Brief Pain Inventory Short Form Research Articles

Abstract PO5-12-09: A Single-Arm Pilot Study of the Feasibility and Efficacy of Electro-Acupuncture in Subjects with Chemotherapy-Induced Peripheral Neuropathy

Abstract Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a very common dose-limiting side effect of many cancer treatments. However, the optimal treatment for CIPN remains unclear. Electroacupuncture (EA) is a non-pharmacologic treatment that combines traditional acupuncture with electrical stimulation. EA is being examined for CIPN and has shown modest benefits. Design: This is a pilot, single-center, prospective, single-arm, non-blinded study. All subjects had residual grade ≥2 CIPN after having received curative intent chemotherapy for stage I-III breast cancer, completed at least 3 months prior to study enrollment. Patients received 10 sessions of electro-acupuncture, administered by a licensed professional, over the course of 7 weeks. A sub-group of patients also had baseline and post-treatment skin punch biopsies to assess intra-epithelial nerve density (IEND). The primary objective was to determine the feasibility of completing a 10-treatment EA program in this patient population. Feasibility was defined as ≥15 subjects completing ≥8 EA treatments. Secondary endpoints included neuropathic pain, as assessed by the Brief Pain Inventory-Short Form (BPI-SF), and change in the quality of life, as assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-NTX) subscale. Results: Twenty eligible female subjects were included in the study, with a median age of 66.5 years (range 45-81 years old). All patients received taxane chemotherapy, with 15 (75%) patients receiving weekly paclitaxel, 4 (8%) patients receiving Taxotere every 3 weeks, and 1 (2%) patient received weekly abraxane. The duration between chemotherapy completion and EA treatment initiation ranged between 4-92 months, with a median of 29 months. Eight (40%) patients were taking gabapentin, 2 (10%) on duloxetine, 1 (5%) pregabalin, and 3 (15%) on NSAIDS before and during the study. The study met its primary endpoint of feasibility, with 18 of 20 (90%) patients completing 8 or more EA sessions. Pain level, as assessed by the worst pain score on BPI-SF, improved significantly from a mean of 6.3 to 3.7, 2 weeks after completion of EA treatments (p = .0058). FACT/GOG-NTX quality of life measurement, “I am bothered by side effects of my treatment” also significantly improved from a mean score of 2.1 to 0.8 (p = .0177). There were no major adverse events (AEs) related to EA. Nine mild AEs were noted among 6 (30%) patients; localized skin biopsy site infections: G1=3, G2=3, nonlocalized cellulitis G3=1, Fatigue G1-2 =2. The localized skin biopsy site infections led to the discontinuation of further skin biopsy procedures. [We will also present data on the IEND for the nine patients who have paired before and after skin punch biopsies – this will be available at the time of the conference.] Conclusion: Electroacupuncture is a feasible treatment for CIPN. Furthermore, this pilot study did show a benefit for perceived pain and quality of life. Further studies will need to be conducted in regards to longevity of response. As larger studies in the future confirm the benefit of acupuncture, insurance payors are more likely to cover this important service. Citation Format: Nikitha Vobugari, John Paul Liang, Loni Savage, Dharamvir Jain, Kai Sun, Hanh Mai, Jenny Chang, Monica Desai, Tejal Patel, Polly Niravath. A Single-Arm Pilot Study of the Feasibility and Efficacy of Electro-Acupuncture in Subjects with Chemotherapy-Induced Peripheral Neuropathy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO5-12-09.

Acupuncture in Multiple Myeloma Peripheral Neuropathy: A Systematic Review.

Peripheral neuropathy (PN) is a prevalent complication of multiple myeloma (MM), due to the disease itself or its treatment. Despite extensive research, the optimal treatment for multiple myeloma peripheral neuropathy (MMPN) remains unclear. Clinical practice has shown the potential efficacy of acupuncture in managing MMPN. This study aimed to conduct a comprehensive analysis of the literature to assess the effectiveness and safety of acupuncture as a treatment for MMPN. The PubMed, Web of Science, MEDLINE, Cochrane Library, and Embase databases were comprehensively searched from inception to November 1, 2023 to identify relevant studies pertaining to the use of acupuncture to treat MMPN. A total of five studies, encompassing 97 patients diagnosed with drug-related PN, were ultimately included in this analysis. The literature lacks any reports pertaining to the utilization of acupuncture for disease-related PN. ST36, LI4, SP6, and EX-LE-10 were found to be the most frequently chosen acupoints. Following acupuncture treatment, there was a consistent reduction in scores on the Visual Analogue Scale (VAS), Neuropathic Pain Scale (NPS), Brief Pain Inventory-Short Form (BPI-SF), and Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) among MMPN patients. The results of Nerve Conduction Velocity (NCV) tests yielded conflicting results. No severe adverse effects were reported. The use of acupuncture for disease-related PN has not been studied to date. Acupuncture is safe for drug-related PN and is helpful for relieving pain. But uncertainty exists regarding the efficacy of this approach because there is substantial heterogeneity with respect to acupuncture treatment regimens, and more high-quality studies on this topic are warranted.

Outcomes of a Standardized Pain Pathway for Transgender Patients Undergoing Vaginoplasty and Vulvoplasty

OBJECTIVETo establish and evaluate a multimodal, opioid-minimizing pathway for gender affirming vaginoplasty (GAVa) and vulvoplasty (GAVu) in treating postoperative pain. METHODSA standardized pain pathway including opioids, non-opioid analgesics, and patient counseling was implemented at a single academic institution with a center for transgender care. Postoperative pain levels, analgesia methods, and opioid use for 84 GAVa and 64 GAVu patients were prospectively gathered during inpatient postoperative days 2-4 and outpatient follow up at 2 weeks. Pertinent patient, operative, and medication administration data were extracted from patient charts and outpatient pain was measured with the Brief Pain Inventory short form (BPI-sf). RESULTSOn average, GAVa patients used 89.3 MME and GAVu patients used 41.8 MME during inpatient stay. MME decreased daily for both groups. There was no difference in MME between open and robotic GAVa. 49% of GAVa patients and 54% of GAVu patients used ketorolac with decreasing daily inpatient use. Postoperative pain levels were similar between GAVa and GAVu patients. 50% of respondents denied postoperative pain in the 24 hours preceding the survey. 44% of GAVa and of GAVu patients did not use any opioid medications in the outpatient setting, while 81% of GAVa and 83% of GAVu patients used fewer than 20 of 30 prescribed opioid tablets. Ibuprofen and acetaminophen were rated the most effective outpatient analgesics among GAVa and GAVu patients, respectively. CONCLUSIONThe multimodal pathway demonstrated effective postoperative pain control for GAVa and GAVu patients while minimizing opioid use and has changed institutional prescribing practice.

Postoperative Patient Pain Severity and Its Association With Anxiety, Depression, and Sleep Quality.

Introduction The experience of pain is a complex phenomenon. A patient in the acute postsurgical pain setting may feel a constant bombardment of nociceptive input from the surgical site; this in turn influences psychological factors that determine the overall emotional experience of pain, which is significant. The aim of our study was to investigate the severity of pain in postsurgical patients three days after surgery using the 100 mm visual analog scale (VAS). Methods This was a cross-sectional assessment of postoperative pain. Participants were patients between 18 and 64 years of age who had undergone a surgical procedure (laparoscopic or open surgery), three days prior to the data collection and who were admitted or discharged postoperatively at the Al Salmaniya Complex, Manama, Bahrain. Participants were asked demographic questions about whether they had laparoscopic or open surgeries and completed self-reporting scales. Patient Health Questionnaire-9 (PHQ-9) was utilized to screen for both the presence and severity of depression; Generalized Anxiety Disorder 7-item (GAD-7) was administered to screen for anxiety; the Insomnia Severity Index (ISI) was used to evaluate insomnia; and the VAS was used to evaluate pain. Results Sixty-seven patients were recruited, with a mean age of 61.53 years (SD = 7.37). Twenty-nine (43%) were females, 38 (57%) were males, 36 (54%) underwent elective surgery, 31 (46%) underwent emergency surgery, 31 (46%) underwent laparoscopic surgery, and 36 (54%) underwent open surgery. The average score on the Brief Pain Inventory Short Form (BPISF) was 8.12 (SD = 1.16), indicating a moderate level of pain. Twenty-six (43%) patients had moderate-severe insomnia, 21 participants (31%) had no insomnia, 17 participants (25%) had subthreshold insomnia, 28 (42%) had moderate depression, five (7%) had moderate-severe depression, and 34 (51%) had severe depression. Eighteen participants (27%) had mild anxiety, 46 (69%) had moderate anxiety, and 3 (4%) had severe anxiety. Six of the participants (9%) reported moderate pain, while 61 participants (91%) reported severe pain.

The relationship among emotion regulation and pain catastrophizing in chronic pain patients.

Pain catastrophizing (PC) is a cognitive/emotional response to and in anticipation of pain, which may be maladaptive, further exacerbating pain and the difficulty in emotion regulation (ER). There is a lack of research on the interplay between PC and ER and its impact on pain. Our aim was to investigate whether ER exacerbated the pain experience through PC. Adults with chronic pain of > 3 months' duration (n = 150) with non-cancer pain and taking opioid medication were recruited from a large medical center in Pennsylvania. A battery of questionaries was conducted to gather data on demographics, substance use, mental health histories, and health and pain outcomes. Measures used included Difficulties in Emotion Regulation Scale 18 Item, Pain Catastrophizing Scale (PCS), Brief Pain Inventory-Short Form (BPI-SF), and Hospital Anxiety and Depression Scale (HADS). A structural equation model with latent variables was conducted to examine our aim. Both pain interference and severity were significantly positively associated with several psychosocial variables, such as anxiety, depression, ER constructs, PC and distress intolerance. The associations between subscales and pain interference were larger than those with pain severity. PC fully mediated the paths from ER to pain experiences. Our results highlight the importance of several cognitive and emotional constructs: Non-acceptance of negative emotions, lack of emotional awareness, magnification of pain experience, and a sense of helplessness. Further, by showing the indirect effects from PC in affecting ER and pain, we posit that ER, mediated by PC, may serve a critical role in influencing the pain experience in chronic pain patients.

Patient-reported outcomes (PRO) in patients (pts) with BRCA1/2-altered metastatic castration-resistant prostate cancer (mCRPC) receiving niraparib (NIRA) with abiraterone acetate and prednisone (AAP): Results from MAGNITUDE study.

105 Background: MAGNITUDE, an international phase 3 randomized double-blind study, demonstrated that mCRPC pts with BRCA1/2 alterations receiving NIRA + AAP had significantly improved radiographic progression-free survival, and clinically relevant prolongations in time to symptomatic progression and time to cytotoxic chemotherapy compared with placebo (PBO) + AAP. Here, we report PRO results (pain, health-related quality of life [HRQoL], and side effect bother) in the BRCA1/2 subset of mCRPC pts in the final analysis of MAGNITUDE. Methods: Pts were screened prospectively for homologous recombination repair (HRR) gene alterations. Eligible pts had ECOG status ≤1 and a Brief Pain Inventory–Short Form (BPI-SF) worst pain score ≤3 (scale of 0-10), and were randomized 1:1 to NIRA + AAP or PBO + AAP orally daily in 28-day cycles. PRO assessments on day 1 of specified cycles included BPI-SF and Functional Assessment of Cancer Therapy–Prostate (FACT-P). Time to deterioration (TTD) in pain (BPI-SF worst, average, and pain interference, and FACT-P pain-related scale [PRS]) were compared between treatment arms using proportional hazards regression models. Changes from baseline in HRQoL (FACT-P total, scale of 0-156) were compared using repeated measures analysis, and side-effect bother was assessed in both arms as a single item from FACT-P (GP5). Results: PRO compliance for FACT-P and BPI-SF was >85% in 225 pts with BRCA1/2-altered mCRPC. At baseline, mean BPI-SF pain scores was 1.09 (SD, 1.57) in NIRA + AAP and 1.35 (SD, 1.98) in PBO + AAP. Mean FACT-P Total in NIRA + AAP and PBO + AAP was 116.33 (SD, 18.42) and 114.8 (SD, 18.9), respectively. Median TTD in BPI-SF worst pain, pain interference, average pain, and FACT-P PRS were numerically longer for NIRA + AAP vs. PBO + AAP (Table). Repeated measures results showed HRQoL was maintained on treatment for the BRCA subgroup with no clinically meaningful differences in the FACT-P total score over time or between treatment arms. Analysis of FACT-P item GP5 in the BRCA subset showed side effect bother was rated “not at all” or “a little bit” by 87% of NIRA + AAP and 92% of PBO + AAP subjects across treatment cycles. Conclusions: In pts with BRCA1/2-altered mCRPC, NIRA + AAP maintained HRQoL. Pts experienced minimal bother from side effects associated with treatment. These data further support the benefit-risk profile of NIRA + AAP for the treatment of mCRPC pts with BRCA1/2 alterations. Clinical trial information: NCT03748641 . [Table: see text]

Randomized placebo-controlled, double-blind clinical trial of nanoemulsion curcumin in women with aromatase inhibitor-induced arthropathy: an Alliance/NCORP pilot trial

PurposeAromatase inhibitor (AI) therapy reduces risk of recurrence and death for postmenopausal women with breast cancer (BC); however, AI-induced arthralgia (AIIA) can lead to discontinuation of treatment. Curcumin, a bioactive polyphenolic substance, may help ameliorate inflammation-related conditions including osteoarthritis and pain.MethodsWe conducted a multisite randomized placebo-controlled, double-blind pilot trial (Alliance A22_Pilot9) to evaluate the effects of nanoemulsion curcumin (NEC, 200 mg/day) in postmenopausal women experiencing AIIA for ≥ 3 months. The primary objective was to determine the feasibility of using Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) to detect changes from 0 (T0) to 3 months (T3) of NEC treatment in AI-induced symptoms and well-being; secondary objectives included evaluation of changes in Disabilities of the Shoulder, Arm, and Hand (DASH), Brief Pain Inventory-short form (BPI-SF), grip strength, and biomarkers at T0 and T3.ResultsForty-two patients were randomized to NEC or placebo; 34 women completed the 3-month study. Patient-reported outcome measures (PROMs: FACT-ES, DASH, BPI-SF) and biospecimens were collected at T0-T3 in > 80% of participants. Adherence was ≥ 90% for both arms. PROMs and grip strength did not differ significantly by treatment arm. Plasma curcumin was detected only in NEC arm participants. Serum estradiol and estrone levels were below detection or low on study agent. Gastrointestinal adverse effects were commonly reported in both arms.ConclusionNEC versus placebo in a multisite randomized trial is feasible and well-tolerated. Additional studies with larger sample size are needed to further evaluate the efficacy and safety of NEC in treatment of AIIA.ClinicalTrials.gov Identifier: NCT03865992, first posted March 7, 2019.

Teleyoga for Patients With Alzheimer's Disease and Chronic Musculoskeletal Pain and Their Caregivers: A Feasibility Study.

Chronic musculoskeletal pain is common in patients with Alzheimer's disease (AD), and there is growing awareness that chronic pain has an impact on the progression of dementia. Yoga has shown promise in treating chronic pain. However, attending in-person yoga can be difficult for AD patients. To assess the feasibility, acceptability and preliminary efficacy of an online yoga (teleyoga) protocol suitable for AD patients with chronic pain, and their caregivers. Patients with comorbid mild AD and chronic musculoskeletal pain (n = 15, 57-95 y/o; 73% Female) and their caregivers (n = 15, 50-75 y/o; 67% Female) received 12-week of teleyoga individually (n = 5 dyads) or in groups (n = 10 dyads). Study measures included standard feasibility metrics, and secondary outcomes included the Brief Pain Inventory-Short Form (BPI-SF), Beck Depression Inventory-II (BDI-II), and cognitive function using the Cambridge Neuropsychological Test Automated Battery (CANTAB). Caregivers also completed measures of caregiver burden, and quality of life (Short Form Health Survey-36, SF-36). Feasibility measures showed adequate treatment adherence (85.1% in patients and 86.3% in caregivers), acceptability (mean acceptability rating = 3.0 for patients and 3.3 for caregivers, indicating positive approval), recruitment rate (n = 16 dyads within 1-year), retention rate (87%), missing data rate (.03%), and fidelity of treatment delivery (87%). Preliminary efficacy findings in the AD group showed significant reductions in pain severity (BPI-SF mean Δ = -.93, P = .045) and depression (BDI-II; mean Δ = -9.85, P = .005). %). Preliminary efficacy findings in the caregiver group showed significant reductions in depression (BDI-II mean Δ = -6.88, P = .036) and fatigue (SF-36 mean Δ = 9.81, P = .021). Results show that teleyoga is a feasible treatment for patients with comorbid mild AD and chronic musculoskeletal pain. Results also provide preliminary evidence of health benefits of teleyoga for both AD patients and their caregivers.

FACTOR STRUCTURE OF THE BRIEF PAIN INVENTORY–SHORT FORM IN AFRICAN AMERICAN OLDER ADULTS WITH OSTEOARTHRITIS

Abstract The Brief Pain Inventory-Short Form (BPI-SF) is a widely used questionnaire designed to assess aspects of cancer pain, such as pain intensity and pain interference. Psychometric properties have rarely been evaluated in other pain conditions such as osteoarthritis. Osteoarthritis is a major contributor to pain and physical disability in African Americans (AA) older adults. Thus, it is important to evaluate the psychometric properties of BPI-SF in this health disparity population. Participants were AA aged 50-94 years with self-reported osteoarthritis. The final convenience sample (N=110) completed surveys including a demographics questionnaire and the validated BPI-SF. Confirmatory Factor Analysis (CFA) was used to evaluate the factor structure. Measurement invariance across two age groups [i.e., young-old (50-69); old-old (70-94)] was examined. CFA revealed that a three-factor model (i.e., pain intensity, activity interference, and affective interference) demonstrated the best fit (χ2/df=1.595, CFI=0.949, RMSEA=0.074) to the data. AAs reported pain intensity (M=4.58, SD=2.01), affective interference (M=3.03, SD=2.54), and activity interference (M=4.19, SD=3.25). The change of CFI between configural and metric invariance is below the cutoff point of .01, supporting the full metric (i.e., factor loadings) invariance across two age groups. However, the full scalar (i.e., items intercepts) invariance was not established. The results support a three-factor structure of BPI-SF that is invariance across two age groups at the full metric level. This suggests that the BPI-SF is an appropriate measure to characterize chronic pain intensity, affective interference, and activity interference for older AAs with osteoarthritis.

Treatment of Greater Trochanteric Pain Syndrome With Ultrasound-Guided Bipolar Pulsed Radiofrequency of the Trochanteric Branches of the Femoral Nerve: A Case Series of Nine Patients.

Greater trochanteric pain syndrome (GTPS) is a prevalent cause of lateral hip pain that often leads to significant functional limitations. Conservative treatment options include physical therapy, pharmacological treatment, and more invasive techniques such as corticosteroid injections. However, despite the high success rates reported with corticosteroid injections, a significant number of patients have their symptoms persist or recur. In this case series, we present the outcomes of nine patients with GTPS who underwent ultrasound-guided bipolar pulsed radiofrequency targeting the trochanteric branches of the femoral nerve. We aim to discuss the effectiveness and safety of this approach. Eligible patients referred to our centre underwent ultrasound-guided bipolar pulsed radiofrequency aimed at the trochanteric branches of the femoral nerve. The procedure consisted of one cycle at 42°C for six minutes, followed by the injection of ropivacaine (0.2%, 3 mL) and dexamethasone (12 mg). The Brief Pain Inventory - Short Form (BPI-sf)and Lequesne Algofunctional Index (LAI) were used before the procedure and at the third and sixth months post-procedure. We monitored immediate and late complications, as well as adverse effects. Our results indicate a favourable outcome for most patients, with an average pain reduction of 76.51% according to their report of the BPI-sf. Additionally, eight out of nine patients experienced at least 50% relief. These findings align with a previous case series, which reported a similar average pain reduction. Before the procedure, most patients were classified as "extremely severe" in the LAI, with an average score of 18.17. Although there was only a slight reduction of 16.84% at the six-month follow-up, this suggests a potential improvement in their functional status. We did not observe any immediate complications or adverse effects after the procedure, nor were any reported at the subsequent follow-ups, which is consistent with existing literature. Our study suggests that ultrasound-guided bipolar pulsed radiofrequency treatment is a promising minimally invasive technique for GPTS, especially for patients who do not respond to conservative treatments. Although our case series provides some evidence of effectiveness and safety, further controlled studies on a larger scale are necessary, particularly to compare this intervention with the use of corticosteroid injections alone.

Effect of whole-body cryotherapy versus placebo cryotherapy on joint pain induced by aromatase inhibitors in women with early stage breast cancer: a randomised clinical trial

IntroductionHormone therapy (HT) is a major adjuvant treatment for breast cancer. Despite their effectiveness, aromatase inhibitors can cause several side effects, including arthralgia in 35%–50% of patients. These side effects...

A Comparison of Pain Before and After Transfusion in Adult transfusion-dependent thalassemia (TDT) Using BPI-SF

Background Pain is a complication in patients with transfusion-dependent thalassemia (TDT). There are several mechanisms underlying pain in people with thalassemia and low hemoglobin at the end of the transfusion cycle was the most etiology. Pain can develop into chronic pain and interfere with the quality of life. The Brief Pain Inventory Short Form (BPI-SF) can help identify pain in people with TDT. The present study aimed to compare pain before and after transfusion in adult TDT patients. Methods It was an analytical observational study using a cross-sectional design on adult TDT patients with pain who came to the Haemato-Oncology Clinic of Dr. Hasan Sadikin Hospital Bandung. This study was conducted from December 2020 to July 2021. All subjects were assisted in filling out the Indonesian version of the BPI-SF questionnaire hemoglobin levels were examined and before and after transfusion, then paired test analysis was performed using the Wilcoxon Test. Results This study is conducted on 60 adult TDT patients with symptoms of pain. The median value of pain intensity and pain interferes with life obtained from the Indonesian version of the BPI-SF score after transfusion decreased significantly compared to before transfusion (NRS 5 vs. 0 and 2.8 vs. 0; p=0.0001). Conclusion There is a significant difference in pain intensity and pain interfere with life in adults with TDT before and after transfusion. It is necessary to carry out pain assessments for thalassemia patients.

Effect of research participation versus usual clinical care in patients with rheumatic and musculoskeletal disorders: a prospective cohort study

ObjectiveTo compare illness perception (IP), pain, functional level and health-related quality of life (HR-QoL) between patients with musculoskeletal pain who participate versus those who do not participate in clinical research...

Initial effect of high-volume mobilisation with movement on shoulder range of motion and pain in patients with rotator cuff-related shoulder pain: protocol for a randomised controlled trial (Evolution Trial)

IntroductionMobilisation with movement (MWM) is commonly used for treating patients with rotator cuff-related shoulder pain (RCRSP). However, the evidence supporting MWM efficacy for improving shoulder range of motion (ROM) and...

Efficacy of metformin in prevention of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled trial.

Background: Paclitaxel-induced peripheral neuropathy (PN) is a serious clinical problem with no approved drug for prevention. This study aimed to examine the neuroprotective effect of metformin against paclitaxel-induced PN in breast cancer patients. Methods: Patients with confirmed breast cancer diagnosis who were planned to receive paclitaxel were randomized to receive either metformin or placebo. Both groups received the standard chemotherapy protocol for breast cancer. Patients started metformin/placebo 1week before paclitaxel initiation and continued study interventions thereafter for nine consecutive weeks. The primary outcome was the incidence of development of grade two or more paclitaxel-induced sensory PN. The PN was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Patients' quality of life (QoL) was assessed by the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACTGOG-Ntx) subscale. Pain severity was measured by the Brief Pain Inventory Short Form (BPI-SF). Serum levels of nerve growth factor (NGF) and neurotensin (NT) were measured at baseline and at the end paclitaxel treatment. Results: A total of 73 patients (36 in the metformin arm and 37 in the control arm) were evaluated. The cumulative incidence of development of grade two or more PN was significantly lower in the metformin arm (14 (38.9%) than the control arm (28 (75.7%); p = 0.001). At the end of paclitaxel treatment, patients' QoL was significantly better in the metformin arm [median (IQR) FACTGOG-Ntx subscale of (24.0 (20.5-26.5)] compared to the control arm (21.0 (18.0-24.0); p = 0.003). The metformin arm showed lower "average" and "worst" pain scores than those detected in the control arm. At the end of the paclitaxel treatment, there was a significant difference in the median serum NGF levels between the two arms, favoring metformin (p < 0.05), while NT serum levels were deemed comparable between the two study arms (p = 0.09). Conclusion: The use of metformin in breast cancer patients offered a marked protection against paclitaxel-induced PN, which translated to better patient QoL. Clinical Trial Registration: https://classic.clinicaltrials.gov/ct2/show/NCT05351021, identifier NCT05351021.

Treatment of sinus headache using a device that combines acoustic vibration with oscillating expiratory pressure.

To determine if simultaneous administration of acoustic vibration and oscillating expiratory pressure affects the severity of facial pain among patients with complaint of "sinus headache". This is a prospective single-arm observational study performed at a tertiary care medical center. Subjects with complaint of sinus headache without evidence of chronic rhinosinusitis on exam or computed tomography participated in a clinical study applying simultaneous acoustic vibrations and positive expiratory pressure to the nasal cavity twice daily over 4 weeks. Efficacy was assessed using three validated pain metrics-pain visual analog scale (VAS), brief pain inventory-short form (BPI-SF), and McGill pain questionnaire-short form (MPQ-SF). Device safety and patient satisfaction were also assessed using questionnaires. Twenty-nine patients (mean age 49 years, 55% female) completed the study without any major adverse events. At the 4 week follow-up, facial pain VAS improved from mean ± SD of 59.6 ± 15.7 to 34.6 ± 21.7 (p < .001), BPI mean pain (mean ± standard deviation) improved from 4.4 ± 2.0 to 2.9 ± 1.9 (p = .007), and MPQ-SF total improved from 12.2 ± 6.5 to 6.5 ± 5.2 (p < .001) with approximately 70% of patients achieving a minimal clinically important difference (MCID) across all metrics. Additionally, pain VAS was assessed 5 min after a single use at baseline with significant improvement (p < .001). Eighty-six percent of subjects would both use device again and recommend it to others. Simultaneous administration of acoustic vibration and oscillating expiratory pressure appears to be a safe treatment for sinus headaches in patients without objective evidence of chronic sinusitis. Results from this initial study are promising with regard to efficacy in treatment of sinus headaches but will require further study. 2c.

Impact of nirogacestat on pain, a key symptom in patients with desmoid tumors (DT): Results from the phase 3 DeFi study.

11564 Background: Pain reduction is a key treatment goal in DT (aggressive fibromatosis): 60% of patients (pts) experience chronic pain. In the phase 3 DeFi trial, nirogacestat (NIRO; n = 70) significantly improved progression-free survival compared with placebo (PBO; n = 72) in pts with progressing DT (HR: 0.29 [95% CI, 0.15–0.55]; P&lt; 0.001). Also as previously reported, NIRO significantly reduced pain severity by 1.50 points (on a 10-point scale) compared with PBO at cycle 10 (28-day cycles; P&lt; 0.001) per the prespecified secondary endpoint of “worst pain” from the Brief Pain Inventory Short Form (BPI-SF). Additional aspects of pain were collected in DeFi to further characterize treatment impact and consistency across multiple pain assessment tools. Methods: In DeFi, pts completed 3 prespecified pain assessment tools through end of treatment: BPI-SF (worst pain), GOunder/Desmoid Tumor Research Foundation DEsmoid Symptom Scale (GODDESS-DTSS pain scale: worst pain, dull pain, shooting pain), European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30 pain scale: pain, pain interference with daily activities). Change from baseline (BL) in pain scores was compared between arms; analyses included mixed models for repeated measures to compare change from BL and stratified Cochran-Mantel-Haenszel to compare proportions of pts with clinically meaningful pain reduction (defined using prespecified thresholds) at cycle 10. Cycle 10 was preselected to allow adequate time for a treatment effect to be observed. Results: Statistically significant and clinically meaningful pain reductions were observed with NIRO compared with PBO at cycle 10 across all assessment tools; statistically significant differences between arms occurred as early as cycle 2 and were sustained throughout treatment. At cycle 10, NIRO reduced mean BL pain per GODDESS-DTSS (0–10 range) by 1.78 points (SE = 0.26) and PBO increased pain by 0.32 points (SE = 0.27; P&lt; 0.001). At cycle 10, NIRO reduced mean BL pain per QLQ-C30 (0–100 range) by 22.05 points (SE = 3.38) and PBO increased pain by 7.19 points (SE = 3.64; P&lt; 0.001). Clinically meaningful pain reduction (by ≥2.0 points) per BPI-SF worst pain (0–10 range) was achieved by 72% of pts with NIRO vs 29% of pts with PBO at cycle 10 ( P&lt; 0.001). Per GODDESS-DTSS, clinically meaningful pain reduction (by ≥1.9 points) was achieved by 62% of pts with NIRO vs 19% of pts with PBO at cycle 10 ( P= 0.002). Conclusions: Rapid, sustained, and consistent reductions in different aspects of pain were observed with NIRO compared with PBO across multiple assessment tools in pts with DT. Furthermore, a significantly greater proportion of pts achieved clinically meaningful reductions in pain with NIRO than with PBO. As pain is the most commonly reported symptom, pain reduction should be a key clinical trial endpoint and a key treatment goal in DT. Clinical trial information: NCT03785964 .

Health-related quality of life (HRQoL) and pain outcomes for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who received abiraterone (abi) and olaparib (ola) versus (vs) abi and placebo (pbo) in the phase III PROpel trial.

5012 Background: PROpel (NCT03732820) met its primary endpoint and showed significantly prolonged investigator-assessed rPFS with abi + ola vs abi + pbo at primary analysis (data cut-off [DCO]: 7/30/21; median 24.8 vs 16.6 months (m); hazard ratio [HR] 0.66, 95% confidence interval [CI] 0.54–0.81; P&lt;0.001). HRQoL (based on The Functional Assessment of Cancer Therapy-Prostate [FACT-P] total score) was not different when ola was combined with standard-of-care abi. We present data at the final prespecified overall survival (OS) DCO (10/12/22). Methods: PROpel is a randomised, double-blind trial in 1L mCRPC. Time to pain progression (TTPP) was based on the Brief Pain Inventory-Short Form (BPI-SF) Item 3 ‘worst pain in 24 hours’ and opiate analgesic use (analgesic quantification algorithm) score. Time to first symptomatic skeletal related event (SSRE) was time to use of therapy to prevent/relieve skeletal symptoms, new bone fractures, spinal compression or surgery on bone metastases. HRQoL was assessed by change from baseline (BL) in FACT-P total and subscale scores, BPI-SF pain severity, pain interference and worst pain score between arms using a mixed model for repeated measures. Results: At median follow-up of 33.6 m with abi + ola and 32.1 m with abi + pbo, 17.0% pts (68/399) in the abi + ola arm and 15.1% pts (60/397) in the abi + pbo arm had pain progression (PP) events. The % of pts who had not experienced PP with abi + ola vs abi + pbo was 76.9% vs 77.2% at 24 m and 70.7% vs 71.0% at 36 m. No meaningful difference in TTPP was observed (16% maturity, HR 1.06, 95% CI 0.75–1.50, P=0.75 [nominal], median not reached [NR] either arm). The % of pts who had not had a SSRE with abi + ola vs abi + pbo was 86.1% vs 82.2% at 24 m and 80.8 vs 78.5% at 36 m. No meaningful difference in time to SSRE was observed (12% maturity, HR 0.82, 95% CI 0.55–1.22, P=0.32 [nominal], median NR vs NR). Least-squares mean changes from BL between arms in BPI-SF pain severity (difference, −0.06; 95% CI −0.23–0.12), pain interference (difference, −0.12; 95% CI −0.31–0.06), worst pain score (difference, −0.12; 95% CI −0.35–0.11) and FACT-P total score (difference, −0.54; 95% CI –3.00–1.92) suggest no clinically meaningful difference in HRQoL with abi + ola vs abi + pbo. Least-squares mean change from BL values for FACT-P subscale scores were consistent with FACT-P total score result. Conclusions: PROpel demonstrated a significant delay in rPFS for pts receiving abi + ola vs abi + pbo. Most pts in the trial did not experience a PP event. Abi + ola showed no difference in HRQoL (assessed by FACT-P total and subscale scores, BPI-SF domain and worst pain scores) vs abi + pbo, suggesting pts can derive clinical benefit from abi + ola while maintaining a similar HRQoL compared with a current standard-of-care treatment. Clinical trial information: NCT03732820 .

ID: 222114 Effects of High Frequency Spinal Cord Stimulation as Measured by Autonomic Tone and fMRI

We investigated high frequency spinal cord stimulation (HF-SCS) efficacy in 1) reducing autonomic output as measured by galvanic skin response (GSR) levels during anticipation of and exposure to noxious thermal stimuli in while undergoing functional magnetic resonance imaging of the brain, and 2) altering subjective experience of pain as measured by the Short Form McGill Pain Questionnaire (SF-MPQ-2) and a modified Brief Pain Inventory Short Form (BPI-SF).

Validity and reliability of the short form brief pain inventory in older adults with nociceptive, neuropathic and nociplastic pain

ObjectiveThe aim of this study was to evaluate the validity and reliability of the Short Form Brief Pain Inventory (SF-BPI) for community-dwelling Brazilian older adults with chronic neuropathic, nociceptive and nociplastic pain. MethodsCross-sectional psychometric testing was conducted in a convenience sample, n=114 (66.5 ± 4.9 years). ResultsThe 2-factor structure of the SF-BPI was ratified by confirmatory factor analysis. Convergent validity was found between the SF-BPI and the Present Pain Intensity (PPI). There was good overall internal consistency (Cronbach's α: 0.87). Test-retest reliability was excellent for pain intensity and interference scores of the SF-BPI (ICC: 0.90 and 0.96, respectively), as well as inter-rater reliability for both dimensions (ICC: 0.77). ConclusionThe findings support the validity and reliability of the SF-BPI for community-dwelling older adults with chronic pain and may contribute to health professionals having a brief multidimensional assessment for more effective therapeutic approaches in this population.