Effects of a back-care bundle for reducing back pain among patients undergoing transfemoral artery coronary angiography: A randomized controlled trial

Objective: This study aimed to evaluate the effects of a back-care bundle on back pain in patients undergoing transfemoral coronary angiography (TFA). Methodology: This randomized controlled trial was conducted between March and June 2020. Thirty-four patients undergoing TFA were randomly assigned to either the back-care bundle or comparison group. The back pain score was measured using a visual analogue scale at baseline and at 2, 3, 4, and 6 h after TFA. Haemorrhage and subcutaneous thrombosis were assessed using a soft measuring tape immediately after TFA, hourly until the 6th hour, or after participants changed their positions. Generalised linear estimating equation models were used to estimate the effects of the interventions on back pain scores. Results: The back pain scores in the intervention group decreased significantly over time (mean difference: −0.15; 95 % confidence interval [CI] -0.23 to −0.07; p-value <0.001), while the back pain scores in the comparison group increased significantly over time (mean difference: 1.30; 95 % CI 1.15 to 1.44; p-value <0.001). Overall, the mean difference of back pain scores between the two groups was −2.98 (95 % CI -3.32 to −2.64; p-value <0.001). Haemorrhage and subcutaneous thrombosis were not detected in either group of patients. Conclusion and recommendations: The back-care bundle effectively alleviated back pain in individuals undergoing TFA, with varying levels of bleeding risk. However, the effects of the back-care bundle on vascular complications remain unclear. For patients who do not have prolonged bleeding time, the duration of bed rest and the placement of a sand cushion on the puncture site can be reduced. Future trials are needed to develop and examine the effect of interventions in reducing back pain in patients with extended bleeding time.