Specifically designed control interventions can account for expectation effects in clinical trials. For the interpretation of efficacy trials of physical, psychological, and self-management interventions for people living with pain, the design, conduct, and reporting of control interventions is crucial. To establish a quality standard in the field, core recommendations are presented alongside additional considerations and a reporting checklist for control interventions.Background
Objectives
The importance of interpreting clinical trial results in terms of the benefits a treatment may offer to individuals with chronic pain is becoming more widely recognized. The clinical meaningfulness of group differences can better be described by looking at the percentages of responders in each treatment group, rather than between group mean differences. We have reassessed the outcomes of a clinical trial for chronic low back pain (LBP) from this new perspective. The randomized clinical trial examined short- (12 weeks) and long-term (52 weeks) efficacy of high-dose, supervised trunk exercise (SET), spinal manipulative therapy (SMT), and a course of home exercise and self-care advice (HEA) for the treatment of LBP ≥ 6 weeks duration. We calculated response to care at 2 levels for 2 variables: numeric back pain scores (NRS) and Roland-Morris Disability (RMD), and at 3 timepoints (Weeks 12, 26 and 52). The 2 levels were calculated as percent improvement from baseline ≥ 30% and ≥75%. Finally, we calculated the relative proportion (± 95% confidence intervals) of the sample (∼100 per treatment group) that achieved each level of improvement.Purpose
Methods
