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
Previous research in people with musculoskeletal low back pain (MLBP) in primary care shows that a reliable and valid measure of consultation-based reassurance enables testing reassurance against patient' outcomes. Little is known about the role of reassurance in people with MLBP consulting spinal surgeons, especially in cases where surgeons recommend not to have surgery. There might be several reasons to exclude surgery as a treatment option, that range from positive messages about symptoms resolving to negative messages, suggesting that all reasonable avenue of treatment have been exhausted. AIM to explore patient's experience of consultation-based reassurance in people with MLBP who have been recently advised not to have surgery. Semi-structured interviews were conducted with 30 low back pain patients who had recently consulted for spinal surgery and were advised that surgery is not indicated. Interview were audio recorded and transcribed, and then coded using NVIVO qualitative software and analysed using the Framework Analysis.Background
Methods