“Spinal alignment” cushion in the management of low back pain – a randomized controlled study

Objectives: To assess the clinical effectiveness of using a spinal alignment cushion compared to standardized care in the management of simple mechanical LBP, whilst laying in the semi-fetal position. Methods: 71 individuals (aged between 18 and 50) with simple mechanical LBP for at least 3 months were recruited to the 4-week intervention after screening using the Red Flags and STarT Back tools. Participants were randomly assigned to either the control (standardized care) or intervention group (standardized care plus spinal alignment cushion). Pre and post assessments were taken using the Roland Morris Disability Questionnaire (RMDQ) (0-24), to assess physical disability associated with low back pain; the Core Outcomes Measure Index (COMI) (0-10), and Patient Reported Outcome Measures that included measures of sleep quality and comfort as well as back and muscle pain and stiffness. Questionnaires were completed online using SNAP survey. Each post assessment was analyzed using ANCOVA with corresponding pre-assessment as a covariate. Results: Clinically and statistically significant differences were seen in the RMDQ (p=0.034) and COMI scores (p=0.008) with the intervention group showing the greater improvement in scores over the four-week intervention. Significant differences were also seen in favor of the intervention group in the frequency (p=0.004) and intensity of back pain (p