Ginsberg JS, Magier D, Mackinnon B, Gent M, Hirsh J.
Intermittent compression units for severe post-phlebitic syndrome: a randomized
crossover study.
CMAJ. 1999 May 4;160(9):1303-6

Department of Medicine, McMaster University, Hamilton, Ont.
ginsbrgj@fhs.csu.mcmaster.ca

BACKGROUND: Although uncommon, severe post-phlebitic syndrome may be associated
with persistent, intractable pain and swelling that interfere with work and
leisure activities. This study was performed to determine whether intermittent
compression therapy with an extremity pump benefits patients with this condition
and, if so, whether the benefit is sustained. METHODS: The study was a randomized
crossover trial. Over the period 1990 to 1996, all patients in the clinical
thromboembolism program of an Ontario teaching hospital who had a history of deep
vein thrombosis and intractable symptoms of post-phlebitic syndrome were
recruited into the study. The study involved using an extremity pump twice daily
for a total of 2 months (20 minutes per session). The patients were randomly
assigned to use either a therapeutic pressure (50 mm Hg) or a placebo pressure
(15 mm Hg) for the first month. For the second month, the patients used the other
pressure. A questionnaire assessing symptoms and functional status served as the
primary outcome measure and was administered at the end of each 1-month period. A
symptom score was derived by summing the scores for individual questions. At the
end of the 2-month study, patients were asked to indicate their treatment
preference and to rate the importance of the difference between the 12 pressures.
Treatment was considered successful if the patient preferred the therapeutic
pressure and stated that he or she would continue using the extremity pump and
that the difference between the therapeutic and placebo pressures was of at least
slight importance. All other combinations of responses were considered to
represent treatment failure. Patients whose treatment was classified as
successful were offered the opportunity to keep the pump and to alter pressure,
frequency and duration of pump use to optimize symptom management. In July 1996
the authors contacted all study participants whose treatment had been classified
as successful to determine whether they were still using the pump and, if so,
whether they were still deriving benefit. RESULTS: In total 15 consecutive
patients (12 women and 3 men) were enrolled in the study. The symptom scores were
significantly better with the therapeutic pressure (mean 16.5) than with the
placebo pressure (mean 14.4) (paired t-test, p = 0.007). The treatment for 12 of
the patients (80%, 95% confidence interval 52% to 96%) was considered successful.
Of these, 9 patients continued to use the pump beyond the crossover study and to
derive benefit. INTERPRETATION: The authors conclude that a trial of pump therapy
is worthwhile for patients with severe post-phlebitic syndrome and that a
sustained beneficial response can be expected in most such patients.