Pain intensity and interference with functioning and well-being in subgroups of patients with chronic pain treated with once-daily hydrocodone tablets

2015 ◽  
Vol 11 (6) ◽  
pp. 519 ◽  
Author(s):  
Adrian Bartoli, MD ◽  
Edward Michna, MD ◽  
Ellie He, PhD ◽  
Warren Wen, PhD

Background: A previous 52-week trial of patients with chronic noncancer, nonneuropathic pain (CNNP) showed clinically meaningful improvement in pain intensity, pain interference, and physical health-related quality of life (HRQL) following daily treatment with an extended-release, once-daily hydrocodone (Hysingla® ER; HYD) bitartrate tablet.Objective: To examine treatment response within patient subgroups and to assess between-subgroup differences in effectiveness and side effect profile. Methods: Data were from an open-label 52-week trial of treatment with HYD tablets (20-120 mg, once-daily) for patients with moderate-to-severe CNNP. Binary subgroups were defined for the following six factors: age, gender, opioid experience, baseline pain severity, history of depression, and stable HYD dose at completion of a 45-day dose-titration period. Univariable and multivariable models examined changes in average pain intensity (API; 11-point numeric rating scale), pain interference (Brief Pain Inventory-Interference subscale [BPI-I]), physical and mental HRQL (36-item Short Form health survey Physical and Mental Component Summaries [PCS and MCS]), and sleep quality (Medical Outcomes Study Sleep Scale Sleep Problems Index [SPI]) from baseline to maintenance, and subgroup differences in adverse events.Results: All subgroups showed clinically meaningful improvements in API, BPII, and PCS scores; no subgroups showed improvements in MCS or SPI. Between subgroup comparisons found greater improvements for opioid-naïve patients and for patients with severe baseline pain. Incidence of adverse events differed minimally between subgroups.Conclusion: Regardless of subgroup, patients with CNNP treated with HYD showed clinically meaningful improvements in pain intensity, pain interference, and physical HRQL, although not in mental HRQL or sleep quality. Improvements were generally larger for opioid-naïve patients and patients with severe baseline pain.

Author(s):  
Anna Lipert ◽  
Remigiusz Kozłowski ◽  
Dariusz Timler ◽  
Michał Marczak ◽  
Kamila Musiał ◽  
...  

Background: The coronavirus pandemic and the government restrictions significantly disturbed the daily functioning of people, thereby influencing healthy behaviors, such as physical activity—the core indicator of well-being. This study evaluates the associations between physical activity (PA), the level of stress and quality of sleep during the COVID-19 pandemic lockdown. Methods: An online survey was distributed during the governmental lockdown in April 2020 and included measures for assessing physical activity, stress and sleep. The surveyed participants included all adults aged 18 years and over. The final data were collected from the 1959 respondents using: International Physical Activity Questionnaire-Short Form (IPAQ-SF), Perceived Stress Scale (PSS) and Pittsburgh Sleep Quality Index (PSQI). Findings: Almost half of the respondents indicated a low level of PA, performing only 60 min of PA daily. Most of the participants reported a moderate or high level of stress (57% and 29%, respectively) and 64% of them reported poor quality of sleep. People with low levels of stress performed on average 85.1 min/day of walking (WPA), 40.9 min/day of moderate PA (MPA) or 52.6 min/day of vigorous PA (VPA). People with good quality of sleep performed 82.9 min/day of WPA, 43.6 min/day MPA and 40.5 min/day VPA. Interpretation: The results from the study indicate that the volume of daily PA may be a predictor of the level of stress and sleep quality in adults during the COVID-19 pandemic lockdown. To retain a low level of stress and good quality of sleep, a lifestyle that allows to achieve a moderate level of physical activity should be maintained. The optimal daily dose of PA is at least 70 min per day, involving different intensities.


Gerontology ◽  
2016 ◽  
Vol 63 (1) ◽  
pp. 3-12 ◽  
Author(s):  
Vahid Eslami ◽  
Mindy J. Katz ◽  
Robert S. White ◽  
Erin Sundermann ◽  
Julie M. Jiang ◽  
...  

Background: Among older adults, pain intensity and pain interference are more common in women than men and associated with obesity and inflammatory markers. Objective: We examined whether the obesity and pain relationship is mediated by the high-sensitivity C-reactive protein (hsCRP), a nonspecific marker of systemic inflammation, and whether this relationship differs by sex. Methods: Items from Medical Outcomes Study Short Form-36 were used to measure pain intensity and pain interference in daily life. Ordinal logistic regression was used to assess the cross-sectional association among body mass index (BMI), hsCRP levels, pain intensity and pain interference using gender-stratified models adjusted for demographic variables. Results: Participants included 667 community-residing adults over the age of 70 years, free of dementia, enrolled in the Einstein Aging Study (EAS). In women (n = 410), pain intensity was associated with obesity [BMI ≥30 vs. normal, odds ratio (OR) = 2.29, 95% confidence interval (CI) 1.43-3.68] and higher hsCRP (OR = 1.28, 95% CI 1.08-1.51). In a model with obesity and hsCRP, both remained significant, but the association between hsCRP and pain intensity was somewhat attenuated. Obesity (OR = 3.04, 95% CI 1.81-5.11) and higher hsCRP levels (OR = 1.30, 95% CI 1.08-1.56) were also independently associated with greater pain interference in women. After adjustment for pain intensity and BMI, hsCRP was no longer associated with pain interference in women. Greater pain intensity and being overweight or obese continued to be significantly associated with pain interference in women. In men (n = 257), obesity and hsCRP were not associated with pain intensity or pain interference. Conclusions: In women, the relationship between obesity and higher levels of pain intensity or interference may be accounted for by factors related to hsCRP.


2020 ◽  
Vol 91 (12) ◽  
pp. 1343-1348
Author(s):  
Qingpei Hao ◽  
Dongliang Wang ◽  
Jia OuYang ◽  
Hu Ding ◽  
Gaungyong Wu ◽  
...  

ObjectivesTo study the efficacy and safety of bilateral globus pallidus internus deep brain stimulation (GPi-DBS) in refractory Meige syndrome (MS) and evaluate the psychiatric disorders before and after surgery.MethodsTwenty-two patients with MS treated with bilateral GPi-DBS were retrospectively analysed before surgery and after continuous neurostimulation. Before surgery, patients were assessed by the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS), Self-Rating Depression Scale, Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) and Pittsburgh Sleep Quality Index (PQSI), which corresponded to motor symptoms, depressive state, quality of life and sleep quality, respectively. The implantable pulse generator of each patient was activated at 1 month after surgery. At 1 month, 3 months, 6 months and 12 months after continuous neurostimulation, all patients were evaluated by the same scales above.ResultsThe BFMDRS movement scores decreased from 15.0±5.3 before surgery to 3.5±4.5 at 12 months after neurostimulation, with a mean improvement of 78% (p<0.001). The BFMDRS disability scores improved from 7.4±4.9 before surgery to 4.0±4.6 at 12 months after neurostimulation, with a mean improvement of 56% (p<0.001). The postoperative SF-36 scores had the remarkable improvement compared with baseline scores. Impaired sleep quality was found in 82% of patients and depression in 64% before surgery, which didn’t neither obtained amelioration after continuous neurostimulation.ConclusionsBilateral pallidal neurostimulation is a beneficial therapeutic option for refractory MS, which could improve the motor symptoms except for depression and sleep quality.


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A760-A760
Author(s):  
Om P Dhingra ◽  
James Bernstein ◽  
Shaina D Barnes ◽  
Hannah VanLaanen ◽  
Natasha Wadlington ◽  
...  

Abstract Introduction: Male hypogonadism results from insufficient secretion of testosterone (T) and is characterized by low serum T concentrations. Common symptoms of hypogonadism include decreased libido, impotence, weakness, low energy, depression and/or loss of motivation, memory and concentrating issues, and sleep disturbances. Several forms of T replacement are available. Testosterone undecanoate (TU) is a testosterone prodrug available in oral formulations. A novel TU formulation, SOV2012-F1, has been submitted for FDA consideration under the name KYZATREX®. While TU efficacy is measured by serum total T, patientfocused endpoints such as Patient Reported Outcomes (PROs) are valuable indicators of well-being and psychosexual symptom abatement. Methods: A Phase 3, randomized, multicenter, open-label, active-controlled trial, comparing SOV2012F1 (testosterone undecanoate capsules) (n=214) with AndroGel® (1.62% topical testosterone gel) (n=100) enrolled males aged 18 to 65 years with hypogonadism (serum total T levels ≤281 ng/dL). A key exploratory endpoint was change from Baseline (ΔBL) after 52 weeks of treatment in the following PROs: International Prostate Symptom Score (IPSS), Psychosexual Daily Questionnaire (PDQ), Short Form Health Survey 36 item (SF-36), and the International Index of Erectile Function (IIEF). Results: Total or overall scores for all PROs (IPSS, PDQ, SF-36 and IIEF) showed increased improvement in the SOV2012-F1 group relative to the Androgel group, and all but IPSS demonstrated improvement relative to BL. For IPSS, due to the potential that T could worsen urinary symptoms, the ΔBL would ideally be small to reflect minimal impact. Change for the SOV2012-F1 and AndroGel groups was, respectively, 0.6 and 1.0. Further, the IPSS total score was not significantly different from BL in the patients receiving SOV20212-F1 (p = 0.5659). For PDQ, a clinically meaningful improvement of sexual desire in hypogonadal men age ≥65 years is ≥0.7; mean ΔBL was 1.6 in the SOV2012-F1 group versus 1.4 in the AndroGel group. In the SF-36, the mean ΔBL total score was 83.7 in the SOV2012-F1 group and 70.2 in the AndroGel group. Further, post hoc analysis of the Health Change category found a significant (p ≤ 0.05) improvement in patient perspectives on health over the course of the study. The overall satisfaction score of the IIEF trended towards significance for the SOV2012-F1 group with a mean ΔBL score of 2.3 versus and 1.6 in the AndroGel group. The ΔBL for the 4 domains of male sexual function were small and consistent between the SOV2012-F1 and AndroGel groups. Comparable results were noted for Early Withdrawals and All Subjects across all PROs. Conclusion: Treatment with SOV2012-F1 for 52 weeks exceeded AndroGel patient satisfaction as measured by PROs including IPSS, PDQ, SF-36 and IIEF, demonstrating clinical distinction. Further analysis of SOV2012-F1 will be forthcoming.


Hand ◽  
2021 ◽  
pp. 155894472110541
Author(s):  
Abbas Peymani ◽  
Max M. Lokhorst ◽  
Austin D. Chen ◽  
Chantal M.A.M. van der Horst ◽  
Bernard T. Lee ◽  
...  

Background Madelung deformity is a rare congenital hand difference with little known regarding the patient perspective. In this cross-sectional survey study, we harnessed the global reach of social media to understand the clinical spectrum of Madelung deformity and its impact on physical, mental, and social health. Methods A survey was developed based on a previously published protocol and multiple Patient-Reported Outcomes Measurement Information System (PROMIS) short forms. The survey was distributed on several Madelung deformity communities on Facebook and Instagram. T-scores were calculated, interpreted, and compared between patients who underwent surgery and those who did not. Correlations between scores were calculated using the Spearman rank correlation coefficient. Results Mean PROMIS scores for adults were as follows: pain intensity, 4.9 ± 2.8; pain interference, 57.6 ± 10.0; upper extremity, 35.2 ± 8.1; depression, 53.8 ± 11.1; anxiety, 55.4 ± 11.4; and ability to participate in social roles and activities, 42.5 ± 7.7. Mean scores for children were as follows: pain intensity, 5.0 ± 2.8; pain interference, 55.7 ± 11.3; upper extremity function, 24.6 ± 10.4; depressive symptoms, 57.7 ± 11.3; anxiety, 57.3 ± 11.9; and peer relationships, 42.2 ± 10.3. Conclusions Madelung deformity has significant effects on patients’ physical, mental, and social well-being, even after surgical treatment. Using social media, we were able to compensate for Madelung deformity’s rarity by engaging an international audience, demonstrating the feasibility to conduct research through it, and providing a global perspective of the disease entity.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9618-9618 ◽  
Author(s):  
Yanni Hao ◽  
Charles S. Cleeland ◽  
Dennis Gagnon ◽  
Derek Espindle ◽  
Arturo Molina ◽  
...  

9618 Background: The COU-AA-301 phase 3 trial showed that AA + prednisone (P) improved overall survival in mCRPC patients (pts) post-docetaxel. Compared with P alone, AA + P also had significant benefits on patient-reported pain. Here we describe post hoc sensitivity analyses of pain data from that trial, using different methods to compensate for the potential impact of missing data. Methods: Pts with mCRPC progressing after docetaxel-based chemotherapy were randomized 2:1 to AA + P or placebo + P. Pain intensity and interference of pain with daily activities were assessed with the Brief Pain Inventory-Short Form (BPI-SF) questionnaire at baseline, Day 15 of Cycle 1, and Day 1 of each 28-day treatment cycle thereafter until treatment discontinuation. The effect of treatment on BPI-SF scores was analyzed using repeated measure mixed-effects (RMM) models, piecewise linear mixed-effects (PWLME) models, and joint mixed-effects and log time-to-dropout (JMEL) models. RMM and PWMLE models assumed missing data (due to death, study dropout, or administrative issues) to be missing at random, the JMEL model to be missing not at random. Model results were compared between treatment arms. Results: 797 pts were randomized to AA + P, and 398 to P only. RMM model estimates suggested statistically significant (p < 0.05) differences in change from baseline for pain intensity and pain interference scores in favor of AA + P at the majority of study visits through cycle 11. PWLME models yielded significantly smaller areas under the curve (AUCs) for AA + P vs P for pain intensity (p = 0.0031) and pain interference (p = 0.0006); smaller AUCs reflect better pain outcomes. Results using JMEL models were nearly identical to those with PWLME models, with AUCs for AA + P significantly smaller than for P alone for pain intensity (p = 0.0031) and pain interference (p = 0.0007). Conclusions: Using various modeling methods that assess the impact of missing data, AA + P showed superior patterns of pain outcomes over time compared with P only in mCRPC pts refractory to docetaxel. These results support the previously reported pain benefits of AA + P over P alone from the same trial. Clinical trial information: NCT00638690.


2019 ◽  
Vol 20 (4) ◽  
pp. S48
Author(s):  
C. Mun ◽  
M. Davis ◽  
C. Campbell ◽  
P. Finan ◽  
H. Tennen

2020 ◽  
Vol 2020 ◽  
pp. 1-12
Author(s):  
Chongjie Yao ◽  
Zhenrui Li ◽  
Shuaipan Zhang ◽  
Zhiwei Wu ◽  
Qingguang Zhu ◽  
...  

Low back pain (LBP) is one of the major concerns of the current health care. The guidelines for chronic LBP recommend traditional Chinese exercise as an effective treatment. As one of the representatives of traditional Chinese exercise, Wuqinxi has been famous in China for its effects on improving health and treating chronic diseases for thousands of years. The objectives of the study were to assess the effects of Wuqinxi in the patients with chronic LBP on pain intensity, trunk muscle strength, and quality of life. The primary outcome measure was assessed by the Short-Form McGill Pain Questionnaire (SF-MPQ), including the Visual Analog Scale (VAS) and Present Pain Intensity (PPI) as the subtables. The effects of Wuqinxi on the quality of life were also assessed by the Short-Form Health Survey (SF-36) and the Pittsburgh Sleep Quality Index (PSQI) from physical component summary (PCS), mental component summary (MCS), and sleep quality. Besides, the electrical activities of the rectus abdominis (RA), obliquus externus abdominis (OEA), lumbar erector spinae (ES), and multifidus (MF) were assessed by integrated electromyogram (iEMG) after the end of the intervention. Both the groups showed statistically significant improvement in SF-MPQ, SF-36, PSQI, and iEMG at 12 weeks and 24 weeks when compared with baseline (P<0.05). However, Wuqinxi demonstrated better effects in SF-MPQ and MCS after 24 weeks of intervention compared with the general exercise (P<0.05). The patients in the Wuqinxi group (WQXG) also showed a significantly higher iEMG on OEA than the general exercise group (GEG) in 30°/s and 90°/s (P<0.05). Our results showed that Wuqinxi had better effects on chronic LBP for a long time compared with general exercise, including pain intensity and quality of life. Thus, Wuqinxi should be recognized as a possible standalone therapy and self-management skill in chronic LBP, which is suitable for long-term practice.


2010 ◽  
Vol 23 (3) ◽  
pp. 485-495 ◽  
Author(s):  
Maria I. Lapid ◽  
Katherine M. Piderman ◽  
Susan M. Ryan ◽  
Kristin J. Somers ◽  
Matthew M. Clark ◽  
...  

ABSTRACTBackground:Quality of life is important for all individuals, but is frequently overlooked in psychiatric populations. Our purpose was to assess the quality of life (QOL) of depressed psychiatrically hospitalized elderly patients, examine the association of QOL and depression, and explore any QOL differences related to electroconvulsive therapy (ECT).Methods:This Institutional Review Board (IRB)-approved prospective study recruited geropsychiatric inpatients aged 65 years and older who were depressed, had Mini-mental State Examination (MMSE) scores >18/30, and adequate communication skills. Surveys were completed upon admission and discharge to measure depression (Hamilton Depression Rating Scale (HDRS)), quality of life (Linear Analogue Scales of Assessment (LASA); Medical Outcomes Short Form-36 Health Survey (SF-36)), cognitive function (MMSE; Executive Interview (EXIT 25)), and coping (Brief COPE Inventory (COPE)). Spearman correlations and Wilcoxon signed rank tests were used to assess changes in measures during hospitalization and relationships among variables.Results:The 45 study participants who completed the study had a mean age of 74 years. The majority were female (67%), married (58%), Protestant (60%), with at least high school education (78%). Admission scores demonstrated severe depression (HDRS 24.88 ± 10.14) and poor QOL (LASA overall QOL 4.4 ± 2.79, and SF-36 mental [27.68 ± 9.63] and physical [46.93 ± 10.41] component scores). At discharge, there was a significant improvement of depression (HDRS 24.88v12.04, p < 0.0001) and QOL (LASA overall QOL 4.4v6.66, p < 0.0001; and SF-36 mental [27.68v39.10, p < 0.0001] and physical [46.93v50.98, p = 0.003] component scores). Not surprisingly, depression was negatively correlated with overall QOL, mental well-being, physical well-being, and emotional well-being at both admission and discharge. For the group who received ECT, there was a greater magnitude of improvement in SF-36 vitality (p = 0.002) and general health perception (p = 0.04), but also a reduction in EXIT 25 scores at discharge (p = 0.008).Conclusions:There was improvement of both QOL and depression during the course of hospitalization. Additionally, improvement of QOL was associated with improvement of depression. Perhaps future studies could develop interventions to improve both mood and QOL in elderly depressed inpatients.


2021 ◽  
Author(s):  
Shuo He ◽  
Xue-Jia Ke ◽  
Yan Wu ◽  
Xiao-Yi Kong ◽  
Ping Zhang ◽  
...  

Abstract Background The objective of this study was to explore the stigma and related influencing factors in patients with chronic insomnia disorder (CID). Methods A total of 70 CID patients and 70 healthy controls (CON) were enrolled in the study. The Pittsburgh Sleep Quality Index (PSQI) and the 17-Item Hamilton Depression Rating Scale (HAMD-17) were used to assess sleep quality and depressive symptoms, respectively. The Chinese-Beijing version of the Montreal Cognitive Assessment scale (MoCA-C) was used to assess cognitive function. Stigma and life quality were measured using the Chronic Stigma Scale and the 36-Item Short-Form Health Survey (SF-36). Results The ratio of individuals with stigma was significantly different between CID and CON groups (C2 = 35.6, p < 0.001). Compared with the CON group, the CID group had higher scores for total stigma (U = 662.0, p < 0.001), internalized stigma (U = 593.0, p < 0.001), enacted stigma (U = 1568.0, p < 0.001), PSQI (U = 2485.0, p < 0.001) and HAMD-17 (U = 69.5, p < 0.001) as well as lower scores for MoCA-C (U = 3997.5, p < 0.001) and SF-36 for the items of physical role (U = 1560.5, p < 0.001), body pain (U = 1633.5, p < 0.001), general health (U = 1194.0, p < 0.001), vitality (U = 1169.5, p < 0.001), social function (U = 1703.0, p = 0.001), emotional role (U = 1451.5, p < 0.001), mental health (U = 1147.0, p < 0.001) and health transition (U = 1341.0, p < 0.001). Partial correlation analysis showed that different items of the Chronic Stigma Scale were positively correlated with illness duration, PSQI and HAMD-17 scores, while negatively correlated with one or more items of the SF-36. Multivariate regression analysis showed that illness duration and the mental health domain of the SF-36 were independent risk factors for one or more items of stigma in CID patients. Conclusion Patients with CID have an increased risk of stigma. Moreover, illness duration and mental health may be primary factors related to stigma.


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