 1 (BPI-SF 0–1 and PSA <80 ng/ml and GS <8; p=0.006; hazard ratio [HR]: 0.61) and group 2 (BPI-SF 2–3 and/or PSA ≥80 ng/ml and/or GS ≥8; p=0.03; HR: 0.84). The differences observed for treatment effects between groups 1 and 2 for OS (HR: 0.61 vs 0.84), rPFS (HR: 0.41 vs 0.59), and time to chemotherapy (HR: 0.64 vs 0.71) were not statistically significant. ConclusionsAAP significantly improved outcomes in mCRPC patients compared with prednisone alone regardless of baseline pain and PSA level, and GS at primary diagnosis with no significant differences between observed treatment effects in groups 1 and 2. Patient summaryTreatment with abiraterone acetate and prednisone (compared with treatment with prednisone only) for metastatic castration-resistant prostate cancer increased survival in all patients in the study regardless of pain, prostate-specific antigen levels at the start of treatment, and Gleason score at primary diagnosis.

Multimodal Frequency Treatment for Facial Pain Caused by Chronic Rhinosinusitis: A Pilot Study

Chronic rhinosinusitis (CRS) is a common disease that affects over 200 million patients worldwide. CRS often presents with facial pain, which is considered an important criterion for the diagnosis of CRS. A single-arm clinical study was designed to test the effect of simultaneous high (1 MHz) and low frequencies (70–80 Hz) on facial pain in 14 CRS patients at the Sarah Bush Lincoln Health Center, Mattoon, IL, USA. We used two quality of life (QOL) instruments to test the effect of multimodal frequencies on patients suffering from CRS: the Brief Pain Inventory Short Form (BPI-SF), and the Sino-Nasal Outcome Test (SNOT-22). Mean BPI-SF severity scores improved by 0.80 points (Wilcoxon rank sum test p < 0.01) in all 14 patients. In patients with baseline facial pain (n = 9), the scores improved by an average of 1.5 (p < 0.01) points in the pain severity domain and by 1.4 points in the pain interference domain. Additionally, the mean improvement in SNOT-22 scores was 14.11 (p < 0.05), which is above the minimal clinically-important difference (MCID) of nine points. Our pilot study indicates that multimodal vibration frequencies applied over the facial sinuses reduce pain, possibly through the reduction of the inflammatory response and modulation of the pain receptors. This study suggests the possibility that combining different frequencies could have an enhanced effect on reducing CRS-related facial pain.

Predicting treatment outcomes of major depressive disorder by early improvement in painful physical symptoms: a pooled analysis of double-blind, placebo-controlled trials of duloxetine.

ObjectiveWe determined if early improvement in painful physical symptoms (PPS) can be a predictor of remission in the treatment of major depressive disorder (MDD).MethodsWe included randomized, double-blind, parallel-group clinical trials of duloxetine (40–60 mg/day) versus placebo for the acute treatment of MDD with associated PPS. Only those studies using the Montgomery–Åsberg Depression Rating Scale (MADRS) and the Brief Pain Inventory – Short Form (BPI-SF) were included. Three studies met all criteria and included male or female outpatients aged ≥18 years who met the diagnostic criteria for MDD, had a MADRS total score ≥20, and had at least moderate pain (BPI-SF average pain score ≥3). Positive predictive values (PPVs) and negative predictive values (NPVs) of early improvement in PPS for remission were analyzed. PPVs were the proportion of patients with remission (MADRS total score ≤10) at week 8 out of patients who experienced early improvement in BPI-SF average pain score (≥30% decrease from baseline at week 1, 2, or 4). NPVs were the proportion of patients without remission (MADRS total score >10) at week 8 out of patients who did not experience early improvement in PPS.ResultsData from 1,320 patients were analyzed (duloxetine N=641 and placebo N=679). The overall remission (MADRS total score ≤10 at week 8) rate for the duloxetine group was significantly higher than the placebo group (38.5% vs 21.8%; P<0.0001). For both treatment groups, PPVs of early improvement in BPI-SF (30% improvement from baseline) were higher than the overall remission rate for all weeks examined (weeks 1, 2, and 4); in general, NPVs of early improvement in BPI-SF for nonremission were higher than the overall nonremission rate.ConclusionEarly improvement in PPS can be a useful clinical indicator of subsequent treatment outcome for MDD patients with associated PPS.

An observational study of duloxetine versus SSRI monotherapy for the treatment of painful physical symptoms in Japanese patients with major depressive disorder: primary analysis.

ObjectiveThe objective of this study was to assess the effectiveness of duloxetine monotherapy, in comparison with selective serotonin reuptake inhibitor (SSRI) monotherapy, in the treatment of painful physical symptoms (PPS) in Japanese patients with major depressive disorder (MDD) in real-world clinical settings.MethodsThis was a multicenter, 12-week prospective, observational study. This study enrolled MDD patients with at least moderate PPS, defined as a Brief Pain Inventory-Short Form (BPI-SF) average pain score (item 5) ≥3. Patients were treated with duloxetine or SSRIs (escitalopram, sertraline, paroxetine, or fluvoxamine) for 12 weeks, and PPS were assessed by BPI-SF average pain score. The primary outcome was early improvement in the BPI-SF average pain score at 4 weeks post-baseline.ResultsA total of 523 patients were evaluated for treatment effectiveness (duloxetine N=273, SSRIs N=250). The difference in BPI-SF average pain score between the two groups was not statistically significant at 4 weeks post-baseline, the primary endpoint (least-squares mean change from baseline [95% confidence interval]: duloxetine, −2.8 [−3.1, −2.6]; SSRIs, −2.5 [−2.8, −2.3]; P=0.166). There was a numerical advantage for duloxetine in improvement from 4 to 12 weeks post-baseline, and the difference was statistically significant at 8 weeks post-baseline (least-squares mean change from baseline [95% confidence interval]: duloxetine, −3.6 [−3.9, −3.3]; SSRIs, −3.1 [−3.4, −2.8]; P=0.023). The 30% and 50% responder rates were significantly higher in patients treated with duloxetine at 4 and 8 weeks post-baseline. There were no serious adverse events experienced by duloxetine-treated patients. The rate of discontinuations due to adverse events was similar for duloxetine and the SSRIs (1.0% and 0.8% of patients, respectively).ConclusionIn this observational study, BPI-SF improvement was not significantly different at 4 weeks, the primary endpoint; however, patients treated with duloxetine tended to show better improvement in PPS compared to those treated with SSRIs.

Impact of Empathy in the Patient-Doctor Relationship on Chronic Pain Relief and Quality of Life: A Prospective Study in Spanish Pain Clinics.

To assess the impact of the empathy of physicians, perceived by patients with chronic pain, regarding pain relief and health-related quality of life (HR-QoL). A prospective noninterventional study was conducted in 2,898 patients with moderate to severe chronic pain who were referred to pain clinics. The same physician visited each patient at baseline and after one and three months. Study questionnaires included the Jefferson Scale of Patient Perceptions of Physician Empathy (JSPPPE), the Life Orientation Test-Revised (LOT-R), the Pain Coping Questionnaire (CAD-R), the Brief Pain Inventory Short Form (BPI-SF), and the EuroQol-5D (EQ-5D). Regression analyses were used to evaluate the independent contribution of the changes in perceived empathy over pain intensity and improvement of HR-QoL. BPI-SF scores for pain intensity, rated as worst, least, average, and current pain, decreased significantly (P < 0.001) from baseline to month 3, with reductions of 33.7%, 42.5%, 40.0%, and 46.9%, respectively. Pain intensity decreased from 6.3 ± 1.5 at baseline to 4.7 ± 1.8 at one month and 3.8 ± 1.9 at three months (P < 0.050). Significant (P < 0.001) improvements in the EQ-5D tariff (+37.1%) and EQ-5D VAS (+26.7%) were also recorded. In the linear regression analysis, JSPPPE and LOT-R, but not CAD-R, were significantly associated with pain relief and HR-QoL. Physicians' empathy and patients' dispositional optimism have a role in determining positive outcomes in patients with chronic pain. Physicians' empathy may therefore be a suitable, yet relatively unexplored, target for intervention.

Multicenter, cross-sectional observational study of the impact of neuropathic pain on quality of life in cancer patients

PurposeNeuropathic cancer pain (NCP) is a common and potentially debilitating symptom in cancer patients. We investigated the prevalence of NCP, as well as its management and association with QOL.MethodsCancer patients with pain ≥1 on the visual analogue scale (VAS) were surveyed with the Douleur Neuropathique (DN4) questionnaire, the Brief Pain Inventory-Short Form (BPI-SF), and the EuroQOL five dimensions (EQ-5D) questionnaire. The associations between NCP and pain severity or NCP and QOL, while controlling for variables relevant to QOL, were then analyzed.ResultsA total of 2003 patients were enrolled in this survey; the prevalence of NCP was 36.0% (n = 722, 95% CI, 32.5–39.5). We found that NCP in cancer patients was closely correlated to a higher pain severity (BPI-SF; 4.96 ± 1.94 versus 4.24 ± 2.02, p < 0.001), and in patients with NCP, pain more severely interfered with daily living, as compared to those without NCP (BPI-SF; 4.86 ± 2.71 versus 4.41 ± 2.87, p < 0.001). Patients with NCP also had worse QOL than those without NCP, as measured by EQ-5D index score (0.47 ± 0.30 vs. 0.51 ± 0.30, p = 0.005), and this was confirmed using multivariate analysis (p < 0.001), even after controlling for other variables such as age, sex, disease stage, cancer duration, radiotherapy, chemotherapy, and comorbidities. Importantly, adjuvant analgesics were used in less than half of patients with NCP (n = 358, 46.4%).ConclusionsWe found that NCP in cancer patients was significantly associated with a worsened QOL, and current management is inadequate. Therefore, future research aimed at developing improved strategies for management of NCP is required.

Oral vitamin B12 to improve aromatase inhibitors (AI)-associated musculoskeletal symptoms (AIMSS).

e21679 Background: Breast cancer patients undergoing Aromatase Inhibitor (AI) therapy often experience many side effects, which include musculoskeletal and joint pain. Vitamin B12 has often been used as a naturopathic supplement to relieve joint pain that is caused by arthritis. The purpose of this study was to evaluate the effect of Vitamin B12 supplements on musculoskeletal pain and arthralgias induced by aromatase inhibitors (AI) therapy. Methods: After approval by Institutional Review Board (IRB), we enrolled consecutive patients treated at the Texas Tech Breast Care Center who had a diagnosis of invasive breast cancer, Stages I-III, and were taking an AI and experiencing significant musculoskeletal symptoms assessed by the Brief Pain Inventory-Short Form (BPI-SF) questionnaire. Participants received 2500 mcg of sublingual vitamin B12 daily for 90 days. Assessments included improvement in BPI-SF pain scores at 3 months, the impact on quality of life determined by the Functional Assessment of Cancer Therapy–Endocrine Symptoms, FACT-ES and correlative serum markers. Results: A total of forty-one patients were enrolled, five patients withdrew, leaving thirty-six patients to complete the study. Analysis of the data collected indicate a 34% average pain improvement (P-value = 0.0001) as reported by patients at baseline and at the end of treatment in the BPI-SF questionnaire. Additionally, a 23 % worst pain improvement (P-value = 0.0003) was obtained for worst pain scores evaluated similarly, at baseline and at the end of treatment. Analysis of the results for the FACT-ES scoring showed improvement on all scales. No significant adverse events were observed. Additionally, decrease in pain score was correlated with increased serum B12 levels. A paired t-test was used to assess the mean difference between baseline and endpoint. Conclusions: This study suggests that vitamin B12 reduces pain and improves quality of life for patients taking AIs who experienced AI-related musculoskeletal symptoms. If confirmed in large randomized prospective trials, Vitamin B12 would be a safe and cost effective option for the treatment of AI -related musculoskeletal symptoms.

Assessment of chronic pain in military patients with PTSD

IntroductionPatients with post-traumatic stress disorder (PTSD) presents often with several concomitant physical and mental health problems. Recent evidence suggests that pain is one of the most commonly reported symptoms in patients with PTSD, regardless of the nature of their traumatic experience.Aim of the studyTo evaluate chronic pain in patients with PTSD in a Tunisian military sample.MethodsTransversal descriptive study of a sample of 22 patients treated for PTSD in the Principal Military Hospital of Instruction of Tunis during the period between August and October 2016.The PTSD Checklist for DSM-5 (PCL-5), Hospital Anxiety and Depression scale (HAD), and the Brief Pain Inventory Short Form (BPI-SF) were administered for patients.ResultsAll the patients of the study were male. The mean age of the sample was 29.6 years. Fifty percent presented with a co-morbid major depression and 59.1% with chronic pain symptoms. Locations of chronic pain were as follow: limb pain (69.23%), back pain (38.46%), headache (30.76%) and torso pain (7.69%). Sequelae from combat-related trauma were present in 31.8% of cases.ConclusionThe results of this study illustrate a high rate of chronic pain symptoms among PTSD patients. This suggests that closer attention should be given to the interaction of medical problems, especially pain, with PTSD symptomatology in clinical management and in future research.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Validity and reliability of a Turkish Brief Pain Inventory Short Form when used to evaluate musculoskeletal pain.

The Brief Pain Inventory (BPI) is both a questionnaire and an outcome measure that is used widely in clinical trials to assess pain associated with many conditions. The BPI Short Form has been extensively translated into foreign languages. The aim of this study was to assess the validity and reliability of a Turkish Brief Pain Inventory Short Form (BPI-TR) to evaluate musculoskeletal pain. In total, 297 patients with musculoskeletal pain participated in the study. Demographic characteristics and brief medical histories were recorded. Pain intensity was assessed using a visual analogue scale (VAS) and quality-of-life was assessed using the Short Form 36 (SF-36). Pain was evaluated using the BPI-TR in all patients. Internal consistency and test-retest analysis were used to assess reliability. The internal consistency of the scale items was assessed by calculating Cronbach's α value, which was expected to be > 0.7. The criterion validity of the BPI-TR was assessed by correlation with VAS scores. Pain intensity, pain interference, and other components of the Turkish version were consistent with validity thereof. Cronbach's α was 0.84 for pain intensity and 0.89 for pain interference. The extent of BPI-TR and VAS correlation was statistically significant. The BPI-TR may be used for assessment of musculoskeletal pain.

Impact of symptomatic skeletal events on health-care resource utilization and quality of life among patients with castration-resistant prostate cancer and bone metastases.

Data regarding the impact of symptomatic skeletal events (SSEs) on health economics and patient-reported outcomes in men with castration-resistant prostate cancer (CRPC) and bone metastases from a clinical setting are lacking. Hence, this study aimed to quantify the effects of SSEs on health-care resource utilization (HRU), health-related quality of life (HRQoL) and pain in men with CRPC metastasized to bone. This cohort study included men with CRPC and bone metastasis treated at a tertiary center during December 1996-July 2015. SSEs, including pathological fracture, radiation to bone, spinal cord compression and bone surgery, as well as HRU were identified retrospectively through medical records and clinical database. A subset of surviving patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory-Short Form (BPI-SF) questionnaires. The incremental effect of SSEs on HRU was evaluated using multivariable generalized linear regression. Questionnaire scores were compared using effect sizes (ES); ES⩾0.33 indicated meaningful differences between SSE and non-SSE cohorts. Lower scores suggest lower HRQoL and pain. Of the 832 patients, 207 developed ⩾1 SSE (mean 1.5±0.8) during follow-up (median 2.1 years). Radiation to bone was the most common SSE (84.1%). SSE cohort had significantly higher emergency room (incidence rate ratio (IRR)=1.48; P=0.006), outpatient (IRR=1.17; P=0.005) and inpatient (IRR=1.74; P<0.001) visits. Of the 107 eligible survey patients, 103 (96.3%) responded. SSE cohort had lower mean FACT-P functional well-being (17.5 vs 19.8; P=0.158; ES=0.36), higher mean pain severity (2.5 vs 1.6; P=0.048; ES=0.47) and worst pain scores (3.6 vs 2.3; P=0.033; ES=0.50) compared with the non-SSE cohort, indicating meaningful differences between cohorts. This study demonstrated high economic and HRQoL burden of SSEs. The findings underscore the need for better supportive and disease-modifying treatments for these patients.

Abstract OT3-02-04: A randomized controlled trial comparing acupuncture versus usual care for the treatment of aromatase inhibitor-induced arthralgia (AIIA) in women with early-stage breast cancer

Abstract BACKGROUND: The increase in breast cancer (BC) survival is largely due to the benefits of hormonal therapy, such as tamoxifen and aromatase inhibitors (AIs), for the treatment of hormone-sensitive breast cancer. Recent clinical trials have demonstrated that AIs are more effective than tamoxifen at reducing BC recurrences. However, BC patients receiving AIs have a higher incidence of osteoporosis, bone fractures, and musculoskeletal symptoms, particularly joint pain and stiffness. The incidence of AIIA in the ATAC trial was 27.8% in patients taking anastrozole versus (vs) 21% in patients taking tamoxifen (Baum M, Lancet 2002). The arthralgia associated with AIs can be so debilitating that it contributes to a significant percentage of non-compliance and discontinuation of systemic treatment. Patients with cancer often show interest in complementary and integrative modalities for symptom management (Vickers AJ, Lancet 2001), of which Acupuncture (Ac) is one of the most utilized therapies. ELIGIBILITY: Subjects must be female ≥18 years, have undergone mastectomy or breast-sparing surgery, and must have recovered from all pain-related effects of the surgery and radiotherapy with a minimum washout period of 30 days prior to registration. Patients should have ER and PR positive BC and be actively taking a 3rd-generation AI (Anastrozole, Letrozole, or Exemestane) for at least the 30 days prior to registration and plan to continue for at least one year after registration. ECOG PS &amp;lt;2 and platelets counts &amp;gt; 50,000/uL. Patients must not have received topical analgesic with exception of oral NSAIDS drugs ≤14 days to registration. TRIAL DESIGN: This is a 12-week, two arm randomized (1:1) trial evaluating the benefit of Ac in BC patients experiencing AIIA. AIMS: The aim of this study is to investigate the effectiveness of an integrative approach using Ac vs usual care (UC) treatment consisting of NSAIDs for the management of the AIIA.Primary endpoint is to compare the difference of Brief Pain Inventory-Short Form (BPI-SF) score at baseline vs week 8 between Ac and UC groups. Secondary endpoints are a) to compare the difference of BPI-SF score at baseline vs week 12 between Ac and UC groups, b) to compare the difference in AI adherence between Ac and UC groups and c) to compare the difference in patient initiated AI discontinuation between Ac and UC groups. STATS/TARGET ACCRUAL: This is a randomized controlled phase II study with the goal to compare reduction in BPI-SF score for patients treated with Ac vs UC alone. Patients are randomized 1:1 between the two arms. Prior work has indicated a 2-point BPI-SF score reduction as clinically meaningful. A sample size of 56 patients yields a study with 90% power and a one-sided significance level of 0.025 to determine a difference in pain reduction ≥2. These calculations are based on the assumptions of normal distribution of the improvement in BPI-SF score and a standard deviation that is conservatively calculated to be 2.3. An additional 6 patients will be accrued to account for attrition. Citation Format: Frank HS, Bendinger GM, Ensor Jr. JE, Neufeld N, Nixon D, Randolph K, McGuire E, Rados K, McNight JE, Pabbathi H, Panicker R, Johnson AT, Lammersfeld C, Alvarez R. A randomized controlled trial comparing acupuncture versus usual care for the treatment of aromatase inhibitor-induced arthralgia (AIIA) in women with early-stage breast cancer [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr OT3-02-04.

Evaluation of spinal cord stimulation on the symptoms of anxiety and depression and pain intensity in patients with failed back surgery syndrome.

Spinal cord stimulation (SCS) is now established as the primary treatment for failed back surgery syndrome (FBSS). Commonly, patients with chronic pain and FBSS often report symptoms of anxiety and depression resulting from this condition. These factors can modulate and amplify the pain experience, therefore, further challenging treatment success. This study examined the efficacy of SCS on alleviating the symptoms of anxiety and depression associated with chronic pain as well as pain intensity in a group of patients with FBSS. A convenience sample (n=26) was selected for participation. Questionnaires [Hospital Anxiety and Depression Scale (HADS) and Brief Pain Inventory Short Form (BPI-SF)] were completed and examined pre and post spinal cord implant. Analysis of the data 1year following SCS indicates that there was a statistical significant improvement in the symptoms of depression and anxiety reported as well as pain intensity in all participants (p<0.001). Both anxiety and depression scores on the HADS were significantly lower compared to baseline (p<0.001). Pain intensity scores decreased by ≥50% from baseline in all participants. Opioid analgesia was discontinued by 90% (n=8) of participants. Whilst it is already recognised that SCS reduces pain in FBSS, this study demonstrated that it also reduced the symptoms of anxiety and depression with an associated reduction in opioid consumption.

PCN46 - Patient Reported Outcomes In Japanese Oncology Products - Review Of The Pmda Labels

With the growing importance of value-based care, patient-reported outcomes (PRO) has been gradually incorporated into various areas of healthcare. This study focuses on PRO that may be used in marketing, by reviewing labels within oncology products from 2007-2016 in Japan. Oncology labels were identified by reviewing the Pharmaceutical and Medical Devices Agency (PMDA) postings of label approval and changes for the past 9 years (2007- February 2016). Labels, Patient guidance Form (PF) and Interview Forms (IF) were acquired from PMDA webpage and reviewed for all relevant products. The IF is used as a supplement to the label which provides additional information that will not fit within the package insert. The PF is a brief summary of the label providing patient-oriented information on drug use. Labels, PFs and IFs for 109 active ingredients (170 products) were identified and reviewed. 34 (31%) IFs presented PROs, whereas both labels and PFs did not contain any PRO data. PROs were most frequently reported in 2013 (n=12) and 2014 (n=8). “QOL” and pain were the most commonly mentioned PROs. 18 IFs provided details of PROs while, the remaining simply noted that “QOL” was measured as secondary endpoint. The EORTC (European Organisation for Research and Treatment of Cancer) was most commonly used to assess patients’ QOL, followed by FACT (Functional Assessment of Cancer Therapy) and other generic QOL measurement tools such as EQ-5D and HUI. For pain assessment, Brief Pain Inventory – Short Form (BPI-SF) and the Visual Analog Scale (VAS) were identified through the review. One-third of oncology products contained PROs in the IF. Although the number of PROs has increased, in proportion to the number of oncology drugs listed per year, fewer than half report measurement of PROs. More efforts are needed to increase the importance of PROs in Japan.

Frequency of pain and eating disorders among professional and amateur dancers.

The pursuit of perfection can cause anxiety and lead dancers to exceed their physical limits. The aim here was to evaluate the prevalence of pain symptoms and eating disorders among professional and amateur dancers. Observational cross-sectional study; Curitiba, PR, Brazil. Data on 150 professional and non-professional practitioners of ballet, jazz and street dance were collected through specific questionnaires: Brief Pain Inventory-Short Form (BPI-SF), Eating Attitudes Test-26 (EAT-26), Bulimic Investigatory Test Edinburgh (BITE) and State-Trait Anxiety Inventory-T-6 (STAI-T-6). Pain was observed in 58.6% of the sample, equally between professionals and amateurs (P = 0.19). Ballet dancers had more lower-limb pain than the other groups (P = 0.05). EAT-26 showed a tendency towards more eating disorders among the amateurs (P = 0.06). Higher risk of eating disorders was found among ballet dancers (P = 0.004) and jazz practitioners (P = 0.02) than among street dancers. Amateurs had more symptoms on the BITE scale (P < 0.0001), more pain (P = 0.002) and higher anxiety (P < 0.0001). Eating disorders were more common among females (P = 0.01) and singles (P = 0.02). Professionals were more satisfied with their own body image than amateurs (P < 0.001). Pain symptoms were found in almost half of the sample, equally among professionals and amateurs as well as between the three dance styles. Female and singles had more eating disorders. Those with eating disorders had higher levels of pain and anxiety.

The pain-depression dyad and the association with sleep dysfunction in chronic rhinosinusitis.

Depression, pain, and sleep disturbance is a symptom cluster often found in patients with chronic illness, exerting a large impact on quality of life (QOL). A wealth of literature exists demonstrating a significant association between depression, pain, and sleep dysfunction in other chronic diseases. This relationship has not been described in patients with chronic rhinosinusitis (CRS). Sixty-eight adult patients with CRS were prospectively enrolled. Patients at risk for depression were identified using the Patient Health Questionnaire-2 (PHQ-2) using a cut-off score of ≥1. Pain experience was measured using the Brief Pain Inventory Short Form (BPI-SF) and the Short Form McGill Pain Questionnaire (SF-MPQ). Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Forty-seven patients were at risk for depression. Significant positive correlations were found between total PSQI scores and all pain measures (R = 0.38-0.61, p ≤ 0.05) and between total PSQI scores and PHQ-2 scores (R = 0.46, p < 0.05). For patients at risk for depression, significant, positive correlations were found between pain measures, the total PSQI score, and the 3 PSQI subdomains (sleep latency, sleep quality, and daytime dysfunction; R = 0.31-0.61, p < 0.05). The relationship between pain and sleep dysfunction scores was not seen in the absence of depression. Depression, pain, and sleep dysfunction are interrelated in patients with CRS. In the absence of depression, significant correlations between pain and sleep are not observed, suggesting that depression plays a key role in this interaction. Further research is needed to investigate the complex relationship between depression, pain, and sleep dysfunction in CRS.

Patient Satisfaction with Spanish Pain Centers: Observational Study with More than 3,000 Patients.

Chronic pain is a serious problem in Spain. This multicenter, epidemiological 3-month follow-up study investigates pain management efficacy in Spanish centers using patient satisfaction criteria. 3,414 eligible adult patients (65,6% female) with moderate to severe chronic pain from 146 pain centers were included. Patient satisfaction was assessed based onto question 18 of Spanish healthcare barometer-CSI. Pain evolution (Brief Pain Inventory-Short Form (BPI-SF) and visual analog scale (VAS)), quality of life/EuroQol-5, and pain control expectations fulfillment were also assessed. Mean age was 61.3 years. 64.4% of participating centers employed multidisciplinary pain management approach. After 3 months, mean patient satisfaction was 7.8 (1–10) on the CIS barometer. Medical staff received the highest scores, whereas waiting for tests, appointment request to appointment date time, and waiting times at the center the lowest. Mean pain decreased from 7.4 to 4.0; BPI-SF intensity decreased from 6.5 to 3.8; pain control expectations were met in 78.7% of patients; EuroQoL-5D utility index increased from 0.37 to 0.62, p < 0.001, and health status (VAS) from 40.6 to 61.9, p < 0.001. Chronic pain patients (90%) are satisfied with Spanish centers care; 80% had their pain control expectations met. Quality of life improved remarkably: 71% felt moderately to significantly better. However, waiting times need improvement.

Health-related quality of life (EQ-5D) early after injury predicts long-term pain after burn

BackgroundChronic pain after burn can have severe physical and psychological effects on former patients years after the initial injury. Although the issue of pain after burn has gained increased attention over the past years, prospective, longitudinal studies are scarce. Our aim was to prospectively investigate consecutive burn patients for pain severity over time and to evaluate the prevalence and characteristics of post-burn pain to 2–7 years after the burn. As an additional aim, the effects of burn and individual-related factors, especially health-related Quality of Life (HRQoL), were investigated. MethodSixty-seven consecutive burn patients were assessed during acute care at 3, 6, 12 and 24 months, as well as at 2–7 years post-burn. HRQoL, symptoms of post-traumatic stress disorder (PTSD) and other psychiatric disorders were investigated. During the interviews that took place 2–7 years after the injury (mean 4.6±1.9 years), current chronic post-burn pain was assessed using the Brief Pain Inventory-Short Form (BPI-SF). ResultsOne-third of the patients still reported pain 2–7 years after the injury. Pain severity and interference with daily life were mainly mild to moderate though they were found to be associated with significantly lower HRQoL. Chronic pain after burn was associated with both burn- and individual-related factors. In logistic regression analysis HRQoL at 3 and 12 months and symptoms of PTSD at 12 months were independent factors in predicting chronic pain after burn. ConclusionPain after burn becomes a chronic burden for many former burn patients and decreases HRQoL. A novel finding in this study was that HRQoL assessed early after burn was a predictor for the development of chronic pain. This finding may help to predict future pain problems and serve as an indicator for pain preventive measures.