Abstract
BackgroundWe 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.Methods110 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.ResultsThe 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).ConclusionsBoth 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.Trial registrationThe study was registered at ClinicalTrials.gov (identifier: NCT02090686).
Highlights
We aimed to investigate the effectiveness of two different forms of dry pulsatile cupping in patients with chronic low back pain compared to medication on demand only in a three-armed randomized trial
110 chronic low back pain (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)
The mean baseline-adjusted Visual Analogue Scale (VAS) after 4 weeks was 34.9 mm 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)
Summary
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. The Global Burden of Disease 2010 study showed that globally low back pain causes more disability than any other condition, the global point prevalence was 9.4% (95% CI 9.0 to 9.8) [5]. Pharmacological treatments alone do often not lead to sufficient clinical responses, and the use of non-steroidal anti-inflammatory drugs (NSAIDs, in particular) may lead to negative side effects such as gastrointestinal or renal complications. CLPB patients often use complementary and integrative medicine (CIM) therapies like acupuncture, manual therapy, or cupping, but the effectiveness of many CIM treatments is unclear
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