Pulsatile dry cupping in chronic low back pain - A randomized three-armed controlled clinical trial

Abstract

Background: We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain (cLBP) compared to medication on demand only in a three-armed randomized trial. Methods: 110 cLBP patients were randomized to regular pulsatile cupping with 8 treatments plus paracetamol on demand (n =37), minimal cupping with 8 treatments plus paracetamol on demand (n =36) or the control group with paracetamol on demand only (n=37). Primary outcome was the pain intensity on a visual analogue scale (VAS, 0-100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rücken' (FFbH-R) and health related quality of life questionnaire Short form 36 (SF-36) after 4 and 12 weeks. Results: The mean baseline-adjusted VAS after 4 weeks was 34.9 mm (95% CI: 28.7; 41.2) for pulsatile cupping, 40.4 (34.2; 46.7) for minimal cupping and 56.1 (49.8; 62.4) for control group, resulting in statistically significant differences between pulsatile cupping vs. control (21.2 (12.2; 30.1); p <0.001) and minimal cupping vs. control (15.7 (6.9; 24.4); p =0.001). After 12 weeks, mean adjusted VAS difference between pulsatile cupping vs. control was 15.1 ((3.1; 27.1); p =0.014), and between minimal cupping vs. control 11.5 ((-0.44; 23.4); p =0.059). Differences of VAS between pulsatile cupping and minimal cupping showed no significant differences after 4 or 12 weeks. Pulsatile cupping was also better (-5.8 (-11.5;-0.1); p =0.045) compared to control for back function after 4 weeks, but not after 12 weeks (-5.4 (-11.7;0.8); p =0.088), pulsatile cupping also showed better improvements on SF-36 physical component scale compared to control at 4 and 12 weeks (-5.6 (-9.3;-2.0); p =0.003; -6.1 (-9.9;-2.4); p =0.002). For back function and quality of life minimal cupping group was not statistically different to control after 4 and 12 weeks. Paracetamol intake did not differ between the groups (cupping vs. control (7.3 (-0.4;15.0); p =0.063); minimal cupping vs. control (6.3 (-2.0;14.5); p =0.133). Conclusions: Both forms of cupping were effective in cLBP without showing significant differences in direct comparison after four weeks, only pulsatile cupping showed effects compared to control after 12 weeks.