RESUMEN
OBJECTIVE: Chronic low back pain (cLBP) is the leading cause of disability. Interdisciplinary pain management is recommended for patients with severe/high-impact cLBP. Such programs are expensive, not easily accessible, and have limited effect; therefore, new cost-effective strategies are warranted. Cognitive functional therapy (CFT) has shown promising results but has not been compared with an interdisciplinary pain management approach. The primary aim of this randomized controlled trial is to investigate if a pathway starting with CFT including psychologist support (CFT+) with the option of additional usual care (if needed) is superior in improving disability and more cost-effective at 12 months compared with an interdisciplinary pain management pathway (usual care). METHODS: This pragmatic, 2-arm, parallel-group randomized controlled trial will randomly allocate patients (n = 176) aged 18 to 75 years referred to an interdisciplinary pain center due to severe cLBP to 1 of 2 groups (1:1 ratio). Participants randomized to CFT+ will participate in a 3-month functional rehabilitation pathway with the option of additional usual care (if needed), and participants randomized to the interdisciplinary pain management pathway will participate in an individualized program of longer duration designed to best suit the individual's situation, needs, and resources. The primary outcome is the proportion of participants with an 8-point improvement in the Oswestry Disability Index score at 12 months. Exploratory outcomes are change in Oswestry Disability Index scores over time and an economic analysis of quality-adjusted life years using the 3-level version of the EuroQol EQ-5D. IMPACT: The study evaluates the cost-effectiveness of CFT+ with the option of additional usual care (if needed) for individuals with severe cLBP. Findings can potentially improve future care pathways and reduce cost for the health care system.
Asunto(s)
Terapia Cognitivo-Conductual/métodos , Comunicación Interdisciplinaria , Dolor de la Región Lumbar/terapia , Manejo del Dolor/métodos , Adulto , Enfermedad Crónica , Terapia Combinada , Femenino , Humanos , Masculino , Persona de Mediana Edad , Grupo de Atención al Paciente/organización & administración , Modalidades de Fisioterapia/organización & administración , Ensayos Clínicos Controlados Aleatorios como Asunto , Proyectos de InvestigaciónRESUMEN
Objectives Depression symptomatology is highly prevalent in patients with chronic pain, but accurate identification of major depression may be challenged due to time constraints and diagnostic interviews are therefore not routinely performed in clinical practice. Assessment of depression may be facilitated through the use of full-length depression screening questionnaires with acceptable construct validity and test-retest reliability. However, as previously indicated screening questionnaires may overestimate depression in patients with chronic pain, possibly due to overlapping symptoms. However, the failure to screen for depression may raise a concern for missing relevant cases with depression. The objectives of this study were to (1) quantify the validity of the 9-items Patient-Health Questionnaire (PHQ9) and the Major Depression Inventory (MDI) compared with a diagnostic interview in patients with chronic pain seeking specialist pain treatment, and (2) assess the relative test-retest reliability of PHQ9 and MDI over two weeks. Methods Responses to the PHQ9 and MDI were compared with a Present-State-Examination (PSE) interview in 99 patients with chronic pain referred to interdisciplinary pain treatment. PHQ9 and MDI were completed twice over two weeks. Construct validity were assessed with the area under the curve (AUC) analysis, and performance characteristics derived from 2 × 2 contingency tables in which scores on the screening questionnaires were dichotomized and compared with the classification of clinical depression based on the diagnostic interview. Relative test-retest reliability was assessed with intraclass correlation coefficients (ICC). Results Based on the PSE interview, the prevalence of depression was 22.2%, and according to the PHQ9 and MDI questionnaires the prevalence was 26.3 and 34.3%, respectively. Compared with the diagnostic PSE, the PHQ9 and MDI questionnaires had areas under the curve of 0.83 and 0.88, respectively. Both questionnaires had high negative predictive values (PHQ9: cut-off of 11; MDI: cut-off of 26), but low positive predictive values for all possible scores. ICC values were excellent. Conclusions The PHQ9 and MDI questionnaires reliably identified chronic pain patients unlikely to have clinical depression, but showed limited validity identifying patients with clinical depression. These preliminary results may have clinical implications in depression screening in patients with chronic pain seeking specialist pain treatment. Clinicians in a specialty care pain clinic can use these screening questionnaires to identify patients without depression, but caution should be used when positive cases are identified by PHQ9 or MDI due to the risk of false positives.