Feasibility Study and Process Evaluation of MRI Plus Physiotherapy vs. Physiotherapy alone in Non-Specific Chronic Low Back Pain Among Patients in Saudi Arabia
Abstract Aim To determine the feasibility of conducting a definitive randomized control trial (RCT) to answer the question of whether an MRI diagnosis can negatively influence psychosocial and disability outcomes in patients with chronic low back pain (CLBP) treated by physiotherapy in Saudi Arabia.Methods In a feasibility RCT in Riyadh City from 01/03/2018 until 29/07/2018, CLBP patients presenting to spine clinics were randomized to receive an MRI (intervention) plus physiotherapy rehabilitation or physiotherapy alone (control group). The acceptability of randomization to the control group (non-MRI) was tested during the recruitment by qualitatively interviewing study participants and referring physicians. Moreover, interviews with study participants exploring the broader social, political, economic, and environmental (context) aspects that may influence trial delivery and intervention implementation.Results The recruitment target was not met: 16/24 (66%) participants were recruited in 4 months (12.4% of those screened); 33% declined. The process evaluation identified numerous factors that may affect the success of a definitive RCT in Saudi Arabia. These were research resources, the lack of research infrastructure to support recruitment to trials; limited research capacity in terms of knowledge and skills of the healthcare team; and limited funding. Conclusion A definitive RCT to test the influence of MRI diagnosis on the psychosocial and disability outcomes in people with CLBP treated with physiotherapy in Saudi Arabia is feasible. However, the lack of research infrastructure, research capacity, the impact of MRI on patient outcomes, and a lack of clinical equipoise in the treatment and management of CLBP in Saudi Arabia pose major barriers to clinical trials.