Considerations of trial design and conduct in behavioral interventions for the management of chronic pain in adults

INTRODUCTION: A growing number and type of nonpharmacological approaches for the management of chronic pain have demonstrated at least modest evidence of efficacy, and for some, there is emerging evidence of their effectiveness in relatively large scale trials. Behavioral approaches are those that generally seek to promote adaptive behavioral change in the service of reducing pain and improving physical and emotional functioning and quality of life. Despite a substantial empirical literature supporting the clinical utility of these approaches, a large number of unanswered questions remain and clinical trials to answer some of these questions are needed. Although considerations for development and enactment of data-analytic plans are generally similar to those in pharmacological trials (eg, intent-to-treat, prespecifying outcomes and time points, and handling of missing data), there may be some important differences to consider when planning and conducting clinical trials examining these behavioral approaches. OBJECTIVES: The primary objective of this article is to describe some aspects of clinical trials for behavioral approaches for the management of chronic pain that requires special consideration. METHODS: Important topics discussed include: (1) intervention development, (2) research design considerations (adequate and appropriate control and comparison conditions), (3) appropriate outcomes, (4) recruitment and sampling biases and blinding, (5) intervention fidelity and adherence, and (6) demographic and cultural considerations. RESULTS AND CONCLUSIONS: A number of methodological recommendations are made in the service of encouraging the conduct of high-quality research comparable with that performed for pharmacological and other medical interventions.