RESUMEN
Importance: Low back and neck pain are often self-limited, but health care spending remains high. Objective: To evaluate the effects of 2 interventions that emphasize noninvasive care for spine pain. Design, Setting, and Participants: Pragmatic, cluster, randomized clinical trial conducted at 33 centers in the US that enrolled 2971 participants with neck or back pain of 3 months' duration or less (enrollment, June 2017 to March 2020; final follow-up, March 2021). Interventions: Participants were randomized at the clinic-level to (1) usual care (n = 992); (2) a risk-stratified, multidisciplinary intervention (the identify, coordinate, and enhance [ICE] care model that combines physical therapy, health coach counseling, and consultation from a specialist in pain medicine or rehabilitation) (n = 829); or (3) individualized postural therapy (IPT), a postural therapy approach that combines physical therapy with building self-efficacy and self-management (n = 1150). Main Outcomes and Measures: The primary outcomes were change in Oswestry Disability Index (ODI) score at 3 months (range, 0 [best] to 100 [worst]; minimal clinically important difference, 6) and spine-related health care spending at 1 year. A 2-sided significance threshold of .025 was used to define statistical significance. Results: Among 2971 participants randomized (mean age, 51.7 years; 1792 women [60.3%]), 2733 (92%) finished the trial. Between baseline and 3-month follow-up, mean ODI scores changed from 31.2 to 15.4 for ICE, from 29.3 to 15.4 for IPT, and from 28.9 to 19.5 for usual care. At 3-month follow-up, absolute differences compared with usual care were -5.8 (95% CI, -7.7 to -3.9; P < .001) for ICE and -4.3 (95% CI, -5.9 to -2.6; P < .001) for IPT. Mean 12-month spending was $1448, $2528, and $1587 in the ICE, IPT, and usual care groups, respectively. Differences in spending compared with usual care were -$139 (risk ratio, 0.93 [95% CI, 0.87 to 0.997]; P = .04) for ICE and $941 (risk ratio, 1.40 [95% CI, 1.35 to 1.45]; P < .001) for IPT. Conclusions and Relevance: Among patients with acute or subacute spine pain, a multidisciplinary biopsychosocial intervention or an individualized postural therapy intervention, each compared with usual care, resulted in small but statistically significant reductions in pain-related disability at 3 months. However, compared with usual care, the biopsychosocial intervention resulted in no significant difference in spine-related health care spending and the postural therapy intervention resulted in significantly greater spine-related health care spending at 1 year. Trial Registration: ClinicalTrials.gov Identifier: NCT03083886.
Asunto(s)
Dolor Musculoesquelético , Enfermedades de la Columna Vertebral , Femenino , Humanos , Persona de Mediana Edad , Terapia Combinada , Gastos en Salud , Dolor Musculoesquelético/economía , Dolor Musculoesquelético/psicología , Dolor Musculoesquelético/terapia , Automanejo , Columna Vertebral , Enfermedades de la Columna Vertebral/economía , Enfermedades de la Columna Vertebral/psicología , Enfermedades de la Columna Vertebral/terapia , Masculino , Modalidades de Fisioterapia , Consejo , Manejo del Dolor/economía , Manejo del Dolor/métodos , Derivación y ConsultaRESUMEN
BACKGROUND: Low back and neck pain (together, spine pain) are among the leading causes of medical visits, lost productivity, and disability. For most people, episodes of spine pain are self-limited; nevertheless, healthcare spending for this condition is extremely high. Focusing care on individuals at high-risk of progressing from acute to chronic pain may improve efficiency. Alternatively, postural therapies, which are frequently used by patients, may prevent the overuse of high-cost interventions while delivering equivalent outcomes. METHODS: The SPINE CARE (Spine Pain Intervention to Enhance Care Quality And Reduce Expenditure) trial is a cluster-randomized multi-center pragmatic clinical trial designed to evaluate the clinical effectiveness and healthcare utilization of two interventions for primary care patients with acute and subacute spine pain. The study was conducted at 33 primary care clinics in geographically distinct regions of the United States. Individuals ≥18 years presenting to primary care with neck and/or back pain of ≤3 months' duration were randomized at the clinic-level to 1) usual care, 2) a risk-stratified, multidisciplinary approach called the Identify, Coordinate, and Enhance (ICE) care model, or 3) Individualized Postural Therapy (IPT), a standardized postural therapy method of care. The trial's two primary outcomes are change in function at 3 months and spine-related spending at one year. 2971 individuals were enrolled between June 2017 and March 2020. Follow-up was completed on March 31, 2021. DISCUSSION: The SPINE CARE trial will determine the impact on clinical outcomes and healthcare costs of two interventions for patients with spine pain presenting to primary care. TRIAL REGISTRATION NUMBER: NCT03083886.