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BACKGROUND: The strategies patients use to cope with chronic pain are key determinants of pain-related treatment outcomes and are often targeted in psychosocial interventions for chronic pain. However, improvements in coping often fade after intervention completion. Here, we test whether previously reported improvements in coping following two novel mind-body and activity interventions are maintained 3 months after completion. METHODS: Eighty-two patients with heterogeneous chronic pain were randomized to two identical mind-body and activity interventions, one with the addition of a Fitbit device (GetActive-Fitbit) and one without it (GetActive; n = 41 each). Participants completed measures of pain-catastrophizing, kinesiophobia, mindfulness, adaptive coping, and pain-resilience at baseline, post-intervention, and at 3-month follow-up. RESULTS: At follow-up, participants in both groups exhibited sustained improvements in all five coping measures compared to baseline (significant in both groups for all measures except for p = .05 in kinesiophobia in GetActive and p = .07 in pain resilience in GetActive-Fitbit). CONCLUSIONS: Overall, GetActive and GetcActive-Fitbit are promising interventions to sustainably improve coping with chronic pain. TRIAL REGISTRATION: This trial is registered under ClinicalTrials.gov identifier NCT03412916.
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Dor Crônica , Atenção Plena , Adaptação Psicológica , Catastrofização , Dor Crônica/terapia , Humanos , Resultado do TratamentoRESUMO
Chronic pain is associated with substantial decreases in physical and emotional health. Psychosocial and physical restoration interventions, although potentially helpful, typically show small-to-moderate improvements that are limited to the short term, and often exhibit problematic adherence. Here, we present GetActive-Fitbit, a novel 10-week group program that integrates mind-body skills, pain coping and gradual increases in activity reinforced by a commercially available digital monitoring device (Fitbit). We illustrate the program among a group of 4 adults with heterogeneous chronic pain. We also highlight pre to post-program improvements in physical function (objective, performance-based and self-report), emotional function (depression and anxiety) and other relevant outcomes targeted by the program (e.g., pain intensity, catastrophizing, mindfulness, coping, kinesiophobia, emotional support, social isolation, pain resilience, program satisfaction and impression of change). Group participants' experiences suggest that GetActive-Fitbit is credible, useful, and shows potential to improve physical and emotional function among this challenging population.Clinical trial number: NCT03412916.
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Dor Crônica , Atenção Plena , Adaptação Psicológica , Adulto , Ansiedade , Catastrofização , Dor Crônica/terapia , HumanosRESUMO
OBJECTIVE: To determine the relationship between opioid dose change, pain severity, and function in patients with chronic pain. DESIGN: Retrospective cohort study. SETTING: Community interdisciplinary pain management practice. SUBJECTS: A total of 778 patients with chronic pain prescribed opioids for three or more consecutive months between April 1, 2013, and March 1, 2015. METHODS: Changes in opioid dose, pain severity rating, modified Roland Morris Disability Questionnaire score, and opioid risk data were extracted from medical records and analyzed for associations. RESULTS: Two hundred forty-three subjects (31.2%) had an overall dose decrease, 223 (28.7%) had a dose increase, and 312 (40.1%) had no significant change in dose (<20% change). There was a weak negative correlation between change in opioid dose and change in pain severity (r = -0.08, P = 0.04) but no association between change in disability scores and dose change (N = 526, P = 0.13). There was a weak positive correlation between change in pain severity rating and change in disability scores (r = 0.16, P < 0.001). CONCLUSIONS: The results suggest that escalating opioid doses may not necessarily result in clinically significant improvement of pain or disability. Similarly, significant opioid dose reductions may not necessarily result in worsened pain or disability. This exploratory investigation raised questions of possible subgroups of patients who might demonstrate improvement of pain and disability with opioid dose adjustments, and further research should prospectively explore this potential, given the limitations inherent in retrospective analyses. Prescribers should still consider reduction of opioid doses as recommended by current guidelines, in an effort to mitigate the potential risks associated with high-dose treatment.
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Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Manejo da Dor , Adulto , Pessoas com Deficiência/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Medição da Dor/métodos , Estudos RetrospectivosRESUMO
OBJECTIVE: This manuscript reviews medical literature published pertaining to the management of chronic pain with medical marijuana therapy (MMJ), with an emphasis on the social, medical, and legal aspects of therapy. DESIGN: Narrative review of peer-reviewed literature. METHODS: The 3rd Symposium on Controlled Substances and Their Alternatives for the Treatment of Pain was held in Boston on February 27, 2016, with a focus on MMJ for the treatment of chronic pain. Invited speakers had diverse backgrounds, including pain management, addiction psychiatry, neurology, and legal authorities. The purpose of this conference and this subsequent narrative review is to provide a medical, legal, and logistical framework for physicians and other health care providers to refer to when considering the initiation of medical marijuana therapy. RESULTS: The invited speakers each covered a unique aspect of MMJ therapy for the treatment of chronic pain. These presentations highlighted the current data for and against the use of MMJ as a pain therapy. Optimal patient selection and screening, in addition to policy developments, were discussed. CONCLUSIONS: Increasing interest in MMJ for chronic pain underscores a need for primary care and pain physicians to better understand the indications and evidence for its use free from cultural bias. Given a lack of full conclusive clinical utility, continued research is needed to better understand how to best utilize MMJ therapy for the treatment of chronic pain. Policy initiatives, such as enumerated indications, should follow medical science in order to prevent another abused substance epidemic.
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Analgésicos Opioides/uso terapêutico , Analgésicos/uso terapêutico , Cannabis , Dor Crônica/tratamento farmacológico , Maconha Medicinal/uso terapêutico , Humanos , Manejo da Dor/métodosRESUMO
Objective: Health care providers are likely to see an increase in the concomitant use of cannabis and opioids, particularly with the increased liberalization and ongoing research into the possible role of medical marijuana for chronic pain. Recent literature reports a prevalence of concurrent use ranging from 8.9% to 31.8%. The primary aim of this study was to determine the relationship between cannabis use and aberrant drug behaviors in noncancer pain patients receiving chronic opioid therapy. Design: Retrospective chart review. Setting: Community-based, interdisciplinary pain management center. Subjects: Data from 209 patients who were evaluated for a medication management program between October 1, 2011, and January 1, 2014, and met inclusion criteria. Forty-four were positive for cannabis in their initial random urine drug toxicology. Methods: Data from electronic health records, including demographics, urine drug toxicology, disability, opioid dose, opioid risk assessment data, and pain severity were analyzed to examine differences among cannabis users and noncannabis users. Results: Subjects with cannabis in their initial urine drug toxicology were more likely to have a future occurrence of an opioid-related aberrancy (P < 0.001), be male (P = 0.047), have a history of substance abuse (P = 0.013), and be enrolled into a higher level of clinical monitoring of opioid medication use (P = 0.008). No other associations with demographic and clinical variables reached statistical significance. Conclusions: Concurrent use of cannabis and opioids by patients with chronic pain appears to indicate higher risk for opioid misuse. Closer monitoring for opioid-related aberrancy is indicated for this group of patients.
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Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Uso da Maconha/epidemiologia , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Clínicas de Dor , Estudos Retrospectivos , Fatores de RiscoRESUMO
BACKGROUND: The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item questionnaire designed to assess risk of aberrant medication-related behaviors in chronic pain patients. The introduction of short forms of the SOAPP-R may save time and increase utilization by practitioners. OBJECTIVE: To develop and evaluate candidate SOAPP-R short forms. DESIGN: Retrospective study. SETTING: Pain centers. SUBJECTS: Four hundred and twenty-eight patients with chronic noncancer pain. METHODS: Subjects had previously been administered the full-length version of the SOAPP-R and been categorized as positive or negative for aberrant medication-related behaviors via the Aberrant Drug Behavior Index (ADBI). Short forms of the SOAPP-R were developed using lasso logistic regression. Sensitivity, specificity, and area under the curve (AUC) of all forms were calculated with respect to the ADBI using the complete data set, training-test analysis, and 10-fold cross-validation. The coefficient alpha of each form was also calculated. An external set of 12 pain practitioners reviewed the forms for content. RESULTS: In the complete data set analysis, a form of 12 items exhibited sensitivity, specificity, and AUC greater than or equal to those of the full-length SOAPP-R (which were 0.74, 0.67, and 0.76, respectively). The short form had a coefficient alpha of 0.76. In the training-test analysis and 10-fold cross-validation, it exhibited an AUC value within 0.01 of that of the full-length SOAPP-R. The majority of external practitioners reported a preference for this short form. CONCLUSIONS: The 12-item version of the SOAPP-R has potential as a short risk screener and should be tested prospectively.
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Comportamento Aditivo/diagnóstico , Dor Crônica/diagnóstico , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Medição da Dor/normas , Inquéritos e Questionários/normas , Adulto , Analgésicos Opioides/efeitos adversos , Comportamento Aditivo/epidemiologia , Comportamento Aditivo/psicologia , Dor Crônica/epidemiologia , Dor Crônica/psicologia , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos Relacionados ao Uso de Opioides/epidemiologia , Transtornos Relacionados ao Uso de Opioides/psicologia , Medição da Dor/métodos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Detecção do Abuso de Substâncias/psicologia , Detecção do Abuso de Substâncias/normasRESUMO
Migraine can impact every aspect of a person's functioning. Psychological comorbidities, cognitive constructs, and behavioral responses to pain greatly impact the perception of migraine pain, treatment efficacy and outcome, and overall quality of life and functioning. Current considerations for migraine treatment emphasize the utility of the biopsychosocial model in understanding and treating migraine, noting both the importance of addressing psychological factors such as cognitive beliefs as well as psychiatric comorbidities. The guidelines for migraine treatment implicate opioid therapy as a second or third tier treatment. Guidelines and recommendations for the safe use of opioid medications among patients with chronic pain emphasize the importance of screening prior to prescribing opioid medications. Chronic opioid therapy has been shown to further levels of disability, decrease quality of life, and correlate to psychiatric comorbidities, concerns that are already present in migraine patients. While opioid treatment provides an alternative for persons with contraindications for alternative migraine treatments, it is critical that opioids be used sparingly and exclusively in conjunction with comprehensive assessment and integration of psychological treatment.
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Analgésicos Opioides/uso terapêutico , Transtornos de Enxaqueca/tratamento farmacológico , Dor Crônica/tratamento farmacológico , Dor Crônica/psicologia , Humanos , Transtornos de Enxaqueca/psicologia , Guias de Prática Clínica como Assunto , Fatores de RiscoRESUMO
BACKGROUND: The Screener and Opioid Assessment for Patients with Pain-Revised (SOAPP-R) is a 24-item self-report instrument that was developed to aid providers in predicting aberrant medication-related behaviors among chronic pain patients. Although the SOAPP-R has garnered widespread use, certain patients may be dissuaded from taking it because of its length. Administrative barriers associated with lengthy questionnaires further limit its utility. OBJECTIVE: To investigate the extent to which two techniques for computer-based administration (curtailment and stochastic curtailment) reduce the average test length of the SOAPP-R without unduly affecting sensitivity and specificity. DESIGN: Retrospective study. SETTING: Pain management centers. SUBJECTS: Four hundred and twenty-eight chronic non-cancer pain patients. METHODS: Subjects had taken the full-length SOAPP-R and been classified by the Aberrant Drug Behavior Index (ADBI) as having engaged or not engaged in aberrant medication-related behavior. Curtailment and stochastic curtailment were applied to the data in post-hoc simulation. Sensitivity and specificity with respect to the ADBI, as well as average test length, were computed for the full-length test, curtailment, and stochastic curtailment. RESULTS: The full-length SOAPP-R exhibited a sensitivity of 0.745 and a specificity of 0.671 for predicting the ADBI. Curtailment reduced the average test length by 26% while exhibiting the same sensitivity and specificity as the full-length test. Stochastic curtailment reduced the average test length by as much as 65% while always exhibiting sensitivity and specificity for the ADBI within 0.035 of those of the full-length test. CONCLUSIONS: Curtailment and stochastic curtailment have potential to improve the SOAPP-R's efficiency in computer-based administrations.
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Analgésicos Opioides/efeitos adversos , Dor Crônica/diagnóstico , Dor Crônica/tratamento farmacológico , Diagnóstico por Computador/métodos , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Transtornos Relacionados ao Uso de Opioides/prevenção & controle , Analgésicos Opioides/administração & dosagem , Boston , Tomada de Decisão Clínica/métodos , Estudos de Viabilidade , Feminino , Humanos , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Projetos Piloto , Reprodutibilidade dos Testes , Estudos Retrospectivos , Sensibilidade e Especificidade , Software , Validação de Programas de Computador , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The Current Opioid Misuse Measure (COMM) is a self-report questionnaire designed to help identify aberrant drug-related behavior in respondents who have been prescribed opioids for chronic pain. The full-length form of the COMM consists of 17 items. Some individuals, especially compromised individuals, may be deterred from taking the full questionnaire due to its length. This study examined the use of curtailment and stochastic curtailment, two computer-based testing approaches that sequentially determine the test length for each individual, to reduce the respondent burden of the COMM without compromising sensitivity and specificity. METHODS: Existing data from n = 415 participants, all of whom had taken the full-length COMM and had been classified via the Aberrant Drug Behavior Index (ADBI), were divided into training (n = 214) and test (n = 201) sets. Post-hoc analysis of the test set was performed to evaluate the screening results and test lengths that would have been obtained, if curtailment or stochastic curtailment had been used. Sensitivity, specificity, and average test length were calculated for each method and compared with the corresponding values of the full-length test. RESULTS: The full-length COMM had a sensitivity of 0.703 and a specificity of 0.701 for predicting the ADBI. Curtailment reduced the average test length by 22% while maintaining the same sensitivity and specificity as the full-length COMM. Stochastic curtailment reduced the average test length by as much as 59% while always obtaining a sensitivity of at least 0.688 and a specificity of at least 0.701 for predicting the ADBI. CONCLUSIONS: Curtailment and stochastic curtailment have the potential to achieve substantial reductions in respondent burden without compromising sensitivity and specificity. The two sequential methods should be considered for future computer-based administrations of the COMM.
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Diagnóstico por Computador , Transtornos Relacionados ao Uso de Opioides/diagnóstico , Adulto , Analgésicos Opioides/uso terapêutico , Dor Crônica/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Retrospectivos , Autorrelato , Sensibilidade e EspecificidadeRESUMO
This article presents the case of a patient with persistent right-sided jaw pain with a history of multiple temporomandibular joint surgeries in the setting of persistent widespread body pain, the causes of which were fibromyalgia and osteoarthritis with multiple joint replacements, as well as psychological diagnoses of PTSD and depression. Despite extensive treatment from her orofacial pain team in combination with neurology and neurosurgery, her severe pain persisted, likely due to the consequences of untreated PTSD and depression, which led to avoidance of activities that would exacerbate her pain and thus to further disability and emotional deterioration.
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Dor Crônica , Pessoas com Deficiência , Transtornos de Estresse Pós-Traumáticos , Feminino , Humanos , Transtornos de Estresse Pós-Traumáticos/complicações , Transtornos de Estresse Pós-Traumáticos/epidemiologia , Transtornos de Estresse Pós-Traumáticos/psicologia , Dor Facial/etiologia , Dor Crônica/complicações , ComorbidadeRESUMO
The use of chronic opioid therapy for persistent headache remains controversial because of limited supporting data and potential risks. In addition to possible individual risks for the patient, society risks associated with diversion and substance abuse are well documented. Few studies directly address risk stratification for opioid therapy where a diagnosis of headache is present, making it necessary to extrapolate from other pain research when developing recommendations for screening and patient management. Considering the historical framework of opioid prescribing, relevant studies assessing risk stratification of chronic opioid therapy are reviewed. Specific risk factors that may lead to a problematic course with chronic opioid therapy are outlined. Both clinical experience and the limited empirical research underscore the need for multiple assessment tools and ongoing patient monitoring in the evaluation of these risk factors.
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Analgésicos Opioides/efeitos adversos , Transtornos da Cefaleia/tratamento farmacológico , Transtornos Relacionados ao Uso de Opioides/etiologia , Analgésicos Opioides/uso terapêutico , Humanos , Fatores de RiscoRESUMO
BACKGROUND: Improving physical function among patients with chronic pain is critical for reducing disability and healthcare costs. However, mechanisms underlying improvement in patient-reported, performance-based, and ambulatory physical function in chronic pain remain poorly understood. PURPOSE: To explore psychosocial mediators of improvement in patient-reported, performance-based, and objective/accelerometer-measured physical function among participants in a mind-body activity program. METHODS: Individuals with chronic pain were randomized to one of two identical 10-week mind-body activity interventions aimed at improving physical function with (GetActive-Fitbit; N=41) or without (GetActive; N=41) a Fitbit device. They completed self-reported (WHODAS 2.0), performance-based (6-minute walk test), and objective (accelerometer-measured step-count) measures of physical function, as well as measures of kinesiophobia (Tampa Kinesiophobia Scale), mindfulness (CAMS-R), and pain resilience (Pain Resilience Scale) before and after the intervention. We conducted secondary data analyses to test mediation via mixed-effects modeline. RESULTS: Improvements in patient-reported physical function were fully and uniquely mediated by kinesiophobia (Completely Standardized Indirect Effect (CSIE)=.18; CI=0.08, 0.30; medium-large effect size), mindfulness (CSIE=-.14; CI=-25, -.05; medium effect size) and pain resilience (CSIE=-.07; CI=-.16, -.005; small-medium effect size). Improvements in performance-based physical function were mediated only by kinesiophobia (CSIE=-.11; CI=-23, -.008; medium effect size). No measures mediated improvements in objective (accelerometer measured) physical function. CONCLUSION: Interventions aiming to improve patient-reported physical function in patients with chronic pain may benefit from skills that target kinesiophobia, mindfulness, and pain resilience, while those focused on improving performance-based physical function should target primarily kinesiophobia. More research is needed to understand mechanisms of improvement in objective, accelerometer-measured physical function. TRIAL REGISTRATION: ClinicalTrials.gov NCT03412916.
RESUMO
Despite an explosion of mobile app offerings for management of pain and anxiety, the evidence for effectiveness is scarce. Placebo-controlled trials are the most desirable but designing inactive placebo apps can be challenging. For a prospective randomized clinical trial with 72 patients in a craniofacial pain center, we created an app with self-hypnotic relaxation (SHR) for use with iOS and Android systems. A placebo background audio (BA) app was built with the same look and functionality. Both iOS and Android SHR apps alone and in comparison to the BA group significantly reduced pain and anxiety during the waiting-room time. The Android BA app significantly reduced anxiety but not pain. The iOS BA app affected neither pain nor anxiety, functioning as an ideal placebo. Usage analysis revealed that different default approaches of the iOS and Android devices accounted for the difference in results.
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Hipnose , Aplicativos Móveis , Ansiedade/terapia , Humanos , Hipnóticos e Sedativos , Dor , Estudos ProspectivosRESUMO
Over the past year our attention has inevitably been on the coronavirus pandemic, the health and welfare of our families, patients, and office staffs as well as the re-opening of our dental practices. In addition, the opioid crisis continues, is very likely to worsen as a result of the pandemic and continues to be a challenge to Dentistry. National public health issues and healthcare disparities continue and have created a global concern for providing evidence-based, adequate pain management in the dental setting. We have brought together a group of national thought leaders and experts in this field who will share their insights on the current state of opioid prescribing in Dentistry and describe some of the exciting work being done in advancing pain management. The learning objectives for this conference proceedings were: Describing the implications of current public health concerns for safe and effective pain management in dental medicine.Identifying risk factors and understanding the current guidelines for the use of opioid and non-opioid medications in dental medicine.Analyzing the interprofessional collaborations necessary for effective pain management in dental medicine.Recognizing the challenges and opportunities brought about by the COVID-19 pandemic for the dental profession.Applying evidence-based strategies for managing the complex pain patient in the dental setting.Appraising new and future modalities for the assessment and management of orofacial pain.
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Dentistry is in a unique position among the health care professions to assess and manage the patient with controlled substance risk. The concern over opioid risk is not new, and historically dentists have had to balance the critical need for adequate pain care with the importance of recognizing the consequences of using controlled substances for their patients. Barriers for providing adequate patient assessment and management may be greater in dentistry than other health care fields, although these barriers can be recognized and overcome. Collaboration with cotreating providers will improve patient outcomes and reduce patient risk.
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Substâncias Controladas , Analgésicos Opioides , Odontologia , Humanos , DorRESUMO
Dental patients who experience comorbid psychiatric and medical conditions present an elevated risk of medication misuse, abuse, substance use disorders, and overdose. The authors review the role of notable comorbidities in predicting the development of substance use disorder, including medical, psychiatric, and other psychosocial factors that can be assessed in general dental practice. Psychiatric disorders commonly cooccur with substance abuse, and these typically include anxiety disorders, mood disorders (major depression, bipolar), posttraumatic stress, as well as sleep and eating disorders. Medical disorders commonly found to be present with substance use disorders are also reviewed, including common cardiovascular and pulmonary disorders.
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Substâncias Controladas , Transtornos Relacionados ao Uso de Substâncias/epidemiologia , Transtornos de Ansiedade/epidemiologia , Comorbidade , HumanosRESUMO
Substance use disorder assessment strategies are increasingly being employed by dentistry, while adequate evaluation requires reaching out to other cotreating providers and collaborating on patient care. The field of dentistry has a range of barriers often not experienced in other professions, including limitations on e-record communication and clinical practice setting often isolated from the patient's general medical care. Barriers can be overcome if the dentist facilitates communication.
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Comunicação , Transtornos Relacionados ao Uso de Substâncias , Comportamento Cooperativo , Humanos , Equipe de Assistência ao PacienteRESUMO
Dentistry should be proud of its history of providing responsible pain relief, as well as becoming more cautious in prescribing opioid medications when other safer pharmacologic options exist. Our training directs us to first eliminate the source of dental pain and prescribe analgesics only as adjunctive relief. Prescriptions must be written for a legitimate dental purpose and for a patient of record. Through self-regulation, the dental profession must continue to establish pain management guidelines based on scientific evidence and clinical experience to avoid further regulatory action restricting our prescribing privileges, which remain one of our most powerful therapeutic tools.
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Analgésicos Opioides , Padrões de Prática Odontológica , Humanos , Manejo da DorRESUMO
BACKGROUND: Improving all aspects of physical function is an important goal of chronic pain management. Few studies follow recent guidelines to comprehensively assess physical function via patient-reported, performance-based, and objective/ambulatory measures. PURPOSE: To test 1) the interrelation between the 3 types of physical function measurement and 2) the association between psychosocial factors and each type of physical function measurement. METHODS: Patients with chronic pain (N=79) completed measures of: 1) physical function (patient-reported disability; performance-based 6-minute walk-test; objective accelerometer step count); 2) pain and non-adaptive coping (pain during rest and activity, pain-catastrophizing, kinesiophobia); 3) adaptive coping (mindfulness, general coping, pain-resilience); and 4) social-emotional dysfunction (anxiety, depression, social isolation and emotional support). First, we tested the interrelation among the 3 aspects of physical function. Second, we used structural equation modeling to test associations between psychosocial factors (pain and non-adaptive coping, adaptive coping, and social-emotional dysfunction) and each measurement of physical function. RESULTS: Performance-based and objective physical function were significantly interrelated (r=0.48, p<0.001) but did not correlate with patient-reported disability. Pain and non-adaptive coping (ß=0.68, p<0.001), adaptive coping (ß=-0.65, p<0.001) and social-emotional dysfunction (ß=0.65, p<0.001) were associated with patient-reported disability but not to performance-based or objective physical function (ps>0.1). CONCLUSION: Results suggest that patient-reported physical function may provide limited information about patients' physical capacity or ambulatory activity. While pain and non-adaptive reactions to it, adaptive coping, and social-emotional dysfunction may potentially improve patient-reported physical function, additional targets may be needed to improve functional capacity and ambulatory activity. TRIAL REGISTRATION: ClinicalTrials.gov NCT03412916.
RESUMO
BACKGROUND: Chronic pain is associated with poor physical and emotional functioning. Nonpharmacological interventions can help, but improvements are small and not sustained. Previous clinical trials do not follow recommendations to comprehensively target objectively measured and performance-based physical function in addition to self-reported physical function. OBJECTIVE: This study aimed to establish feasibility benchmarks and explore improvements in physical (self-reported, performance based, and objectively measured) and emotional function, pain outcomes, and coping through a pilot randomized controlled trial of a mind-body physical activity program (GetActive) with and without a digital monitoring device (GetActive-Fitbit), which were iteratively refined through mixed methods. METHODS: Patients with chronic pain were randomized to the GetActive (n=41) or GetActive-Fitbit (n=41) programs, which combine relaxation, cognitive behavioral, and physical restoration skills and were delivered in person. They completed in-person assessments before and after the intervention. Performance-based function was assessed with the 6-min walk test, and step count was measured with an ActiGraph. RESULTS: Feasibility benchmarks (eg, recruitment, acceptability, credibility, therapist adherence, adherence to practice at home, ActiGraph wear, and client satisfaction) were good to excellent and similar in both programs. Within each program, we observed improvement in the 6-min walk test (mean increase=+41 m, SD 41.15; P<.001; effect size of 0.99 SD units for the GetActive group and mean increase=+50 m, SD 58.63; P<.001; effect size of 0.85 SD units for the GetActive-Fitbit group) and self-reported physical function (P=.001; effect size of 0.62 SD units for the GetActive group and P=.02; effect size of 0.38 SD units for the GetActive-Fitbit group). The mean step count increased only among sedentary patients (mean increase=+874 steps for the GetActive group and +867 steps for the GetActive-Fitbit group). Emotional function, pain intensity, pain coping, and mindfulness also improved in both groups. Participants rated themselves as much improved at the end of the program, and those in the GetActive-Fitbit group noted that Fitbit greatly helped with increasing their activity. CONCLUSIONS: These preliminary findings support a fully powered efficacy trial of the two programs against an education control group. We present a model for successfully using the Initiative on the Methods, Measurement, and Pain Assessment in Clinical Trials criteria for a comprehensive assessment of physical function and following evidence-based models to maximize feasibility before formal efficacy testing. TRIAL REGISTRATION: ClinicalTrial.gov NCT03412916; https://clinicaltrials.gov/ct2/show/NCT03412916.