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PURPOSE/OBJECTIVE: Higher levels of resilience is associated with improved pain outcomes in chronic pain and other neurological populations, but the role of resilience in pain following spinal cord injury (SCI) remains unclear. This study examined resilience as a moderator in the relationship between perceived stress and both pain intensity and interference during acute rehabilitation for SCI. RESEARCH METHOD/DESIGN: Individuals admitted to inpatient rehabilitation acutely following SCI (N = 57) completed measures of perceived stress, resilience, pain intensity, and interference. The Johnson-Neyman procedure was used to examine significance of conditional relationships that emerged. RESULTS: Resilience was found to moderate the relationship between perceived stress and pain interference, but not pain intensity, during inpatient rehabilitation. CONCLUSIONS/IMPLICATIONS: When resilience is low, perceived stress has a more profound and adverse impact on pain interference during inpatient rehabilitation, suggesting therapeutic strategies that build components of resilience are needed during acute rehabilitation following SCI. The relationship between stress, resilience, and pain may differ postinpatient rehabilitation for SCI and warrants further investigation. (PsycInfo Database Record (c) 2024 APA, all rights reserved).
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Resiliência Psicológica , Traumatismos da Medula Espinal , Estresse Psicológico , Humanos , Traumatismos da Medula Espinal/reabilitação , Traumatismos da Medula Espinal/psicologia , Traumatismos da Medula Espinal/complicações , Feminino , Masculino , Estresse Psicológico/psicologia , Estresse Psicológico/complicações , Pessoa de Meia-Idade , Adulto , Medição da Dor , Idoso , Dor/psicologia , Dor/reabilitaçãoRESUMO
STUDY DESIGN: Expert opinion, feedback, revisions, and final consensus. OBJECTIVES: To update the International Spinal Cord Injury Pain Basic Data Set (ISCIPBDS version 2.0) and incorporate suggestions from the SCI pain clinical and research community with respect to overall utility. SETTING: International. METHODS: The ISCIPBDS working group evaluated these suggestions and made modifications. The revised ISCIPBDS (Version 3.0) was then reviewed by members of the International SCI Data Sets Committee, the American Spinal Injury Association (ASIA) Board, the International Spinal Cord Society (ISCoS) Executive and Scientific Committees, individual reviewers and societies, and posted on the ASIA and ISCoS websites for 1 month to elicit comments before final approval by ASIA and ISCoS. RESULTS: The ISCIPBDS (Version 3.0) was updated to make the dataset more flexible and useful: 1. The assessment can be based on the patient's perception of several of his/her "worst" pain(s) or based on the International SCI Pain (ISCIP) Classification-defined or other pain types, depending on the specific research questions or clinical needs. 2. Pain interference should usually be rated for overall pain but may also be used for specific pain problems if needed. 3. An optional pain drawing was added to complement the check box documentation of pain location. 4. Data categories consistent with the Extended Pain Dataset list of current treatments were added. 5. Several new training cases were added.
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Traumatismos da Medula Espinal , Humanos , Masculino , Feminino , Estados Unidos , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/epidemiologia , Traumatismos da Medula Espinal/terapia , Dor/diagnóstico , Dor/etiologia , Bases de Dados FactuaisRESUMO
Context: Little is understood about differences in resting neural activity among those with spinal cord injury (SCI)-related neuropathic pain. The purpose of this pilot study was to determine resting cerebral blood flow differences in persons with SCI-related neuropathic pain compared to healthy, pain-free able-bodied controls.Methods: Five persons with paraplegia and ten able-bodied participants were included in this study. Resting blood flow, as measured by a continuous arterial spin labeling (ASL) method of fMRI, was analyzed via statistical parametric mapping.Results: Persons with SCI-related neuropathic pain had significantly lower resting blood flow in the cerebellum (Crus I/II), rostral ventromedial medulla and left insular cortex. In contrast, greater resting blood flow occurred in the medial orbitofrontal cortex among those with SCI-related neuropathic pain compared to controls.Conclusion: Differences in resting blood flow were observed among those with SCI-related pain, particularly in regions that may be involved in affective-motivational and cognitive-evaluative aspects of pain. Larger ASL studies in addition to functional connectivity studies using fMRI are needed to clarify unique neural patterns in this complex and often intractable form of pain.
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Neuralgia , Traumatismos da Medula Espinal , Cerebelo/diagnóstico por imagem , Humanos , Neuralgia/etiologia , Projetos Piloto , Córtex Pré-Frontal/diagnóstico por imagem , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/diagnóstico por imagemRESUMO
PURPOSE: This study is an examination of the efficacy of a virtual walking protocol to treat spinal cord injury (SCI)-related pain. METHOD: A total of 59 individuals with SCI and neuropathic pain (NP) were randomly assigned to receive 20 min of virtual walking, the treatment condition, or virtual wheeling, the control condition. Although having NP was a requirement to participate in the study, participants also underwent pain classification of up to 3 worst pain sites to also examine the effects of virtual walking on nonneuropathic pain. Pain outcomes included changes in pain severity across all pain types, NP unpleasantness, and severity of various sensory qualities of NP. DESIGN: This was a randomized, controlled, single-blinded trial. RESULTS: There was no significant difference in change in pain between groups, though there was a significant pre- to posttreatment reduction across all pain types in the virtual walking condition, but not the control condition. Specific to NP, there was a significant reduction in pain unpleasantness, but not neuropathic pain intensity. NP experienced as "cold," "deep," and with increased skin sensitivity were significantly reduced following virtual walking compared with the control condition. CONCLUSION: Results from this trial suggest that virtual walking treatment may benefit certain aspects of NP, such as associated unpleasantness, as well as certain sensory qualities of that pain. Efficacy of this treatment modality to reduce overall pain severity remains unclear, and may be modulated by other injury, individual, or personality characteristics. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
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Neuralgia/etiologia , Neuralgia/reabilitação , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/reabilitação , Realidade Virtual , Caminhada , Adulto , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Método Simples-Cego , Adulto JovemRESUMO
BACKGROUND: Understanding factors associated with high placebo responses in clinical trials increases the likelihood of detecting a meaningful treatment effect. The aim of the present study was to identify subject-level factors that contribute to placebo variability in patients with neuropathic pain due to spinal cord injury (SCI). METHODS: Multiple regression analysis of patient data from randomized, double-blind, placebo-controlled trials (duration >4 weeks) involving individuals with SCI was performed. Patient demographics, as well as injury and pain characteristics were examined for their association with changes in pain rating from baseline to the end of the trial (i.e., placebo response). The overall effect of individual predictors was quantified with meta-analysis statistics. RESULTS: A total of 276 patients with SCI from six studies were included in the analysis. Based on the meta-analysis of subject-level predictors, larger placebo responses were associated with male subjects (ß=0.635; standard error [SE]=0.262; p=0.016) and higher baseline pain (ß=-0.146; SE=0.073; p=0.044). There were no significant effects for injury characteristics (i.e., severity, level, and time since injury) or pain characteristics (i.e., location and evoked). No significant publication bias was detected. CONCLUSION: The current meta-analysis of individual patient data demonstrated the importance of sex and baseline pain intensity on changes in pain ratings in the placebo arm of SCI central neuropathic pain randomized controlled clinical trials. Overall, our findings indicate that placebo responses occur independent of injury characteristics.
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INTRODUCTION: The objective of this study was to assess the feasibility of the use of functional magnetic resonance imaging (fMRI) to evaluate the spinal activation during sexual response of the thoracic, lumbar and sacral spinal cord. MATERIALS AND METHODS: This is a laboratory-based pilot study in human females at a University-based medical center in the United States. In three healthy spinal cord injury (SCI) females, spinal cord activations during sexual audiovisual stimulation (alone), genital self-stimulation (alone) and simultaneous audiovisual and genital self-stimulation (combined) were assessed and then compared with each subjects' remaining sensory and motor function. RESULTS: Spinal fMRI responses of the intermediolateral columns were found during audiovisual stimulation in both subjects with incomplete injuries, but they were not observed in the subject with a complete injury. Moreover, sacral responses to combined stimulation differed greatly between the subjects with complete and incomplete injuries. CONCLUSION: These results not only provide the first in vivo documentation of spinal fMRI responses associated with sexual arousal in women with SCIs, but also suggest that spinal cord fMRI is capable of distinguishing between injury subtypes. Therefore, although there are certain limitations associated with fMRI during sexual stimulation (for example, movement artifacts, an artificially controlled environment and so), these findings demonstrate the potential utility of incorporating spinal cord fMRI in future research to evaluate the impact of specific patterns of SCI on sexual responses and/or the effects of treatment.
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The Spinal Cord Injury Model Systems (SCIMS) centers have provided continuous, comprehensive multidisciplinary care for persons with spinal cord injury (SCI) in the United States since their inception in 1970. In addition, the research conducted and the analysis of data collected at these centers facilitate advances in the care and the overall quality of life for people with SCI. Over the past 45 years, the SCIMS program and National Spinal Cord Injury Database (NSCID) have undergone major revisions, which must be recognized in the planning, conduct, and interpretation of SCIMS research to prevent misinterpretation of findings. Therefore, we provide herein a brief review of the SCIMS program and the associated NSCID throughout its history, emphasizing changes and accomplishments within the past 15 years, to facilitate a better understanding and interpretation of the data presented in SCIMS research publications, including the articles published in this special issue of the Archives.
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Pesquisa Biomédica/organização & administração , Bases de Dados Factuais , Centros de Reabilitação/organização & administração , Traumatismos da Medula Espinal/reabilitação , Comportamento Cooperativo , Humanos , Equipe de Assistência ao Paciente/organização & administração , Vigilância da População/métodos , Avaliação de Programas e Projetos de Saúde , Qualidade de Vida , Fatores Socioeconômicos , Estados UnidosRESUMO
OBJECTIVE: To examine the association of neuropathic and nociceptive pain severity and interference with quality of life (QoL) in persons with spinal cord injury (SCI) who underwent a randomized controlled 12-week trial of an antidepressant to treat depression. A secondary objective was to assess the effect of changes in pain on mobility and physical independence. DESIGN: Multivariable ANCOVA models controlling for relevant demographic covariates, treatment condition, and baseline pain and QoL were used. SETTING: Six rehabilitation centers. PARTICIPANTS: Of the 133 persons who were randomized into the trial, 108 provided pain severity and interference ratings through follow-up. INTERVENTIONS: Not applicable. OUTCOME MEASURES: The Satisfaction with Life Scale and the physical and mental component summary scores of the 12-Item Short-Form Health Survey (SF-12). Secondary outcome measures included the mobility and physical independence subscales of the Craig Handicap Assessment and Reporting Technique (CHART). RESULTS: Broadly, few associations between pain and QoL were evident. Results revealed relationships between lower baseline nociceptive pain interference and higher satisfaction with life and mental health-related QoL at 12 weeks. Similarly, lower neuropathic pain interference was associated with change in physical independence, but unrelated to mobility. CONCLUSIONS: Pain interference over time may be differentially related to QoL outcomes based on the type of pain following SCI, but overall, there were no extensive relationships between pain and QoL in this sample of depressed persons with SCI.
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Depressão/diagnóstico , Neuralgia/epidemiologia , Dor Nociceptiva/epidemiologia , Qualidade de Vida , Traumatismos da Medula Espinal/diagnóstico , Atividades Cotidianas , Adolescente , Adulto , Antidepressivos/efeitos adversos , Antidepressivos/uso terapêutico , Depressão/complicações , Depressão/tratamento farmacológico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neuralgia/diagnóstico , Neuralgia/etiologia , Dor Nociceptiva/diagnóstico , Dor Nociceptiva/etiologia , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/reabilitaçãoRESUMO
Using functional magnetic resonance imaging, the authors aimed to determine the roles of the human spinal cord in mediating sexual responses in women. Functional magnetic resonance imaging of the entire lower thoracic, lumbar, and sacral spinal cord was performed using a sexual stimulation paradigm designed to elicit psychological and physical components of sexual arousal. Responses were measured in 9 healthy adult women during 3 consecutive conditions: (a) erotic audiovisual, (b) manual clitoral, and (c) audiovisual plus manual stimulation. Functional magnetic resonance imaging results in healthy subjects demonstrate that this method is sensitive for mapping sexual function in the spinal cord, and identify several key regions involved in human sexual response, including the intermediolateral cell column, the dorsal commissural nucleus, and the sacral parasympathetic nucleus. Using spinal functional magnetic resonance imaging, this study identified many of the spinal cord regions involved in female sexual responses. Results from audiovisual and manual clitoral stimulation correspond with previous data regarding lumbar and sacral neurologic changes during sexual arousal. This study provides the first characterization of neural activity in the human spinal cord underlying healthy female sexual responses and sets a foundation for future studies aimed at mapping changes that result from sexual dysfunction, spinal cord trauma or disease.
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OBJECTIVE: To determine unique associations of suicidal ideation (SI) and lifetime suicide attempts (SAs) in individuals with spinal cord injury (SCI). DESIGN: Cross-sectional analysis. SETTING: Outpatient. PARTICIPANTS: Individuals with SCI (N=2533) who were 18 years or older with a history of traumatic SCI. INTERVENTIONS: None. MAIN OUTCOME MEASURES: Any SI in the past 2 weeks (9-item Patient Health Questionnaire) and any lifetime SA. RESULTS: Three hundred twenty-three individuals (13.3%) reported SI in the past 2 weeks and 179 (7.4%) reported lifetime SA. After controlling for other factors, both lifetime SA and current SI were associated with study site and current level of depression. In addition, SA was associated with less education, younger age at injury, having current or past treatment of depression, and having bipolar disorder or schizophrenia. SI was associated with more years since injury and lifetime SA. Several psychological factors were associated with current SI and lifetime SAs, including lower environmental reward and less positive affect. In addition, control of one's community activities and spiritual well-being were associated with current SI. In bivariate comparisons, severity of SCI was also associated with the 47% of the SAs that occurred after injury. CONCLUSIONS: Several unique associations of SI and lifetime SA in individuals with SCI were identified, including level of environmental reward and control, spiritual well-being, and severity of SCI. These factors bear further investigation as prospective risk factors for suicidal behavior after SCI.
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Transtornos Mentais/epidemiologia , Traumatismos da Medula Espinal/epidemiologia , Ideação Suicida , Tentativa de Suicídio/estatística & dados numéricos , Adulto , Fatores Etários , Estudos Transversais , Meio Ambiente , Feminino , Inquéritos Epidemiológicos , Humanos , Masculino , Transtornos Mentais/psicologia , Pessoa de Meia-Idade , Estudos Prospectivos , Fatores de Risco , Participação Social , Fatores Socioeconômicos , Traumatismos da Medula Espinal/psicologia , Tentativa de Suicídio/psicologia , Índices de Gravidade do TraumaRESUMO
IMPORTANCE: Depression is prevalent and associated with negative outcomes in individuals with spinal cord injury (SCI). Antidepressants are used routinely to treat depression, yet no placebo-controlled trials have been published in this population to our knowledge. OBJECTIVE: To determine the efficacy and tolerability of venlafaxine hydrochloride extended-release (XR) for major depressive disorder (MDD) or dysthymic disorder in persons with chronic SCI. DESIGN, SETTING, AND PARTICIPANTS: Multisite, randomized (1:1), double-blind, placebo-controlled Project to Improve Symptoms and Mood After SCI (PRISMS) trial. All research staff conducting screening, intervention, and outcome procedures were blinded to randomization status. We screened 2536 patients from outpatient clinics at 6 SCI treatment centers in the United States and randomized 133 participants into the trial. Participants were 18 to 64 years old and at least 1 month after SCI, with MDD or dysthymic disorder. Seventy-four percent of participants were male, and participants were on average 40 years old and 11 years after SCI. Forty-seven percent had cervical injuries, 53.4% had American Spinal Injury Association injury severity A (complete injury) SCI, 24.1% had at least 2 prior MDD episodes, and 99.2% had current MDD. Common comorbidities included chronic pain (93.9%), significant anxiety (57.1%), and history of substance dependence (44.4%). INTERVENTIONS: Twelve-week trial of venlafaxine XR vs placebo using a flexible-dose algorithm. MAIN OUTCOMES AND MEASURES: The Hamilton Depression Rating Scale (HAM-D 17-item version and Maier subscale, which focuses on core depression symptoms and excludes somatic symptoms) over 12 weeks. RESULTS: Mixed-effects models revealed a significant difference between the venlafaxine XR and placebo groups in improvement on the Maier subscale from baseline to 12 weeks (treatment effect, 1.6; 95% CI, 0.3-2.9; P = .02) but not on the HAM-D 17-item version (treatment effect, 1.0; 95% CI, -1.4 to 3.4; P = .42). Participants receiving venlafaxine XR reported significantly less SCI-related disability on the Sheehan Disability Scale at 12 weeks compared with placebo (treatment effect, 4.7; 95% CI, 1.5-7.8; P = .005). Blurred vision was the only significantly more common new or worsening adverse effect in the venlafaxine XR group compared with the placebo group over 12 weeks. CONCLUSIONS AND RELEVANCE: Venlafaxine XR was well tolerated by most patients and an effective antidepressant for decreasing core symptoms of depression and improving SCI-related disability. Further research is needed to determine the optimal treatment and measurement approaches for depression in chronic SCI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00592384.
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Cicloexanóis/farmacologia , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Distímico/tratamento farmacológico , Inibidores Seletivos de Recaptação de Serotonina/farmacologia , Traumatismos da Medula Espinal/psicologia , Adolescente , Adulto , Doença Crônica , Cicloexanóis/administração & dosagem , Cicloexanóis/efeitos adversos , Preparações de Ação Retardada , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores Seletivos de Recaptação de Serotonina/administração & dosagem , Inibidores Seletivos de Recaptação de Serotonina/efeitos adversos , Traumatismos da Medula Espinal/tratamento farmacológico , Resultado do Tratamento , Cloridrato de Venlafaxina , Adulto JovemRESUMO
OBJECTIVES: To (1) determine the efficacy of venlafaxine XR for the treatment of pain (secondary aim) in individuals with spinal cord injury (SCI) enrolled in a randomized controlled trial (RCT) on the efficacy of venlafaxine XR for major depressive disorder (MDD) (primary aim); and (2) test the hypothesis that venlafaxine XR would be effective for both neuropathic and nociceptive pain. DESIGN: Multisite, double-blind, randomized (1:1) controlled trial with subjects block randomized and stratified by site, lifetime history of substance abuse, and prior history of MDD. SETTING: Six Departments of Physical Medicine and Rehabilitation in university-based medical schools. PARTICIPANTS: Individuals (N=123) with SCI and major depression between 18 and 64 years of age, at least 1 month post-SCI who also reported pain. INTERVENTION: Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: A 0-to-10 numeric rating scale for pain, pain interference items of the Brief Pain Inventory; 30% and 50% responders. RESULTS: The effect of venlafaxine XR on neuropathic pain was similar to that of placebo. However venlafaxine XR resulted in statistically significant and clinically meaningful reductions in nociceptive pain site intensity and interference even after controlling for anxiety, depression, and multiple pain sites within the same individual. For those who achieved a minimally effective dose of venlafaxine XR, some additional evidence of effectiveness was noted for those with mixed (both neuropathic and nociceptive) pain sites. CONCLUSIONS: Venlafaxine XR could complement current medications and procedures for treating pain after SCI and MDD that has nociceptive features. Its usefulness for treating central neuropathic pain is likely to be limited. Research is needed to replicate these findings and determine whether the antinociceptive effect of venlafaxine XR generalizes to persons with SCI pain without MDD.
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Cicloexanóis/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/epidemiologia , Dor/epidemiologia , Traumatismos da Medula Espinal/epidemiologia , Adolescente , Adulto , Cicloexanóis/administração & dosagem , Cicloexanóis/efeitos adversos , Preparações de Ação Retardada , Método Duplo-Cego , Feminino , Humanos , Masculino , Adesão à Medicação , Pessoa de Meia-Idade , Neuralgia/tratamento farmacológico , Neuralgia/epidemiologia , Dor Nociceptiva/tratamento farmacológico , Dor Nociceptiva/epidemiologia , Dor/tratamento farmacológico , Escalas de Graduação Psiquiátrica , Índices de Gravidade do Trauma , Cloridrato de Venlafaxina , Adulto JovemRESUMO
OBJECTIVE: Individuals who assume caregiving duties for a family member disabled in a traumatic injury often exhibit considerable distress, yet few studies have examined characteristics of those who may be resilient in the initial year of caregiving. Reasoning from the influential Pearlin model of caregiving (Pearlin & Aneshensel, 1994) and the resilience process model (Bonanno, 2005), we expected a significant minority of caregivers would be chronically distressed and another group would be resilient throughout the inaugural year of caregiving for a person with a traumatic spinal cord injury (SCI), and these groups would differ significantly in primary and secondary stress and in personal resources and mediators. METHOD: Twenty men and 108 women who identified as caregivers for a family member who incurred a traumatic SCI consented to complete measures during the inpatient rehabilitation and at 1 month, 6 months, and 12 months postdischarge. RESULTS: Latent growth mixture modeling of depression symptoms over time revealed 3 groups of caregivers: chronic (24%), recovery (24%) and resilient (48%). The chronic group reported more anxiety, negative affect, and ill health than the other 2 groups throughout the year. The resilient group was best characterized by their enduring levels of positive affect and supportive social networks. CONCLUSIONS: A large percentage of individuals are resilient in the initial year of caregiving, and those who have problems adapting exhibit significant distress soon following the traumatic event. Early detection of and psychological interventions for individuals who have difficulty adjusting are indicated, as their distress is unlikely to abate untreated over the year.
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Adaptação Psicológica , Ansiedade/etiologia , Cuidadores/psicologia , Depressão/etiologia , Negativismo , Resiliência Psicológica , Apoio Social , Traumatismos da Medula Espinal/enfermagem , Atividades Cotidianas , Adulto , Idoso , Doença Crônica , Conflito Familiar , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Autorrelato , Índice de Gravidade de Doença , Fatores de TempoRESUMO
OBJECTIVES: (1) To examine the mediating effects of depressive symptoms on the relations between employment, grief, depression treatment, and participation enfranchisement after spinal cord injury (SCI); and (2) to examine the moderating role of demographic and injury characteristics, including sex, race, marital status, education, and injury level, and completeness on these relations. DESIGN: Cross-sectional survey as part of the Project to Improve Symptoms and Mood after SCI (PRISMS). SETTING: Rehabilitation facilities. PARTICIPANTS: Persons with SCI (N=522; average age, 42 y; 76% men; 64% white; 64% completed at least a high school education) enrolled from 2007 to 2011. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Participation enfranchisement. RESULTS: The final model fit the data relatively well (comparative fix index=.939; Tucker-Lewis Index=.894; root mean square error of approximation=.066; 90% confidence interval, .043-.089), explaining 32% of the variance in participation enfranchisement. Enfranchisement was positively related to employment and negatively related to depression. Grieving the loss of a loved one and the use of an antidepressant or psychotherapy were related to participation enfranchisement; these relations were mediated by depressive symptoms. Multigroup analyses supported the model's invariance across sex, marital status, severity of injury, and level of injury. CONCLUSIONS: Depression appears to mediate the influence of employment, grief, and depression treatments on participation enfranchisement after SCI. These relations are applicable regardless of sex, marital status, and injury completeness and level. These findings highlight efforts to improve the detection and treatment of depression in SCI rehabilitation programs that may enhance participation.
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Transtorno Depressivo/epidemiologia , Pessoas com Deficiência/reabilitação , Emprego/estatística & dados numéricos , Perfil de Impacto da Doença , Traumatismos da Medula Espinal/reabilitação , Adulto , Idoso , Antidepressivos/uso terapêutico , Estudos Transversais , Transtorno Depressivo/diagnóstico , Transtorno Depressivo/tratamento farmacológico , Escolaridade , Feminino , Pesar , Humanos , Escala de Gravidade do Ferimento , Masculino , Estado Civil , Pessoa de Meia-Idade , Modelos Teóricos , Prognóstico , Psicometria , Centros de Reabilitação , Fatores Socioeconômicos , Traumatismos da Medula Espinal/diagnóstico , Traumatismos da Medula Espinal/epidemiologia , Adulto JovemRESUMO
CONTEXT/OBJECTIVE: We describe the rationale, design, methods, and lessons learned conducting a treatment trial for major depressive disorder (MDD) or dysthymia in people with spinal cord injury (SCI). DESIGN: A multi-site, double-blind, randomized (1:1) placebo controlled trial of venlafaxine XR for MDD or dysthymia. Subjects were block randomized and stratified by site, lifetime history of substance dependence, and prior history of MDD. SETTING: Six SCI centers throughout the United States. PARTICIPANTS: Across participating centers, 2536 subjects were screened and 133 were enrolled into the trial. Subjects were 18-64 years old and at least 1 month post-SCI. Interventions Twelve-week trial of venlafaxine XR versus placebo using a flexible titration schedule. OUTCOME MEASURES: The primary outcome was improvement in depression severity at 12 weeks. The secondary outcome was improvement in pain. RESULTS: This article includes study methods, modifications prompted by a formative review process, preliminary data on the study sample and lessons learned. We describe common methodological and operational challenges conducting multi-site trials and how we addressed them. Challenges included study organization and decision making, staff training, obtaining human subjects approval, standardization of measurement and treatment, data and safety monitoring, subject screening and recruitment, unblinding and continuity of care, database management, and data analysis. CONCLUSIONS: The methodological and operational challenges we faced and the lessons we learned may provide useful information for researchers who aim to conduct clinical trials, especially in the area of medical treatment of depression in people with SCI.
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Transtorno Depressivo Maior/tratamento farmacológico , Transtorno Depressivo Maior/etiologia , Dor/prevenção & controle , Traumatismos da Medula Espinal/complicações , Traumatismos da Medula Espinal/tratamento farmacológico , Cloridrato de Venlafaxina/administração & dosagem , Adolescente , Adulto , Antidepressivos de Segunda Geração/administração & dosagem , Transtorno Depressivo Maior/psicologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Avaliação de Resultados em Cuidados de Saúde/métodos , Dor/etiologia , Dor/psicologia , Projetos de Pesquisa , Traumatismos da Medula Espinal/psicologia , Resultado do Tratamento , Adulto JovemRESUMO
UNLABELLED: Smoking has been associated with increased pain severity in general chronic pain populations. Less is known about the effects of smoking and nicotine on the multifaceted and often complex subtypes of pain that frequently occur following spinal cord injury (SCI). The purpose of this study was to examine the effects of nicotine on self-reported pain among individuals with SCI and to determine if the effect of nicotine varied by pain subtype. A randomized, placebo-controlled crossover design was used to determine the effect of nicotine exposure on subtypes of SCI-related pain among smokers and nonsmokers. A complex relationship emerged, such that the degree of reported pain with exposure to 2 mg of nicotine compared to placebo varied according to pain type and smoking status of the subject. Pain sites that had characteristics of both neuropathic and musculoskeletal symptoms (deemed complex neuropathic pain sites) exhibited pain reduction after nicotine exposure in nonsmokers. In sharp contrast, smokers with this form of pain exhibited an increase in pain severity. Data were also examined descriptively to determine potentially unique factors associated with complex neuropathic pain that may explain trends associated with clinically relevant changes following nicotine exposure. In sum, smoking or tobacco use history may determine the analgesic (or enhanced pain perception) effect of nicotine on post-SCI pain. PERSPECTIVE: Pain characterized by both neuropathic and musculoskeletal symptoms decreased in severity after nicotine exposure in nonsmokers with SCI but increased in severity among smokers with SCI. The analgesic (or enhanced nociceptive) effect of nicotine may depend on tobacco use history.
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Nicotina/administração & dosagem , Nicotina/efeitos adversos , Dor/induzido quimicamente , Dor/tratamento farmacológico , Fumar , Traumatismos da Medula Espinal/tratamento farmacológico , Adulto , Estudos Cross-Over , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Dor/psicologia , Medição da Dor/métodos , Fumar/psicologia , Traumatismos da Medula Espinal/psicologia , Resultado do Tratamento , Adulto JovemRESUMO
The purpose of this study was to determine whether spinal cord functional magnetic resonance imaging could be used to map neural activity throughout the lower thoracic, lumbar, and sacral spinal cord regions during sexual arousal in healthy men. The authors found that viewing erotic films and genital self-stimulation elicited predominantly increased signal, indicative of amplified neuronal input to the dorsal and ventral horns and in the autonomic preganglionic nuclei of the lower thoracic, lumbar, and sacral spinal cord. In addition, linear regression analyses revealed a number of robust correlations (|R| ≥ 0.7) between signal intensity changes in these spinal cord regions and self-reported ratings of mental and physical sexual arousal. Taken together, these results demonstrate that spinal cord functional magnetic resonance imaging is an effective and sensitive technique for mapping the neural correlates of sexual arousal in the spinal cords of able-bodied men. Most important, the results from this study indicate that spinal cord functional magnetic resonance imaging may have important applications as a clinical tool for assessing and mapping the changes that occur in the spinal cords of men suffering from sexual dysfunction as a result of spinal cord trauma.
Assuntos
Nível de Alerta/fisiologia , Mapeamento Encefálico/métodos , Heterossexualidade/fisiologia , Estimulação Luminosa/métodos , Medula Espinal/fisiologia , Adulto , Humanos , Modelos Lineares , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Fenômenos Fisiológicos do Sistema Nervoso , Neurônios , Valores de ReferênciaRESUMO
OBJECTIVE: To identify modifiable risk factors for depression in people with spinal cord injury (SCI). DESIGN: Cross-sectional survey. SETTING: Outpatient and community settings. PARTICIPANTS: Community-residing people with SCI (N=244; 77% men, 61% white; mean age, 43.1y; 43% with tetraplegia) who were at least 1 month postinjury. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Depression severity (Patient Health Questionnaire-9 [PHQ-9]), physical activity (International Physical Activity Questionnaire [IPAQ]), pleasant and rewarding activities (Environment Rewards Observation Scale [EROS]), and self-efficacy to manage the effects of SCI (Modified Lorig Chronic Disease Self-Management Scale). RESULTS: Greater depression severity was associated with being 20 to 29 years of age, not completing high school, not working or attending school, and being ≤4 years post-SCI. After controlling for demographic and injury characteristics (adjusted R(2)=.13), lower EROS scores (change in adjusted R(2)=.34) and lower self-efficacy (change in R(2)=.13) were independent predictors of higher PHQ-9 scores. Contrary to predictions, physical activity as measured by the IPAQ did not predict depression severity. CONCLUSIONS: Our findings suggest that having fewer rewarding activities, and to a lesser extent, having less confidence in one's ability to manage the effects of SCI are independent predictors of greater depression severity after SCI. Interventions such as behavior activation, designed to increase rewarding activities, may represent an especially promising approach to treating depression in this population.