LBP is a common, costly, and suboptimally managed condition. It is also a prime candidate for studies that explore the effectiveness and cost-effectiveness, or lack thereof, of “integrative care models” that combine access to both conventional and complementary care options. The results of this prospective pilot randomized trial address the hypothesis that coordinated access to a trained multidisciplinary, outpatient team consisting of medical doctors, allied health care personnel, and licensed CAM providers may result in enhanced clinical outcomes for adults with persistent LBP when compared to usual care alone. The results suggest that (1) it is feasible to assemble and train a clinical team of conventional and licensed CAM providers within an academic teaching hospital; (2) treatments delivered by CAM professionals within this model as applied to patients with LBP are safe; and (3) access to an expanded multidisciplinary (i.e., integrative care) model may benefit patients with persistent LBP. However, confirmation of the findings of this pilot study in a fully powered trial needs to be established in order to consider possible implications for clinicians, economists, and self-insured corporations.
This pilot study has raised a number of issues that would need to be addressed in a full-scale trial designed to definitively evaluate these questions: (1) sufficient numbers of eligible patients with back pain would be required to ensure the comparability of the baseline characteristics between the treatment groups, as well as to provide adequate power to detect clinically meaningful treatment effects; (2) there was a high loss to follow-up in the UC group, and approaches to maximize follow-up rates such as offers of financial incentives for completion of all outcome measures, which should ideally be applied to both UC and IC groups, need to be considered; (3) blinding on the part of interviewers will be essential in any subsequent trial; and (4) in this pragmatic study, there was no a priori algorithm delineating specific referral patterns. No 2 patients received identical patterns (i.e., “fingerprints”) or “doses” of “integrative care.” Indeed, this may not be dissimilar from the need for individualized, nonidentical care for individuals with a variety of complex, chronic medical conditions such as cancer, diabetes, or depression. A full-scale trial would need to balance the need for a reproducible intervention model that does not overly constrain clinicians caring for LBP patients, and the need to explore treatment patterns for subgroups of LBP patients to determine whether optimal treatment algorithms can be developed and prospectively tested.
A major limitation in this study relates to the likely differences between study arms regarding patient contact and communication with clinical providers. It is possible that the observed differences between groups were the result of enhanced patient contact, interaction, education, and encouragement by the several members of the integrative care team participating in each patient's treatment, and that this enhanced contact, as opposed to increased use of CAM therapies, was the “active ingredient” leading to the observed differences. Indeed, the results of studies by Karjalainen et al.20,21
clearly indicated that added to usual care, a mini-intervention by a physician specializing in back pain and a physiotherapist involving a clinical examination, information, support, and simple advice reduced daily symptoms and absenteeism, and led to better treatment satisfaction and adaptation to pain, compared with UC for patients with subacute LBP.
In another study intended to evaluate “an integrative care program” to treat subjects with subacute LBP, Lambeek et al., in studies reported in 2007, 2009, and 201022,23,24
compared subjects (n
=40) half of whom were randomized to receive usual care and half to receive a model of “integrated care” that combined a “patient-directed and workplace-directed” intervention provided by a multidisciplinary team, including an occupational physician. The conclusions of the Lambeek et al. studies, like those of the Karjalainen et al. studies, included the observation that subjects treated by a multidisciplinary team experienced improved clinical outcomes as compared with “usual care.” Importantly, however, both the Karjalainen and Lambeek studies excluded licensed CAM professionals (e.g., chiropractors, massage therapists, and acupuncturists) from their respective multidisciplinary teams. Ultimately, the question of which combination of licensed health care professionals, including both CAM and conventional providers, should ideally be involved in optimally cost-effective, multidisciplinary approaches to treat persistent lower back pain will remain unanswered until a fully powered trial with a comparable attention control such as integrated conventional care only is included. Lambeek et al. estimated that a sample of approximately 150 subjects would be needed for a properly powered study to address this question.22
Finally, a future trial needs to track not only clinical and functional outcomes, but also relevant financial outcomes including costs of patient visits, diagnostic tests, surgical procedures, medications, absenteeism, work status, worker productivity, short- and long- term disability payments, and employee replacement costs.
Evaluating these questions is important for two reasons. The first relates to the enormous societal costs of LBP and the need for novel therapeutic strategies to contain or reduce health care expenditures. Luo et al. reported that on average, individuals with LBP incur health care expenditures about 60% higher than individuals without LBP, with incremental expenditures attributable to the management of LBP in the United States accounting for 2.5% of all health care expenditures in 1998.12
In a more recent analysis of the Medical Expenditure Panel Survey (n=22,258),31
investigators reported that total estimated expenditures among respondents with spine problems increased 65% from 1997 to 2005. However, age- and sex-adjusted measures of physical function, work limitations, social limitations, and mental health among LBP sufferers were all considerably worse in 2005 than in 1997.31
Even a modest but statistically and clinically significant difference in symptoms, functional status, productivity, and utilization of services among LBP patients would have a significant impact on overall health care costs in the United States and could translate into a savings of billions of dollars annually.
Second, while the popularity of CAM therapies by U.S. adults is no longer debated, the role of these therapies in future models of coordinated, evidence-based, preference driven, fiscally responsible health care remains unclear. The Institute of Medicine, in its report entitled “Complementary and Alternative Medicine in the United States,” includes the following recommendation regarding the need for additional studies to evaluate “integrative models” of care: “Studies show that patients frequently do not limit themselves to a single modality of care—they do not see complementary and alternative medicine (CAM) and conventional medicine as being mutually exclusive— and this pattern will probably continue and may even expand as evidence of therapies effectiveness accumulate. Therefore, it is important to understand how CAM and conventional medical treatments (and providers) interact with each other and to study models of how the two kinds of treatments can be provided in coordinated ways. In that spirit, there is an urgent need for health systems research that focuses on identifying the elements of these integrative medical models, their outcomes and whether they are cost effective when compared to conventional practice.”32