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

Henrik Hoel; Erik Mulder Pettersen; Lars Øivind Høiseth; Iacob Mathiesen; Arne Seternes; Jonny Hisdal

doi:10.1016/j.jvs.2020.10.024

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

J Vasc Surg. 2021 May;73(5):1750-1758.e1. doi: 10.1016/j.jvs.2020.10.024. Epub 2020 Oct 22.

Authors

Henrik Hoel¹, Erik Mulder Pettersen², Lars Øivind Høiseth³, Iacob Mathiesen⁴, Arne Seternes⁵, Jonny Hisdal⁶

Affiliations

¹ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Vascular Surgery, Oslo University Hospital, Oslo, Norway; Otivio AS, Oslo, Norway. Electronic address: henrho@ous-hf.no.
² Department of Surgery, Sørlandet Hospital, Kristiansand, Norway; Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.
³ Department of Anesthesiology, Oslo University Hospital, Oslo, Norway.
⁴ Otivio AS, Oslo, Norway.
⁵ Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway; Section for Vascular Surgery, Department of Surgery, St. Olavs Hospital, Trondheim, Norway.
⁶ Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway; Department of Vascular Surgery, Oslo University Hospital, Oslo, Norway.

PMID: 33899743
DOI: 10.1016/j.jvs.2020.10.024

Abstract

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 mm Hg INP (treatment group) or -10 mm Hg 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], 11-89; P = .014). The PWD had increased by 68 m (P < .001) in the treatment group and 18 m (P = .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 = .139). The MWD had increased by 62 m (P = .006) in the treatment group and 20 m (P = .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, 2-83; P = .042; and estimated treatment effect, 62 m; 95% CI, 5-118; P = .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.

Keywords: Intermittent claudication; Intermittent negative pressure treatment; Peripheral artery disease.

Publication types

Multicenter Study
Randomized Controlled Trial

MeSH terms

Aged
Aged, 80 and over
Ankle Brachial Index
Double-Blind Method
Exercise Tolerance
Female
Humans
Intermittent Claudication / diagnosis
Intermittent Claudication / physiopathology
Intermittent Claudication / therapy*
Intermittent Pneumatic Compression Devices* / adverse effects
Lower Body Negative Pressure / adverse effects
Lower Body Negative Pressure / instrumentation*
Male
Middle Aged
Norway
Pain Measurement
Peripheral Arterial Disease / diagnosis
Peripheral Arterial Disease / physiopathology
Peripheral Arterial Disease / therapy*
Plethysmography
Prospective Studies
Quality of Life
Recovery of Function
Time Factors
Treatment Outcome
Walk Test
Walking