key: cord-0287091-qzulabi8 authors: Santiago, María Granados; Núñez, Javier Martín; Ciuró, Alejandro Heredia; Rubio, Araceli Ortiz; Mateo, Andrés Calvache; López, Laura López; Valenza, Marie Carmen title: Cross-sectional study of pain-related variables before and during the COVID-19 pandemic in patients with COPD date: 2022-05-27 journal: nan DOI: 10.1016/j.pmn.2022.05.001 sha: e47f46280f840e43fc161d97d1640ac79505de97 doc_id: 287091 cord_uid: qzulabi8 Objective The aim of this study was to analyze the pain-related variables before and during the COVID-19 pandemic in COPD patients. Methods In this cross-sectional case-control study, stable COPD patients without a COVID-19 diagnosis were evaluated before and during the pandemic. The main outcomes were the pronociceptive pain profile (general pain sensitivity, pain intensity, pain interference, and pressure pain sensitivity) and the psychological vulnerability (perceived health status, anxiety, and depression). Results Our results showed that COPD patients during COVID-19 pandemic experienced higher general pain sensitivity and intensity with statistical differences in pain interference (p<0.001), being the overall perceived health status lower than before the pandemic (p<0.05). Conclusion We concluded that COPD patients during the COVID-19 pandemic showed a rise the pronociceptive pain profile accompanied by increased psychological vulnerability. Since the first case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) was reported, the health care systems are impacted by the spreading of the cases around the world increasing the difficulty to manage the population needs (Ohannessian et al. 2020) . In this situation, the impact of the COVID-19 pandemic has been particularly strong on subjects suffering from single or multiple chronic illness, usually disabled, and those with unstable health status (Giansanti et al. 2020) . In this sense, we can include all chronic respiratory patients, being particularly affected by this outbreak. In the case of COPD patients, while the COVID-19 pandemic continues, the health system has led to many difficulties with their diagnosis and routine management. Additionally, COPD patients show increased anxiety in the presence of infection, denial of care, associated symptoms, and death. (Philip et al. 2020 ). The COVID-19 pandemic influences the general health status of patients with COPD and other comorbidities, impacting all health-related outcomes due to their previous vulnerability (Leung et al. 2020 ). Well-known symptoms in COPD are dyspnea, cough and wheezing, whereas other symptoms such as nausea, fatigue, and insomnia are also usually reported (Janssen et al. 2011 ), but recent literature indicates that pain is also a significant symptom in COPD patients with an estimated prevalence of 32-60% (van Isselt et al. 2014 ). There are multiple factors related to COPD that may contribute to a higher pain prevalence in COPD patients, highlighting the systemic inflammatory process, musculoskeletal disorders, comorbidities (Roberts et al. 2013) , sedentary lifestyle and worse clinical symptoms such as quality of life, breathlessness, insomnia, fatigue, anxiety, depression (Borge et al. 2010 ) and malnutrition risk (Borge et al. 2011 ). However, the actual situation has exposed a variety of chronic pathologies with a worsening of their clinical outcomes due to the restriction of physical activity, social isolation, the difficulty of follow-ups and general management of the pathologies. In this line, more research on this topic is needed, specifically pain-related variables can be impacted during the COVID -19 pandemic in COPD patients worsening all healthrelated outcomes. Therefore, the purpose of this study was to analyze the pain-related variables before and during the COVID-19 pandemic in COPD patients. This cross-sectional case-control study was performed between November 2018 and February 2021. Ethical approval for this study was obtained from the ethics committee of the San Cecilio and Virgen de las Nieves University Hospital (Granada, Spain) in accordance with the Declaration of Helsinki review in 2013. The study was registered in ClinicalTrial.org (NCT04319523). Participants COPD patients were recruited during their routine clinical visits from the Pneumology Service. The inclusion criteria of COPD patients were: 1) stable COPD patients with a grade III and IV of Global Initiative for Chronic Obstructive Lung Disease (GOLD) (Vestbo et al. 2013) ; 2) 60 years of age or older without COVID-19 diagnosis during the study; and 3) provided informed consent for research participation. Patients were excluded if: 1) the presence of psychiatric or cognitive disorders, progressive neurological disorders, cancer, or chronic pain; 2) patient with cognitive impairment or unable to understand the tests; 3) diagnosis of widespread chronic pain or other causes of acute pain; and 4) incapacity to provide informed consent. Patients who suffered any health problem and experienced an exacerbation of COPD in the previous month were also excluded to ensure the patient's symptoms were stable. Patients who agreed to participate which met the eligibility criteria were provided with an explanation of the study protocol and invited to give written informed consent. All participants in this study signed informed consent before their inclusion in the study. After signing informed consent, all participants were evaluated pre-and during the COVID-19 pandemic, being the COVID-19 lockdown on the 14 March 2020. Descriptive data of participants (age, sex, comorbidities, employment status and marital status), body mass index and handgrip strength were collected. The comorbidities were assessed by the Charlson Comorbidity index (Charlson et al. 1994 ). The cognitive impairment was measured with the Montreal Cognitive Assessment (MoCA) (Nasreddine et al. 2005) . The functionality was evaluated with the Functional Independence Measure (FIM) (Hamilton et al. 1994) . The sleep quality was assessed by the Pittsburgh sleep quality index (PSQI) (Buysse et al. 1989) . Respiratory function outcomes measured included forced expiratory volume in the first second (FEV1%), dyspnea and fatigue perceptions. FEV1% was assessed with a spirometer (CareFusion, Micro Spirometer, Basingstoke, UK) following the criteria of the American Thoracic Society (ATS) (Watz et al. 2009 ). Additionally, dyspnea perception was recorded using the modified Borg Scale (Borg et al. 1982) , the functional impairment related to dyspnea was measured with the London Chest Activity of Daily Living Scale (LCADL) (Garrod et al. 2000) , and fatigue perception with the Fatigue Several Scale (FSS) (Fisk et al. 1994 ). The health impairment in COPD patients was evaluated using the St George's Respiratory Questionnaire (Jones et al. 1991 ). This questionnaire is divided into the following domains: respiratory symptoms, activities limited by dyspnea, and psychosocial impacts. The pain-related variables comprise the pronociceptive pain profile defined as patients with facilitated pain processing and/or reduced pain-modulatory capabilities (Cheng, et al. 2015 ) (general pain sensitivity, pain intensity, pain interference, and pressure pain sensitivity) and the coexistence of psychological vulnerability (perceived health status, anxiety and depression) among COPD patients. The Pain Sensitivity Questionnaire (PSQ) evaluated general pain sensitivity. It is composed of 17 items, each describing an activity of daily life and asking the patients to rate how painful this activity would be for them on a numeric rating scale ranging from 0 (not painful) to 10 (worst pain imaginable). A higher score in the questionnaire indicated a greater pain sensitivity (Ruscheweyh et al.2012 ). The Brief Pain Inventory (BPI) assessed pain intensity and pain interference. Patients rate the intensity of their pain during the previous week, on average, and "right now." Patients also rate their level of pain interference in seven backgrounds: 1) work, 2) activity, 3) mood, 4) enjoyment, 5) sleep, 6) walking, and 7) relationships. The intensity subscale is scored between 0 and 40, and the interference subscale is between 0 and 70. Higher scores reflect worse pain intensity or interference (Cleeland et al. 1994 ). Pressure pain thresholds (PPT) was used to measure pressure pain sensitivity in muscles with the algometer (Somedic AB, Horby, Sweden). With the patient in a seated position, the pressure was applied three times at five bilateral points of the body: the distal thumb phalangeal, the gracilis muscle tendon at the inside of the knee, the distal of the middle part of the clavicle, the supraspinous muscle and the trapezius muscle's second portion. When the participant reported that pressure changed to pain, the pressure was stopped, and the mean value was registered (Johansson et al. 2012 ). The perceived health status was measured with the EuroQol-5D (EQ-5D) tool. This measure contains two parts, a descriptive questionnaire about health impairment and a numerical scale about health status perception. The descriptive questionnaire includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The numerical scale ranges from 0 (defined as the worst imaginable health state) to 100 (defined as the best imaginable health state) (Rabin et al. 2001 ). The Hospital Anxiety and Depression Scale (HAD) measured the anxiety and depression symptoms. It consists of 14 items, depression (seven items) and anxiety (seven times), each with four answer options. Each of the subscale scores ranges from 0 to 21, corresponding to total scores of 0 to 42, with higher scores indicating major anxiety and depression symptoms (Herrero et al. 2003) . The sample size calculation was guided by estimates of the minimal clinically important difference in the Brief Pain inventory (Tanaka et al. 2002) . Our analysis indicated that a sample size of 24 participants will be needed to ensure at least 21 participants to find significant differences between groups, assuming a loss rate of 10% with a significance level of 0.05. Statistical analyses were performed using IBM SPSS Statistics 23.0 software for Windows (SPSS Inc. and IBM Company). Results are expressed as mean and statistical deviation (SD). Differences in characteristics between COPD patients pre-and post-COVID-19 pandemic were tested using the independent sample t-test for numeric variables with normal distribution, the Wilcoxon test for numeric variables with no normal distribution, and the chi-square test for nominal variables. The statistical analysis was conducted at a 95% confidence level. A P value <0.05 was considered statistically significant. The recruitment and selection of COPD patients across the study appeared in Figure 1 . Please, insert figure 1 The characteristics of COPD patients evaluated at pre-and during COVID-19 pandemic are shown in Table 1 . Please, insert table 1 The mean age of COPD patients was 67.60±6.13 years with a male predominance (79%) and the incidence of comorbidities was 3.75±0.89. All patients were retired and the 87.3% living accompanied. When COPD patients were compared at pre-and during COVID-19, the descriptive data of participants showed no significant differences between groups. The BMI, cognitive impairment, handgrip strength, functionality and sleep quality were similar pre and during COVID-19 (p<0.05). However, regarding respiratory function, COPD patients have shown statistical differences in dyspnea and fatigue perception, and respiratory symptoms over time (p<0.001). The pronociceptive pain profile and psychological vulnerability of COPD patients are shown in the table 2. Investigating the pronociceptive pain profile and the psychological vulnerability of COPD patients at pre-and during COVID-19 pandemic revealed all symptoms increased over time in COPD patients during COVID-19 pandemic. Table 2 , COPD patients during the COVID-19 pandemic experienced higher general pain sensitivity and intensity with statistical differences in pain interference (p<0.001). Furthermore, the pressure pain sensitivity in the five bilateral points of the body have shown a higher sensitivity during COVID-19, highlighted the bilateral thumbs, gracilis, and supraspinous muscles (p<0.001). The overall perceived health status shown much lower during COVID-19 than in the pre-COVID-19 period (p<0.05). Although, the anxiety and depression were not statistically different between pre-and during COVID-19 pandemic. We have shown that during the COVID-19 pandemic, there was an increase in the pronociceptive pain profile and the psychological vulnerability enhanced in COPD patients. Patients presenting with COPD during COVID-19 pandemic had intensified the dyspnea and fatigue perfection compared to before the pandemic but had similar FEV-1 obstructive degree. Thus, these findings highlight the impact of respiratory symptoms, being the most affected of the health characteristics of COPD. The COVID-19 pandemic produced for some people the suspension of commuting, changes to education and work, and increased time with family, highlighted a decreased stress and increased psychological general wellbeing. (Sevilla et al. 2020; Greenberg et al. 2020 ). However, other people developed more anxiety, anger, stress, or agitation during the lockdown mainly due to the fear of infection, loneliness, socioeconomic problem and loss of employment. (World Health Organization, 2020; Townsend et al. 2020; Bu et al. 2020) . Evidence from around the world on psychological change potentially attributable to the COVID-19 pandemic is being studied. McGinty, et al. 2020 showed an increased rates of psychological distress among adults during COVID-Depression and anxiety are associated with increased pain perception, whereas prolonged duration of pain leads to increased psychological vulnerability (Zis et al. 2017 ). In addition, Vardar-Yagli, et al. observed that pain perception, severity, and sensitivity are increased in patients with COPD compared to the general population (Vardar-Yagli et al. 2019) . Recently, similar studies to ours also observed a change in the clinical profile of acute (Silva et al. 2020 ) and chronic (Tilliridou et al. 2021) respiratory diseases between the pre-and during COVID-19 pandemic. Several limitations of this study should be considered. First, the sample size was relatively small but sufficient to detect statistical differences in pain assessments. Second, the use of questionnaires may have underestimated or overestimated some of the information. In addition, the course of COPD is clinically characterized by a worsening of dyspnea, cough, and sputum production, which were not analyzed in this study. Moreover, the population included in the study had a moderate to severe profile of COPD. Our initial purpose here was to investigate the association between the painrelated variables and the presence of psychological vulnerability among stable COPD patients, although, given these special circumstances, our methods required some modifications. Participants may have been less motivated to engage in the study during the COVID-19 pandemic. Likewise, our evaluation was modified as we initially planned, for instance the Semmes-Weinstein monofilaments were excluded in the evaluation of sensitivity to pressure/touch. A further limitation of this study is that it focused on examining the pain-related variables before and during the COVID-19 pandemic in COPD patients, a healthy control group to compare should be recommended. Further studies are needed to determine other aspects of COPD symptomatology that can be influenced during COVID-19 pandemic. These findings highlight the patient's psychological distress likely due to the pandemic added to patients' own symptoms reported such as pain. Developing and implementing education programs that allow COPD patients to achieve and enhance the control of their illness is recommended. Moreover, early diagnostic surveys should be recommended to prevent and recognize pain in these patients. Future studies evaluating pain and its characteristics to determine the health status impact are recommended. The illness knowledge, psychological, physical, and social aspects should be encouraged to prevent pronociceptive pain in COPD patients. During the COVID-19 pandemic, COPD patients showed an increase in the pronociceptive pain profile accompanied by a worse psychological vulnerability compared with COPD patients before COVID-19 pandemic. 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