Use the Back button in your browser to see the other results of your search or to select another record.

Detailed Search Results

Randomized controlled trial of vacuum therapy for intermittent claudication [with consumer summary]
Hageman D, Fokkenrood HJP, van Deursen BAC, Gommans LNM, Cancrinus E, Scheltinga MRM, Teijink JAW
Journal of Vascular Surgery 2020 May;71(5):1692-1701
clinical trial
8/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; 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: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program. METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life. RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control n = 34; intervention n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205 to 756) meters in control patients and +250 (77 to 466) meters in intervention patients (p = 0.109), whereas functional treadmill walking distance increased +230 (135 to 480) meters and +188 (83 to 389) meters (p = 0.233), respectively. Mean +/- standard deviation change in the 6-minute walk test was +36 +/- 48 meters and +55 +/- 63 meters (p = 0.823), respectively. Ambulatory ability and quality of life improved equally in both groups. CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program.

Full text (sometimes free) may be available at these link(s):      help