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Pulsatile dry cupping in chronic low back pain -- a randomized three-armed controlled clinical trial
Teut M, Ullmann A, Ortiz M, Rotter G, Binting S, Cree M, Lotz F, Roll S, Brinkhaus B
BMC Complementary and Alternative Medicine 2018 Apr 2;18(115):Epub
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: No; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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 to 100 mm) after 4 weeks, secondary outcome parameter included VAS pain intensity after 12 weeks, back function as measured with the 'Funktionsfragebogen Hannover Rucken' (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 to 41.2) for pulsatile cupping, 40.4 (34.2 to 46.7) for minimal cupping and 56.1 (49.8 to 62.4) for control group, resulting in statistically significant differences between pulsatile cupping versus control (21.2 (12.2 to 30.1); p < 0.001) and minimal cupping versus control (15.7 (6.9 to 24.4); p = 0.001). After 12 weeks, mean adjusted VAS difference between pulsatile cupping versus control was 15.1 (3.1 to 27.1; p = 0.014), and between minimal cupping versus control 11.5 (-0.44 to 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 to -0.1); p = 0.045) compared to control for back function after 4 weeks, but not after 12 weeks (-5.4 (-11.7 to 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 to -2.0); p = 0.003; -6.1 (-9.9 to -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 versus control (7.3 (-0.4 to 15.0); p = 0.063); minimal cupping versus control (6.3 (-2.0 to 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. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov (identifier NCT02090686).

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