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A randomized controlled trial of treatment with intermittent negative pressure for intermittent claudication [with consumer summary]
Hoel H, Pettersen EM, Hoiseth LO, Mathiesen I, Seternes A, Hisdal J
Journal of Vascular Surgery 2021 May;73(5):1750-1758
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; 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*

OBJECTIVE: We investigated the effects of lower extremity intermittent negative pressure (INP) treatment for 1 hour two times daily for 12 weeks on the walking distance of patients with intermittent claudication (IC). METHODS: Patients with IC were randomized to treatment with -40 mmHg INP (treatment group) or -10 mmHg INP (sham control group). Pain-free walking distance (PWD) and maximal walking distance (MWD) on a treadmill, resting and postexercise ankle-brachial index, resting and postischemic blood flow (plethysmography), and quality of life (EQ-5D-5L and Vascuqol-6) were measured at baseline and after 12 weeks of treatment. RESULTS: A total of 72 patients were randomized, and 63 had data available for the intention-to-treat analyses. The between-group comparisons showed a significant change in the PWD, favoring the treatment group over the sham control group (estimated treatment effect 50 m; 95% confidence interval (CI) 11 to 89; p = 0.014). The PWD had increased by 68 m (p < 0.001) in the treatment group and 18 m (p = 0.064) in the sham control group. No significant difference was found in the change in the MWD between the two groups (estimated treatment effect 42 m; 95% CI -14 to 97; p = 0.139). The MWD had increased by 62 m (p = 0.006) in the treatment group and 20 m (p = 0.265) in the sham control group. For patients with a baseline PWD of < 200 m (n = 56), significant changes had occurred in both PWD and MWD between the two groups, favoring the treatment group (estimated treatment effect 42 m; 95% CI 2 to 83; p = 0.042; and estimated treatment effect 62 m; 95% CI 5 to 118; p = 0.032; respectively). Both overall and for the group of patients with a PWD < 200 m, no significant differences were found in the changes in the resting and postexercise ankle-brachial index, resting and postischemic blood flow, or quality of life parameters between the two groups. CONCLUSIONS: Treatment with -40 mm Hg INP increased the PWD compared with sham treatment in patients with IC. For the patients with a baseline PWD of < 200 m, an increase was found in both PWD and MWD compared with sham treatment.

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