Abstract
AimTo determine the feasibility of conducting a definitive randomised control trial (RCT) to answer the following questions: (1) Is early physiotherapy treatment acceptable and feasible for patients and direct healthcare providers? and (2) Is early physiotherapy intervention associated with better disability and psychosocial outcomes compared with the practice of routine MRIs?MethodsIn a feasibility RCT in Riyadh City from 01 March 2018 until 29 July 2018, chronic low back pain (CLBP) patients presenting to spine clinics were randomised to receive an MRI (intervention) plus physiotherapy rehabilitation or physiotherapy alone (control group). The acceptability of randomisation to the control group (non-MRI) was tested during the recruitment by qualitatively interviewing study participants and referring physicians. Moreover, interviews with study participants explored the broader social, political, economic, and environmental (context) aspects that may influence trial delivery and intervention implementation.ResultsThe 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.ConclusionA 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.