A randomized controlled trial of treatment with intermittent negative pressure for intermittent claudication

Abstract

This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Lower Extremity Intermittent Negative Pressure for Intermittent Claudication. Follow-Up after 24 Weeks of Treatment

“…Several studies have suggested clinical effects of INP treatment on walking distance in patients with IC [9][10][11] . In a recently published randomized controlled trial from our research group 12 , we found a significant effect of INP treatment on PWD compared to sham treatment after 12 weeks. Further, a subgroup analysis showed a significant effect on both the PWD and the MWD compared to sham treatment for the patients with the most symptomatic disease (baseline PWD<200 m) 12 .…”

“…Post hoc tests revealed that PWD increased significantly from baseline to 12 weeks (mean 81 m; 95% CI [6,156]; p=0.032), but there was no significant change in PWD from 12…”

“…The present study was a follow-up after a randomized controlled trial investigating the clinical effects of INP treatment for one hour, twice daily for 12 weeks in 63 patients with IC (active treatment n=32, sham treatment n=31) 12 . After 12 weeks of treatment, patients in the active treatment group receiving -40 mmHg INP were offered to continue treatment for 12 additional weeks (24 weeks in total).…”

“…INP of -40 mmHg was applied in a pressure chamber sealed around the patient's lower leg in cycles of 10 s negative pressure and 7 s atmospheric pressure generated by a pumping device, as previously described 12 (Fig. 1).…”

“…Lower extremity intermittent negative pressure (INP) treatment increases blood flow, reduces leg symptoms and has been suggested as a treatment option for patients with PAD in several studies [6][7][8][9][10][11][12] . In a recent double-blind randomized sham-controlled trial from our research group, we found that treatment with lower extremity INP one hour twice daily for 12 weeks increased walking capacity in patients with IC compared to sham treatment 12 . However, the potential clinical effects of continued INP treatment beyond 12 weeks have not been elucidated.…”